Nutrition / Supplements

Meta Labs Pharmaceuticals, LLC

FDA issued a warning letter to Meta Labs Pharmaceuticals, LLC (Roswell, GA) following a December 2025 facility inspection and April 2026 website review, finding that six products — Diabetic Advantage, Yacon Root Extract, Nattokinase Max, Viral Immune Booster, Arthritis Bursitis Rheumatism, and Respiratory Response — bore disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. The products were also found misbranded for lacking adequate directions for use, and two products (Diabetic Advantage and Respiratory Response) were adulterated due to serious CGMP violations including absent finished-product specifications, missing component identity testing, and incomplete master manufacturing and batch production records. FDA demanded a written corrective-action response within 15 working days and warned that failure to comply may result in seizure or injunction.

Foshan Miwei Cosmetics Co., Ltd.

FDA issued a warning letter to Foshan Miwei Cosmetics Co., Ltd. (China) for manufacturing OTC sunscreen drug products — Trust MD SPF 30 Stem Cell Face Cream and inBlair Elevate SPF 15 Moisturizer — that are unapproved new drugs and misbranded under the FD&C Act, in addition to multiple CGMP violations. The products' labeling made pharmacological claims for ingredients such as plant-based stem cells, sodium hyaluronate, vitamins B/C, and vitamin B3 (e.g., collagen promotion, cell repair, reducing hyperpigmentation/inflammation) that rendered them unapproved drugs not conforming to the OTC sunscreen monograph M020. FDA had already placed the firm on Import Alert 66-40 as of February 13, 2026, and the letter demands corrective action within 15 working days or continued refusal of admission of the firm's products into the United States.

TruHeight (Vanilla Chip LLC)

Nevada-based Vanilla Chip LLC (d/b/a TruHeight) and its two principals, Eden Stelmach and Justin Rapoport, agreed to settle FTC charges that they deceptively marketed supplements as supporting height growth in children and teenagers without adequate substantiation. The FTC also charged the company with relying on fake or incentivized reviews — written by employees or consumers offered free products or discounts in exchange for 5-star ratings — to bolster product credibility. The matter resulted in a consent order requiring corrective action.

Nature’s Elements, Inc.

FDA issued a warning letter to Nature's Elements, Inc. (Bohemia, NY) following an October 2025 facility inspection and website review, finding that five dietary supplement products — He Shou Wu, Advanced He Shou Wu, Schizandra Berry extract, DHT Blocker, and Cordyceps — bore disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The DHT Blocker and Schizandra Berry extract were additionally cited as misbranded drugs for lacking adequate directions for use. Multiple products were also found adulterated due to serious CGMP violations including absent product specifications, missing master manufacturing records, and no batch production records. FDA warned that failure to correct these violations may result in seizure or injunction.

Nupack Inc.

FDA issued a warning letter to Nupack Inc. (Elgin, IL) following a facility inspection and website review, finding that six dietary supplement products — Cardiag, Diabetech, Cleanse-CAMP, MACA, Kidney Cleanse, and Pure Psyllium Husk — bore disease-treatment and prevention claims that rendered them unapproved new drugs under the Act. Three products (Cardiag, Diabetech, MACA) were also deemed misbranded drugs for lacking adequate directions for use. Additionally, Cardiag, Cleanse-CAMP, and MACA 1000 mg were found adulterated due to serious CGMP violations including absent product specifications, master manufacturing records, and batch production records. FDA warned that failure to correct these violations may result in seizure and injunction.

Diamond-Herpanacine of PA, Inc.

FDA issued a warning letter to Diamond-Herpanacine of PA, Inc. (President Leslie A. Diamond) on January 22, 2026, after reviewing the company's website and Facebook page in September 2025. The agency determined that marketing claims for two dietary supplements — Diamond Eye Health and Herpanacine Skin Support — characterized the products as intended to cure, mitigate, treat, or prevent diseases (including macular degeneration, herpes, eczema, and bacterial/viral skin conditions), rendering them unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Supersmart USA, LLC

FDA issued a warning letter to Supersmart USA, LLC (Miami, FL) in January 2026 after reviewing their website and finding that eleven dietary supplement products — including Berberine, Aminoguanidine HCL, Glucofit, Super DHA, Celadrin, and others — bore disease-treatment and drug-effect claims that caused them to be regulated as unapproved new drugs under the FD&C Act. The claims covered blood sugar regulation, anti-inflammatory effects, cardiovascular disease prevention, joint pain relief, and treatment of depression, among others. Super DHA was additionally cited as a misbranded drug for lacking adequate directions for use for conditions requiring licensed-practitioner supervision. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Golden Sunrise Nutraceutical, Inc.

The FTC filed a federal court complaint in July 2020 against Golden Sunrise Nutraceutical, Inc., its affiliated corporation, and two executives (CEO Huu Tieu and Medical Director Stephen Meis) for marketing fraudulent 'plans of care' priced between $23,000 and $200,000 that falsely claimed to treat or cure COVID-19, cancer, Parkinson's disease, and other serious conditions. A proposed order barring the defendants from making bogus health claims was announced in June 2021. The FTC subsequently established a consumer refund process in January 2024 and began distributing refund checks to defrauded consumers in February 2026.

Center For Immunology Science, LLC

FDA issued a warning letter to Center For Immunology Science, LLC (CEO Bruce S. Gillis, M.D.) following an inspection revealing that the company conducted a clinical investigation of heat-killed Mycobacteria smegmatis on 200 human subjects without submitting a required Investigational New Drug (IND) application, in violation of 21 CFR 312. The company had marketed the substance as a dietary supplement/biotic to boost immune system and microbiome health, but FDA determined the investigation's intent was to treat or mitigate immune-deficiency diseases, qualifying it as a drug under the FD&C Act. The company's response claiming IND exemption under DSHEA was deemed inadequate because it lacked a corrective and preventive action plan. FDA warned that failure to adequately address the violations may lead to further regulatory action.

CC Pollen Company

FDA issued a warning letter to CC Pollen Company (Glendale, AZ) following an April 2025 inspection of its dietary supplement manufacturing facility. The agency found multiple serious CGMP violations related to its Bee Pollen Granules and Royal Jelly capsules, including failure to establish finished product specifications, failure to reject out-of-spec components, missing master manufacturing records, and inadequate identity testing of dietary ingredients. The products were also deemed misbranded due to an incorrect serving size declaration on the Royal Jelly capsules label. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Prodrome Sciences USA, LLC

FDA issued a warning letter to Prodrome Sciences USA, LLC (CEO Dayan B. Goodenowe, Ph.D.) following an inspection that found the company conducted a clinical investigation of ProdromeNeuro™ Oil on 29 human subjects with mild to moderate dementia without submitting a required Investigational New Drug (IND) application, in violation of 21 CFR 312. The company claimed the product was a dietary supplement exempt from IND requirements, but FDA determined the study design — including neurocognitive outcome assessments and enrollment of dementia patients — established the product was being investigated as a drug. FDA found the company's corrective action plan inadequate because it lacked sufficient detail on how future IND compliance would be ensured, and warned that failure to adequately address the deficiencies may lead to further regulatory action.

LXR Biotech, LLC

FDA issued a warning letter to LXR Biotech, LLC (Rochester Hills, MI) following a February–March 2025 facility inspection, citing serious Current Good Manufacturing Practice (CGMP) violations related to their dietary supplement products Eternal Energy Grape and Eternal Energy Tropical Punch. The violations include failure to establish complete finished product specifications, failure to establish identity specifications for components, and use of testing methods that are not scientifically valid to confirm ingredient identity. FDA found the products adulterated under 21 U.S.C. 342(g)(1) and warned that failure to correct these violations may result in seizure or injunction.

Agebox Inc.

FDA issued a warning letter to Agebox Inc. (Wang Zheng) regarding its 'iKids-Growth IGF-1 Support Day Formula' and 'iKids-Growth IGF-1 Support Night Formula' products, which were found through laboratory analysis to contain the undeclared and unapproved ingredient ibutamoren mesylate (MK-677), a growth hormone secretagogue. The products were marketed as dietary supplements for children's height growth but are classified as unapproved new drugs because ibutamoren is excluded from the dietary supplement definition and lacks FDA approval. The products are also misbranded because their labels fail to disclose the presence of ibutamoren mesylate, which can cause serious side effects. FDA warned that failure to correct violations may result in seizure and injunction.

Mahita LLC dba PushMyCart

FDA issued a warning letter to Mahita LLC dba PushMyCart (Richmond, TX), an online retailer selling homeopathic and Ayurvedic products, after reviewing its website and Facebook account in September 2025. The agency found eleven products — including homeopathic dilutions and herbal formulations — marketed with claims to cure, treat, or prevent serious conditions such as measles, hepatitis, diabetes, Parkinson's disease, cancer, and glaucoma, without FDA-approved applications. FDA determined these products are unapproved new drugs under sections 301(d) and 505(a) of the FD&C Act, and warned that failure to correct violations could result in seizure or injunction.

Handelnine Global, LLC dba Navafresh

FDA issued a warning letter to Handelnine Global, LLC dba Navafresh (South Plainfield, NJ) after reviewing its website in September 2025 and finding ten products — including Ayurvedic, homeopathic, and herbal preparations — marketed as unapproved new drugs for serious conditions such as cancer, diabetes, measles, Parkinson's disease, and arthritis. Laboratory testing of 'Rheumacare Capsules' revealed lead contamination at approximately 7,000 times the permitted daily exposure limit, plus preliminary findings of mercury, strychnine, brucine, and arsenic, rendering the product adulterated and misbranded. FDA cited violations of FD&C Act sections 301(a), 301(d), 502, and 505(a) and warned that failure to respond may result in seizure or injunction. The company was directed to notify FDA in writing within fifteen working days of corrective steps taken.

Swift Digital Group LLC dba Swadesii

FDA issued a warning letter to Swift Digital Group LLC dba Swadesii (Raleigh, NC) in November 2025 after reviewing their website and finding ten products — including Ayurvedic, homeopathic, and herbal preparations — marketed with claims to treat, cure, or prevent serious conditions such as measles, cancer, diabetes, stroke, Alzheimer's, and hepatitis. These products are classified as unapproved new drugs under section 505(a) of the FD&C Act because no FDA-approved applications are in effect for them, and their sale in interstate commerce violates sections 301(d) and 505(a). FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Distacart Inc.

FDA issued a warning letter to Distacart Inc. (Mountain View, CA) after reviewing its website in September 2025 and finding nine products — including homeopathic, Ayurvedic, and ophthalmic preparations — marketed as treatments for serious conditions such as malaria, depression, asthma, measles, and various eye diseases without FDA approval. The products are classified as unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective for the claimed uses. FDA expressed particular concern that consumers may forgo proven medical treatments and that ophthalmic products bypass natural bodily defenses. Distacart was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.

VarunKart Group LLC dba Organic Wellnesses

FDA issued a warning letter to VarunKart Group LLC dba Organic Wellnesses (Albuquerque, NM) after reviewing its website in September 2025 and finding nine products — including homeopathic drops, Ayurvedic preparations, herbal supplements, and ophthalmic eye drops — marketed with claims to cure or treat serious conditions such as measles, cancer, diabetes, tuberculosis, syphilis, HIV, and hepatitis. All nine products are classified as unapproved new drugs under FD&C Act section 505(a) because no FDA-approved applications are in effect for them, and their sale in interstate commerce violates sections 301(d) and 505(a). FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Time Challenger Labs International, Inc.

FDA issued a warning letter to Time Challenger Labs International, Inc. (Round Rock, TX) following a December 2024 facility inspection and May 2025 website review, finding that five herbal tincture products — Adrenal Boost, Chaga, Brain & Vein, Thyroid Support, and UTI — were marketed with disease treatment and drug-effect claims that rendered them unapproved new drugs under the FD&C Act. The company also committed multiple repeat CGMP violations (no product specifications, no master manufacturing records, no batch production records, no quality control procedures) causing its dietary supplements to be adulterated. Additionally, its Resveratrol product label was misbranded for failing to identify the product as a dietary supplement and omitting plant-part sourcing information. FDA warned that failure to correct these violations may result in seizure or injunction.

Stellalife, Inc.

FDA issued a warning letter to Stellalife, Inc. (Northbrook, IL) on September 16, 2025, after reviewing the company's website and social media accounts and finding that five homeopathic oral care products — including the VEGA Oral Care Recovery Kit, gels, and rinses — were being marketed as unapproved new drugs. The products' labeling and online claims described intended uses to treat, mitigate, or cure disease conditions (e.g., mucositis, periodontal disease, post-surgical wound healing, xerostomia from radiation therapy) without an approved FDA application, violating sections 505(a) and 301(d) of the FD&C Act. FDA also flagged heightened public health concern because the products target vulnerable populations including children and post-surgical patients, and because prior lots were recalled for microbial contamination. The agency demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure or injunction.

Eniva USA, Inc.

FDA issued a warning letter to Eniva USA, Inc. (Plymouth, MN) following a November 2024–January 2025 facility inspection, citing serious CGMP violations under 21 CFR Part 111 for its Immune Support (formerly Cold Buster) and Ashwagandha Gummies dietary supplements. The violations include failure to establish adequate finished product specifications for identity, purity, strength, and composition, and failure to document material review and disposition decisions. FDA found the company's February 2025 corrective-action responses inadequate and lacking supporting evidence. The letter warns that failure to address these violations may result in seizure or injunction.

Life Enthusiast Co-op

FDA issued a warning letter to Life Enthusiast Co-op (President Martin Pytela) on August 25, 2025, after reviewing the company's website and finding three ophthalmic products — 'Amazing Colyrio,' 'Fulvic Eyes,' and 'MSM Gold Drops' — marketed with drug claims (treating eye irritation, restoring vision, fighting infections) without FDA approval. The products are classified as unapproved new drugs under section 505(a) of the FD&C Act because they are intended to diagnose, cure, mitigate, treat, or prevent disease and are not generally recognized as safe and effective for their labeled uses. FDA noted particular public health concern because ophthalmic products bypass natural bodily defenses. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Supply Center USA

FDA issued a warning letter to Supply Center USA (Sheridan, WY) on August 25, 2025, after reviewing their website and finding they were selling multiple Similasan and Boiron homeopathic ophthalmic drug products that lack FDA approval. The products — including various Similasan eye relief drops and Boiron Optique 1 — are marketed with therapeutic claims (e.g., relieving allergy symptoms, pink eye, redness, burning) that qualify them as unapproved new drugs under section 505(a) of the FD&C Act. FDA determined these products are not generally recognized as safe and effective (GRASE) for their labeled uses, making their interstate sale a violation of sections 301(d) and 505(a). The agency demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure or injunction.

Homeopathic Educational Services dba Homeopathic Family Medicine

FDA issued a warning letter to Homeopathic Educational Services dba Homeopathic Family Medicine (owner Dana Ullman, Berkeley, CA) after reviewing their website in May 2025 and finding that 'Cineraria Maritima Eye Drops' was being sold as an unapproved new drug. The product's website claimed it was indicated for cataracts, establishing drug-intended-use without FDA approval under FD&C Act sections 301(d) and 505(a). FDA flagged ophthalmic products as posing heightened public health risk due to the eye-administration route bypassing natural defenses, and warned that failure to correct violations could result in seizure, injunction, or import detention.

Mericon Industries, Inc.

FDA issued a warning letter to Mericon Industries, Inc. (Peoria, IL) following a facility inspection and website review, finding that its Florical 100 Capsules, Florical 500 Capsules, and Meribin 120 Capsules were marketed with disease-treatment claims (notably osteoporosis prevention and remediation) that rendered them unapproved new drugs under the FD&C Act. The products were also found to be misbranded drugs (lacking adequate directions for use), adulterated dietary supplements (due to serious CGMP violations including absent finished-product identity specifications and inadequate batch records), and misbranded dietary supplements (non-compliant nutrition labeling). FDA warned that failure to correct these violations may result in seizure or injunction, and required a written response within 15 working days.

Vidaslim Co.

FDA issued a warning letter to Vidaslim Co. (San Antonio, TX) following a December 2024 facility inspection that uncovered serious CGMP violations and labeling deficiencies across multiple dietary supplement product lines. The company failed to establish written procedures for quality control, distribution, reserve samples, complaint handling, returned products, and packaging/labeling operations. Multiple products — including Vidaslim Total Control Fat Burning Capsules, Vidaslim Gut Check Probiotic Super Greens, and others — were found misbranded due to missing adverse-event contact information, undeclared ingredients, improper Supplement Facts formatting, absent structure/function claim disclaimers, and inaccurate net quantity declarations. FDA warned that failure to adequately address these violations may result in seizure or injunction.

Valentine Enterprises, Inc.

FDA issued a warning letter to Valentine Enterprises, Inc. (Lawrenceville, GA) following an October 2024 facility inspection, citing serious CGMP violations and misbranding of multiple dietary supplement products including Vibrant Health Green Vibrance, MuscleTech EuphoriQ Pre-Workout, Vibrant Health Joint Vibrance, and Premium Green Superfood Cytogreens. CGMP violations included failure to establish adequate finished-product identity specifications, failure to verify laboratory testing method suitability, and incomplete batch production records. Misbranding violations included failure to declare common or usual names of all ingredients and incorrect serving size declarations. FDA warned that failure to adequately address these violations may result in seizure or injunction.

EyeTech One, LLC

FDA issued a warning letter to EyeTech One, LLC (doing business as EYELIVIO) on July 9, 2025, citing its EYELIVIO lubricant eye ointment as an unapproved new drug and misbranded drug sold via its website and Instagram. The product's formulation includes botanical active ingredients (Aloe vera, Arnica montana, Calendula officinalis) not permitted under OTC Monograph M018 for ophthalmic emollients, and its labeling makes claims for anti-inflammatory benefits and ocular surface protection that exceed permitted OTC indications. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within 15 working days.

Revitalize Energy, Inc.

FDA issued a warning letter to Revitalize Energy, Inc. (Pittsburgh, PA) regarding its Revitalize Energizing Eye Drops, finding the product to be an unapproved new drug and misbranded under the FD&C Act. The product's website and Facebook marketing made drug claims — including relieving eye strain, boosting focus, fighting screen fatigue, and protecting against cataracts — using active ingredients (menthol, camphor, caffeine, taurine) not permitted under the applicable OTC monograph M018. The product's labeling also falsely displayed FDA logos with claims of 'FDA COMPLIANT,' 'MADE IN A FDA REGISTERED FACILITY,' and 'FDA GRAS APPROVED,' creating a misleading impression of FDA approval. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure and injunction.

Roca Labs, Inc.

The FTC took action against Roca Labs, Inc., a Florida-based marketer of weight-loss supplements, for making allegedly baseless efficacy claims and using 'gag clause' contract provisions to suppress negative consumer reviews and testimonials online. A federal district court issued summary judgment in the FTC's favor in September 2018. In July 2025, the Commission announced it was returning more than $409,000 to defrauded consumers as consumer redress.

My Smoke Wholesale

FDA issued a warning letter to My Smoke Wholesale (Houston, TX), owned by Laila Dawoodani, regarding their '777 Jackpot Alkaloids, 18 mg tablets' product containing 7-hydroxymitragynine (7-OH), a new dietary ingredient with opioid-like effects. FDA determined the product is adulterated under the Federal Food, Drug, and Cosmetic Act because there is inadequate information to provide reasonable assurance that 7-OH does not present a significant or unreasonable risk of illness or injury. The agency cited adverse event reports and the absence of any pre-October 1994 marketing history for 7-OH as a dietary ingredient. The recipient was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Shaman Botanicals, LLC

FDA issued a warning letter to Shaman Botanicals, LLC (CEO Stephen Vincent Sanders II) regarding two chewable tablet products containing 7-hydroxymitragynine (7-OH) marketed as dietary supplements. FDA determined that 7-OH is a new dietary ingredient with inadequate safety information to provide reasonable assurance it does not present a significant or unreasonable risk of illness or injury, rendering the products adulterated under section 402(f)(1)(B) of the Act. The agency cited opioid-like effects, adverse event reports, and lack of pre-market safety evaluation as serious concerns. FDA warned that failure to address the violations may result in seizure and injunction, and required a written response within 15 working days.

American Behavioral Research Institute, LLC

American Behavioral Research Institute, LLC (ABRI), the maker and sponsor of the dietary supplement Relaxium® Sleep, received an FDA Warning Letter dated April 30, 2025, for conducting a clinical investigation (Protocol ABRI-002) on human subjects to evaluate Relaxium's effects on insomnia without first submitting a required Investigational New Drug (IND) application. FDA determined that because the study was designed to assess Relaxium's efficacy in treating insomnia — a disease — the product was being used as a drug under the FD&C Act, regardless of its commercial marketing as a dietary supplement. ABRI's response, which argued Relaxium was a dietary supplement and that no future studies were planned, was deemed inadequate because it lacked a corrective and preventive action plan for IND compliance. FDA required ABRI to respond within 15 business days with actions taken to prevent future violations, warning that failure to do so may lead to regulatory action.

M.O.M. Enterprises, LLC

FDA issued a warning letter to M.O.M. Enterprises, LLC (Mommy's Bliss) following a 2024 inspection of its Richmond, CA dietary supplement facility, citing serious cGMP violations, failure to submit required Serious Adverse Event Reports for infant injuries, misbranding of supplement labels, and unapproved new drug status for Gripe Water Original. The company's website blog posts made disease-treatment claims linking Gripe Water Original to relief of acid reflux, GERD, asthma, and colic, causing the product to be regulated as an unapproved new drug. FDA warned that failure to address these violations may result in seizure or injunction, and required a written response within 15 working days.

Anti L’Age

FDA issued a warning letter to Anti L'Age (owner Dr. Arash Mohrdar, Riverside, CA) following a September–October 2024 facility inspection, citing extensive CGMP violations for three dietary supplement products — ESR Amino, Transfer Factor C, and Heart Amino — including failure to establish product specifications, maintain batch records, or implement quality control procedures. The products were also found misbranded for missing required labeling elements such as the 'dietary supplement' statement of identity, adverse event reporting contact, manufacturer information, correct serving size declarations, and required FDA structure/function claim disclaimers. FDA warned that failure to adequately address these violations may result in seizure or injunction. The recipient had not responded to the FDA 483 issued at the close of inspection prior to this letter.

Gluten Free Remedies LLC

FDA issued a warning letter to Gluten Free Remedies LLC (CEO Alex Shikhman, San Diego, CA) regarding its product 'Sulbutiamine Plus Brain Support,' labeled as a dietary supplement. The agency found that sulbutiamine — declared on the label as a dietary ingredient — does not qualify as a dietary ingredient under section 201(ff)(1) of the Act, making the product misbranded under section 403(a)(1). FDA warned that failure to address the violation could result in seizure or injunction, and required a written response within 15 working days.

PMS4PMS, LLC

FDA issued a warning letter to PMS4PMS, LLC (Clarence, NY) after a November 2024 inspection found significant CGMP violations and determined that their 'Comforté® Menstrual Cramp RELIEF CREAM' is an unapproved new drug and misbranded product. The product's labeling includes menstrual cramp relief indications not covered under OTC monograph M017 for external analgesics, making it a new drug marketed without an approved application. FDA also cited failures in release testing, stability programs, and quality unit oversight. The company is required to respond within 15 working days, and failure to comply may result in seizure, injunction, or withholding of export certificates and new application approvals.

Mother Earth Minerals, Inc.

FDA issued a warning letter to Mother Earth Minerals, Inc. (Ogden, UT) after inspecting their facility and reviewing their website, finding that their Calcium, Magnesium, and Silver products were marketed with disease-treatment and prevention claims—including for cancer, multiple sclerosis, diabetes, AIDS, and other conditions—rendering them unapproved new drugs and misbranded drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to widespread CGMP violations including absent identity specifications, missing master manufacturing records, incomplete batch production records, no written quality control procedures, and failure to retain reserve samples. FDA warned that failure to adequately address these violations may result in seizure and injunction.

Naturista Store LLC

FDA issued a warning letter to Naturista Store LLC (Downey, CA) for selling 'ADVANCE KING,' a product marketed as a dietary supplement but found via laboratory analysis to contain undeclared pharmaceutical ingredients dexamethasone, diclofenac, and methocarbamol. The product was marketed with disease-treatment claims for conditions such as sciatica, osteoarthritis, gout, and joint pain, making it an unapproved new drug under the FD&C Act. FDA also flagged eight additional similarly named products sold on the website as posing serious safety concerns based on prior analyses of comparable products. The agency demanded a written corrective response within 15 working days and warned that failure to comply may result in seizure and/or injunction.

Xlear, Inc., U.S. v.

The FTC, acting through DOJ, sued Xlear, Inc. in October 2021 under the COVID-19 Consumer Protection Act, alleging the Utah-based company falsely marketed its saline nasal sprays as effective for preventing and treating COVID-19. The core violation was unsubstantiated efficacy claims tied to a serious infectious disease. In March 2025, DOJ agreed to dismiss the case with prejudice, resulting in no final judgment or penalty against Xlear.

B4B Corp.

The FTC, DOJ, and FDA jointly sued B4B Corp., a New York-based herbal tea marketer, seeking a permanent injunction to halt deceptive advertising for its 'Earth Tea' product. The company claimed its tea was clinically proven to treat, cure, and prevent COVID-19, which constitutes unsubstantiated and forbidden health claims under FTC and FDA standards. The enforcement action seeks to permanently block these deceptive advertisements.

C & A Naturistics

FDA issued a warning letter to C & A Naturistics (National City, CA) for selling multiple products — including AK Forte, TE DE MORONEL, Jengibre en Polvo, Té Uva Ursi, RenaLimp, and two ophthalmic products — as unapproved new drugs and misbranded drugs. Lab analysis confirmed AK Forte contained undeclared acetaminophen and diclofenac, posing serious risks of liver damage, cardiovascular events, and dangerous drug interactions. The products bore disease-treatment claims (cancer, arthritis, kidney stones, conjunctivitis) without FDA approval, and labeling failed to disclose active pharmaceutical ingredients or provide adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure and/or injunction.

ISOThrive, Inc.

FDA issued this warning letter to ISOThrive, Inc. (CEO Jack Oswald) following a June 2023 inspection under the Bioresearch Monitoring Program. The agency found that ISOThrive conducted two clinical investigations of an investigational drug — marketed commercially as a dietary supplement — on a combined 288 human subjects without first submitting or having in effect an Investigational New Drug (IND) application, as required by 21 CFR 312. FDA determined the studies were designed to assess treatment of disease (not merely tolerability), making the product a drug under FD&C Act §201(g)(1) and disqualifying it from IND exemption. ISOThrive was directed to respond within 15 business days with corrective actions, with failure to do so potentially triggering further regulatory action.

Mihon Corp. d/b/a VitalityVita and Boulla, LLC

FDA issued a warning letter to Mihon Corp. d/b/a VitalityVita and Boulla, LLC for marketing four products — VitalityXtra, PeakMax, ZapMax, and ZoomMax — as dietary supplements while laboratory analysis confirmed they contained undeclared active pharmaceutical ingredients sildenafil (a PDE-5 inhibitor, the active ingredient in Viagra) and, in three products, diclofenac (an NSAID). The products are classified as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act and as misbranded drugs under section 502 for failing to disclose prescription drug ingredients, lacking adequate directions for use, and omitting required safety warnings. FDA demanded written corrective action within fifteen working days and warned that failure to comply may result in seizure and injunction.

Western Innovations, Inc.

FDA issued a warning letter to Western Innovations, Inc. (Denver, CO) following a January–February 2024 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations under 21 CFR Part 111, including failures to establish component specifications, written quality control procedures, proper master manufacturing records, and complete batch production records for their Acetyl-glutathione product. These violations render the dietary supplements adulterated under section 402(g)(1) of the FD&C Act, and FDA warned that failure to correct them may result in seizure or injunction.

Supercore Products Group, Inc.

FDA issued a warning letter to Supercore Products Group, Inc. (Atlanta, GA) regarding its 'Hard Steel' and 'Gold Hard Steel Plus' products, which were marketed as dietary supplements but found via laboratory analysis to contain undeclared pharmaceutical ingredients sildenafil and acetaminophen. The products were cited as unapproved new drugs and misbranded drugs under the FD&C Act due to erectile dysfunction treatment claims and failure to disclose active drug ingredients that pose serious health risks. The company had already issued a voluntary recall in July 2024, but FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.

Far East Summit LLC

FDA issued a warning letter to Far East Summit LLC (Dexter, OR) following a January–February 2024 inspection of their facility and review of their website and product catalog. The agency found that multiple traditional Chinese herbal products—including Si Ni San, Gan Mao Ling, Tong Jing Tang, and others—bore drug claims (e.g., 'Relieves pain,' 'Arrests diarrhea,' 'Suppresses cough') that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The company also committed significant dietary supplement CGMP violations (inadequate specifications, failure to investigate an adverse event involving hallucinations, lack of contamination limits) and misbranded several dietary supplement products through improper labeling. FDA warned that failure to correct these violations may result in seizure or injunction.

SoloVital

FDA issued a warning letter to SoloVital (Chula Vista, CA) on August 27, 2024, regarding their product 'Umary Hyaluronic Acid,' which laboratory analysis confirmed contained undeclared drug ingredients diclofenac (an NSAID) and omeprazole (a PPI). The product was marketed as a dietary supplement but is classified as an unapproved new drug under the FD&C Act because it contains approved drug substances not disclosed on the label, rendering it both an unapproved new drug and a misbranded drug. FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.

MexHealth LLC d/b/a Al Natural E-Shop

FDA issued a warning letter to MexHealth LLC d/b/a Al Natural E-Shop (Travis Bunch, La Mesa, CA) regarding their product 'Ossos-Sans,' marketed as a dietary supplement. Laboratory analysis confirmed the product contained undeclared diclofenac (an NSAID) and methocarbamol (a muscle relaxant), rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made numerous disease-treatment claims (arthritis, osteoporosis, fractures, etc.) without FDA approval, and failed to disclose the presence of active pharmaceutical ingredients. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Restorative Botanicals, LLC

FDA issued a warning letter to Restorative Botanicals, LLC (Longmont, CO) following a November–December 2023 facility inspection that found significant Current Good Manufacturing Practice (CGMP) violations in the production of two dietary supplement products: My GUT Shrooms Gummies 60 ct. and My IMMUNE Shrooms Capsules 60 ct. The violations included failure to establish adequate component identity and contamination-limit specifications (including toxic element testing for mushroom ingredients), discrepancies between batch production records and product labels, and incomplete master manufacturing and batch production records. FDA declared the products adulterated under 21 U.S.C. § 342(g)(1) and warned that failure to correct violations may result in seizure or injunction.

Txsyn Int. LLC

FDA issued a warning letter to Txsyn Int. LLC (San Antonio, TX) following an October–November 2023 inspection of their dietary supplement repackaging and labeling facility. The agency identified five significant CGMP violations under 21 CFR Part 111, including failure to retain reserve samples for required periods, lack of written procedures for received products, packaging/labeling operations, and returned dietary supplements, as well as releasing product for distribution without quality control approval. No marketing claims were flagged; the violations are entirely operational/manufacturing in nature, and FDA warned that failure to correct may result in seizure or injunction.

Formulation Technology, Inc.

FDA issued a warning letter to Formulation Technology, Inc. (Oakdale, CA) following a facility inspection in October–November 2023, citing violations across three categories: marketing a product as an unapproved new drug (with disease-treatment claims implying migraine cure/mitigation), adulterated dietary supplements due to cGMP failures (missing heavy metal and strength specifications), and misbranded dietary supplements due to incorrect serving size declarations and non-compliant Supplement Facts labeling. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Natural Ginger, Corp/Jonaus Corp

FDA issued a warning letter to Natural Ginger, Corp/Jonaus Corp (owner Jose Ramirez, Medley, FL) after reviewing the company's website and Facebook page in June 2024. The agency found that marketing claims for six products — including ginger/honey/aloe syrups, AFA Blue Green Algae, Magnesium Complex, and Vitamin C capsules — characterized them as intended to cure, mitigate, treat, or prevent diseases such as flu, coughs, sore throats, and inflammation, rendering them unapproved new drugs under the FD&C Act. Two of the syrup products were also found misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

West Coast Laboratories, Inc.

FDA issued a warning letter to West Coast Laboratories, Inc. (Gardena, CA) following an October 2023 facility inspection, citing serious CGMP violations in the manufacture of Calcium Pyruvate, Chromium Picolinate, and CalComplex dietary supplements. Violations included failure to conduct identity testing on dietary ingredients, inadequate component specifications, releasing products before quality control approval, and deficient batch production records. The products were also found misbranded due to missing adverse event reporting contact information and non-compliant Supplement Facts label formatting. FDA warned that failure to adequately address these issues may result in seizure or injunction.

Top Health Manufacturing, LLC

FDA issued a warning letter to Top Health Manufacturing, LLC (Spanish Fork, UT) following a October 2023 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations — including failures in quality control procedures, missing component and finished-product specifications, incomplete master manufacturing records, and deficient batch production records — causing products 'Grandma's Herbs Kidney' and a redacted product to be adulterated under 21 U.S.C. § 342(g)(1). Additionally, both products were found misbranded for labeling deficiencies including failure to identify plant parts for botanical ingredients, a false ingredient declaration (candelilla wax listed but not used), and non-compliant nutrition information formatting. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Nerium International, LLC

The FTC sued Nerium International (later Neora, LLC) and its CEO Jeffrey Olson, alleging the company operated as an illegal pyramid scheme and made deceptive health claims about its 'EHT' supplements, specifically that they could treat or prevent concussions, chronic traumatic encephalopathy (CTE), Alzheimer's disease, and Parkinson's disease. The FTC sought a permanent injunction to stop the deceptive practices. In September 2023, the district court ruled against the FTC on its claims, and in May 2024 the court further ruled that Neora could not recover its fees and expenses because the FTC's litigation position was 'substantially justified.'

Biomic Sciences, LLC dba ION Intelligence of Nature

FDA issued a warning letter to Biomic Sciences, LLC dba ION Intelligence of Nature (owner Dr. Zachary Bush) following a June–August 2023 inspection of their Charlottesville, VA facility. The agency found the ION Intelligence of Nature Sinus Support Nasal Spray to be adulterated due to gross microbial contamination (up to 1,100,000 CFU/mL), prompting a voluntary recall of all nasal spray lots. Additional violations included multiple drug CGMP failures, dietary supplement CGMP failures for Ion Gut Support, low-acid canned food registration and process-filing violations, and misbranding of dietary supplement labels. FDA warned that failure to adequately address these matters may result in seizure and injunction.

APG SEVEN, INC

FDA issued a warning letter to APG SEVEN, INC (Miami, FL) regarding 14 dietary supplement products sold under the Alpagi brand, including BioMoringa, BioDiabetin, HongoTrap, and BioCell. The products' labels and social media marketing made disease treatment, cure, and prevention claims — including claims to destroy cancer cells, eliminate fungal infections from the blood, increase insulin production, and treat fibromyalgia — rendering them unapproved new drugs under the FD&C Act. FDA also found five products (BioMoringa, BioDiabetin, Maca Plus, Ginkgo Biloba, BioCell) to be misbranded for lacking adequate directions for use. The company was directed to respond within 15 working days or face potential seizure and injunction.

The Bountiful Company

The Bountiful Company, a marketer of vitamins and dietary supplements, was charged by the FTC for 'review hijacking' — abusing an Amazon.com feature to make newly introduced supplements appear to have more ratings, higher average scores, and prestigious badges like '#1 Best Seller' and 'Amazon's Choice' by misappropriating reviews from other products. This was the FTC's first law enforcement action challenging review hijacking as a deceptive practice. The company agreed to pay $600,000 in consumer redress to settle the complaint, with over $527,000 subsequently distributed to affected consumers in March 2024.

Carbon Fire, LLC

FDA issued a warning letter to Carbon Fire, LLC (Saint Louis, MO) regarding its dietary supplement product '213° Metabolism Boosting Complex,' which contains N-Methyltyramine, a new dietary ingredient (NDI) not marketed in the U.S. before October 15, 1994. FDA determined the product is adulterated under the Federal Food, Drug, and Cosmetic Act because no NDI notification was submitted to FDA as required under section 413(a)(2) and 21 CFR 190.6. The agency warned that failure to address the violations may result in seizure or injunction, and required a written response within fifteen working days.

Native Salts LLC

FDA issued a warning letter to Native Salts LLC (Chicago, IL) on February 28, 2024, concerning its 'N, Native Salts' smelling salts product marketed as an OTC stimulant. The agency found the product to be an unapproved new drug under FD&C Act section 505(a) because it contains ammonium as a reflex stimulant ingredient — a use FDA determined not to be generally recognized as safe and effective in a 2008 proposed rule — and does not conform to OTC Monograph M011, which permits only caffeine as an active stimulant ingredient. The product was also found to be misbranded under section 502(ee). FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.

Precision Patient Outcomes

The FTC filed a complaint in November 2022 against California-based Precision Patient Outcomes, Inc. and its CEO Margrett Priest Lewis for marketing an OTC dietary supplement — containing only vitamins, zinc, and a flavonoid — as an effective treatment to mitigate the effects of COVID-19. The FTC alleged the defendants engaged in deceptive practices by making unsupported disease-treatment claims for a product with no demonstrated efficacy against COVID-19. In February 2024, a settlement order was announced barring the defendants from the alleged deceptive practices.

Inmar Supply Chain Solutions, LLC

FDA issued a warning letter to Inmar Supply Chain Solutions, LLC (Winston-Salem, NC) following a June–July 2023 inspection of its Arlington, TX warehouse that revealed a severe rodent infestation affecting human foods, dietary supplements, OTC drugs, and medical devices. Investigators documented live and dead rodents, rodent excreta pellets too numerous to count, gnawed food and drug packaging, and putrid spilled product throughout the facility, constituting adulteration under multiple provisions of the FD&C Act. The company had initiated a voluntary recall of affected products and taken some corrective actions, but FDA found the responses inadequate for devices and warned that failure to fully remediate could result in seizure or injunction.

Botanical Be

FDA issued a warning letter to Botanical Be (Edgar H. Felix, El Paso, TX) regarding three products — 'Kuka Flex Forte,' 'Reumo Flex,' and 'Artri King Reforzado con Ortiga y Omega 3' — sold via botanical-be.com. Laboratory analysis confirmed the products contained undeclared diclofenac, a prescription NSAID, making them unapproved new drugs and misbranded under the FD&C Act. The products were marketed with disease-treatment claims for arthritis, rheumatism, sciatica, and pain relief without FDA approval. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Curtis Jacquot dba Pacific BioLogic Co.

FDA issued a warning letter to Curtis Jacquot dba Pacific BioLogic Co. (Concord, CA) following a June 2023 inspection and July 2023 website review, finding that multiple dietary supplement products (ArteClear Circulation 2, Headache Release, Natura-Mune-2, Pain Release, and Attack 2) bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The company also committed numerous CGMP violations including failure to establish component/finished-product specifications, missing master manufacturing records and batch production records, inadequate complaint handling, and failure to collect reserve samples. FDA noted these are repeat violations from a 2014 warning letter and a 2015 regulatory meeting, and warned that failure to correct may result in seizure or injunction.

Amazon.com, Inc.

FDA issued a warning letter to Amazon.com, Inc. (CEO Andy Jassy) regarding its distribution via Fulfillment by Amazon of seven products — marketed as energy supplements or food — that laboratory analysis confirmed contained undeclared active pharmaceutical ingredients sildenafil or tadalafil (PDE-5 inhibitors). The products were deemed unapproved new drugs and misbranded under the FD&C Act because their labeling failed to disclose the presence of prescription drug ingredients that can cause dangerous interactions with nitrates. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Hua Da Trading, Inc.

FDA issued a warning letter to Hua Da Trading, Inc. (Brooklyn, NY) regarding its 'WeFun' product, which was marketed as a dietary supplement but found via laboratory analysis to contain undeclared sildenafil, a prescription PDE-5 inhibitor. The product was deemed an unapproved new drug and misbranded under the FD&C Act because its labeling lacked adequate directions for use, failed to disclose the active pharmaceutical ingredient, and bore false or misleading claims. FDA warned that failure to address violations could result in seizure and/or injunction, and required a written response within fifteen working days.

Lone Star Botanicals Inc.

FDA issued a warning letter to Lone Star Botanicals Inc. (doing business as Dr. Botanical Health) in Tyler, TX, citing serious CGMP violations at their food manufacturing facility, unapproved new drug claims across 11 botanical supplement products, and extensive food misbranding violations. The company's website, product labels, and brochures made disease treatment and prevention claims — including curing colds/flu, reducing anxiety and depression, fighting cancer, stabilizing blood sugar, and lowering cholesterol — that caused the products to be classified as unapproved new drugs under the FD&C Act. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

K W Technology Inc., et al. (1 Invisible Mask), FTC v.

The FTC sued K W Technology Inc. and three related defendants for deceptively marketing the '1 Virus Buster Invisible Mask,' a product claimed to create a three-foot protective barrier against 99.9% of all viruses and bacteria, including COVID-19. The agency alleged these efficacy claims lacked any scientific substantiation. The lawsuit sought to halt the deceptive marketing practices.

Abbott Laboratories

FDA issued a warning letter to Abbott Laboratories (CEO Robert B. Ford) regarding its Similac® Probiotic Tri-Blend dietary supplement marketed for use in preterm infants. FDA found that marketing claims on Abbott's websites and sales handouts — stating the product reduces necrotizing enterocolitis (NEC), mortality, and sepsis — rendered the product an unapproved new drug and unlicensed biological product under the FD&C Act and PHS Act. The product was also found adulterated because it contains B. infantis (Bb-02), an unsafe food additive for preterm infant use, and S. thermophilus (TH-4®), a new dietary ingredient lacking adequate safety assurance for this population. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.

Natural Relief Inc.

FDA issued a warning letter to Natural Relief Inc. (owner Omar Ashraf, Coshocton, OH) following a March–April 2023 facility inspection and June 2023 website review, finding that two products — Edema NatRelief 6 and BP NatRelief 11 — were marketed with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to extensive CGMP violations including absent specifications, inadequate quality control procedures, and deficient manufacturing records. FDA warned that failure to adequately address these violations may result in seizure and injunction, and required a written response within 15 working days.

Walgreens Boots Alliance, Inc.

FDA issued a warning letter to Walgreens Boots Alliance, Inc. on September 11, 2023, regarding three homeopathic ophthalmic products — 'Walgreens Allergy Eye Drops,' 'Walgreens Stye Eye Drops,' and 'Walgreens Pink Eye Drops' — sold on walgreens.com. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective (GRASE) for their labeled uses, and their contract manufacturer was found to have significant CGMP violations rendering the products adulterated. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure, injunction, or detention of products at the U.S. border.

TRP Company, Inc

FDA issued a warning letter to TRP Company, Inc. (Reno, NV), owned by Thomas Pominville, regarding twelve ophthalmic homeopathic drug products sold at thereliefproducts.com, including 'Dryness Relief,' 'Pink Eye Relief,' 'Allergy Eyes Relief,' and others. The products were deemed unapproved new drugs under FD&C Act section 505(a) because they are not generally recognized as safe and effective for their labeled uses and lack FDA-approved applications. FDA also cited adulteration violations stemming from CGMP failures at the contract manufacturer. The letter warns that failure to correct violations may result in seizure, injunction, and import detention.

CVS Health

FDA issued a warning letter to CVS Health (President & CEO Karen S. Lynch) on September 11, 2023, regarding its 'CVS Health Pink Eye Relief Drops,' a homeopathic ophthalmic product sold on cvs.com. FDA determined the product is an unapproved new drug under FD&C Act section 505(a) because it is not generally recognized as safe and effective for its labeled uses, and also deemed adulterated due to CGMP violations at its contract manufacturer. FDA further flagged safety concerns about the use of silver sulfate as a preservative. CVS was directed to respond within 15 working days with corrective steps, with failure to comply potentially resulting in seizure or injunction.

DR Vitamins, LLC dba DR Vitamin Solutions

FDA issued a warning letter to DR Vitamins, LLC dba DR Vitamin Solutions (North Richland Hills, TX) on September 11, 2023, citing four ophthalmic eye drop products — 'Vision Clarity Eye Drops,' 'Life Extension Brite Eyes III,' 'Can-C Eye Drops,' and 'Longevity Science Visual Ocuity' — as unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502(o). The products were marketed with claims to treat or prevent cataracts, glaucoma, floaters, and dry eyes using N-Acetyl-Carnosine (NAC), an ingredient not permitted under OTC Monograph M018 for ophthalmic demulcents. FDA found no adequate clinical evidence supporting GRASE status and noted the drug listing for 'Vision Clarity Eye Drops' had been inactive since January 2020. The company was directed to respond within 15 working days with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Natural Ophthalmics, Inc.

FDA issued a warning letter to Natural Ophthalmics, Inc. (Lafayette, CO) on September 11, 2023, after reviewing the company's website and finding six homeopathic ophthalmic products — including 'Cataract Eye Drops with Cineraria' and 'Women's Tear Stimulation Dry Eye Drops' — marketed with disease-treatment claims that render them unapproved new drugs under section 505(a) of the FD&C Act. The products are not generally recognized as safe and effective for their intended uses and lack any FDA-approved application. FDA warned that failure to correct violations may result in seizure or injunction, and required a written response within fifteen working days.

Boiron, Inc.

FDA issued a warning letter to Boiron, Inc. on September 11, 2023, regarding their homeopathic 'Optique 1 Eye Drops' product sold via their website and social media channels. FDA determined the product is an unapproved new drug under section 505(a) of the FD&C Act because it is marketed with drug claims (treating eye irritation, dryness, allergies, and eyestrain) without an approved application, and is not generally recognized as safe and effective for those uses. The agency flagged the product as especially concerning due to the ophthalmic route of administration, which bypasses natural bodily defenses. Boiron was directed to respond within 15 working days and warned that failure to comply could result in seizure, injunction, or import detention.

InnoMark, Inc.

FDA issued a warning letter to InnoMark, Inc. (Saint George, UT) following a March 2023 facility inspection, citing multiple serious violations of dietary supplement cGMP regulations (21 CFR Part 111) and misbranding under the Federal Food, Drug, and Cosmetic Act. The company's products were found to be adulterated due to failures in establishing product and component specifications, identity testing, supplier COA qualification, and incomplete master manufacturing and batch production records. Product labels were also found to be false or misleading, declaring ingredients not present in the products, omitting ingredients that were present, and failing to comply with Supplement Facts labeling requirements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Osmosis, LLC

FDA issued a warning letter to Osmosis, LLC (CEO Dr. Benjamin T. Johnson, MD) in Evergreen, CO following a January 2023 facility inspection and June 2023 website review. The agency determined that three products — Osmosis Skin Perfection Elixir, Sugar Detox Elixir, and Elevate — were being marketed as unapproved new drugs due to disease-treatment claims (e.g., treating eczema, psoriasis, rosacea, diabetes, and high cholesterol) on product labels and the company website. FDA also cited multiple dietary supplement CGMP violations and misbranding violations across several products, warning that failure to correct these issues may result in seizure or injunction.

Amazon.com, Inc

FDA issued a warning letter to Amazon.com, Inc. (CEO Andrew Jassy) regarding the distribution of four unapproved new drug products — 'Naturasil Molluscum Treatment Kit,' 'Conzerol 2 Step Treatment for Molluscum Contagiosum,' 'ZymaDerm for Molluscum,' and 'HealthyDerm Molluscum Contagiosum Treatment' — sold via Amazon's Fulfillment by Amazon service. These products were marketed with drug claims to treat molluscum contagiosum, a condition with no legally marketed OTC drug products, without FDA approval. FDA flagged particular public health concern because the products were marketed for use in children and could cause consumers to forgo proper medical diagnosis. Amazon was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure and/or injunction.

Walmart, Inc

FDA issued a warning letter to Walmart, Inc. (CEO Doug McMillon) regarding its distribution of the 'Naturasil Molluscum Treatment Kit' through Walmart Fulfillment Services on walmart.com. The product was flagged as an unapproved new drug under sections 301(d) and 505(a) of the FD&C Act because it bears claims to treat molluscum contagiosum, a condition with no legally marketed OTC drug products, and is not FDA-approved. FDA expressed particular public health concern because the product is marketed for use in children and may cause consumers to forgo proper medical diagnosis of potentially serious conditions. Walmart was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure and/or injunction.

Thrasio, LLC D/B/A ZymaDerm

FDA issued a warning letter to Thrasio, LLC d/b/a ZymaDerm on August 18, 2023, regarding their 'ZymaDerm for Molluscum' product marketed on naturopathix.com and Facebook. The agency determined the product is an unapproved new drug under section 505(a) of the FD&C Act because it makes drug-intended-use claims for treating molluscum contagiosum, a condition with no legally marketed OTC drug products. FDA flagged multiple efficacy, cure, and clinical-proof claims across the company's website and social media, and noted particular public health concern because the product is marketed for use in children. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Nature’s Innovation, Inc.

FDA issued a warning letter to Nature's Innovation, Inc. (CEO William Carlson) on August 18, 2023, after reviewing the company's website and social media pages and finding that its 'Naturasil Molluscum Treatment Kit' and 'Naturasil Shingles' products were being marketed as treatments for molluscum contagiosum and shingles without FDA approval. The products were deemed unapproved new drugs under section 505(a) of the FD&C Act because the marketing claims established drug intent, and neither product is generally recognized as safe and effective for the claimed uses. FDA expressed particular public health concern because the molluscum product is marketed for children and the shingles product could cause patients to forgo necessary antiviral treatment. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

ALVA-AMCO Pharmacal Companies, LLC

FDA issued a warning letter to ALVA-AMCO Pharmacal Companies, LLC regarding their 'Nauzene Kids' homeopathic product, finding it to be an unapproved new drug under section 505(a) of the FD&C Act. The product's label and website made drug claims (nausea and upset stomach relief) without an FDA-approved application, and the product is not generally recognized as safe and effective for its intended uses. Additional concern was raised because the product is directed at young children and was manufactured by a facility with known CGMP violations. FDA demanded written corrective action within fifteen working days, warning that failure to comply may result in seizure or injunction.

CalmCo LLC previously named Ketomi LLC

FDA issued a warning letter to CalmCo LLC (formerly Ketomi LLC) in August 2023 regarding its 'Colic Calm' and 'Colic Calm +' homeopathic products marketed for infant colic, gas, and reflux relief. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act because they are not generally recognized as safe and effective for their intended uses and lack an approved NDA. The products are of heightened public health concern because they are directed at infants and were manufactured by a third party (Denison Pharmaceuticals) cited for significant CGMP violations. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Biorica International Corp.

FDA issued a warning letter to Biorica International Corp. (Hollywood, FL) regarding its Plaquex® Oral Dietary Supplement, finding that marketing claims on multiple websites and Facebook pages established the product was intended to treat, prevent, or mitigate diseases including cardiovascular disease, high cholesterol, liver and kidney disease, psoriasis, and potentially cancer. Because the product is not generally recognized as safe and effective for these uses, FDA determined it constitutes an unapproved new drug under section 201(p) of the Act and is also misbranded under section 502(f)(1) for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc.

FDA issued a warning letter to Moor Herbs, Inc. (Detroit, MI) following a facility inspection and website review, finding that 19 herbal products were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. Products such as 'Full Body Antibiotic,' 'Tumor Release,' 'Un-Vax,' and 'Venereal Defense' bore explicit cure, treatment, and prevention claims for serious conditions including cancer, HIV, herpes, and sexually transmitted infections. The facility also violated dietary supplement CGMP regulations across eight categories (specifications, quality control, recordkeeping, cleaning, etc.) and multiple products were misbranded due to labeling deficiencies. FDA warned that failure to correct violations may result in seizure or injunction.

Gadget Island, Inc.

FDA issued a warning letter to Gadget Island, Inc. (President/CEO Naeem Azizian) regarding three male sexual enhancement products — 'NUX Male Enhancement,' 'DYNAMITE Male Sexual Enhancement,' and 'ProPower Knight Plus 2550mg' — sold on www.gearisle.com. Laboratory analysis confirmed each product contained undeclared pharmaceutical ingredients tadalafil and sildenafil (active ingredients in FDA-approved prescription drugs Cialis and Viagra), rendering them unapproved new drugs and misbranded under the FD&C Act. The products were marketed as dietary supplements but cannot qualify as such under federal law because tadalafil and sildenafil were approved as drugs before being marketed as supplements. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Rejuvica, LLC., FTC v.

The FTC took action against Rejuvica, LLC, the maker of Sobrenix, for deceptively marketing the product as able to reduce and even eliminate alcohol cravings and consumption. The FTC alleged violations of the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act (OARFPA). Defendants agreed to a court order permanently banning them from making unsubstantiated claims about health care products or services and were required to pay $650,000 in consumer refunds. In November 2024, the FTC distributed $536,000 in refunds to affected consumers.

Eden’s Answers, Inc.

FDA issued a warning letter to Eden's Answers, Inc. (Tampa, FL) following an August–November 2022 inspection of their Ohio manufacturing facility. The agency found serious CGMP violations related to inadequate identity and finished-product specifications, incomplete batch production records, and deficient master manufacturing records for dietary supplements including Dental Health, Honey Herbal Syrup, and Lil' Ones Sleepy Time. Additionally, the Honey Herbal Syrup and Sleepy Time product labels were found misbranded for failing to declare serving sizes, servings per container, and quantitative amounts per serving for each intended group. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Healthtex Distributors, Inc.

FDA issued a warning letter to Healthtex Distributors, Inc. (Miami, FL) following a January–February 2023 inspection of their dietary supplement warehouse. The agency found serious CGMP violations — including no written quality control procedures, no identified QC personnel, and inadequate holding/distribution procedures — rendering their Dr. Sana Cod Liver Oil and Dr. Sana Orange Blossom Flower Water products adulterated. Additionally, both products were found misbranded due to incomplete ingredient declarations, missing bilingual label requirements, improper nutrition facts formatting, absent adverse event reporting contact information, missing dietary supplement identity statements, and structure/function claims lacking the required FDA disclaimer. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Hekma Center, LLC

FDA issued a warning letter to Hekma Center, LLC (Wilmington, DE) in June 2023 after reviewing the company's website and social media pages, finding that its dietary supplement products — including packages marketed for anemia, cardiomyopathy, diabetes, hypertension, stroke, multiple sclerosis, and depression — bore disease-treatment claims that legally classified them as unapproved new drugs under the FD&C Act. The products were also found to be misbranded because adequate directions for use by a layperson could not be written for conditions requiring licensed practitioner supervision. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

A&Z Pharmaceutical, Inc.

FDA issued a warning letter to A&Z Pharmaceutical, Inc. (Hauppauge, NY) regarding its Chewable Calcium 600MG with Vitamin D for Kids product, finding that disease-treatment claims on the company's website and Facebook pages rendered the dietary supplement an unapproved new drug under the FD&C Act. Flagged claims included assertions that the product could prevent osteoporosis, treat hypocalcemia, lower blood pressure, reduce depression, and cut the risk of COVID-19. FDA also found the product misbranded for lacking adequate directions for use. The company was directed to respond within 15 working days and warned that failure to act could result in seizure or injunction.

Cosmax NBT USA

FDA issued a warning letter to Cosmax NBT USA, a dietary supplement manufacturer in Garland, TX, following a 2021 facility inspection that revealed serious CGMP violations and labeling deficiencies. The company failed to establish adequate product and component specifications, verify component identity before use, and properly document pesticide testing, causing products to be adulterated under 21 CFR Part 111. Multiple finished products were also found misbranded due to non-compliant Supplement Facts labeling, including improper Daily Value declarations, missing ingredient common names, and erroneous calorie statements. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club

FDA issued a warning letter to Tager Online, Inc. DBA Volt Candy regarding its 'PrimeZEN Black 6000' product, which was marketed as a dietary supplement but found through laboratory analysis to contain undeclared pharmaceutical ingredients tadalafil and sildenafil — the active ingredients in FDA-approved prescription drugs Cialis and Viagra. The product was deemed an unapproved new drug and misbranded drug under the FD&C Act due to its drug-intent marketing claims, failure to declare PDE-5 inhibitor ingredients, and lack of adequate directions for use or safety warnings. The company had already voluntarily recalled the product in February 2023, but FDA warned that failure to adequately address violations could result in seizure and/or injunction.

EarthLab, Inc., dba Wise Woman Herbals

FDA issued an amended warning letter to EarthLab, Inc. dba Wise Woman Herbals (Park City, UT) following a 2022 facility inspection and review of its website and Facebook page. The agency found that eight herbal supplement products — including Green Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, Elderberry Plus Syrup, and others — were marketed with disease-treatment and prevention claims (stroke, cancer, influenza, joint pain, respiratory infections) that rendered them unapproved new drugs under the FD&C Act. FDA also cited serious CGMP violations, including failure to establish adequate specifications, use of components that failed microbial and heavy-metal (lead) limits, and failure to follow written laboratory procedures. The letter warns that failure to correct these violations may result in seizure or injunction.

Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc.

FDA issued a warning letter to Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. (CEO Arthur Mikaelian) in April 2023 after reviewing their websites and finding that five 'Escozine' products — marketed as homeopathic remedies containing polarized blue scorpion venom — were being sold with claims to treat, cure, or mitigate serious conditions including cancer, HIV, and COVID-19. FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act, as no approved application is in effect for any of them. The agency warned that failure to correct violations could result in seizure and injunction, and required a written response within fifteen working days.

STPCA Inc. dba Sun Ten Laboratories

FDA issued a warning letter to STPCA Inc. dba Sun Ten Laboratories (Irvine, CA) following a facility inspection and website review, finding that eight products (Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2) were marketed with disease-treatment claims that rendered them unapproved new drugs under the Act. The agency also cited serious CGMP violations for dietary supplement products (Lycium Formula Huan Shao Dan, and two redacted products), including failures in identity specifications, quality control disposition decisions, and master manufacturing records. Additionally, multiple products were found misbranded due to labeling deficiencies including foreign-language label requirements, missing plant-part identification, and non-compliant Supplement Facts panels. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

SCS Direct, Inc.

FDA issued a warning letter to SCS Direct, Inc. (CEO Howard Greenspan) regarding its dietary supplement products Uplift Max and Shred Her Max, finding both adulterated under the FD&C Act because they contain hordenine HCl, which is not a recognized dietary ingredient and is not GRAS-approved as a food additive. FDA also flagged a misrepresentation on the company's website falsely implying affiliation with Optimum Nutrition, Inc. The agency demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.

ByPro Nutrition LLC

FDA issued a warning letter to ByPro Nutrition LLC (owner Dr. Robert L. Bynum) regarding their product Dodecin, a nutraceutical supplement marketed for pain and inflammation relief. The agency determined that claims on the product label, website, YouTube video, and customer testimonials established Dodecin as an unapproved new drug intended to cure, mitigate, treat, or prevent diseases such as osteoarthritis, rheumatoid arthritis, fibromyalgia, neuropathy, and lupus. Because Dodecin lacks FDA approval and fails to bear adequate directions for use, it is both an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. FDA warned that failure to address the violations may result in seizure or injunction.

Brand Packaging Group, Inc.

FDA issued a warning letter to Brand Packaging Group, Inc. (Farmingdale, NY) following a March–April 2022 inspection that revealed significant CGMP violations in their dietary supplement manufacturing operations. The company failed to properly verify finished batch specifications, test incoming dietary ingredients for identity, reject components that failed established specifications, maintain valid laboratory controls for reference standards, and follow calibration procedures for testing instruments. FDA found these violations caused their dietary supplement products to be adulterated under 21 U.S.C. § 342(g)(1), and warned that failure to correct the issues could result in seizure or injunction.

Spartan Enterprises Inc. dba Watershed Wellness Center

FDA issued a warning letter to Spartan Enterprises Inc. dba Watershed Wellness Center (Lansing, MI), a dietary supplement manufacturer, after inspecting its facility and reviewing its websites and YouTube channel. The company's products — including Dr. Bob's Naturals Yew VeggieCaps, Parasite Killer, Magtein, Ginkgo Magic, and others — bore claims that cancer treatment, Alzheimer's, kidney stone removal, parasite killing, and blood sugar regulation, rendering them unapproved new drugs and misbranded drugs under the FD&C Act. The facility also had serious CGMP violations including missing specifications, inadequate batch records, and unsanitary conditions. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure and injunction.

Herbal Vitality, Inc.

FDA issued a warning letter to Herbal Vitality, Inc. (Sedona, AZ) after a July 2022 facility inspection revealed that 21 herbal supplement products — including formulas named for Lyme disease, Hepatitis C, COPD, PCOS, asthma, and kidney stones — were being marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The products were also found misbranded due to inadequate labeling, missing allergen declarations, and improper supplement facts formatting. Additionally, the company had significant CGMP violations including absent component specifications, no finished-product specifications, and failure to collect reserve samples. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

doTERRA - Wong

The FTC, through the Department of Justice, filed lawsuits against three current and former high-level doTERRA distributors — all healthcare practitioners — for claiming that doTERRA essential oils and dietary supplements could treat, prevent, or cure COVID-19. The claims were made during webinars in early 2022, with defendants leveraging their medical credentials to lend credibility to the product recommendations. The complaints allege violations of both the FTC Act and the COVID-19 Consumer Protection Act. This case represents a critical enforcement action targeting unsubstantiated disease-cure claims tied to MLM health product marketing.

doTERRA - Busch

The FTC, through the Department of Justice, filed lawsuits against three current and former high-level doTERRA distributors — all healthcare practitioners — for claiming that doTERRA essential oils and dietary supplements could treat, prevent, or cure COVID-19. The claims were made during webinars in early 2022, where the defendants leveraged their medical credentials to promote the products. The complaints allege violations of both the FTC Act and the COVID-19 Consumer Protection Act.

doTERRA - Bacot

The FTC, through the Department of Justice, filed lawsuits against three current and former high-level doTERRA distributors who were also healthcare practitioners for claiming that doTERRA essential oils and dietary supplements could treat, prevent, or cure COVID-19. The claims were made during webinars in early 2022, with the defendants leveraging their medical credentials to lend credibility to the product recommendations. The complaints allege violations of both the FTC Act and the COVID-19 Consumer Protection Act. This enforcement action represents a critical regulatory outcome targeting unsubstantiated disease-cure claims tied to a multi-level marketing health product line.

American Chinese Natural Herbs, Inc.

FDA issued a warning letter to American Chinese Natural Herbs, Inc. (Garland, TX) following a February–March 2022 inspection, citing serious CGMP violations and widespread misbranding across approximately 13 dietary supplement products including Almond Plus, Stomach Miracle, King Kong, LIV-97, and others. CGMP violations included failure to establish component and finished-product specifications, inadequate master manufacturing records and batch production records, and absent quality control procedures. Misbranding violations included false or misleading quantity statements, missing allergen declarations (oyster), absent or improperly linked structure/function claim disclaimers, and failure to declare standardized common names and plant parts for botanical ingredients. FDA demanded a written corrective-action response within 15 working days and warned that failure to comply could result in seizure or injunction.

ZyCal Bioceuticals Healthcare Company, Inc.

The FTC filed a federal complaint against ZyCal Bioceuticals Healthcare Company, Inc. and related party Excellent Marketing Results, Inc. (EMR) for making unsubstantiated health claims about Cyplexinol-based products marketed for joint pain, arthritis, bone tissue, and cartilage growth. EMR claimed its StimTein product was 'clinically proven' to stimulate bone and cartilage cell growth without adequate scientific support. EMR and its president settled, were barred from making unsupported health claims, and over $110,000 was returned to consumers; in February 2023, a proposed order was announced barring ZyCal defendants from the deceptive conduct alleged in the complaint.

Organic Heirloom Plants

FDA issued a warning letter to Organic Heirloom Plants (Wendy Wiegert, Hancock, MI) in January 2023 after reviewing the company's website and Facebook page, finding that six products — Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Ivermectwin, Nature's Ancer, Zeolite, and Chaga Mushroom — were marketed with disease-treatment and cure claims (including for mpox, cancer, HIV, diabetes, and COVID-19) that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The products lacked FDA approval and bore no adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Old Tiles Wallpaper, LLC DBA Old Tiles Decor

FDA issued a warning letter to Old Tiles Wallpaper, LLC DBA Old Tiles Decor (Payson, UT) for selling three products — 'Wind River Skin Comfort Blend,' 'Wind River Cayenne Tincture,' and 'Wind River Elderberry Tincture' — as unapproved new drugs in violation of the FD&C Act, with particular concern over mpox-related claims and marketing to children and infants. The products were found to make drug-intended-use claims (treating monkeypox sores, heart conditions, cold and flu) without FDA approval or authorization. Two of the products were also found to be misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Adept Life Science, LLC

FDA issued a warning letter to Adept Life Science, LLC (Chandler, AZ) following an April 2022 facility inspection that uncovered serious CGMP violations and misbranding of dietary supplement products. The CGMP violations included failures to establish identity and purity specifications for raw materials, inadequate quality control release procedures, and incomplete master manufacturing records. The misbranding violations involved non-compliant Supplement Facts labeling — including incorrect serving sizes, missing consumer group declarations, wrong units of measurement, and failure to declare common ingredient names. FDA warned that failure to correct these violations could result in seizure or injunction.

Zing Brothers LLC

FDA issued a warning letter to Zing Brothers LLC (Salt Lake City, UT) following an August 2022 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations including failure to establish component and product specifications, lack of written quality control procedures, missing master manufacturing records, and incomplete batch production records. Additionally, two products were found misbranded because their labels falsely claimed ingredients not present in formulations, failed to declare actual ingredients, omitted artificial coloring disclosures, presented nutrition information incorrectly, and lacked a domestic contact address for adverse event reporting. FDA warned that failure to correct these violations may result in seizure or injunction.

Buzzagogo, LLC

FDA issued a warning letter to Buzzagogo, LLC regarding their 'Allergy Bee Gone for Kids' nasal swab product, finding it to be an unapproved new drug under section 505 of the FD&C Act based on disease-treatment claims on its labeling and website. FDA laboratory analysis also found the product adulterated with objectionable microbial contamination including Bacillus cereus, posing serious risk to children as young as one year old. The company had already conducted a voluntary recall of lot 2006491 in June 2022. FDA demanded a written response within 15 working days detailing corrective actions, and warned that failure to comply could result in seizure and injunction.

HIS Enterprise Inc dba Adam’s Secret USA, LLC

FDA issued a warning letter to HIS Enterprise Inc dba Adam's Secret USA, LLC for marketing multiple 'Adam's Secret' sexual enhancement products and 'Dr. Reade Slim Sense' as dietary supplements while laboratory analysis confirmed they contained undeclared pharmaceutical ingredients — tadalafil, sildenafil, and lorcaserin. These products were deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act and misbranded under section 502 for failing to declare active drug ingredients and lacking adequate directions for use. The undeclared PDE-5 inhibitors pose serious risks of dangerous drug interactions, particularly with nitrates, and lorcaserin (a withdrawn drug) carries cancer and psychiatric risks. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Distributor RFR, LLC

FDA issued a warning letter to Distributor RFR, LLC (owner Roger L. Flores, Doral, FL) regarding its product 'SANGTER Natural Male Energy Supplement,' which was found through laboratory analysis to contain undeclared sildenafil — the active ingredient in FDA-approved prescription drug Viagra. The product was marketed as a dietary supplement with drug-intent claims related to erectile dysfunction and sexual performance, making it an unapproved new drug and misbranded drug under the FD&C Act. FDA required a written response within 15 working days detailing corrective steps, and warned that failure to comply could result in seizure or injunction; the company had already initiated a voluntary nationwide recall in August 2022.

Quality Supplement Manufacturing, Inc.

FDA issued a warning letter to Quality Supplement Manufacturing, Inc. (Oklahoma City, OK) following a June 2022 facility inspection that revealed serious Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 111, resulting in dietary supplement products being deemed adulterated. Violations included failures to establish finished product specifications, prepare and follow master manufacturing records, verify batch specifications for identity/purity/strength/composition, and document quality control approvals. Additionally, multiple products were found misbranded due to non-compliant supplement facts labeling, undeclared allergens, missing ingredient common names, and absence of a domestic adverse event reporting contact. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Aspire Pharmaceuticals, Inc.

FDA issued a warning letter to Aspire Pharmaceuticals, Inc. (Somerset, NJ) following a joint inspection of their dietary supplement and drug manufacturing facility in late 2021 and early 2022. The agency found significant cGMP violations including use of scientifically invalid testing methods, failure to conduct material reviews for out-of-specification results, data integrity breaches (including an analyst who falsified sample weights to pass release specifications), and inadequate OOS investigation practices for both dietary supplement and drug products. The letter also cited misbranding of a dietary supplement due to an incorrect serving size declaration. FDA warned that failure to adequately address these violations may result in seizure and injunction.

Evimeria El Aztecano, Inc.

FDA issued a warning letter to Evimeria El Aztecano, Inc. (owner Michael A. Vizcarrondo, Gardena, CA) regarding their 'Yerbas Finas Leche de Alpiste con Guanabana y Omega-3' dietary supplement following a November 2021 facility inspection. The product was found to be misbranded on multiple grounds, including false or misleading nutrient content claims (declaring protein levels far below what 'high in protein' and 'as much protein as meat' claims require), inaccurate mineral content declarations, numerous Supplement Facts label formatting violations, missing structure/function claim disclaimers, and failure to repeat required label information in both languages. FDA required a written response within 15 working days detailing corrective actions, and warned that failure to comply may result in seizure or injunction.

Essential Elements

FDA issued a warning letter to Essential Elements (Lindon, UT) in November 2022 regarding their CholestAid dietary supplement, sold at essentialelementsnutrition.com and on Amazon. The agency determined that marketing claims about lowering LDL cholesterol, managing blood pressure, and improving heart health rendered the product an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacked adequate directions for use for conditions requiring licensed practitioner supervision. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Anabolic Laboratories Inc

FDA issued a warning letter to Anabolic Laboratories Inc. (Lake Forest, CA) in November 2022 after reviewing website claims for two products — CoQ10 Ubiquinol Prime and Policosanol Microtabs — that characterized them as intended for treatment of cardiovascular disease, heart failure, cholesterol management, and related conditions. These claims caused the products to be classified as unapproved new drugs under the FD&C Act, and CoQ10 Ubiquinol Prime was additionally found to be misbranded for lacking adequate directions for use. FDA demanded written corrective action within fifteen working days and warned that failure to comply could result in seizure or injunction.

Calroy Health Sciences, LLC

FDA issued a warning letter to Calroy Health Sciences, LLC (Scottsdale, AZ) in November 2022 regarding their Arterosil dietary supplement product. The agency determined that website claims on arterosil.com — including assertions about plaque regression, blood pressure reduction, and diabetic neuropathy improvement — rendered Arterosil an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacks adequate directions for use for conditions requiring licensed practitioner supervision. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Chambers' Apothecary

FDA issued a warning letter to Chambers' Apothecary (Robert Norris, Chambersburg, PA) after reviewing their website in October 2022 and finding that marketing claims for their Blood Pressure Support and CoEnzyme Q10 products established drug-intended use under the FD&C Act. Specific claims about lowering blood pressure, reducing cholesterol, and improving heart disease outcomes rendered these products unapproved new drugs. FDA also found both products misbranded for lacking adequate directions for use. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

Healthy Trends Worldwide, LLC

FDA issued a warning letter to Healthy Trends Worldwide, LLC (operating as GoldenAfter50.com) regarding their BPS-5 dietary supplement product. The company's website, Facebook, and YouTube marketing claimed the product could lower blood pressure, fight blood disorders, and address heart disease, causing FDA to classify BPS-5 as an unapproved new drug under the FD&C Act. FDA also found the product misbranded because it lacked adequate directions for use for conditions requiring licensed practitioner supervision. The letter demands corrective action within 15 working days and warns that failure to comply may result in seizure or injunction.

BergaMet North America LLC

FDA issued a warning letter to BergaMet North America LLC in November 2022 regarding its 'Cholesterol Command' dietary supplement, finding that claims on its website, Facebook page, and Walmart product listing established the product as an unapproved new drug intended to treat or mitigate diseases such as high cholesterol, type 2 diabetes, inflammation, and heart disease. The agency cited both direct marketing claims and endorsed customer testimonials as evidence of drug-intended use. The product was also deemed misbranded under section 502(f)(1) for lacking adequate directions for use. FDA demanded corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

iwi

FDA issued a warning letter to iwi (Houston, TX) in November 2022 after reviewing the company's website, social media, Amazon, and Walmart pages for its 'iwi Cholesterol' dietary supplement. The agency determined that marketing claims — including that the product is 'clinically shown to decrease cholesterol' and can 'protect your heart by lowering bad cholesterol' — rendered the product an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act. FDA demanded written corrective action within fifteen working days, warning that failure to comply could result in seizure or injunction.

Todos Medical Ltd aka Todos Medical USA Inc

FDA issued a warning letter to Todos Medical Ltd (CEO Gerald Commissiong) on November 7, 2022, for marketing their dietary supplement Tollovid 3CL Protease Inhibitor Delayed Release as intended to mitigate, prevent, treat, diagnose, or cure COVID-19 without FDA approval or authorization. The agency cited website claims, social media posts, and customer testimonials as evidence of intended drug use, classifying Tollovid as an unapproved new drug and misbranded drug under the FD&C Act. FDA demanded the company cease sales immediately, respond within 48 hours with corrective steps, and warned that failure to comply could result in seizure or injunction.

Amazon.com, Inc.

FDA issued a warning letter to Amazon.com CEO Andy Jassy regarding Amazon's distribution of three products — 'Artri Ajo King,' 'Artri King Reforzado con Ortiga y Omega 3,' and 'Ortiga Mas Ajo Rey' — marketed as dietary supplements but found via laboratory analysis to contain undisclosed diclofenac, a prescription NSAID. The products bore disease-treatment claims (arthritis, osteoarthritis, joint deterioration) that caused them to be classified as unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502(a) due to failure to disclose the active pharmaceutical ingredient. FDA demanded a written response within fifteen working days and warned that failure to comply could result in seizure and/or injunction.

Walmart Inc.

FDA issued a warning letter to Walmart Inc. (CEO Doug McMillon) regarding its distribution of 'Artri King Reforzado con Ortiga y Omega 3,' a product sold via Walmart.com and fulfilled through Walmart Fulfillment Services. Laboratory analysis confirmed the product contained undeclared diclofenac, an NSAID not listed on the label, rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made multiple disease-treatment claims (arthritis, joint deterioration, cartilage restoration) that established drug intent without FDA approval. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure and/or injunction.

Muscle Sports Products, LLC

FDA issued a warning letter to Muscle Sports Products, LLC (CEO Jason R. Mancuso) after reviewing multiple company websites and social media in May and September 2022. The agency found that numerous products — including CardioBurn For Her Powder, Rhino Rampage Capsules, Joint Revolution Capsules, IMMUNITY+ Powder, THERMX, HYPEX, RECOMP Capsules, and others — bore claims establishing drug intent (cure, mitigation, treatment, or prevention of disease) without FDA approval, rendering them unapproved new drugs and misbranded drugs under the FD&C Act. Several products also made COVID-19 mitigation and prevention claims. FDA warned that failure to address violations may result in seizure and injunction, and required a written response within 15 working days.

The Elderberry Fairy & Co., LLC

FDA issued a warning letter to The Elderberry Fairy & Co., LLC (owner Catie Fasano) in August 2022 after reviewing the company's website and Facebook page, finding that marketing claims for Elderberry Syrup with Honey, Elderberry Syrup with Agave, and Organic Fire Cider established these products as unapproved new drugs intended to cure, mitigate, treat, or prevent disease. Claims included fighting colds and flu, relieving allergies, suppressing coughs, and acting as a sinus decongestant, none of which have FDA approval. FDA determined the products were also misbranded for lacking adequate directions for use, and warned that failure to correct violations could result in seizure or injunction.

Oregon’s Wild Harvest, Inc.

FDA issued a warning letter to Oregon's Wild Harvest, Inc. following a September 2021 inspection of their Redmond, Oregon dietary supplement manufacturing facility. The agency found serious CGMP violations including failure to establish adequate product specifications, use of scientifically invalid testing methods (e.g., relying on input calculations rather than validated analytical methods for strength), failure to reject components contaminated with allergens, rodent feces, glass, and other foreign materials, and failure to verify microbial testing methodology. FDA warned that failure to adequately address these violations may result in legal action including seizure and injunction.

Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc.

FDA issued a warning letter to Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc. (Missoula, MT) following a September 2021 facility inspection. The agency found serious CGMP violations — including failures to verify finished batch specifications, follow quality control procedures, validate testing methodologies, and establish proper reference standard criteria — rendering multiple dietary supplement products adulterated. Additionally, several products were found misbranded due to incorrect serving size declarations, improper nutrient naming conventions, and failure to declare ingredients by their common or usual names. FDA required a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.

Deggeh Foods, Inc.

FDA issued a warning letter to Deggeh Foods, Inc. (Bronx, NY) after inspecting their facility and reviewing their website and Facebook page, finding that four products — Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, and Moringa Tea Bags — bore disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. The products were also found to be adulterated dietary supplements due to multiple CGMP violations, and misbranded due to extensive labeling deficiencies. FDA demanded a written response within 15 working days and warned that failure to comply may result in seizure or injunction.

Muscle Feast, LLC

FDA issued a warning letter to Muscle Feast, LLC (Nashport, OH) following a December 2021–January 2022 inspection of their dietary supplement manufacturing facility. The agency identified seven serious CGMP violations under 21 CFR Part 111, including failures to establish identity and purity specifications for components and finished products, inadequate quality control review of batch records, and improper reserve sample storage. FDA found these violations caused the company's dietary supplement products to be adulterated under section 402(g)(1) of the FD&C Act, and warned that failure to correct the issues could result in seizure or injunction.

NatureLab Corp.

FDA issued a warning letter to NatureLab Corp. (Carrollton, TX) following inspections in April–May and October 2021 of their dietary supplement manufacturing facility. The agency found serious CGMP violations under 21 CFR Part 111, including failure to establish required specifications, maintain adequate master manufacturing records and batch production records, and implement written complaint procedures, rendering multiple products adulterated. Additionally, numerous products were found misbranded due to incorrect serving size declarations, improper Supplement Facts label formatting, missing statement of identity, absent adverse event contact information, and non-compliant FDA disclaimers. FDA warned that failure to correct these violations may result in seizure or injunction.

1am USA Incorporated dba Pleasure Products USA

FDA issued a warning letter to 1am USA Incorporated dba Pleasure Products USA regarding its product X RATED HONEY FOR MEN, sold at pleasureproductsusa.com. Laboratory analysis confirmed the product contained undeclared tadalafil (the active ingredient in FDA-approved prescription drug Cialis), making it an adulterated food under section 301(ll) of the FD&C Act and disqualifying it from being marketed as a dietary supplement. The product poses serious health risks due to potential dangerous interactions with nitrate-containing prescription drugs. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Thirsty Run LLC / US Royal Honey LLC

FDA issued a warning letter to Thirsty Run LLC / US Royal Honey LLC (Dearborn, MI) after laboratory analysis confirmed that their honey products Etumax Royal Honey for Him and Dose Vital Honey for Men contained undeclared tadalafil, and Secret Miracle Royal Honey for Her contained undeclared sildenafil — both prescription-only PDE-5 inhibitors. The products were marketed with disease-treatment claims on the company's websites, making them unapproved new drugs under the FD&C Act, and their introduction into interstate commerce was also a prohibited act under section 301(ll) for adding approved drug ingredients to food. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure and injunction.

Health Research Laboratories, LLC

Health Research Laboratories, LLC, a Texas-based dietary supplement company, and its owner were banned from advertising or selling dietary supplements under an FTC consent order finalized in June 2022. The enforcement action was triggered by claims that their products treat, cure, or reduce the risk of disease — classic disease-claim violations under FTC and FDA standards. The proposed settlement was announced in March 2022 and received final approval in June 2022, resulting in a permanent ban on supplement sales and disease-related marketing claims.

Golden Lab LLC

FDA issued a warning letter to Golden Lab LLC (Jacksonville, FL), owned by Dr. Howard J. Loff, M.D., following a November 2021 facility inspection. The agency found that three ocular health supplement products — DoctoRx's Optimal Formula Ocular Pressure & Optic Nerve Support Formula, Meso Plus Astaxanthin Ocular Support Capsule, and Alereve Seasonal Allergy Support Ocular Health Capsule — bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The letter also cited multiple cGMP violations including missing finished-product and component specifications and incomplete batch production records. FDA warned that failure to correct these violations may result in seizure and injunction.

AdvoCare International, L.P.

AdvoCare International, L.P., a multi-level marketer of health and wellness products, and its former CEO agreed to pay $150 million and accept a permanent ban from the MLM business to resolve FTC charges that the company operated an illegal pyramid scheme. The FTC alleged AdvoCare deceived consumers into believing they could earn significant income as distributors of its health and wellness products. Two top promoters also settled related charges, agreeing to an MLM ban and a $4 million judgment (suspended upon surrender of substantial assets). The enforcement action targeted deceptive income opportunity claims tied to the distribution of nutrition and wellness products.

Complete Nutrition

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Complete Nutrition (Omaha, NE) regarding their dietary supplement product 'DR1,' which contains 5-alpha-hydroxy-laxogenin. The FDA determined that 5-alpha-hydroxy-laxogenin does not qualify as a dietary ingredient under the FD&C Act and is not GRAS, making it an unsafe food additive that renders DR1 an adulterated dietary supplement. Introducing or delivering the product into interstate commerce constitutes a prohibited act under section 301(a) of the FD&C Act. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Max Muscle

FDA issued a warning letter to Max Muscle (Sioux Falls, SD) regarding two dietary supplement products, Lipo Red and StimoVEX XT, finding both adulterated under the FD&C Act. StimoVEX XT was found to contain hordenine HCl, which is not a dietary ingredient and is an unapproved food additive, rendering the product adulterated under section 402(a)(2)(C)(i). Lipo Red was found to contain octopamine, a new dietary ingredient for which no required premarket notification was submitted to FDA, making it adulterated under sections 402(f) and 413(a). FDA warned that failure to address these violations could result in seizure and injunction.

New York Nutrition Company

FDA issued a warning letter to New York Nutrition Company (American Metabolix) regarding its dietary supplement products 'Lean Muscle For Her' and 'Lean Muscle,' which were found to contain 5-alpha-hydroxy-laxogenin, a substance that does not qualify as a dietary ingredient under the FD&C Act. Because this substance is neither GRAS nor approved as a food additive, the products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply may result in seizure or injunction.

Assault Labs

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Assault Labs (Burbank, CA) regarding their dietary supplement product 'Wild Thing Tropical Tornado flavor.' The product was found to be adulterated because it contains hordenine HCl and higenamine HCl, which are not dietary ingredients under the FD&C Act and are not generally recognized as safe (GRAS), making them unapproved food additives. FDA determined that marketing this product violates section 402(a)(2)(C)(i) of the FD&C Act. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Performax Labs Inc

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Performax Labs Inc. (Torrance, CA) regarding two products — Brute BCAA and Predator Pro — labeled as dietary supplements. Both products declare 5-alpha-hydroxy-laxogenin as a dietary ingredient; however, FDA determined this substance does not qualify as a dietary ingredient under the FD&C Act and is not GRAS, making it an unapproved food additive. As a result, both products are deemed adulterated under section 402(a)(2)(C)(i) of the FD&C Act, and FDA warned that failure to address the violations may result in seizure or injunction.

Complete Nutrition

FDA issued a warning letter to JW Nutritional LLC (McKinney, TX) following a September 2025 inspection of their OTC drug manufacturing facility. The agency cited significant CGMP violations including failure to perform adequate identity and contamination testing on incoming components, lack of process validation, inadequate water system validation, and use of food/dietary supplement microbiological standards instead of USP drug standards. FDA warned that failure to correct these violations could result in seizure, injunction, withholding of export certificates, and denial of new drug application approvals.

Nutritional Sales and Customer Service, LLC

FDA's Center for Food Safety and Applied Nutrition issued a warning letter to Nutritional Sales and Customer Service, LLC (metabolicnutrition.com) regarding their dietary supplement product Synedrex. The product was found to be adulterated because it contains three new dietary ingredients — octopamine, hordenine, and higenamine — for which no required premarket new dietary ingredient (NDI) notifications were submitted to FDA. Additionally, FDA determined that hordenine and higenamine lack adequate safety evidence and present a significant or unreasonable risk of illness or injury, making the product adulterated under the FD&C Act regardless of notification status. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

Steel Supplements Inc

FDA issued a warning letter to Steel Supplements Inc. of Sarasota, FL regarding six dietary supplement products (Shredded-AF, Charged-AF, Alpha-AF, 3-EPI-Andro, Focused-AF, and Amped-AF) found to be adulterated under the FD&C Act. The products were found to contain ingredients — hordenine HCl, higenamine HCl, and 5-alpha-hydroxy-laxogenin — that either do not qualify as dietary ingredients and lack GRAS status, or are new dietary ingredients for which required premarket notifications were never submitted. FDA warned that continued interstate commerce of these adulterated products is prohibited and that failure to address the violations may result in seizure or injunction.

Exclusive Nutrition Products, LLC

FDA issued a warning letter to Exclusive Nutrition Products, LLC (operating as Black Dragon Labs) regarding two dietary supplement products, Thermo Burn and 5-Alpha. The agency found both products adulterated under the FD&C Act because they contain higenamine HCl and 5-alpha-hydroxy-laxogenin, respectively, which do not qualify as dietary ingredients and are not GRAS, making them unsafe food additives. FDA warned that continued interstate commerce of these adulterated products is a prohibited act and that failure to address the violations may result in seizure or injunction. The company was given 15 working days to respond with corrective steps.

Advanced Nutritional Supplements LLC

FDA issued a warning letter to Advanced Nutritional Supplements LLC (Harrisburg, PA) regarding six products — New God of Rage, God of War, New God of Fire, Legion: Extreme Fat Burner, Laxovar: Natural Recomposition, and Uprising: Natural Testosterone Support — labeled as dietary supplements. The agency found that the declared ingredients higenamine HCl, hordenine HCl, and 5-alpha-hydroxy-laxogenin do not qualify as dietary ingredients under the FD&C Act and are unapproved food additives, rendering all six products adulterated. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

National Urological Group, Inc., et al.

National Urological Group, Inc. and associated defendants, including repeat offender Jared Wheat, were found in contempt by a federal district judge in October 2017 for violating prior court orders related to the sale of weight-loss dietary supplements. The court imposed a judgment exceeding $40 million against the defendants. The FTC used a portion of those funds to mail refunds totaling more than $8.5 million to defrauded consumers in May 2020.

MCACO, LTD

FDA issued a warning letter to MCACO, LTD (Grand Prairie, TX) following a November–December 2021 inspection that revealed serious Current Good Manufacturing Practice (CGMP) violations in the production of dietary supplements. Violations included failure to establish finished product and component specifications, failure to qualify suppliers via confirmed certificates of analysis, inadequate laboratory testing methodologies, incomplete master manufacturing records, and backdated batch production records. FDA warned that failure to adequately address these violations may result in legal action including seizure and injunction.

NDAL Mfg Inc.

FDA issued a warning letter to NDAL Mfg Inc. (Monterey, CA) following a September 2021 inspection, citing significant CGMP violations and identifying three Manuka Honey nasal spray products as unapproved new drugs. The company's product labels and website made drug-intended-use claims — including treating sinus infections, supporting immune function, and clearing nasal passages — without FDA-approved applications. FDA also flagged inadequate quality control, failure to investigate microbial contamination, and lack of stability testing. The letter demands corrective actions within 15 working days and warns that failure to comply may result in seizure, injunction, or withholding of export certificates.

Jason Cardiff (Redwood Scientific Technologies, Inc.)

The FTC filed a complaint against Jason Cardiff and Redwood Scientific Technologies, Inc. in October 2018, alleging a scheme using illegal robocalls to deceptively market dissolvable oral film strips as effective smoking cessation, weight-loss, and sexual-performance aids. An initial 2019 settlement permanently banned co-defendant Danielle Cadiz from all robocall activities and imposed an $18.2 million judgment against her. In March 2022, the FTC announced final court orders against all remaining defendants, including Cardiff. The enforcement actions addressed both the deceptive health efficacy claims and the illegal robocall marketing methods used to promote the products.

Health Research Laboratories, LLC

The FTC and State of Maine brought a complaint against Health Research Laboratories, LLC and its principal for deceptively marketing two dietary supplements, BioTherapex and NeuroPlus, with claims not supported by competent and reliable scientific evidence. A final Commission order was entered, and over $750,000 in consumer redress was distributed to approximately 16,596 affected consumers in November 2018. The defendants were subsequently alleged to have violated the final order by continuing to market supplements with unsupported claims, leading to a contempt motion and later an administrative complaint. A proposed settlement order was announced in March 2020.

Weight Watchers/WW

The FTC reached a settlement with WW International, Inc. (formerly Weight Watchers) and its subsidiary Kurbo, Inc. over allegations that they marketed a weight-loss app targeting children as young as eight years old and collected their personal information without obtaining verifiable parental consent, in violation of the Children's Online Privacy Protection Act (COPPA). The case resulted in a settlement requiring corrective actions and financial penalties.

MYA International, Inc.

FDA issued a warning letter to MYA International, Inc. (Chula Vista, CA) after inspecting their facility and reviewing product labeling for nine dietary supplement products (Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea/Tea Cellular, Quiebra Piedras, Shark Cartilage, and Helper). The products' catalog claims established drug intent — including treating diabetes, cancer, bacterial infections, and psychiatric disorders — making them unapproved new drugs and misbranded drugs under the FD&C Act. FDA also cited serious cGMP violations and numerous dietary supplement labeling deficiencies, and warned that failure to correct violations may result in seizure or injunction.

Princess Lifestyles, LLC

FDA issued a warning letter to Princess Lifestyles, LLC (San Gabriel, CA) following a March 2021 facility inspection and February 2022 website review, finding that multiple dietary supplement products — including TMAXX and PS Brain — bore disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The agency also cited extensive CGMP violations (no written QC procedures, missing component specifications, inadequate complaint and returns handling), an adulterated product containing ephedrine alkaloids (Stomaisu), and widespread labeling deficiencies across 13 product lines. FDA warned that failure to promptly correct violations may result in seizure or injunction.

Teami, LLC

The FTC sued Teami, LLC and its owners in March 2020 for making deceptive health claims about their tea products without reliable scientific evidence, and for paying social media influencers who failed to adequately disclose their paid relationships. Teami claimed its 30 Day Detox Pack would cause weight loss and that other teas could fight cancer, clear clogged arteries, decrease migraines, treat and prevent flu, and treat colds. The case resulted in the FTC returning more than $930,000 in consumer redress to buyers of the products.

BASF SE

BASF SE, along with DIEM Labs, agreed to pay over $416,000 to settle FTC charges that they deceptively marketed dietary fish oil supplements as clinically proven to reduce liver fat in adults and children with non-alcoholic fatty liver disease (NAFLD). The FTC found the efficacy claims were unsubstantiated. The settlement funds were used to provide consumer refunds, and both companies were barred from the allegedly illegal conduct under final consent orders approved in June 2021.

Sunny Creek Farm, Inc.

FDA issued a warning letter to Sunny Creek Farm, Inc. (Tryon, NC) following an August 2021 inspection that found serious violations of the Produce Safety Rule, including distributing sprouts after pathogen-positive test results and inadequate sanitation of food contact surfaces. Additionally, FDA reviewed the company's website and determined that marketing claims for broccoli sprout products — including claims that they treat cancer, Alzheimer's, heart disease, autism, and schizophrenia — rendered those products unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act. The company was directed to respond within 15 working days with corrective actions, and FDA warned that failure to comply could result in seizure or injunction.

Wholly Liquid Nutritional Supplements LLC

FDA issued a warning letter to Wholly Liquid Nutritional Supplements LLC (Hampton, NH) in December 2021 after reviewing their website and Facebook page and finding that seven products — SpiroLaze, BioLaze, LiquiLaurin, Vit-B12, DeStress, Omega Plus, and Ionized Silver — were marketed with disease-treatment claims (including Lyme disease, cancer, diabetes, ADHD, Alzheimer's, and numerous bacterial/viral pathogens) that rendered them unapproved new drugs under the FD&C Act. Because the products lacked FDA approval and bore no adequate directions for use, they were also deemed misbranded. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Western Herb Products, Inc.

FDA issued a warning letter to Western Herb Products, Inc. (Index, WA) following a May 2021 inspection of their dietary supplement manufacturing facility. The agency found serious CGMP violations including failures to establish adequate specifications, master manufacturing records, and batch production records for their Wormwood/Aloes dietary supplement capsules. Additionally, the product's labeling was found to be misbranded on multiple grounds, including incorrect plant part declarations, non-compliant Supplement Facts formatting, failure to declare common ingredient names, and use of 'approximately' in net quantity statements. FDA required a written response within 15 working days and warned that failure to correct violations could result in seizure or injunction.

NV Nutrition, LLC

FDA issued a warning letter to NV Nutrition, LLC (operating nutrovape.com and nutriair.com) in December 2021, finding that its inhaled 'vaporizer' and 'diffuser' products—marketed under the nutrovape and nutriair brands—were unapproved new drugs sold in violation of the FD&C Act. The agency cited numerous disease-treatment and structure/function claims on the company's websites, social media, and product packaging that established drug intent, including claims about treating insomnia, anxiety, hangovers, ADHD, and immune function. Because the products are intended for inhalation rather than ingestion, they also do not qualify as dietary supplements under the FD&C Act. FDA warned that failure to promptly correct violations could result in seizure and/or injunction.

VitaStik, Inc.

FDA issued a warning letter to VitaStik, Inc. (Beverly Hills, CA) in December 2021 after reviewing the company's website and social media, finding that its line of oral inhalation/aromatherapy sticks made disease-treatment claims for conditions including asthma, COPD, anxiety, PTSD, epilepsy, insomnia, and nasal congestion. These claims caused the products to be classified as unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and FDA also noted the products do not qualify as dietary supplements because they are intended for inhalation, not ingestion. FDA warned that failure to promptly correct violations could result in seizure and/or injunction, and required a written response within fifteen working days.

Eagle Energy USA, Inc.

FDA issued a warning letter to Eagle Energy USA, Inc. in December 2021 regarding its inhalable 'Caffeine Pen' products (Lychee Ice and Guarana Berry), finding them to be unapproved new drugs under the FD&C Act. The company's website, Facebook page, and product packaging made drug-like claims about treating GERD, boosting immune function, reducing inflammation, improving memory, and preventing osteoporosis, among others. Because the products are intended for inhalation rather than ingestion, they do not qualify as dietary supplements, and no FDA-approved applications exist for them. FDA demanded a written response within 15 working days and warned that failure to act could result in seizure and/or injunction.

Saffron Health Sciences

FDA issued a warning letter to Saffron Health Sciences (Dr. Song Gao, E Brunswick, NJ) in November 2021 regarding three dietary supplement products — Crocin Rich, Crocin Rich II, and Crocin Rich Plus — marketed with disease-treatment claims covering Alzheimer's, COVID-19, multiple sclerosis, stroke, depression, macular degeneration, and other conditions. The agency determined these claims caused the products to be classified as unapproved new drugs under the FD&C Act, and also found them misbranded for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Synaptent, LLC

FDA issued a warning letter to Synaptent, LLC (operating liftmode.com) in November 2021 for marketing numerous dietary supplement products—including Phenibut, Berberine HCL, Curcumin, and others—with disease treatment and drug-effect claims that rendered them unapproved new drugs under the FD&C Act. The agency cited claims such as anti-inflammatory, anxiolytic, blood pressure reduction, and erectile dysfunction uses as evidence of drug intent without FDA approval. Several products were also cited as misbranded drugs for lacking adequate directions for use, and four products were cited as misbranded dietary supplements for incomplete labeling. FDA demanded a written corrective response within 15 working days and warned that failure to comply could result in seizure or injunction.

Dominant Nutrition LLC formerly 8 Weeks Out Labs

FDA issued a warning letter to Dominant Nutrition LLC (formerly 8 Weeks Out Labs) in October 2021 after reviewing their website and finding serious violations related to four products: ADIPROPEN ULTRA, SUPERJOINTS, OPTIMUM-CLA, and LipogenX. LipogenX was found to be an adulterated dietary supplement due to the inclusion of Hordenine, a new dietary ingredient lacking the required FDA safety notification. ADIPROPEN ULTRA, SUPERJOINTS, and OPTIMUM-CLA were deemed unapproved new drugs based on disease-treatment claims on the company's website, with OPTIMUM-CLA additionally cited as a misbranded drug. The company was given 15 working days to respond with corrective actions, with FDA warning that failure to comply could result in seizure or injunction.

Nordic Clinical, Inc. and Encore Plus Solutions, Inc.

Nordic Clinical, Inc. and Encore Plus Solutions, Inc., marketers of supplements Neurocet, Regenify, and Resetigen-D, settled FTC charges in April 2020 for deceptively promoting their products to older Americans with false claims that the supplements could stop pain and treat age-related ailments. The FTC found the health benefit claims were unsubstantiated and not supported by scientific evidence. The resulting order barred the defendants from making any health benefit claims unless true and backed by scientific evidence. In October 2021, the FTC announced it was returning $1.1 million to consumers who purchased the defendants' products.

Organa International Corp.

FDA issued a warning letter to Organa International Corp. (Springville, UT) after reviewing its website and Facebook page in June 2021, finding that at least 19 products — including colloidal minerals, Silver Gel, Relieve Progesterone Cream, Essiac Tea, and MSM — were marketed with disease-treatment and cure claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The claims spanned cancer, HIV, diabetes, osteoporosis, Alzheimer's disease, arthritis, and numerous infections, none of which are supported by FDA-approved applications. FDA also cited extensive dietary-supplement labeling violations and demanded written corrective action within 15 working days, warning that failure to comply could result in seizure or injunction.

Quicksilver Scientific

FDA issued a warning letter to Quicksilver Scientific (Louisville, CO) on October 13, 2021, finding that website claims for four products — Nanoemulsified Milk Thistle, Cat's Claw Elite, Nanoemulsified CoQ10, and Liposomal GABA with L-Theanine — established drug intent by referencing disease treatment, prevention, and mitigation (e.g., heart failure mortality reduction, liver protection from alcohol, antimicrobial effects). FDA determined the products are unapproved new drugs under the FD&C Act and misbranded because they lack adequate directions for use. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc.

FDA issued a warning letter to RAAS Nutritionals, LLC/Rare Antibody Antigen Supply, Inc. (CEO Kieu Hoang) following a March 2021 inspection under the Bioresearch Monitoring Program. The agency found that RAAS conducted multiple clinical investigations of investigational drug products — including a COVID-19 study — without submitting required Investigational New Drug (IND) applications, in violation of 21 CFR 312. RAAS argued its products were dietary supplements not subject to IND requirements, but FDA determined the products were being studied as drugs because the investigations were designed to evaluate their ability to cure, mitigate, and treat disease. RAAS was directed to respond within 15 business days with a corrective action plan, with failure to comply potentially triggering further regulatory action.

ICA Health, LLC/Future Formulations, LLC

FDA issued a warning letter to ICA Health, LLC/Future Formulations, LLC (Dr. James L. Wilson) after reviewing three websites in July 2021 and finding that five dietary supplement products — Dr. Wilson's Good Sugar, Super Immune Space Sprinkles, Cortisol Stress Reset, BFF, and Nat-Stim — were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The claims linked the products to conditions including diabetes, metabolic syndrome, cardiovascular disease, autoimmune disorders, herpes, fibromyalgia, and cancer-related adrenal fatigue, among others. Four of the five products were also found to be misbranded because adequate directions for layperson use could not be written for prescription-level intended uses. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Holographic Health, Inc.

FDA issued a warning letter to Holographic Health, Inc. (President Theodore Baroody) regarding 14 products — including Glyco-Well, Pan-Gest, Heart-Line, Passionate Pursuit, Better Mood, and others — sold on holographichealth.com. The agency determined these products were unapproved new drugs because website claims established intent to cure, mitigate, treat, or prevent diseases such as diabetes, arthritis, erectile dysfunction, depression, and hemorrhoids. The products were also found to be misbranded for lacking adequate directions for use, and Pink Lady was found to be improperly labeled as a dietary supplement despite being a topical product. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Holistic Healer & Wellness Center, Inc.

FDA and FTC jointly issued a warning letter to Holistic Healer & Wellness Center, Inc. (Dearborn, MI) regarding its 'Diabalance Diabetes Supplement' product. The product's website claims established it as an unapproved new drug under the FD&C Act by asserting it could treat, mitigate, or aid diabetes and blood sugar conditions without FDA approval. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims. The company was required to respond within 15 working days and faces potential seizure, injunction, civil penalties up to $43,792 per violation, and consumer refunds.

Lysulin, Inc.

FDA and FTC jointly issued a warning letter to Lysulin, Inc. (San Diego, CA) in September 2021 regarding five dietary supplement products marketed for diabetes and prediabetes management. The regulators found that claims on the company's website, social media pages, and Amazon storefront established the products as unapproved new drugs intended to cure, mitigate, treat, or prevent disease — specifically diabetes and prediabetes — without FDA approval. FDA cited violations for introducing unapproved new drugs and misbranded drugs into interstate commerce, while the FTC issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and consumer redress obligations.

Ar-Rahman Pharm LLC

FDA and FTC jointly issued a warning letter to Ar-Rahman Pharm LLC (Abdur-Rahmaan Felder) in September 2021 regarding its 'Diabetes Support' dietary supplement. The agencies found that website and social media claims—asserting the product balances blood sugar, supports insulin/glucagon, and manages diabetes—rendered the product an unapproved new drug under the FD&C Act and a misbranded drug lacking adequate directions for use. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and possible consumer redress.

Aceva, LLC

FDA and FTC jointly issued a warning letter to Aceva, LLC (CEO Joseph Esposito) in September 2021 regarding their 'Sugar Balance' dietary supplement. The agencies found that website and social media claims — including assertions about improving insulin sensitivity, controlling blood glucose, and helping manage diabetes — caused the product to be classified as an unapproved new drug and a misbranded drug under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand, warning that unsubstantiated disease-treatment claims could result in civil penalties of up to $43,792 per violation and consumer refund obligations. Aceva was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure, injunction, or FTC legal action.

Radhanite, LLC d/b/a Curalife Ltd

FDA and FTC jointly issued a warning letter to Radhanite, LLC d/b/a Curalife Ltd (CEO Ron Elul) regarding their CuraLin dietary supplement, marketed on their website and social media. The regulators found that claims on the company's website, Instagram, and Facebook pages — including references to managing blood sugar, treating Type 2 Diabetes, and ingredient-level claims about insulin sensitivity — rendered CuraLin an unapproved new drug and a misbranded drug under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and possible consumer redress. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure, injunction, or civil penalties.

Live Good Inc.

FDA and FTC jointly issued a warning letter to Live Good Inc. (Miami, FL) regarding its 'Berry Gen Sugar Control' dietary supplement marketed via website, Facebook, Instagram, and Amazon. The product's marketing claims — including treating diabetes, controlling blood sugar and insulin levels, and protecting the pancreas — caused FDA to classify it as an unapproved new drug and misbranded product under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated disease-treatment claims, warning of potential civil penalties up to $43,792 per violation and possible consumer redress obligations.

Metamune Inc

FDA and FTC jointly issued a warning letter to Metamune Inc (doing business as Bodymune) in September 2021 regarding its 'DiabetesSupport' dietary supplement sold via its website, Facebook page, and Amazon storefront. The agencies determined that marketing claims positioning the product as a treatment, cure, or support for diabetes and pre-diabetes rendered it an unapproved new drug and a misbranded drug under the FD&C Act. The FTC separately issued a cease-and-desist demand, warning that unsubstantiated disease-treatment claims violate the FTC Act and could result in civil penalties of up to $43,792 per violation plus consumer refunds. Both agencies required written corrective action within fifteen working days.

Nuturna International LLC

FDA and FTC jointly issued a warning letter to Nuturna International LLC (Orlando, FL) regarding its 'Diabetic Support Formula' dietary supplement. The agencies found that website and Amazon product page claims — including customer testimonials and direct marketing language — positioned the product as intended to treat, cure, or mitigate diabetes and related conditions, making it an unapproved new drug under the FD&C Act and a misbranded drug for lacking adequate directions for use. The FTC separately demanded the company cease and desist from making unsubstantiated disease-treatment claims, warning that violations could result in civil penalties of up to $43,792 per violation, consumer refunds, injunctions, or administrative cease and desist orders.

Phytag Labs

FDA and FTC jointly issued a warning letter to Phytag Labs (George Rivera, Bee Cave, TX) regarding their 'GLUCOTYPE2' dietary supplement, which was marketed with claims that it could treat, prevent, or cure Type 2 diabetes and related conditions. The agencies determined the product constituted an unapproved new drug under the FD&C Act and was misbranded due to inadequate directions for use. The FTC simultaneously issued a cease-and-desist demand, warning that continued unsubstantiated disease claims could result in civil penalties of up to $43,792 per violation, injunctions, and consumer redress obligations.

Pharmaganics LLC

FDA and FTC jointly issued a warning letter to Pharmaganics LLC (CEO Tom Redmond III) regarding its 'Diabetes Doctor Pre-Diabetes' and 'Diabetes Doctor Blood Sugar 24 Hour' dietary supplement products sold via its website, Amazon, Walmart, Facebook, and Instagram. The products were found to bear disease-treatment claims — including preventing, treating, and mitigating Type 2 diabetes and insulin resistance — that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The FTC simultaneously issued a cease-and-desist demand for unsubstantiated efficacy claims, warning of civil penalties up to $43,792 per violation and potential consumer redress. Both agencies required written response within 15 working days.

McDaniel Water, LLC

FDA issued a warning letter to McDaniel Water, LLC (directors Gary McDaniel and Ruth Shields) regarding their product 'Black Indian Salve,' also marketed as 'Indian Herb,' 'X,' and 'Black Salve.' The product, which contains bloodroot and zinc chloride — known corrosive agents capable of causing tissue necrosis — was found to be an unapproved new drug marketed with disease-treatment and anti-cancer claims in violation of FD&C Act sections 505(a) and 301(d). FDA noted a prior 2019 warning letter to a related entity and a voluntary recall of a similar product, and warned that failure to address violations may result in seizure and injunction.

Fibromyalgia Treatment Group - FTG, LLC

FDA issued a warning letter to Fibromyalgia Treatment Group - FTG, LLC (James L. Sparling, Manager) in August 2021 for marketing four products—Fibrolief Support Formula, Nerve Renew, Neuro Boost Optimizer, and Immune Support—with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The websites made explicit claims about treating fibromyalgia, neuropathy, depression, cancer, diabetes, and other conditions without FDA approval, and falsely stated that their manufacturing facility was 'FDA approved.' FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure and injunction.

Je Dois Lavoir LLC

FDA issued a warning letter to Je Dois Lavoir LLC (CEO Sandra Orozco) regarding its '365 Skinny High Intensity' weight-loss product, which laboratory analysis confirmed contained undeclared sibutramine — a withdrawn prescription drug linked to increased risk of heart attack and stroke. The product was marketed as a natural dietary supplement but was deemed an unapproved new drug and misbranded drug under the FD&C Act due to drug-intent claims on the company's website and social media. FDA warned that failure to address violations could result in seizure and/or injunction, and the firm had already voluntarily recalled the product prior to the letter's issuance.

Genesis Nutrition Ultra Slim dba Genesis Ultra Slim

FDA issued a warning letter to Genesis Nutrition Ultra Slim dba Genesis Ultra Slim (Doral, FL) after laboratory analysis confirmed their 'Genesis Ultra Slim Gold' product contained undeclared sibutramine (a withdrawn prescription drug linked to heart attack and stroke risk) and phenolphthalein (a potential carcinogen). The product was marketed as a dietary supplement for weight loss via websites and social media, but FDA determined it constitutes an unapproved new drug and misbranded drug under the FD&C Act. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure and/or injunction.

1st Phorm LLC

FDA issued a warning letter to 1st Phorm LLC (CEO Andrew Frisella) on July 29, 2021, after reviewing the company's website and finding that two products — Whole Heart Cardiovascular Health Formula and Full-Mega Omega-3 Fish Oil — were marketed with disease-treatment claims that rendered them unapproved new drugs and misbranded drugs under the FD&C Act. Additionally, five products (MegaWatt V2, Thyro-Drive, 1-Db Overdrive Fastpack, 1-Db Goddess, and 1-Db Overdrive & Thyro-Drive) were found to be adulterated dietary supplements because they contained hordenine, a new dietary ingredient for which no required safety notification had been submitted to FDA. The letter demands written corrective action within 15 working days and warns that failure to comply may result in seizure and injunction.

Beeyoutiful.com, LLC

FDA issued a warning letter to Beeyoutiful.com, LLC (Steven M. Tallent) on July 12, 2021, after reviewing the company's website and finding that 26 dietary supplement products were marketed with disease-treatment and cure claims that legally classified them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. The claims spanned a wide range of serious conditions including cancer, diabetes, Alzheimer's, Ebola, AIDS, autism, and multiple sclerosis, among others. FDA also found that many products were misbranded because they lacked adequate directions for use for conditions requiring licensed practitioner supervision. The company was directed to respond within 15 working days with corrective steps, and was warned that failure to comply could result in seizure or injunction.

3RD Day Nutraceuticals, LLC

FDA issued a warning letter to 3RD Day Nutraceuticals, LLC (Bristol, CT) after reviewing its website in April 2021 and finding that four products — Immune Booster, Allergy Support, Inflammatory Response Support, and Revive & Recover — bore disease-treatment and drug-effect claims that caused them to be regulated as unapproved new drugs under the FD&C Act. The claims included antibacterial, antiviral, anti-inflammatory, histamine-suppression, and liver-damage-prevention language tied to specific ingredients, none of which had FDA approval for such uses. The products were also deemed misbranded for lacking adequate directions for use. FDA demanded a written response within 15 working days and warned that failure to comply could result in seizure or injunction.

Phoenix Nutritionals, Inc.

FDA issued a warning letter to Phoenix Nutritionals, Inc. (President Kaleo Steven Whiting) regarding eight dietary supplement products marketed on phoenixvitamins.com, healthyinformation.com, and Facebook. The agency found that disease-treatment claims on the websites — including claims related to cancer, diabetes, heart disease, arthritis, COVID-19, and other conditions — caused the products to be classified as unapproved new drugs under the FD&C Act. The products were also deemed misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Biomedical Research Laboratories, LLC

FDA issued a warning letter to Biomedical Research Laboratories, LLC (CEO Christopher Jacob) in July 2021 after reviewing the company's websites and social media, finding that six products — Calm Legs, Flexify, Collagen Peptides, Prohemia, Altitude RX, and Trimmunity — were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The claims included treating Restless Legs Syndrome, arthritis, anemia, acute mountain sickness, and immune conditions. FDA also found Calm Legs, Collagen Peptides, and Flexify to be misbranded because adequate directions for layperson use could not be written for prescription-level conditions. The company was required to respond within 15 working days and warned that failure to comply could result in seizure or injunction.

Quincy Bioscience Holding Company

The FTC and New York State Attorney General charged Quincy Bioscience, marketers of the dietary supplement Prevagen, with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is 'clinically shown' to work. The regulators alleged these claims lacked adequate scientific substantiation. The joint action represents a significant enforcement effort targeting deceptive health marketing of a widely advertised supplement.

Omega Wonders LLC.

FDA issued a warning letter to Omega Wonders LLC (Bonita Springs, FL) regarding its Cardia 7 Heart Health OMEGA 7 and Advanced Tear Health OMEGA 7 dietary supplement products. The agency found that website and Amazon marketing claims — including statements about reducing cholesterol, fighting inflammation, managing dry eye symptoms, and targeting atherosclerosis and diabetes — rendered the products unapproved new drugs under the FD&C Act. FDA also determined the products were misbranded for lacking adequate directions for use, and warned that failure to correct violations could result in seizure or injunction.

EU Natural Inc.

FDA and FTC jointly issued a warning letter to EU Natural Inc. (President Vinay Amin) regarding its dietary supplement products 'CONCEPTION Female Fertility Prenatal' and 'CONCEPTION MEN Male Fertility.' The products' website and Instagram marketing made disease-treatment claims — including treating PCOS, endometriosis, diabetes, cancer, anxiety, and infertility — that caused the products to be classified as unapproved new drugs and misbranded drugs under the FD&C Act. The FTC separately flagged the efficacy claims as potentially unsubstantiated and warned that violations could result in civil penalties of up to $43,792 per violation, consumer refunds, injunctions, or cease-and-desist orders.

Sal Nature LLC/FertilHerb

FDA and FTC jointly issued a warning letter to Sal Nature LLC/FertilHerb (Hind Tatni, Cheyenne, WY) regarding their 'FertilHerb for Women' dietary supplement. The product's website made claims that it could treat PCOS, ovulatory infertility, endometriosis, amenorrhea, luteal phase defect, and reduce miscarriage risk, causing FDA to classify it as an unapproved new drug and a misbranded drug lacking adequate directions for use. The FTC separately flagged the efficacy claims as potentially unsubstantiated by competent and reliable scientific evidence. The recipient was required to respond within 15 working days with corrective steps, and faces potential seizure, injunction, and civil penalties up to $43,792 per violation.

LeRoche Benicoeur dba ConceiveEasy

FDA and FTC jointly issued a warning letter to LeRoche Benicoeur dba ConceiveEasy (Mary Whittaker, Seaside, CA) regarding their 'ConceiveEasy' dietary supplement marketed for fertility. The product's website and social media made disease-treatment claims — including treating PCOS, endometriosis, luteal phase defect, ovarian cysts, and preventing miscarriage — that caused it to be classified as an unapproved new drug under the FD&C Act and a misbranded drug for lacking adequate directions for use. The FTC separately flagged the efficacy claims as potentially unsubstantiated by competent and reliable scientific evidence, warning of potential civil penalties up to $43,792 per violation. The recipient was required to respond within 15 working days with corrective steps, and failure to comply could result in seizure, injunction, or civil penalties.

Fertility Nutraceuticals LLC

FDA and FTC jointly issued a warning letter to Fertility Nutraceuticals LLC (New York, NY) regarding three products — CONFLAM-Forte™, FERTINATAL® DHEA, and OVOENERGEN™ CoQ10 — marketed on two websites. The regulators found that website and product-insert claims characterizing these supplements as reducing miscarriage risk, treating inflammatory diseases, improving IVF success, and addressing conditions like PCOS and autoimmune disease rendered them unapproved new drugs and misbranded drugs under the FD&C Act. The FTC separately flagged the efficacy claims as potentially unsubstantiated under the FTC Act, warning that deceptive disease-treatment claims could trigger civil penalties of up to $43,792 per violation plus consumer refunds. Both agencies required written corrective responses within 15 working days, and FDA warned that failure to comply could result in seizure or injunction.

NS Products, Inc.

NS Products, Inc. (doing business as NaturaCure) received a joint FDA/FTC warning letter in May 2021 for marketing their herbal dietary supplement as a treatment and cure for infertility disorders including PCOS, endometriosis, uterine fibroids, and tubal blockage. The FDA determined NaturaCure constitutes an unapproved new drug and misbranded drug under the FD&C Act due to disease-treatment claims made on their website. The FTC flagged the same efficacy claims as unsubstantiated and warned that continued violations could result in injunctions, cease-and-desist orders, and civil penalties up to $43,792 per violation, plus consumer refunds.

Great Lakes Gelatin Company

FDA issued a warning letter to Great Lakes Gelatin Company (President James Burkett) on May 10, 2021, after reviewing the company's website, social media, and YouTube channel and finding that marketing claims for its Collagen Hydrolysate, Keto Collagen + MCT, and Collagen Endurance Plus products established intended drug use — specifically for treating joint pain, osteoarthritis, osteoporosis, ulcerative colitis, leaky gut, rheumatoid arthritis, and cardiovascular conditions. FDA determined the products are unapproved new drugs under section 201(p) of the FD&C Act and misbranded under section 502(f)(1) for lacking adequate directions for use. The company was required to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Bio-Botanica, Inc./Nature’s Answer, Inc.

FDA issued a warning letter to Bio-Botanica, Inc./Nature's Answer, Inc. regarding their Coral Calcium dietary supplement, which declares cesium chloride as a dietary ingredient. FDA determined that cesium chloride is a new dietary ingredient for which no required pre-market notification was submitted, rendering the product adulterated under sections 402(f) and 413(a) of the FD&C Act. Additionally, FDA found no evidence of safety for cesium chloride as a dietary ingredient and cited animal and human reports of serious cardiac adverse events. The agency warned that failure to address these violations may result in seizure or injunction.

Quickwork LLC and Eric A. Nepute

St. Louis chiropractor Eric Anthony Nepute and his company Quickwork LLC were charged by the FTC in April 2021 for violating the COVID-19 Consumer Protection Act and the FTC Act. They deceptively marketed vitamin D and zinc products as scientifically proven to treat or prevent COVID-19. This was the first case in which the FTC sought civil penalties under the COVID-19 Consumer Protection Act.

Proper Nutrition Inc.

FDA issued a warning letter to Proper Nutrition Inc. (West Chester, PA) regarding four dietary supplement products — Colostrum 70/40, Intestive, Seacure, and SeaVive — whose website marketing claims established drug intent under the FD&C Act. The claims included treating wound healing, Crohn's disease, IBS, colitis, AIDS, chemotherapy side effects, and killing viruses and bacteria, rendering the products unapproved new drugs. FDA also found Seacure and SeaVive misbranded for lacking adequate directions for use, and warned that failure to correct violations may result in seizure or injunction.

Molecular BioLife International, Inc.

FDA issued a warning letter to Molecular BioLife International, Inc. (Sheldon, IA) regarding its products Shark 2 Collagen and Balanced Kollagen, sold at molecularbiolife.com. The company's website made extensive disease-treatment and cure claims — including treating cancer, arthritis, osteoporosis, and multiple organ diseases — that caused the products to be classified as unapproved new drugs under the FD&C Act. FDA also found the products misbranded because they lacked adequate directions for use for conditions requiring licensed practitioner supervision. The company was directed to respond within 15 working days with corrective steps, and FDA warned that failure to comply could result in seizure or injunction.

Unived Inc

FDA issued a warning letter to Unived Inc. (CEO Amit Mehta) regarding four dietary supplement products — Colox, CalDveg, B12+D3, and D3+K2-7 — sold on the company's website and Amazon. The agency found that marketing claims on both platforms characterized the products as intended to cure, mitigate, treat, or prevent diseases (including osteoporosis, anemia, heart disease, cancer, and neurological disorders), rendering them unapproved new drugs under the FD&C Act. Three of the four products were also deemed misbranded for lacking adequate directions for use. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Immune & Genetics Protocols, LLC

FDA issued a warning letter to Immune & Genetics Protocols, LLC (manager William Denizard-Flores) in March 2021 regarding their product 'Immune Bio Green Cell,' marketed via biogreencell.com and Facebook. The product's website and social media claims — including treating cancer, HIV/AIDS, autism, diabetes, Crohn's disease, and other serious conditions — caused FDA to classify it as an unapproved new drug and a misbranded drug under the FD&C Act. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.

Anna Health, LLC

FDA issued a warning letter to Anna Health, LLC (Tampa, FL) in March 2021 after reviewing the company's website and finding that four products — Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health — were marketed with disease-treatment claims that rendered them unapproved new drugs under the FD&C Act. The Immune Health product specifically claimed to protect against COVID-19, triggering urgent enforcement concern. FDA determined all four products were also misbranded for lacking adequate directions for use. The company was directed to respond within 15 working days with corrective steps, and was warned that failure to comply could result in seizure or injunction.

Duoc Thao Tre Xanh, LLC

FDA issued a warning letter to Duoc Thao Tre Xanh, LLC (Tampa, FL) in March 2021 after reviewing the company's website and finding that four products — Immune Health, Ganoderma Lucidum Red Reishi Mushroom, Papaya Leaf Extract, and Fucoidan — were marketed with disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. The claims included assertions that the products could treat cancer, diabetes, HIV, Alzheimer's disease, and COVID-19, none of which had FDA approval. FDA determined the products were also misbranded for lacking adequate directions for use, and demanded corrective action within 15 working days, warning that failure to comply could result in injunction or seizure.

Trippo International LLC

FDA issued a warning letter to Trippo International LLC (Newington, CT) regarding its 16-ounce Super Caffeine (Anhydrous) powdered dietary supplement. The agency determined the product is adulterated under 21 U.S.C. § 342(f)(1)(A)(i) because its labeling recommends a 200 mg serving size that cannot be accurately measured with common household tools, creating a significant or unreasonable risk of illness or injury given caffeine's potential toxicity at small overdose amounts. FDA warned that failure to address the violations could result in seizure or injunction, and required a written response within 15 working days.

Red's Kitchen Sink at Bourbon Street Ice

FDA issued a warning letter to Red's Kitchen Sink at Bourbon Street Ice (Kennesaw, GA) regarding four product lines — Pressure Be Gone, Cell Defense Shield, Bony-Barony Detox Tea, and Cell Fuel 102 (capsules, powder, and gel) — sold via its website, Facebook, and YouTube. The agency determined that disease-treatment claims on these platforms caused the products to be classified as unapproved new drugs under the FD&C Act, and that the products were also misbranded for lacking adequate directions for use. FDA additionally flagged unauthorized use of the FDA logo on Cell Fuel 102 packaging and demanded written corrective action within 15 working days, warning that failure to comply could result in seizure or injunction.

KDunn and Associates, P.A. dba HealthQuilt

FDA issued a warning letter to KDunn and Associates, P.A. dba HealthQuilt (Dr. Kimberly Dunn) following an August 2020 inspection of a clinical investigation studying an investigational drug for COVID-19 treatment, cure, and prevention. The firm conducted the study without submitting a required Investigational New Drug (IND) application, failed to maintain adequate drug disposition records, used informed consent forms containing prohibited exculpatory/liability-waiver language, and failed to retain required case history records including signed consent forms. FDA found the firm's corrective action responses inadequate and demanded a written response within 15 working days, warning that failure to address violations may result in regulatory action without further notice.

Clarke Pharmaceutical Manufacturing, Inc.

FDA issued a warning letter to Clarke Pharmaceutical Manufacturing, Inc. (Webster, TX) in February 2021 after reviewing the company's website and YouTube channel, finding that five products — OsteoBLAST®, Cell Block #19, High Potency Vitamin D3, Neupanex®, and Natural Progesterone Skin Cream — were marketed with disease-treatment and cure claims that rendered them unapproved new drugs under the FD&C Act. Notably, Cell Block #19 was promoted as able to mitigate or prevent COVID-19. FDA determined all five products were also misbranded for lacking adequate directions for use. The company was given 15 working days to respond with corrective steps, and FDA warned that failure to act could result in seizure or injunction.

American Global Health Group, LLC

FDA issued a warning letter to American Global Health Group, LLC (CEO Jonathan Jewett) in January 2021 regarding its AloeCure brand products sold at aloecure.com and promoted on Facebook. The agency determined that disease-treatment claims on the website and social media — including claims that products treat acid reflux, joint inflammation, arthritis, psoriasis, diabetes, and other conditions — caused the products to be classified as unapproved new drugs under the FD&C Act. FDA also found AloeCure Probiotic & Enzyme Blend and AloeCure VeraFlex to be misbranded because adequate directions for their intended uses cannot be written for laypersons. The company was required to respond within 15 working days and warned that failure to correct violations could result in seizure or injunction.

Entia Biosciences, Inc

FDA issued a warning letter to Entia Biosciences, Inc. (operating via totalnutraceutical.com) in January 2021 for marketing six mushroom-based dietary supplement products — including Lion's Mane, Antrodia, Maitake, Reishi, and two Cordyceps products — with disease treatment and prevention claims that caused them to be classified as unapproved new drugs under the FD&C Act. The website claims referenced anti-inflammatory effects, cancer-fighting properties, cholesterol reduction, blood sugar regulation, and recovery from chemotherapy, among others. FDA also found the products misbranded for lacking adequate directions for use. The letter demanded corrective action within 15 working days and warned that failure to comply could result in seizure and/or injunction.

A.S. Research, LLC (Synovia)

A.S. Research, LLC, marketers of the dietary supplement Synovia, settled FTC charges alleging they used deceptive tactics to mislead consumers into believing Synovia could treat arthritis and alleviate joint pain. The FTC found these claims unsubstantiated and in violation of consumer protection standards. As part of the settlement, the company was required to halt the deceptive marketing practices. In December 2020, the FTC announced it was returning nearly $775,000 to consumers harmed by the deceptively marketed product.

Whole Leaf Organics

Whole Leaf Organics (Marc Ching) was the subject of an FTC complaint in April 2020 resulting in a preliminary order. The California-based supplement marketer was barred from claiming his Vitamin C and herbal extract supplement could treat, prevent, or reduce the risk of COVID-19. The order also prohibited him from marketing three CBD-based products as effective cancer treatments, pending resolution of a parallel administrative case.

Marc Ching

Marc Ching, doing business as Whole Leaf Organics, was the subject of an FTC complaint and consent order for marketing a Vitamin C and herbal extract supplement as effective at treating, preventing, or reducing the risk of COVID-19, and for claiming that three CBD-based products were effective cancer treatments. The FTC issued a preliminary order in April 2020 barring these claims, and a final administrative order was approved in October 2020. The orders prohibit Ching from making unsubstantiated efficacy claims for both the COVID-19 supplement and the CBD cancer-treatment products.

NutraClick, LLC, et al.

NutraClick, LLC and its two principals were charged by the FTC in September 2020 for continuing deceptive marketing practices in violation of a prior 2016 FTC consent order. The company lured consumers with 'free' samples of nutritional supplements and beauty products, then enrolled them in recurring monthly charges without their consent — a negative option marketing scheme. The 2020 settlement bans the defendants from negative option marketing entirely and requires payment of more than $1 million in consumer redress.

Renaissance Health Publishing, LLC

Renaissance Health Publishing, LLC, a Florida-based company, was charged by the FTC for deceptively marketing its Isoprex supplement to older adults as a 'miracle cure' for pain and joint inflammation without substantiation. The FTC settlement bars the company from continuing to make these unproven claims. In September 2020, the FTC announced consumer refunds totaling more than $76,000 to buyers of the deceptively marketed product.

NatureCity, LLC

NatureCity, LLC, a Florida-based marketer of aloe vera-based supplements TrueAloe and AloeCran, settled FTC charges in October 2019 for making false and unsubstantiated claims that their products treated chronic pain, ulcerative colitis, diabetes, and acid reflux in seniors. The court order prohibits the company from making false or unsubstantiated health claims and required payment of $537,500. In May 2020, the FTC distributed over $470,000 in refund checks to affected consumers.

Health Center, Inc.

Nevada-based Health Center, Inc. (HCI) and its owner Peggy Pearce settled FTC charges in March 2020 over allegedly deceptive advertising for three 'cure-all' health and wellness products marketed to older consumers nationwide. The FTC's complaint alleged the advertising claims were deceptive. The resulting order prohibits HCI and Pearce from making such deceptive claims and imposes a partially suspended monetary judgment.

Global Community Innovations LLC, et al. (Geniux)

Global Community Innovations LLC and 15 co-defendants settled FTC charges in April 2019 for deceptively marketing cognitive-improvement supplements (Geniux, Xcel, EVO, Ion-Z) through sham news websites, fabricated clinical studies, and fraudulent celebrity and consumer endorsements. Affiliate marketers were also used to spread deceptive claims. The settlements permanently ban defendants from similar conduct, and in February 2020 the FTC distributed over $551,000 in refunds to defrauded consumers.

Leanspa, LLC, et al.

The FTC and State of Connecticut sued LeanSpa, LLC in December 2011 for using fake websites to deceptively market acai berry and 'colon cleanse' weight-loss products, and for misleading consumers about free trial offers that actually enrolled them in a $79.95 recurring monthly billing scheme that was difficult to cancel. LeanSpa settled in 2014, agreeing to cease deceptive practices and surrender assets for consumer redress. The FTC distributed over $3.7 million to more than 23,000 consumers in 2015, followed by a second round of $321,000 in redress checks in December 2019.

Vemma Nutrition Company

Vemma Nutrition Company was the subject of an FTC enforcement action alleging it operated an illegal pyramid scheme. The FTC determined that consumers lost money through the scheme and ordered consumer redress. As a result, the FTC mailed refund checks totaling more than $2.2 million to affected consumers.

XXL Impressions LLC / J2 Response L.L.P. / Synergixx, LLC

The FTC and Maine AG's office filed a complaint and reached three settlements with dietary supplement marketers — XXL Impressions LLC, J2 Response L.L.P., and Synergixx, LLC — for allegedly using deceptively formatted radio infomercials disguised as talk shows and print ads featuring fictitious endorsers to market supplements (CogniPrin and FlexiPrin) claiming to improve memory and reduce back and joint pain. The settlement orders bar the respondents from making similar deceptive claims and prohibit a wide range of deceptive marketing practices. The FTC issued consumer refunds for CogniPrin purchasers in April 2015 and for FlexiPrin purchasers in August 2019.

Nobetes Corp.

Nobetes Corp. and its officers marketed and sold a pill called Nobetes, claiming it treats diabetes, with advertising the FTC found to be false or unsubstantiated. A December 2018 settlement prohibited the company from making unsubstantiated health claims, using deceptive 'free trial' offers, billing consumers without consent, and misusing expert endorsements and testimonials. The order also required consumer refunds, and in August 2019 the FTC returned $60,791 to affected consumers.

Cure Encapsulations, Inc.

Cure Encapsulations, Inc. and its owner Naftula Jacobowitz settled FTC allegations that they made false and unsubstantiated efficacy claims for their garcinia cambogia weight-loss supplement. The FTC's complaint also alleged that the company paid a third-party website to write and post fake reviews on Amazon.com, marking the FTC's first case challenging a marketer's use of fake paid reviews on an independent retail website. The matter was resolved through a settlement agreement.

Crystal Ewing (Health Nutrition Products, LLC)

The FTC filed a federal lawsuit against Crystal Ewing and Health Nutrition Products, LLC, a dietary supplement marketer, for making misleading claims that its product could help treat and cure opiate addiction, including addiction to prescription pain medications and illegal drugs such as heroin. The enforcement action targeted unsubstantiated cure and treatment claims for a serious medical condition. The FTC sought to stop the deceptive marketing practices through federal court action.

NutriMost LLC

NutriMost LLC, a Pittsburgh-area weight loss program seller, was the subject of an FTC enforcement action resulting in consumer redress. The FTC mailed 3,483 refund checks totaling more than $1.95 million to consumers who purchased the NutriMost Ultimate Fat Loss System between October 1, 2012 and August 9, 2016. Each affected consumer received a refund of $560.54, indicating the FTC found the company's marketing claims for its fat loss system to be deceptive or unsubstantiated.

Anthony Dill, Staci Dill, Direct Alternatives and Original Organics LLC

The FTC, together with the Maine Attorney General's Office, took action against Maine-based sellers Anthony Dill, Staci Dill, Direct Alternatives, and Original Organics LLC for deceptively marketing weight-loss supplements. The enforcement resulted in a settlement that generated nearly $3.5 million in consumer redress, with 104,612 refund checks averaging $33.12 mailed to affected buyers. A related marketing company that created and disseminated advertisements for the weight-loss products was also named in the action.

Tarr Inc.

The FTC pursued enforcement action against Tarr Inc., a network of three individuals and 19 companies, for deceptive marketing of health products. The case resulted in consumer redress totaling more than $6 million distributed to approximately 227,995 affected consumers, with an average refund of $26.57 per consumer. The action reflects a broad deceptive-marketing finding across the Tarr Inc. enterprise.

Redwood Scientific Technologies, Inc.

The FTC brought a federal civil action against Redwood Scientific Technologies, Inc. in the Central District of California (Case No. 2:17-cv-07921) for deceptive and misleading conduct related to health and weight loss product marketing. The case, also linked to individual respondent Jason Cardiff, was filed under consumer protection authority and has since been closed. No specific flagged marketing claims or detailed enforcement action text were included in the available case record excerpt.

Mikey & Momo, Inc. (Aromaflage)

The FTC brought an action against Mikey & Momo, Inc. (doing business as Aromaflage) and its individual officers for allegedly making unsubstantiated health claims related to their fragrance/insect-repellent products. The matter was resolved through a Part 2 Consent Order (Docket C-4655), which typically requires the respondents to have competent and reliable scientific evidence before making health-related claims. No specific dollar penalty is stated in the available document text, but the consent order imposes ongoing compliance obligations on the company and its officers.

Telomerase Activation Sciences, Inc. and Noel Thomas Patton

Telomerase Activation Sciences, Inc. and its officer Noel Thomas Patton entered into an FTC consent order (C-4644) arising from FTC Matter 142-3103. The company marketed dietary supplements (notably TA-65) with claims related to telomerase activation and anti-aging benefits that the FTC found to be unsubstantiated. The consent order required the respondents to have competent and reliable scientific evidence before making health or efficacy claims and imposed compliance monitoring and recordkeeping obligations.

John Fowler

The FTC brought a federal court action in the Middle District of Florida against Tachht, Inc., Teqqi LLC, and individuals Colby Fox and Christopher Reinhold for deceptive and misleading conduct related to health claims and online advertising and marketing. The case (Civil Action No. 8:16-cv-01397) was filed under the FTC's consumer protection authority and involved health claims made to consumers online. The enforcement type is a federal injunction, indicating the FTC sought court-ordered relief. The record was last updated March 15, 2018, and the listed recipient John Fowler appears to be an associated party in the proceeding.

Marketing Architects, Inc.

The FTC and the State of Maine filed a federal injunction action against Marketing Architects, Inc. in the District of Maine (Case No. 2:18-cv-00050). The case involves consumer protection violations related to advertising and marketing, health claims, telemarketing, and billing practices. As a federal injunction enforcement action, the matter represents a critical regulatory intervention, though the full text provided does not detail the specific health claims or penalty amounts at issue.

CellMark Biopharma and Derek E. Vest

The FTC filed a federal lawsuit in the Middle District of Florida against CellMark Biopharma, LLC and its owner Derek E. Vest for making allegedly deceptive health claims in their advertising and marketing. The case was brought under consumer protection authority and resulted in a federal injunction proceeding. The full text of the complaint and specific flagged claims are not included in the provided document excerpt, but the enforcement type indicates a civil injunction action.

NextGen Nutritionals, LLC, Anna McLean, and Robert McLean

The FTC brought a federal injunction action in the Middle District of Florida against NextGen Nutritionals, LLC and related entities (Strictly Health Corporation, LLC and Cyber Business Technology, LLC), along with individual defendants Anna McLean and Robert McLean, for deceptive health claims in the marketing of nutritional supplements. The case, filed under FTC Matter No. 162-3176, resulted in a consent order addressing false or unsubstantiated health and efficacy claims. The enforcement action included federal injunctive relief against the defendants.

Sale Slash, LLC

The FTC brought a federal court action against Sale Slash, LLC, Purists Choice LLC, and associated individuals (Artur Babayan and Vahe Haroutounian) in the Central District of California. The case involved deceptive advertising and marketing practices related to health claims, endorsements, and online marketing. The enforcement action resulted in a federal injunction and consumer refunds, indicating the defendants made unsubstantiated or misleading health-related product claims to consumers.

Health Formulas, LLC, Doing Business As Simple Pure Nutrition

The FTC brought a federal court action in the District of Nevada against Health Formulas, LLC (d/b/a Simple Pure Nutrition) and dozens of related entities and individual defendants for deceptive marketing of dietary supplements and related products, including weight loss, men's health, and skin care items. The case involved unsubstantiated health claims, deceptive telemarketing, and unauthorized billing practices. The matter was resolved through FTC enforcement proceedings and included consumer refunds as a remedy.

Sunrise Nutraceuticals, LLC

The FTC brought a federal court action against Sunrise Nutraceuticals, LLC in the Southern District of Florida (Case No. 9:15-cv-81567) for deceptive health claims in the advertising and marketing of nutritional supplements. The case was tagged for consumer refunds, indicating a consumer redress outcome. The enforcement type was a federal injunction, reflecting a critical regulatory outcome against the company.

CellMark Biopharma, LLC & Lexium International LLC

The FTC brought a federal court action against CellMark Biopharma, LLC and Lexium International LLC in the Middle District of Florida for deceptive and misleading conduct related to weight loss products. The case was handled as a dual enforcement action with the DOJ under consumer protection and health care fraud frameworks. The matter was closed as of June 21, 2017. Specific marketing claims are not detailed in the available case summary, but the action centered on deceptive weight loss advertising.

Genesis Today, Pure Health, and Lindsey Duncan

The FTC brought a federal court action in the Western District of Texas against Genesis Today, Inc., Pure Health LLC, and Lindsey Duncan for deceptive health claims and endorsements related to dietary supplements. The case involved unsubstantiated health and efficacy claims in advertising and marketing materials. The matter was resolved through a federal injunction, and the enforcement tags indicate consumer refunds were part of the outcome. This is a critical enforcement action given the federal injunction and consumer redress components.

Mercola.com, LLC

The FTC brought a federal injunction action in the Northern District of Illinois against Mercola.com, LLC, Mercola.com Health Resources, LLC, and Dr. Joseph Mercola individually, concerning health claims made in the marketing of products sold through the Mercola.com platform. The case (FTC Matter 142-3210) was filed under the Consumer Protection and Health Claims enforcement categories. The available record does not include the full text of specific flagged marketing claims or detailed required actions beyond the federal injunction filing itself.

NPB Advertising, Inc., et al.

The FTC sued Florida-based NPB Advertising, Inc. and its principal Nicholas Scott Congleton for deceptively marketing the dietary supplement Pure Green Coffee using bogus weight loss claims and fake news websites. A U.S. district court issued a summary judgment of $30 million against Congleton and permanently barred him from the deceptive advertising practices at issue. In March 2025, the FTC distributed over $905,000 in refunds to consumers who purchased the product.

Supple LLC

The FTC filed a federal civil action in the Eastern District of Wisconsin against Supple LLC, Peter Apatow Jr., and Monita Poudyal (FTC Matter 142-3231, Civil Action 1:16-cv-1325). The case falls under consumer protection, health claims, and advertising/marketing enforcement, indicating the defendants made unsubstantiated health or efficacy claims for a dietary supplement product. The full text of the complaint and any consent order terms are not included in the provided excerpt, but the civil action filing signals a critical enforcement posture by the FTC.

Trudeau, Kevin, et al.

The FTC brought enforcement actions against Kevin Trudeau and associated entities (Shop America LLC, Robert Barefoot, and others) in two consolidated cases in the Northern District of Illinois. The cases involved deceptive health claims and advertising practices related to consumer products. The enforcement resulted in consumer refunds as a key remedy, reflecting the FTC's determination that consumers were harmed by the defendants' misleading marketing. The matter was last updated in September 2016, indicating ongoing or final resolution of consent order terms.

COORGA Nutraceuticals Corp. (Grey Defence)

The FTC brought a federal injunction case in the District of Wyoming against COORGA Nutraceuticals Corp. and its principal Garfield Coore for their 'Grey Defence' product. The action, filed as civil case 15-CV-72-S, alleged unlawful health claims in the marketing of a nutraceutical supplement. The case was resolved under a federal injunction, consistent with FTC enforcement of unsubstantiated health and advertising claims for dietary supplements.

POM Wonderful LLC and Roll Global LLC

The FTC brought an enforcement action against POM Wonderful LLC, Roll Global LLC, and individual officers Stewart A. Resnick, Lynda Rae Resnick, and Matthew Tupper for deceptive health claims made in advertising for POM Wonderful pomegranate juice and related products. The case centered on unsubstantiated claims that the products could treat, prevent, or reduce the risk of heart disease, prostate cancer, and erectile dysfunction. The matter resulted in a consent order requiring the company to possess competent and reliable scientific evidence before making disease-related health claims in future advertising.

Lunada Biomedical, Inc.

The FTC brought a federal court action against Lunada Biomedical, Inc. and individual defendants Donna Kasseinova, Roman Trunin, and Emil Arutyunov in the Central District of California. The case involved consumer protection violations related to advertising, marketing, health claims, and endorsements for the company's products. The matter resulted in a federal injunction proceeding. No specific flagged claim verbatim text or detailed required-actions language is available in the provided document excerpt.

POM Wonderful LLC, et al.

POM Wonderful LLC and related entities were respondents in an FTC Part 3 administrative proceeding (Docket No. 9344) that was appealed to the U.S. Circuit Court of Appeals for the D.C. Circuit (Civil Action No. 13-1060). The case centered on health claims made in POM Wonderful's advertising for its pomegranate juice and supplement products. The FTC challenged the substantiation behind disease-treatment and prevention claims, and the matter proceeded through administrative adjudication and federal appellate review.

HCG Diet Direct, LLC

The FTC brought a federal civil action in the District of Arizona against HCG Diet Direct, LLC and its principal Clint Ethington for deceptive health and weight-loss marketing claims related to HCG (human chorionic gonadotropin) diet products. The case (FTC Matter 122-3192, Civil Action 2:14-cv-00015-NVW) falls under the FTC's Consumer Protection and Health Claims enforcement priorities. The limited case-proceeding record provided does not include verbatim marketing copy or a detailed consent order, but the filing of a federal civil action indicates a critical enforcement posture consistent with FTC actions against unsubstantiated HCG weight-loss claims.

Solace International, Inc.

The FTC filed a federal civil action in the District of Nevada against Solace International, Inc., Bioscience Research Institute LLC, and individual Aaron Lilly for deceptive health claims and marketing practices. The case involved consumer protection violations related to advertising, health claims, and endorsements. As a court-filed complaint, this represents a formal enforcement action seeking injunctive and monetary relief against the defendants.

NourishLife, LLC

The FTC filed a federal civil action in the Northern District of Illinois against NourishLife, LLC and its principal Mark Nottoli (FTC Matter 132-3152, Civil Action 1:15-cv-00093) for deceptive health claims and marketing practices related to their nutritional supplement products, with the case tagged under Consumer Protection, Health Claims, and Endorsements/Influencers/Reviews. The enforcement action targeted advertising directed at children and involved unsubstantiated health claims. As a federal court case, this represents a critical enforcement action with potential for civil penalties, injunctions, and consumer redress.

Angel Sales, Inc.

The FTC filed a federal lawsuit in the Northern District of Illinois against Angel Sales, Inc. (also doing business as Kagan Unlimited), Robert Engel, and Laura Engel for violations related to health claims in advertising and marketing. The case, filed August 20, 2015, was pursued as a federal injunction action under civil action number 1:15-cv-06542. The limited public record available does not specify the exact marketing claims at issue, but the matter was categorized under consumer protection, advertising and marketing, and health claims enforcement. The FTC sought injunctive relief against the defendants.

Brain Research Labs, LLC

The FTC filed a federal lawsuit in the Central District of California against Brain Research Labs LLC and related entities (Keyview Labs, 20/20 Brain Power Partners, MedHealth Direct, and individual defendants George/Josh Reynolds and John Arnold) for deceptive health claims related to brain or cognitive supplement products. The case was brought under consumer protection and advertising/marketing health claims enforcement. As a federal injunction action, the matter carries the potential for injunctive relief, civil penalties, and consumer redress.

Rise-N-Shine, LLC (Go Away Gray)

The FTC brought a federal injunction case in the District of New Jersey against Rise-N-Shine, LLC (maker of 'Go Away Gray' supplement) and its principal Cathy Beggan. The action targeted unsubstantiated health claims made in the marketing of the Go Away Gray dietary supplement, which purported to reverse or prevent gray hair. The case was filed as a federal injunction, indicating the FTC sought court-ordered relief to stop the allegedly deceptive advertising practices.

GetAwayGrey, LLC

The FTC brought a federal injunction case in the District of South Carolina against GetAwayGrey, LLC and its principal Robin Duner-Fenter for allegedly making unsubstantiated health claims in advertising and marketing. The case falls under consumer protection and health claims enforcement. The matter resulted in a federal injunction proceeding, indicating the FTC sought court-ordered relief against the defendants. Specific marketing claims and final penalty amounts are not detailed in the available case summary.

Focus Education, LLC

The FTC brought an enforcement action against Focus Education, LLC, Michael Apstein, and John Able (FTC Matter 122-3153) resulting in a Part 2 Consent Order finalized April 9, 2015. The case involved advertising and marketing of products with health claims targeting children. The consent order resolved allegations of deceptive health and efficacy claims in the company's marketing. Full claim details and penalty amounts are not available in the provided document excerpt.

Lane Labs-USA, Inc., et al.

The FTC brought a civil action in the District of New Jersey against Lane Labs-USA, Inc., Cartilage Consultants, Inc., and individuals I. William Lane and Andrew J. Lane for deceptive health claims in the marketing of their dietary supplement products. The case, filed under FTC Matter No. 982-3558, involved consumer protection and advertising violations related to unsubstantiated health claims. The matter resulted in a consent order resolving the FTC's allegations. Full claim and penalty details are contained in the underlying court record (Civil Action No. 00CV3174).

7734956 Canada Inc. (Double Shot Weight Regulator)

The FTC brought a federal court action against 7734956 Canada Inc. (operating as Double Shot Weight Regulator, Meilleuers Sélections Du Globe, and Freedom Center Against Obesity) and individual defendant Manon Fernet for deceptive health and weight-loss marketing claims. The case, filed in the District of Maryland, was pursued as a federal injunction under the FTC's consumer protection authority. The enforcement action targeted unsubstantiated advertising claims related to a weight-loss product. The outcome involved federal injunctive relief against the defendants.

Kevin Wright; HCG Platinum, LLC; et al.

The FTC filed a federal civil action in the District of Utah against Kevin Wright, HCG Platinum, LLC, and Right Way Nutrition, LLC, along with several relief defendants, for deceptive health and weight-loss claims related to HCG-branded dietary supplement products. The case (FTC Matter 122-3193) centers on unsubstantiated efficacy and weight-loss claims made in the marketing of HCG Platinum products. The FTC sought injunctive relief and consumer redress against the defendants and disgorgement from the relief defendants who allegedly received proceeds from the scheme.

Wacoal America, Inc.

Wacoal America, Inc. was the subject of an FTC consent order finalized in December 2014 concerning unsubstantiated health claims in its advertising and marketing. The matter (FTC File No. 132-3095) was resolved through a Part 2 Consent, indicating the company made claims about its products that the FTC found lacked adequate substantiation. The full text of the specific claims and required actions is not available in the provided document excerpt, but the enforcement type indicates a formal consent agreement was reached.

Sensa Products, LLC, et al.

The FTC brought an action against Sensa Products, LLC and related defendants — including company executives and endorser Dr. Alan R. Hirsch — in the Northern District of Illinois for deceptive health and weight-loss claims. The case involved unsubstantiated advertising claims that Sensa's sprinkle product caused weight loss. The matter resulted in a consent order requiring consumer refunds as a form of redress.

John Matthew Dwyer III

The FTC brought an enforcement action against John Matthew Dwyer III (also known as Matthew Dwyer) under a Part 2 consent order finalized October 24, 2014. The matter involved consumer protection concerns related to advertising, marketing, and health claims. The full text of the consent order is not provided, but the case classification indicates deceptive or unsubstantiated health marketing claims triggering a formal FTC consent proceeding.

HealthyLife Sciences, LLC

HealthyLife Sciences, LLC was the subject of an FTC consent order finalized on October 24, 2014 (Matter No. 122-3287). The case involved consumer protection concerns related to advertising, marketing, and health claims. As a Part 2 Consent, the order reflects a formal resolution of FTC charges, though the full text of specific claims and required actions is not available in the provided document excerpt.

Norm Thompson Outfitters, Inc.

Norm Thompson Outfitters, Inc. was the subject of an FTC consent order (Matter No. 132-3094) finalized in October 2014. The case involved consumer protection concerns related to advertising, marketing, health claims, and endorsements. The full text of the document is minimal and does not specify the exact product claims or required corrective actions beyond the consent order framework.

Lornamead, Inc.

The FTC brought an action against Lornamead, Inc. (Matter No. 122-3255) concerning advertising and marketing practices, with a focus on health claims and children. The limited available text does not specify the exact marketing claims or products at issue, but the matter was resolved as a consent order finalized on September 17, 2014. No specific penalty amounts or detailed corrective actions are discernible from the provided document excerpt.

Applied Food Sciences, Inc.

The FTC filed a federal court action in the Western District of Texas against Applied Food Sciences, Inc. (FTC Matter 142-3054) for allegedly making unsubstantiated health claims in its advertising and marketing. The case falls under the FTC's Consumer Protection mandate targeting deceptive health claims. The full text of the complaint and specific claims are not detailed in the provided excerpt, but the matter proceeded as a formal federal court case, indicating a critical enforcement posture.

i-Health and Martek

The FTC brought an enforcement action against i-Health, Inc. and Martek Biosciences Corp. regarding health claims made in advertising and marketing for their consumer products. The matter was resolved through a Part 2 Consent Order, indicating the companies agreed to settle FTC allegations related to unsubstantiated health claims. The consent order required the companies to have competent and reliable scientific evidence before making future health-related marketing claims.

Fitness Brands, Inc., et al.

The FTC brought a civil action in the Southern District of Florida against Fitness Brands, Inc. and related entities, along with individual defendants including Michael Casey, David Brodess, Tara Borakos, and Jennifer Nicole Lee, concerning deceptive health and fitness marketing claims. The case, filed under FTC Matter 102-3047, also named The Reader's Digest Association, Inc. as a relief defendant, suggesting proceeds from the alleged deceptive practices flowed through that entity. The enforcement action falls under the FTC's Bureau of Consumer Protection and involves advertising, marketing, endorsements, and health claims. The full text of the complaint and specific flagged claims are not reproduced in the provided document excerpt.

Genelink, Inc.

Genelink, Inc. (also doing business as Genelink Biosciences, Inc.) was the subject of an FTC consent order finalized in May 2014. The FTC challenged the company's marketing claims that its nutritional supplements, purportedly customized based on genetic testing, could address specific health conditions or genetic deficiencies. The consent order resolved allegations of unsubstantiated health and efficacy claims as well as data security failures related to the handling of consumers' sensitive genetic and personal information. The matter resulted in a consent order imposing compliance monitoring, recordkeeping, and restrictions on future advertising claims.

foru™ International Corporation

The FTC brought an action against foru™ International Corporation (formerly Genewize Life Sciences, Inc.) related to health claims in its advertising and marketing practices. The matter, docketed as C4457, resulted in a consent order addressing consumer protection concerns around health-related marketing claims. The full text of the document is limited, but the case tags indicate violations related to health claims and advertising. No specific civil penalties or dollar amounts are stated in the available record.

Wellness Support Network, Inc., et al.

The FTC brought a federal civil action in the Northern District of California against Wellness Support Network, Inc. and its officers Robert and Robyn Held for deceptive health claims in the marketing of their dietary supplement products. The case (10-CV-4879) alleged that the defendants made unsubstantiated claims about their products' ability to treat or manage diabetes-related conditions. The matter was filed under FTC consumer protection and advertising/marketing authority targeting false health claims.

Central Coast Nutraceuticals, Inc.

The FTC brought a federal court action in the Northern District of Illinois against Central Coast Nutraceuticals, Inc. and related entities and individuals — including iLife Health and Wellness, LLC, Simply Naturals, LLC, Fit for Life, LLC, Health and Beauty Solutions LLC, Graham D. Gibson, and Michael A. McKenzy — for deceptive health claims in the marketing of dietary supplements. The case falls under the FTC's consumer protection and health claims enforcement program targeting online advertising and marketing. The proceeding reflects the FTC's ongoing scrutiny of unsubstantiated efficacy and health claims made for nutraceutical products sold online.

Relief-Mart, Inc

The FTC brought an action against Relief-Mart, Inc. in November 2013 (Matter No. 122-3128) concerning advertising and marketing practices, with the case tagged under Health Claims and Environmental Marketing. The available document text is minimal and does not specify the exact claims or products at issue, nor does it detail specific penalties or corrective actions beyond the consent order framework. Based on the FTC tags of 'Health Claims' and 'Advertising and Marketing,' the matter likely involved unsubstantiated health or environmental benefit claims in product marketing.

Iovate Health Sciences USA, Inc.

The FTC brought a federal civil action against Iovate Health Sciences USA, Inc. and related entities in the Western District of New York (Case No. 10-CV-587) for deceptive health and advertising claims related to their consumer products. The case, filed under FTC Matter No. 072-3187, involved allegations of false or unsubstantiated health claims in the marketing of dietary supplements. The proceeding resulted in a consent order requiring corrective actions, consistent with FTC enforcement of substantiation standards for health-related advertising.

Beony International LLC, et al.

The FTC brought a civil action in the Northern District of Illinois against Beony International LLC, Mario Milanovic, and Cody Adams for deceptive advertising and marketing practices related to health claims. The case, filed under civil action number 111-cv-02448, involved consumer protection violations concerning endorsements, health claims, and online advertising. The FTC's action targeted allegedly false or unsubstantiated health-related marketing claims made by the defendants. The matter was resolved through FTC enforcement proceedings.

ABCSP, Inc.

The FTC brought an enforcement action against ABCSP, Inc. in a consent order finalized December 3, 2012, concerning health claims made in advertising and marketing. The matter (FTC File No. 112-3168) falls under consumer protection and health claims enforcement. The full text of the complaint and order details are not provided in the available excerpt, but the consent order indicates the FTC found the company's health-related advertising claims to be deceptive or unsubstantiated. As a consent order, this represents a critical enforcement outcome requiring compliance with FTC standards.

Walgreen Co., also d/b/a Walgreens

The FTC filed a federal court action against Walgreen Co. (d/b/a Walgreens) in the Northern District of Illinois under FTC Matter No. 092-3134. The case involved consumer protection concerns related to advertising and marketing of health claims. The proceeding was last updated November 1, 2012, but the full text of the complaint, specific flagged claims, and required enforcement actions are not included in the provided document excerpt.

Circa Direct LLC, and Andrew Davidson,FTC

The FTC brought a civil action in the District of New Jersey against Circa Direct LLC and its principal Andrew Davidson (FTC Matter 112-3059) for deceptive advertising and marketing practices involving health claims. The case falls under consumer protection, advertising and marketing, endorsements, and health claims categories. The limited available text does not specify the exact products or verbatim marketing claims, but the FTC's filing of a civil action indicates serious violations warranting a critical severity rating. The case was filed in federal court, signaling potential civil penalties or injunctive relief.

Coleadium, Inc., also d/b/a Ads4Dough, and Jason Akatiff

The FTC brought a civil action in the Northern District of Illinois against Coleadium, Inc. (d/b/a Ads4Dough) and Jason Akatiff related to consumer protection violations involving health claims, endorsements, and online advertising and marketing. The case (Civil Action No. 112-cv-06964) centers on deceptive advertising practices including unsubstantiated health claims promoted through an affiliate marketing network. The full text available is limited, but the matter falls under FTC enforcement of health claim and endorsement rules in digital advertising.

RMB Group, LLC, et al.

The FTC filed a federal civil action in the Northern District of California against RMB Group, LLC, Howard Brenner, and Bruce Brenner (Case No. CV12-4632 EDL) for violations related to health claims in advertising and marketing. The case falls under consumer protection and health claims enforcement. The full text of the complaint and specific marketing claims are not detailed in the provided document excerpt, but the FTC's filing of a federal lawsuit indicates serious alleged violations. The matter was assigned FTC File Number 1123127.

Jason Pharmaceuticals, Inc.

Jason Pharmaceuticals, Inc. was the subject of an FTC enforcement action (Docket No. C-3392, Civil Action No. 112-cv-01476) brought by the United States. The case involved consumer protection concerns related to advertising, marketing, and health claims. The limited available text does not specify the exact claims or penalties, but the civil action filing indicates a formal enforcement proceeding consistent with critical-level regulatory action.

Dr. Clark Research Association, Dr. Clark Behandlungzentrum GMbH, d/b/a Dr. Clark Zentrum, and David P. Amrein

The FTC brought an action against Dr. Clark Research Association, Dr. Clark Behandlungzentrum GmbH (d/b/a Dr. Clark Zentrum), and David P. Amrein, along with related defendants including National Urological Group and Hi-Tech Pharmaceuticals, concerning deceptive marketing of health and dietary supplement products. The case record (FTC Matter 022-3165) reflects a formal enforcement proceeding. The full text of the document references multiple corporate and individual defendants associated with weight loss and supplement marketing claims. The outcome is consistent with FTC consent order or injunctive enforcement typical of critical-severity supplement marketing cases.

NBTY, Inc., et al.

The FTC brought an action against NBTY, Inc., Naturesmart LLC, and Rexall Sundown, Inc. regarding health claims made in the marketing of dietary supplements. The case, filed under FTC Matter/File Number 1023080, resulted in a consent order addressing deceptive advertising practices related to children's health claims and supplement efficacy. The consent order required the respondents to substantiate health claims and prohibited unsubstantiated or misleading marketing representations going forward.

IMM Interactive, Inc.

The FTC brought a civil action against IMM Interactive, Inc. (formerly Intermark Communications, Inc., also doing business as COPEAC and Intermark Media), a New York corporation, in the Northern District of Illinois. The case involved consumer protection violations related to advertising and marketing, specifically health claims and endorsements in online advertising. The matter was filed under FTC case number 102-3232 and civil action number 111-cv-02484. The document reflects a formal FTC enforcement proceeding, consistent with a consent order or judgment outcome.

Coulomb Media, Inc., et al.

The FTC brought a civil action against Coulomb Media, Inc. and its officer Cody Low (also known as Joe Brooks) in the Eastern District of Michigan. The case falls under consumer protection, advertising and marketing, endorsements/influencers/reviews, and health claims categories. The limited available text does not specify the exact marketing claims at issue, but the FTC's involvement and civil action filing indicate enforcement related to deceptive health-related advertising or endorsement practices. The matter was filed under FTC case number 112-3072.

DLXM LLC, et al.

The FTC filed a civil action in the Eastern District of New York against DLXM LLC (also doing business as DLX Marketing) and its officer Michael Volozin for allegedly deceptive health claims in advertising and marketing. The case (FTC Matter 112-3061, Civil Action CV 11-1889) falls under consumer protection, advertising and marketing, and health claims enforcement. The full text available is limited, so specific flagged claims and required actions cannot be extracted from the provided record.

Ambervine Marketing LLC, et al.

The FTC filed a civil action in the Northern District of Illinois against Ambervine Marketing LLC, Encastle Inc., and individual Zachary S. Graham for deceptive advertising and marketing practices involving health claims. The case, filed January 25, 2012, falls under FTC consumer protection authority covering health claims, endorsements, and online advertising. The full text of the complaint and specific marketing claims are not detailed in the available document excerpt, but the matter was pursued as a federal civil action indicating serious regulatory concern.

Ricardo Jose Labra, individually, Defendant

The FTC brought a civil action in the Northern District of Illinois against Ricardo Jose Labra individually (FTC Matter 112-3088, Civil Action 111-cv-02485) related to consumer protection violations involving advertising and marketing, health claims, and endorsements in online advertising. The case was filed on January 25, 2012. The available document excerpt does not provide sufficient detail on specific marketing claims or final enforcement outcomes beyond the case filing.

Vaughn, Tanner Garrett, individually and d/b/a Lead Expose, Inc., and Uptown Media, Inc.

The FTC brought a civil action in the Western District of Washington against Tanner Garrett Vaughn, individually and doing business as Lead Expose, Inc., and Uptown Media, Inc., related to advertising and marketing practices involving health claims, endorsements, and online marketing. The case (FTC Matter 112-3067, Civil Action 211-cv-00630-RAJ) falls under consumer protection enforcement focused on deceptive health claims and endorsement practices. The full text of the document provides only case metadata without detailed claim language or specific enforcement outcomes.

Dunlevy, Charles

The FTC brought a civil action against Charles Dunlevy individually in the Northern District of Georgia (Case No. 111-cv-01226-TWT) under FTC Matter 112-3077. The case involves consumer protection concerns related to advertising and marketing, specifically health claims, endorsements, and online advertising. The full text of the proceeding does not include specific verbatim marketing claims or detailed enforcement actions beyond the filing of the civil action.

BuyExclusive.Net (Gene Kim), U.S.

The FTC brought a civil action in the Eastern District of New York against Gene Kim, individually and doing business as BuyExclusive.Net, for violations related to health claims in advertising and marketing. The case (FTC Matter 112-3043, Civil Action 111-cv-05723-DLI-RER) was filed on November 28, 2011. The full text of the document provides only case metadata without detailed claim descriptions or specific enforcement outcomes. Based on the FTC's consumer protection and health claims tags, the action likely involved unsubstantiated health or product efficacy claims made through the BuyExclusive.Net platform.

Stella Labs, LLC, and Neutraceuticals International, LLC, FTC

The FTC filed a federal civil action in the District of New Jersey against Stella Labs, LLC, Nutraceuticals International, LLC, and several individual officers and employees, including David J. Romeo, Deborah B. Vickery, V. Craig Payton, and Zoltan Klivinyi. The case (FTC Matter 082-3130) concerns consumer protection violations related to advertising, marketing, and health claims for nutritional supplement products. As a federal court action, the proceeding carries the potential for injunctive relief, civil penalties, and consumer redress. The limited full text available does not specify the verbatim marketing claims or the exact enforcement remedies ordered, but the FTC's filing under its consumer protection authority signals serious alleged violations.

Finkel, Andrew N., Individually

The FTC brought an action against Andrew N. Finkel individually (Matter No. 102-3206) related to health claims made in advertising and marketing, resulting in a consent order finalized October 25, 2011. The case was handled by the Office of Technology Research and Investigation and involved consumer protection concerns around health-related advertising and online marketing. The full text of the consent order is not provided, so specific flagged claims and enforcement action details cannot be extracted verbatim. The consent order classification indicates a formal resolution with binding compliance obligations.

Gemtronics, Inc., and William H. Isely, individually and as the owner of Gemtronics, Inc.

The FTC brought an enforcement action against Gemtronics, Inc. and its owner William H. Isely concerning health claims made in the company's advertising and marketing materials. The matter (FTC Docket No. 9330) falls under consumer protection and health claims enforcement. The limited text available does not specify the exact claims or final penalties, but the formal docket proceeding indicates a contested or consent-order-level action typical of critical FTC enforcement.

QT, Inc.; Q-Ray Company, et al.

The FTC brought a federal civil action against QT, Inc., Q-Ray Company, Bio-Metal, Inc., and associated individuals (Que Te Park and Jung Joo Park) for deceptive health claims made in marketing the Q-Ray ionized bracelet. The case centered on unsubstantiated claims that the bracelet provided pain relief and other health benefits. The FTC pursued enforcement through federal court, resulting in a significant judgment against the defendants for consumer redress.

Dannon Company, Inc., The

The FTC brought an enforcement action against The Dannon Company, Inc. regarding deceptive health claims made in advertising for its probiotic yogurt products, including Activia and DanActive. Dannon made unsubstantiated claims that these products provided specific digestive and immune health benefits, including reducing the likelihood of getting a cold or flu. The consent order required Dannon to cease making such claims without competent and reliable scientific evidence and to pay $21 million in consumer redress.

Nestlé HealthCare Nutrition, Inc.

The FTC brought an action against Nestlé HealthCare Nutrition, Inc. in a consent order finalized January 18, 2011. The matter concerned advertising and marketing claims, with a focus on health claims directed at children. The consent order resolved the FTC's concerns about unsubstantiated or misleading health-related marketing claims made by Nestlé HealthCare Nutrition. The full text of the document is limited, but the case is categorized under Consumer Protection, Advertising and Marketing, Children, and Health Claims.

Telebrands Corp.

The FTC brought a federal court action in the District of New Jersey against Telebrands Corp., TV Savings LLC, and Ajit Khubani (individually and as president/sole member of the entities), along with relief defendant Poonam Khubani, over deceptive health claims in advertising and marketing. The case (D-9313 / 2:07-cv-3525) falls under the FTC's Consumer Protection and Health Claims enforcement areas. The full text of the proceeding entry is minimal, so specific flagged claims and remedial actions are not enumerated in the provided document.

Mark Dreher, Ph.D.

The FTC brought an enforcement action against Mark Dreher, Ph.D. in matter number 082-3122, resulting in a consent order finalized on November 16, 2010. The case falls under the FTC's Bureau of Consumer Protection and involves advertising, marketing, endorsements, and health claims. The limited available text does not specify the exact marketing claims at issue, but the matter is categorized under health claims and endorsements, suggesting Dreher made or facilitated unsubstantiated health-related promotional statements. A consent order was issued as the resolution of the proceeding.

XACTA 3000, Inc., et al.

The FTC filed a federal civil action in the District of New Jersey against XACTA 3000, Inc. and its officers Baruch Levin and Yehuda Levin (a/k/a Juda Levin) for deceptive health claims in advertising and marketing. The case (09-CV-0399) falls under FTC Matter 082-3170/X090021 and involves consumer protection violations related to health claims. The limited public record available does not specify the exact marketing claims or final penalty amounts, but the filing of a federal civil action indicates a critical enforcement posture.

Direct Marketing Concepts, Inc., et al.

The FTC brought a federal court action against Direct Marketing Concepts, Inc. and related entities and individuals for deceptive health claims in their advertising and marketing of consumer health products. The case, filed in the U.S. District Court for the District of Massachusetts, involved multiple defendants including corporate entities and individual principals. The matter was resolved via a consent order entered October 21, 2010, reflecting the FTC's determination that the defendants' health-related marketing claims were false or unsubstantiated. As a consent order, this represents a critical enforcement outcome with binding legal obligations on the defendants.

Rite Aid Corporation

The FTC brought a federal court action against Rite Aid Corporation in the Middle District of Pennsylvania (FTC Matter No. 072-3236) concerning deceptive health claims in advertising and marketing. The case falls under the FTC's Consumer Protection mandate targeting misleading health claims. The full text of the proceeding is limited, but the matter was filed in federal court, indicating a formal enforcement action rather than an administrative complaint. The outcome details are not provided in the available document excerpt.

Kellogg Company

The FTC brought an action against Kellogg Company regarding health claims made in its advertising and marketing, particularly concerning children. The matter (File No. 082-3145) resulted in a consent order finalized on June 3, 2010. The case centered on unsubstantiated health claims in Kellogg's consumer-facing marketing. The full text provided is minimal, so specific flagged claims and enforcement actions cannot be extracted verbatim from the supplied document.

Improvita Health Products, Inc., et al.

The FTC brought a civil action in the Northern District of Ohio against Improvita Health Products, Inc. and two of its former officers, Thomas B. Klamet and Daniel P. Kohler, for allegedly making deceptive health claims in their advertising and marketing. The case (Civil Action No. 109-CV-00858) was filed under the FTC's consumer protection authority targeting unsubstantiated health claims. The full text of the proceeding entry is limited, but the matter number and court filing indicate formal enforcement action was pursued against the company and its individual officers.

Lance Thomas Atkinson, Inet Ventures Pty Ltd., et al.

The FTC brought a federal court action against Lance Thomas Atkinson, Inet Ventures Pty Ltd., and associated entities for deceptive online advertising and marketing of health-related products. The case, filed in the Northern District of Illinois (08-CV-5666), involved unsubstantiated health claims made through online advertising channels. The matter falls under the FTC's consumer protection and health claims enforcement priorities, targeting an international network of defendants including Australian, Delaware, and Cyprus-registered entities.

Quebec, Inc. also d/b/a Med Provisions, et al.

The FTC brought a federal civil action in the Northern District of Ohio against 9107-4021 Quebec, Inc. (also doing business as Med Provisions and Pronto Meds) and its officers Sameer Malhotra and Pooja Malhotra for deceptive health claims and telemarketing practices. The case involved consumer protection violations related to advertising, marketing, and health claims. As a federal court action, the matter carries the hallmarks of a critical enforcement proceeding with potential for injunctive relief and civil penalties.

Warshak, Steve; Berkeley Premium Nutraceuticals, Inc., Lifekey, Inc., Warner Health Care, Inc., and Wagner Nutraceuticals, Inc., et al.

The FTC brought an enforcement action against Steve Warshak, Berkeley Premium Nutraceuticals, Inc., and related entities for deceptive marketing practices related to dietary supplements. The case involved unsubstantiated and misleading claims made in the marketing of products such as Enzyte. Relief defendants including family members and a trustee were named, indicating the FTC sought to recover ill-gotten gains transferred to third parties. The matter resulted in a formal FTC proceeding with injunctive and monetary relief sought.

Spear Systems, Inc., et al.

The FTC brought a civil action in the Northern District of Illinois against Spear Systems, Inc. and individual defendants Bruce Parker, Lisa Kimsey, and Xavier Ratelle (doing business as eHealthyLife.com) for deceptive health claims in advertising and marketing. The case (FTC Matter 072-3050, Civil Action 07C-5597) falls under consumer protection, advertising and marketing, health claims, and online advertising. The full text of the complaint and specific marketing claims are not detailed in the provided excerpt, but the FTC's involvement signals enforcement of unsubstantiated or deceptive health-related marketing. The case was last updated July 2, 2009.

Medlab, Inc.; Pinnacle Holdings, Inc.; Metabolic Research Associates, Inc.; USA Health, Inc.; et al.

The FTC brought a federal civil action in the Northern District of California against Medlab, Inc., Pinnacle Holdings, Inc., Metabolic Research Associates, Inc., U.S.A. Health, Inc., and individual officer L. Scott Holmes for deceptive health claims in advertising and marketing. The case (FTC Matter 062-3068, Civil Action CV 08 0822) falls under the FTC's Consumer Protection mandate targeting unsubstantiated health claims. The limited public record available does not specify the exact marketing claims or final penalty amounts, but the filing of a federal civil action indicates a critical enforcement posture.

QVC, Inc.

QVC, Inc., the home shopping network, was the subject of an FTC consent order (Docket No. C-3955) related to health claims made in its advertising and marketing. The matter concerned consumer protection violations involving unsubstantiated or misleading health claims broadcast to consumers. The consent order, finalized in May 2009, imposed binding obligations on QVC regarding how health-related product claims could be made on its platform. Full claim and penalty details are not available in the provided document excerpt.

Native Essence Herb Company; Mark J. Hershiser, individually, d/b/a Native Essence Herb Company, and as an officer of the corporation; and Marianne Hershiser, individually, d/b/a Native Essence

The FTC brought an enforcement action against Native Essence Herb Company and its individual officers Mark J. Hershiser and Marianne Hershiser for deceptive health claims in the marketing of herbal products. The case resulted in a consent order (Docket No. 9328) under the FTC's Bureau of Consumer Protection. The full text of the document is minimal, but the matter falls under FTC health claims enforcement, indicating unsubstantiated efficacy or cure-type claims for herbal supplement products. The consent order represents a binding resolution requiring the respondents to comply with FTC advertising standards.

Chinery, Robert Jr.; Tracy A. Chinery; and RTC Research and Development, LL

The FTC brought a civil action in the District of New Jersey against Robert Chinery Jr., Tracy A. Chinery, and RTC Research & Development, LLC (Civil Action No. 05-3460) for deceptive health claims in advertising and marketing. The case resulted in a consent order, indicating the defendants made unsubstantiated or misleading health claims about their products. As a consent order, this represents a binding enforcement outcome requiring the defendants to comply with FTC regulations on health claim advertising.

Mary T. Spohn, individually and d/b/a Herbs for Cancer

The FTC brought an enforcement action against Mary T. Spohn, individually and doing business as Herbs for Cancer, concerning deceptive health claims in advertising and marketing. The case was docketed under FTC Docket No. 9331, indicating formal administrative proceedings. The matter falls under the Bureau of Consumer Protection's oversight of health claims in advertising. The full text of the complaint and any consent order details are not provided in the available document excerpt.

Roex, Inc., FTC

The FTC brought a federal court action against Roex, Inc., Rodney H. Burreson, and Mark Alexander in the U.S. District Court for the Central District of California. The case falls under Consumer Protection, Advertising and Marketing, and Health Claims, indicating the defendants made unsubstantiated or deceptive health-related marketing claims for their products. The matter was filed under FTC File Number 072-3076. Minimal detail is available in the provided text, but the federal court filing signals a critical enforcement posture.

Alexander Heckman, d/b/a Omega Supply, and Erick Del Rio

The FTC opened a proceeding against Alexander Heckman (d/b/a Omega Supply) and Erick Del Rio individually regarding health claims in their advertising and marketing. The matter (FTC File No. 082-3094, Docket No. 9332) falls under the Bureau of Consumer Protection's purview for health claims. The available record is limited to case identification metadata without detailed claim text or final order terms.

Ultralife Fitness, Inc., dba Pure Health Laboratories, et al.

The FTC brought a federal court action against Ultralife Fitness, Inc. (doing business as Pure Health Laboratories, Pure Health Labs, and UltraBurn PM) and Tru Genix Laboratories, LLC (doing business as eFitness Clubhouse and eCurves Clubhouse) in the Central District of California. The case, filed December 3, 2008, falls under the FTC's consumer protection and health claims enforcement umbrella, targeting marketing claims made for what appear to be weight-loss or fitness supplement products. Because the full text of the complaint and consent order are not included in the provided document, specific verbatim flagged claims and enumerated enforcement actions cannot be extracted, but the civil action filing indicates a critical enforcement posture consistent with FTC litigation over unsubstantiated health and weight-loss claims.

Glucorell, Inc., Anafit, Inc., Laurence Berube, and Jerel Scott Ferguson

The FTC brought a civil action in the Middle District of Florida against Glucorell, Inc., Anafit, Inc., Laurence Berube, and Jerel Scott Ferguson (Case No. 608cv-1649-Orl-35KRS) for deceptive health claims in advertising and marketing. The case falls under FTC Matter/File Number 072-3180 and involves consumer protection violations related to health claims. The limited full text available does not specify the exact marketing claims or final remedies, but the filing of a federal civil action indicates a critical enforcement posture.

Bacon, Holly A., d/b/a Cleansing Time Pro.

The FTC brought an enforcement action against Holly A. Bacon, doing business as Cleansing Time Pro, related to health claims made in advertising and marketing. The matter, filed under FTC File Number 082-3119, resulted in a consent order. The full text of the specific claims and required actions is not available in the provided document excerpt, but the case was categorized under Consumer Protection, Advertising and Marketing, and Health Claims, indicating deceptive or unsubstantiated health marketing practices.

Daryl C. Jenks, individually and d/b/a Premium Essiac Tea 4less

The FTC brought an enforcement action against Daryl C. Jenks, operating as Premium Essiac Tea 4less, for making unsubstantiated health claims in the marketing of Essiac tea products. The matter resulted in a consent order, indicating the FTC found the advertising claims to be deceptive or unsubstantiated under consumer protection standards. The case falls under the FTC's Bureau of Consumer Protection, Advertising and Marketing, and Health Claims enforcement areas. The consent order represents a binding resolution requiring Jenks to comply with FTC regulations regarding health-related marketing claims.

Bioque Technologies, Inc., et al.

The FTC brought an enforcement action against Bioque Technologies, Inc. and its individual officers Vittorio A. Bonomo and Christine A. Guilman in connection with health claims made in their advertising and marketing. The matter, filed under FTC Matter/File Number 082-3095, resulted in a consent order. The full text of the specific claims and required actions is not provided in the available document excerpt, but the case is categorized under Consumer Protection, Advertising and Marketing, and Health Claims, indicating deceptive or unsubstantiated health marketing practices.

Advanced Patch Technologies, Inc.; et al.

The FTC brought a federal court action against Advanced Patch Technologies, Inc. and multiple individual and corporate co-defendants in the Northern District of Georgia regarding deceptive health claims made in connection with transdermal patch products. The case, filed as FTC v. Advanced Patch Technologies, Inc. et al., involved allegations of false or unsubstantiated health and efficacy claims in advertising and marketing materials. The matter was resolved via consent order as of September 30, 2008. Full claim and penalty details are not reproduced in the available document text, but the case falls under FTC consumer protection and health claims enforcement.

Clark, James Franklin, also known asJim Clark, et al.

The FTC brought an enforcement action in the Western District of Kentucky against James Franklin Clark (a/k/a Jim Clark) and Carrie Ann Hatcher for violations related to health claims in advertising and marketing. The case resulted in a consent order under the FTC's Bureau of Consumer Protection. Specific marketing claims are not detailed in the available document text, but the matter was categorized under Health Claims and Advertising and Marketing enforcement. The consent order represents a formal resolution of the FTC's allegations against the defendants.

Nu-Gen Nutrition, Inc., et al.

The FTC brought a civil action against Nu-Gen Nutrition, Inc., Vitasalus, Inc., and individual Robert Cloutier in the Northern District of Illinois for deceptive health claims in advertising and marketing of nutritional products. The case resulted in a consent order addressing unlawful health-related marketing practices. The enforcement action falls under the FTC's Bureau of Consumer Protection and concerns health claims made in advertising. Specific claim language and required corrective actions are not detailed in the available document excerpt.

Westberry Enterprises, Inc., et al.

The FTC brought an action against Westberry Enterprises, Inc. and Timothy Westberry in the Western District of Louisiana (Matter No. 082-3102) for deceptive health claims in advertising and marketing. The case resulted in a consent order addressing consumer protection violations related to health claims. Specific marketing copy is not available in the provided document excerpt, but the matter falls under FTC enforcement of advertising and health claims standards.

Airborne Health, Inc.

The FTC brought a federal court action against Airborne Health, Inc. and its principals (Victoria Knight-McDowell and Thomas John McDowell) in the Central District of California. The case concerned health claims made in advertising and marketing for the Airborne dietary supplement product. The FTC alleged that the company made unsubstantiated claims about the product's ability to prevent or reduce the severity of colds and other illnesses. The matter resulted in a consent order requiring consumer redress.

North American Herb and Spice Co., LLC, and Judy Kay Gray, individually and as the owner and manger of North American Herb and Spice Co.

The FTC filed a federal civil action in the Northern District of Illinois against North American Herb and Spice Co., LLC and its owner Judy Kay Gray for allegedly making unsubstantiated or deceptive health claims in the marketing of herb and spice products. The case (Civil Action No. 08 CV 3169) was brought under the FTC's consumer protection authority targeting advertising and marketing of health claims. The limited full text available does not detail specific claims or final remedies, but the filing of a federal civil action indicates a critical enforcement posture.

Seasilver USA, Inc., et al.

The FTC brought a federal court action in the District of Nevada against Seasilver USA, Inc., Americaloe, Inc., and several individual defendants including a chiropractor, alleging deceptive health claims in the marketing of a liquid nutritional supplement product. The case involved unsubstantiated and false claims that the product could treat, cure, or prevent serious diseases. The matter resulted in a consent order with civil penalties and consumer redress obligations against the defendants.

7 Day Marketing, Inc., Anthony Paris DeAguero a/k/a The Healthman, et al.

The FTC brought a civil action against 7 Day Marketing, Inc. and its principals (Anthony Paris DeAguero a/k/a The Healthman, Dieter Ammann, and Laura DeAguero) in the Central District of California for deceptive health claims in advertising and marketing. The case resulted in a consent order addressing consumer protection violations related to health claims. No specific flagged marketing quotes or detailed required-action text were available in the provided document excerpt.

Herbs Nutrition Corporation and Syed M. Jafry

The FTC brought an enforcement action against Herbs Nutrition Corporation and its officer Syed M. Jafry (Matter No. 072-3147, Docket 9325) related to health claims made in advertising and marketing of nutritional or herbal supplement products. The case resulted in a consent order finalized on February 26, 2008. The available document text does not include verbatim marketing claims or detailed required-action language, limiting extraction of specific flagged claims and enforcement actions.

Sili Neutraceuticals, LLC, and Brian McDaid, d/b/a Kaycon Ltd

The FTC brought a federal civil action in the Northern District of Illinois against Sili Neutraceuticals, LLC and Brian McDaid (d/b/a Kaycon Ltd) for deceptive health claims in the marketing of nutraceutical/supplement products. The case (FTC Matter 072-3124, Civil Action 07C 4541) falls under the FTC's Consumer Protection mandate targeting false or unsubstantiated health claims in online advertising. The full text of the complaint and any consent order terms are not included in the provided document excerpt, so specific flagged claims and enforcement actions cannot be directly quoted.

Great American Products, Inc., et al.

The FTC brought a civil action against Great American Products, Inc., Physician's Choice, Inc., Stephan Karian, and Michael Teplitsky, M.D. in the Northern District of Florida for deceptive health claims in advertising and marketing. The case resulted in a consent order entered January 29, 2008. The matter falls under FTC consumer protection and health claims enforcement. Full claim and action details are not available in the provided document text.

Diet Coffee, Inc., David Stocknoff, and David Attarian

The FTC filed a civil action in the Southern District of New York against Diet Coffee, Inc. and its principals David Stocknoff and David Attarian for deceptive health and weight-loss claims related to their diet coffee product. The case falls under consumer protection and advertising/marketing enforcement, specifically targeting health claims. As a federal court action (Case No. 108-cv-0094-JSR-DCF), this represents a formal enforcement proceeding with potential for injunctive relief and civil penalties.

Pro Health Labs, et al.

The FTC brought an action against Lawrence A. Jordan and Stephanie L. Jordan, individuals operating as Springboard and Pro Health Labs, in November 2007 (Matter No. 072-3140). The case resulted in a consent order, indicating the respondents agreed to settle FTC charges related to their health product marketing practices. The full text of the document is minimal and does not specify the exact claims or penalties, but the consent-order format indicates a critical enforcement outcome requiring compliance with FTC regulations.

Health Science International, Inc., and David Martin

The FTC brought an enforcement action against Health Science International, Inc. and its officer David Martin in November 2007 (Matter No. 072-3145). The case resulted in a consent order, indicating the respondents agreed to settle FTC charges related to their health product marketing practices. The limited available text does not specify the exact claims at issue, but the consent-order resolution is consistent with deceptive or unsubstantiated health marketing violations. As a consent order, this constitutes a critical enforcement outcome with binding compliance obligations.

Pacific Herbal Sciences, Inc., et al.

The FTC brought a federal court action against Pacific Herbal Sciences, Inc. and related entities and individuals — including corporate officers John A. Brackett, Jr. and Lei Lu — for deceptive marketing practices related to herbal or natural health products. The case involved multiple California corporations and individuals acting as officers or directors, suggesting a coordinated scheme to market products with unsubstantiated or misleading claims. As an FTC enforcement action filed in federal court, the proceeding carries the potential for injunctive relief, civil penalties, and consumer redress.

Sunny Health Nutrition Technology & Products, Inc. and Sunny Si

The FTC brought a consent order action against Sunny Health Nutrition Technology & Products, Inc. and Sunny Si (FTC Matter 062-3007, filed in the Middle District of Florida). The case involved marketing claims for nutrition or health products. The consent order resolved the FTC's allegations, though the full text of the specific claims and required actions are not available in the provided document excerpt.

Myfreemedicine.com, LLC, a California Limited Liability Corporation, and Geoffrey J. Hasler, Individually and as a Member of Myfreemedicine.com, LL

The FTC filed a federal court action in the Western District of Washington against Myfreemedicine.com, LLC and its member Geoffrey J. Hasler, alleging deceptive practices related to the marketing of free medicine or health products. The case was brought in 2007 and represents a formal enforcement proceeding rather than an administrative complaint. Limited detail is available in the provided text, but the FTC's decision to pursue federal district court litigation indicates serious alleged violations. The outcome and specific claims at issue are not detailed in the available document excerpt.

Goen Technologies Corporation, Nutramerica Corporation, et al.

The FTC brought an enforcement action against Goen Technologies Corporation, Nutramerica Corporation, TrimSpa Inc., and their principal Alexander Szynalski (also known as Alexander Goen) concerning deceptive health and weight-loss claims made in advertising for TrimSpa dietary supplement products. The matter resulted in a consent order requiring the respondents to substantiate future claims and likely pay consumer redress. The case reflects the FTC's ongoing scrutiny of unsubstantiated weight-loss efficacy claims in the dietary supplement industry.

Bayer Corporation v.

The FTC, acting through the U.S. Department of Justice, filed a civil action against Bayer Corporation (Civil Action No. 07-01) in January 2007 related to consumer protection violations involving advertising and marketing of health claims. The case concerned allegedly deceptive or unsubstantiated health claims made in Bayer's marketing materials. The limited publicly available case record indicates this was a civil enforcement action, consistent with FTC practice of seeking injunctive relief and/or civil penalties for false health advertising.

Window Rock Enterprises, Inc., et al.

The FTC filed a civil action in the U.S. District Court for the Central District of California against Window Rock Enterprises, Inc. (also doing business as Window Rock Health Laboratories and CortiSlim), Infinity Advertising, Inc., and individual defendants Stephen F. Cheng, Shawn M. Talbott, and Gregory S. Cynaumon. The case concerned health and weight-loss claims made in marketing for the CortiSlim dietary supplement. As a federal court action, this represents a critical enforcement proceeding targeting unsubstantiated health claims in supplement advertising.

Basic Research

Basic Research was the subject of an FTC enforcement action (Matter No. 002-3300, Docket No. 9318) concerning deceptive health claims in advertising and marketing. The case involved consumer protection violations related to unsubstantiated health and weight-loss claims made for dietary supplement products. The matter resulted in a consent order requiring corrective actions. The civil action number 09-CV-972 indicates formal federal court proceedings were initiated.

Dynamic Health Of Florida, LLC; Chhabra Group, LLC, et al.

The FTC brought an enforcement action against Dynamic Health of Florida, LLC, Chhabra Group, LLC, DBS Laboratories, LLC, and individual officers Vineet K. Chhabra and Jonathan Barash for deceptive advertising and marketing practices related to health products. The matter, docketed as FTC Docket No. 9317, resulted in a consent order finalized in May 2006. The case involved consumer protection violations in the advertising and marketing of health-related products, including claims targeting children. The consent order imposed binding obligations on the respondents to cease deceptive practices and comply with FTC regulations.

Conversion Marketing, Inc., et al.

The FTC brought a civil action in the Central District of California against Conversion Marketing, Inc. and related entities (doing business as National Health Support Center, Natural Bright, Pounds Off Patch, Oratech, Fast White, and others) along with individual defendants Adam Tyler MacDonald and David R. Sharp. The case, filed under FTC Matter 042-3079, involved health claims and advertising and marketing practices including online and telemarketing channels. The action reflects the FTC's enforcement of consumer protection standards against allegedly deceptive health and product marketing claims.

Braswell, Glenn A., JOL Management Co., et al.

The FTC brought a civil action in the Central District of California against Glenn A. Braswell, JOL Management Co., and numerous related entities and individuals for deceptive health claims in advertising. The defendants marketed dietary supplements and health products with unsubstantiated efficacy and health claims. The case resulted in a consent order requiring corrective actions, reflecting the FTC's enforcement of truth-in-advertising standards for health product marketing.

Platinum Health Plus, LLC; Fiesta Marketing, LLC; Telemedia, LLC, et al.

The FTC filed a civil action in the U.S. District Court for the Southern District of Florida against Platinum Health Plus, LLC, Fiesta Marketing, LLC, Telemedia, LLC, Michael P. Garcia, and Alexander R. Garcia (Case No. 05-22465). The case involves deceptive marketing practices related to health products or services promoted by these entities. The FTC sought court intervention to halt the allegedly unlawful conduct and obtain redress for consumers.

Emerson Direct, Inc., d/b/a Council on Natural Health, et al.

The FTC brought a federal court action against Emerson Direct, Inc. (d/b/a Council on Natural Health) and individual defendants including a medical doctor and chiropractor for deceptive health claims in their advertising and marketing. The case, filed in the U.S. District Court for the Middle District of Florida, resulted in a consent order addressing unsubstantiated health claims. The enforcement action reflects the FTC's focus on misleading consumer health marketing, particularly where medical professionals lend credibility to unverified product claims.

FiberThin, LLC, Obesity Research Institute, LLC, Henny Den Uijl, Bryan Corlett James Ayres, and Dr. Jonathan M. Kelley, Defendants

The FTC brought an action in the Southern District of California against FiberThin, LLC, Obesity Research Institute, LLC, and individual defendants including Henny Den Uijl, Bryan Corlett, James Ayres, and Dr. Jonathan M. Kelley for deceptive health and weight-loss claims related to dietary supplement products. The case centered on unsubstantiated efficacy claims made in advertising and marketing materials for fiber-based weight-loss supplements. As an FTC enforcement action filed in federal court, the matter constitutes a critical enforcement proceeding with potential for injunctive relief, civil penalties, and consumer redress.

Harry, Creaghan A., et al.

The FTC brought a federal civil action in the Northern District of Illinois against Creaghan A. Harry, individually and doing business as Hitech Marketing, Scientific Life Nutrition, and Rejuvenation Health Corp. The case (FTC Matter 042-3085, Civil Action 04C-4790) involved marketing practices by these entities, consistent with FTC enforcement against deceptive health or nutrition supplement claims. The full text of the complaint and specific claims are not provided in the available record, but the filing of a federal civil action indicates serious regulatory concern warranting a critical severity designation.

Hi-Health Supermart Corporation and Simon D. Chalpin

The FTC brought an action against Hi-Health Supermart Corporation and its principal Simon D. Chalpin regarding deceptive marketing practices for health and nutrition supplement products. The consent order resolved the matter with required compliance obligations. The full text of the specific claims and required actions is not available in the provided document excerpt, but the consent order represents a formal FTC enforcement resolution. As a consent order, this constitutes a critical enforcement action binding the respondents to FTC oversight.

Phoenix Avatar, LLC, d/b/a Avatar Nutrition, DJL, LLC, et al.

The FTC filed a federal lawsuit in the Northern District of Illinois against Phoenix Avatar, LLC (d/b/a Avatar Nutrition), DJL, LLC, Daniel J. Lin, Mark M. Sadek, James Lin, and Christopher M. Chung (d/b/a AIT Herbal Marketing) for deceptive marketing practices related to nutritional or herbal supplement products. The case (Civil Action No. 04C 2897) was brought under FTC enforcement authority, indicating the defendants made unsubstantiated or false claims in connection with the sale of their products. As a federal court action, this represents a critical enforcement outcome with potential for injunctive relief, civil penalties, and consumer redress.

Body Wise International, Inc., et al., US

The FTC, acting through the U.S. Department of Justice, filed a civil action in the Central District of California against Body Wise International, Inc. and physician Jesse A. Stoff, M.D. for allegedly making unsubstantiated health claims in their advertising and marketing materials. The case involved consumer protection violations related to health claims and endorsements. As a federal court action (SACV-05-43), this represents a critical enforcement proceeding with potential for injunctive relief and civil penalties.

Mark Nutritionals, Inc., et al.

The FTC brought a civil action in the Western District of Texas against Mark Nutritionals, Inc. and individual defendants Harry Siskind and Edward G. Dalessandro, Jr. for deceptive marketing practices related to nutritional supplement products. The case, filed under FTC Matter X0300120, resulted in a consent order resolving the Commission's claims. The enforcement action reflects the FTC's scrutiny of unsubstantiated or misleading health and efficacy claims made in connection with dietary supplement advertising.

Pletschke, Kris A., et al., US

The FTC, acting through the U.S. Department of Justice, filed a civil action in the Western District of North Carolina against Kris A. Pletschke doing business as Raw Health. The case (Civil Action No. 103CV214-T) was filed in federal district court, indicating a formal enforcement proceeding. The available record is limited, but the filing of a federal civil action by the United States as plaintiff signals serious regulatory violations likely involving deceptive health or marketing claims. No specific flagged claims or detailed enforcement actions are extractable from the minimal docket information provided.

Heritage Health Products Company a Colorado Corporation

The FTC filed a civil action in the U.S. District Court for the District of Colorado against Heritage Health Products Company, a Colorado corporation, in April 2004. The case number is 04-WM-0775 (CBS). The full text of the document is minimal and does not detail specific marketing claims or required corrective actions beyond the filing itself. Based on the FTC's typical enforcement pattern against health product companies, this appears to be a consent order proceeding related to health product marketing claims.

Levey Lisa, et al., US

The FTC, on behalf of the United States, brought a civil action in the Central District of California against Lisa Levey (as personal representative of the Estate of Michael Levey), Gary Ballen, Bentley Myers International Co., Publisher's Data Services, Inc., and Nutritional Life, Inc. The case involved consumer protection violations related to advertising, marketing, health claims, and endorsements for nutritional products. The proceeding was a federal civil action (CV 03-4670 GAF (AJWx)), indicating serious enforcement activity consistent with deceptive health marketing practices.

Universal Nutrition Corporation, MTM Marketing and Consulting, Inc., and Robert J. Michnal

The FTC brought a civil action (Case No. 1-03-CV-3822, N.D. Georgia) against Universal Nutrition Corporation, MTM Marketing and Consulting, Inc., and Robert J. Michnal (FTC Matter 022-3189). The case involved marketing and advertising practices by these nutrition/supplement companies and their principal. The limited public record for this proceeding does not detail specific verbatim claims or final penalty amounts, but the filing of a federal civil action indicates serious regulatory concern over deceptive or unsubstantiated marketing of nutritional products.

Mark Nutritionals, Inc., Harry Siskind, and Edward Gl D'Alessandro, Jr

The FTC brought an action in the Western District of Texas against Mark Nutritionals, Inc. and its principals Harry Siskind and Edward G. D'Alessandro, Jr. The case (Matter No. 0123251) resulted in a consent order finalized December 9, 2003. The limited source text does not detail specific marketing claims or penalty amounts, but the FTC's litigation posture and consent-order resolution indicate deceptive advertising practices related to nutritional supplement products.

Snore Formula, Inc., et al., also d/b/a KJ Enterprises

The FTC brought an enforcement action against Snore Formula, Inc. (also d/b/a KJ Enterprises) and its principals, including a physician, for deceptive health claims related to a snoring remedy product. The consent order resolved allegations that the respondents made unsubstantiated claims about the product's ability to treat or eliminate snoring. As a result of the FTC proceeding, the parties entered into a consent order imposing restrictions on future advertising claims and compliance monitoring obligations.

Wellquest International, Inc.; Eddie Mishan; Tony Hoffman Productions, Inc.

The FTC brought a federal court action against Wellquest International, Inc., Eddie Mishan, Tony Hoffman Productions, Inc., Anthony Hoffman, and Mark J. Buchfuhrer, along with several relief defendants, in the Central District of California. The case (FTC Matter 012-3211) involved consumer protection violations related to advertising, marketing, health claims, and endorsements. The consent order resolved allegations that the defendants made deceptive or unsubstantiated health-related marketing claims. The matter resulted in a consent order imposing obligations on the defendants as a resolution of the FTC's enforcement action.

Lifestyle Fascination, Inc., U.S.

The FTC brought a federal court action (CV-03-4670) in the Central District of California against Lifestyle Fascination, Inc. and related individuals and entities — Michael S. Levey, Gary Ballen, Bentley Myers International Co., Publisher's Data Services, Inc., and Nutritional Life, Inc. The case, docketed as C-3459, was filed in 2003 and appears to involve deceptive marketing practices related to nutritional or health products. The full text of the document is limited, but the consent-order classification indicates the matter was resolved through a negotiated settlement imposing binding obligations on the respondents.

Currier, Robert M.

The FTC brought an enforcement action against Robert M. Currier (Matter No. 002-3211, Docket C-4067) related to consumer protection violations involving advertising, marketing, health claims, and endorsements. The case resulted in a consent order finalized on December 20, 2002. The available document text does not include the full details of the specific marketing claims or required actions, but the FTC's categorization under Health Claims and Endorsements indicates deceptive or unsubstantiated health-related advertising practices.

Leiner Health Products, Inc.

Leiner Health Products, Inc. was the subject of an FTC consent order finalized February 22, 2002, related to advertising and marketing practices, specifically concerning 'Made in USA' claims. The FTC found that Leiner's product labeling or marketing made domestic-origin representations that were not adequately substantiated or were otherwise misleading under FTC standards. The consent order required Leiner to comply with FTC guidelines on origin claims going forward.

Western Dietary Products Co. (Skookum), d/b/a Western Herb & Dietary Products, Inc., et al.

The FTC brought a civil action against Western Dietary Products Co. (d/b/a Western Herb & Dietary Products, Inc.) and its principals Marvin and Miguelina Beckwith in 2001. The case (C01-0818R) involved the company's marketing of dietary/herbal supplement products. As an FTC civil action, this represents a critical enforcement action against the respondents for allegedly deceptive or unsubstantiated marketing claims related to their dietary supplement products.

Weider Nutrition International, Inc.

Weider Nutrition International, Inc. was the subject of an FTC consent order (Docket No. C-3983) finalized in November 2000. The matter concerned the company's marketing of nutritional supplement products, with the FTC finding that advertising claims were not adequately substantiated. The consent order required Weider to cease making unsubstantiated claims and to maintain compliance monitoring and recordkeeping obligations going forward.

Novartis Corporation and Novartis Consumer Health, Inc.

The FTC brought an enforcement action against Novartis Corporation and Novartis Consumer Health, Inc. related to advertising claims for consumer health products. The U.S. Court of Appeals for the D.C. Circuit denied Novartis's petition for review of the FTC's final order on August 18, 2000, upholding the Commission's findings. The case resulted in a binding final order against Novartis requiring compliance with FTC advertising standards.

Rose Creek Health Products, Inc. et al.

The FTC brought a civil action against Rose Creek Health Products, Inc. and related parties (Matter No. 992-3107, Civil Action CS-99-0063-EFS) for deceptive marketing practices related to health products. The case was filed in federal court and represents an FTC enforcement action. The available document excerpt does not provide detailed claim language or specific required actions beyond the case filing itself.

General Nutrition Corporation, also trading as Natural Sales Company, and David B. Shakarian; and the Matter of General Nutrition, Inc.

The FTC brought proceedings against General Nutrition Corporation (also trading as Natural Sales Company), David B. Shakarian, and General Nutrition, Inc. under Docket Numbers C-1517 and 9175. The case involved marketing and advertising practices related to nutritional supplement products. The available document text is minimal and does not detail specific claims or outcomes beyond the docket identifiers and parties involved.

AST Nutritional Concepts & Research, Inc., et al.

The FTC brought a civil action against AST Nutritional Concepts & Research, Inc. and related parties (Matter No. 992-3179, Civil Action No. 99-WI-2197) in the District of Columbia. The case resulted in a consent order, indicating the FTC found the respondents engaged in deceptive or unfair marketing practices related to nutritional supplement products. The full text of the document does not provide specific claim language or detailed enforcement terms beyond the case identifiers and filing date.

Pain Stops Here!, Inc. (Operation Cure All)

Pain Stops Here!, Inc. and Sande R. Caplin were the subject of an FTC enforcement action (Matter No. 982-3175, Docket C-3898) under Operation Cure All, the FTC's initiative targeting unsubstantiated health claims made online. The case resulted in a consent order, indicating the respondents made deceptive or unsubstantiated claims about their products' ability to treat or cure pain or other health conditions. The matter was finalized on September 20, 1999.

Ciba-Geigy Corporation / Novartis Corporation

The FTC brought an enforcement action against Ciba-Geigy Corporation (later succeeded by Novartis Corporation and Novartis Consumer Health, Inc.) under Docket No. 9279. The matter involved marketing claims for consumer health products, though the full text of the proceeding entry does not detail specific flagged claims or penalties. The case was updated as of August 21, 1999, reflecting the corporate succession from Ciba-Geigy to Novartis.

Del Pharmaceuticals, Inc. and Del Laboratories, Inc.

Del Pharmaceuticals, Inc. and Del Laboratories, Inc. were the subject of an FTC consent order (Docket No. C-3837) finalized in December 1998. The matter involved marketing claims made by the companies, resulting in a formal consent order requiring compliance. The full text of the document is minimal and does not specify the exact claims or penalties, but the issuance of a consent order indicates a finding of deceptive or unsubstantiated marketing practices.

Nutrition 21, Selene Systems, Inc., and Herbert H Boynton.

The FTC brought an enforcement action against Nutrition 21, Selene Systems, Inc., and Herbert H. Boynton (Docket No. C-3758) resulting in a consent order finalized in July 1997. The matter concerned marketing practices related to nutritional supplement products. The available document text is minimal and does not include verbatim claim language or detailed required-action provisions, but the issuance of a formal consent order indicates the FTC found violations serious enough to warrant binding corrective obligations.

Dean Distributors, Inc., d/b/a Advanced Health Care Systems, Cambridge Direct Sales, and Medibase

The FTC brought an action against Dean Distributors, Inc. (doing business as Advanced Health Care Systems, Cambridge Direct Sales, and Medibase) in a matter finalized on June 20, 1997. The case, docketed as C-3755, involved the company's marketing practices, though the full text of the document does not detail specific claims or required actions. Based on the company's trade names and the FTC's consumer protection focus at the time, the matter likely concerned unsubstantiated health or supplement product claims.

Home Shopping Network, Inc., Home Shopping Club, Inc., and HSN Lifeway Health Products, Inc.

The FTC brought an action against Home Shopping Network, Inc., Home Shopping Club, Inc., and HSN Lifeway Health Products, Inc. (Docket No. C-9272), resulting in a consent order finalized in October 1996. The case involved the marketing and sale of health products through home shopping television broadcasts, where the respondents allegedly made unsubstantiated or deceptive claims about their products. The consent order imposed compliance obligations on the respondents to prevent future deceptive advertising practices.

Home Shopping Network, Inc., Home Shopping Club, Inc. , and HSN Lifeway Health Products, Inc.

The FTC brought an enforcement action against Home Shopping Network, Inc., Home Shopping Club, Inc., and HSN Lifeway Health Products, Inc. (Docket No. 9272) concerning the marketing of health products. The case involved deceptive or unsubstantiated claims made during televised home shopping broadcasts. The full text of the proceeding is minimal in the provided record, but the FTC docket classification indicates a formal consent order or adjudicative proceeding was initiated against these entities.