Functional Medicine

Amare Global Holdings, FTC v.

The FTC sued multilevel marketer Amare Global Holdings Inc. and three of its principals for falsely claiming that its dietary supplements — marketed for both children and adults — could treat or cure health conditions including depression, anxiety, and ADHD. The company also allegedly misled prospective 'brand partner' recruits about their potential earnings. The case represents a critical enforcement action combining unsubstantiated disease-treatment claims for supplements with deceptive income representations in an MLM structure.

OptiHealth Products, Inc.

FDA issued a warning letter to OptiHealth Products, Inc. (President Russell Dickson) regarding their dietary supplement Super Antioxidant (OPCXtra), finding that disease-treatment claims on the company's website and Facebook page caused the product to be regulated as an unapproved new drug under the FD&C Act. The flagged claims included assertions that the product could help manage diabetes, reduce heart disease risk, combat Alzheimer's and Parkinson's disease, and treat macular degeneration. FDA determined the product is both an unapproved new drug under section 505(a) and a misbranded drug under section 502(f)(1) for lacking adequate directions for use. The company was given 15 working days to respond with corrective steps, with failure to comply potentially resulting in seizure or injunction.

ibeautistore.com

FDA issued a warning letter to ibeautistore.com (Dover Plains, NY) regarding its product 'Umary' (sold as 'New Hyaluronic Acid 850 mg Sealed 30 Caps'), which laboratory analysis confirmed contained undeclared active pharmaceutical ingredients diclofenac, dexamethasone, and omeprazole. The product was marketed as a dietary supplement but constitutes an unapproved new drug under FD&C Act section 505(a) and is misbranded under section 502(a) due to failure to disclose these dangerous hidden drug ingredients. FDA warned that failure to address violations may result in seizure and injunction, and required a written response within fifteen working days.

Ray’s Vitamins

FDA issued a warning letter to Rene Gonzalez, owner of Ray's Vitamins (Whittier, CA), regarding the sale of 'Yeicob Ácido Hialurónico,' a product marketed as a dietary supplement for joint and arthritis support. Laboratory analysis confirmed the product contained undeclared active pharmaceutical ingredients diclofenac (an NSAID) and dexamethasone (a corticosteroid), rendering it an unapproved new drug and a misbranded drug under the FD&C Act. The product's labeling made drug-intended-use claims without FDA approval, and the failure to disclose the undeclared ingredients poses serious consumer health risks. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure or injunction.

Central Admixture Pharmacy Services, Inc.

Central Admixture Pharmacy Services, Inc. (CAPS), a 503B outsourcing facility in San Diego, CA, received an FDA Warning Letter following a July–August 2023 inspection that uncovered serious sterility assurance failures, CGMP violations, and failure to meet 503B conditions. The facility produced adulterated and misbranded sterile drug products (including Ephedrine Sulfate, Fentanyl Citrate, Ketamine Hydrochloride, and others) without adequate aseptic controls, proper labeling, or adverse event reporting. CAPS initiated voluntary recalls and subsequently permanently ceased operations at the San Diego location. FDA warned that failure to adequately address violations may result in seizure and injunction.

Easy Healthcare Corporation, U.S. v.

The FTC reached a settlement with Easy Healthcare Corporation, developer of the fertility tracking app Premom, over allegations that it deceived users by sharing sensitive personal health information with unauthorized third parties, including two China-based firms, AppsFlyer, and Google. The company was also alleged to have violated the Health Breach Notification Rule (HBNR) by failing to notify consumers of these unauthorized disclosures. The case resulted in a settlement, representing a critical enforcement action involving deceptive data-sharing practices and health privacy violations.

Dalal A. Akoury d/b/a AWAREmed, et al., U.S. v.

In March 2023, the FTC sued Dr. Dalal A. Akoury and her AWAREmed Health & Wellness Resource Center under the Opioid Addiction Recovery Fraud Prevention Act for making false or unsupported claims about addiction treatment, cancer treatment, and other serious conditions. The proposed consent order bars Dr. Akoury and AWAREmed from making such unsupported claims going forward. Dr. Akoury is also required to pay a $100,000 civil penalty to settle the Commission's complaint.

Conners Clinic

FDA issued a warning letter to Dr. Kevin Conners of Conners Clinic (Lake Elmo, MN) after reviewing the clinic's website and social media accounts (May–August 2022) and finding that ten products — including Fenbendazole Starter Pack #1, Panacur-C Fenbendazole, Breast Cancer Prevention Protocol Bundle, Curcu Clear, Black Cumin Seed Oil, Chronic LX, Cayenne, D3-Xym, Rapid Immune Boost, and Glucosamine Sulfate Chondroitin Sulfate MSM — were marketed with disease-treatment and cancer-cure claims that rendered them unapproved new drugs under the FD&C Act. The claims spanned the clinic's website, Facebook, Instagram, and Twitter, and included explicit anticancer, antiviral, and disease-prevention language. FDA determined the products were also misbranded because adequate directions for layperson use could not be written for conditions requiring licensed-practitioner supervision. The letter demands a written corrective response within 15 working days and warns that failure to comply may result in seizure or injunction.

Varigard, LLC

FDA issued a warning letter to Varigard, LLC (Foley, AL) on December 29, 2021, citing its alcohol-based hand sanitizer products as unapproved new drugs marketed in violation of the FD&C Act. The company's product labels and websites made claims that the products kill and prevent COVID-19 (including specific variants), provide two hours of protection against deadly pathogens, and are flame retardant — claims that go beyond permitted OTC monograph conditions and are false or misleading. FDA also found misbranding violations including unauthorized use of the FDA logo suggesting agency approval. The letter demanded corrective action within 48 hours and warned that failure to comply could result in seizure and injunction.

Agora Financial LLC

The FTC sued Agora Financial LLC and affiliates for deceptively marketing publications to seniors that falsely claimed to cure type 2 diabetes and promoted a fraudulent government check scheme. Key products included 'The Doctor's Guide to Reversing Diabetes in 28 Days' and pitches tied to a fabricated 'Congress' Secret $1.17 Trillion Giveaway.' The complaint alleged these claims were false and targeted older consumers nationwide. A proposed settlement order was announced in February 2021.

Blue Poppy Enterprises Inc

FDA issued a warning letter to Blue Poppy Enterprises Inc (owner Young Li) in August 2021 after reviewing the company's websites, Amazon listings, and social media pages for products including herbal formulas, ointments, tinctures, and topical oils. The agency determined that disease-treatment claims on these platforms — including claims to treat parasites, eczema, herpes simplex, erectile dysfunction, cancer, hypertension, and allergic rhinitis — rendered the products unapproved new drugs under the FD&C Act, and that several products were also 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.

Physician's Technology, LLC

Physician's Technology, LLC, marketers of the Willow Curve low-level light therapy (LLLT) device, settled FTC charges in June 2020 after being accused of deceptively claiming the device treats chronic, severe pain and associated inflammation without adequate scientific evidence. The FTC alleged the device was promoted as 'smart' and 'clinically proven' since 2014 despite lacking substantiation. Two defendants were each required to pay $200,000 to the Commission. In August 2021, the FTC distributed more than $350,000 in refunds to defrauded consumers.

Dr. Thomas Polucki Upper Cervical Chiropractic, Inc.

FDA and FTC jointly issued a warning letter to Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. regarding its website marketing of Nitric Oxide Support and Melatonin products as capable of mitigating, preventing, treating, or curing COVID-19, in violation of the FD&C Act's prohibitions on unapproved new drugs and misbranded drugs. The FTC additionally cited unsubstantiated claims on a chiropractic website implying that upper cervical chiropractic care and immune-boosting supplements could render patients 'Covid proof.' The recipient was ordered to cease all such claims within 48 hours and faces civil penalties of up to $43,792 per violation under the COVID-19 Consumer Protection Act, as well as potential injunction, seizure, and consumer redress.

SmartClick Media LLC, also doing business as Doctor Trusted

The FTC brought a federal injunction case in the Southern District of New York against SmartClick Media LLC (doing business as Doctor Trusted) and its officer Robert Vozdecky. The case centered on consumer protection violations related to advertising, marketing, endorsements, and health claims. As a federal injunction matter, the enforcement action represents a critical regulatory outcome requiring court-ordered compliance.

LearningRx Franchise Corp.

The FTC brought a federal court action against LearningRx Franchise Corp. and its officer Ken Gibson in the District of Colorado, alleging deceptive health and performance claims related to their brain-training programs. The case was filed under consumer protection and health claims enforcement authority. The enforcement type is a federal injunction, indicating the FTC sought court-ordered relief to stop the allegedly deceptive marketing practices. No specific penalty amount or detailed claim text is available in the provided document excerpt.

Zadro Health Solutions, Inc.

The FTC brought a federal court action in the Central District of California against Zadro Health Solutions, Inc. and its principals Zlatko Zadro and Rebecca Zadro for making allegedly deceptive health claims in their advertising and marketing. The case was filed as a federal injunction matter under FTC consumer protection authority. The limited case record available does not specify the exact product claims, but the matter was classified under Health Claims enforcement. The outcome was a federal injunction proceeding against the defendants.

Carrot Neurotechnology, Inc., In the Matter of (UltimEyes)

Carrot Neurotechnology, Inc. (makers of the UltimEyes app), along with individuals Adam Goldberg and Aaron Seitz, were the subject of an FTC consent order (Matter No. 142-3132) finalized February 23, 2016. The FTC challenged the company's health and performance claims for UltimEyes, a vision-training app marketed with assertions that it could improve eyesight and athletic performance. The consent order resolved allegations that these claims were unsubstantiated, requiring the respondents to have competent and reliable scientific evidence before making such claims in the future.

Lumos Labs, Inc. (Lumosity Mobile and Online Cognitive Game)

The FTC filed a federal injunction against Lumos Labs, Inc. (doing business as Lumosity) and its executives Kunal Sarkar and Michael Scanlon in the Northern District of California. The case centered on unsubstantiated health claims that Lumosity's mobile and online cognitive games could improve memory, attention, and cognitive performance, and could delay or reduce the risk of conditions such as Alzheimer's disease and PTSD. The FTC alleged these claims lacked scientific substantiation. The enforcement action resulted in a federal injunction and a significant civil penalty.

Tommie Copper

The FTC brought a federal court action against Tommie Copper, Inc. and its founder Thomas Kallish in the Southern District of New York, alleging that the company made unsubstantiated health claims in advertising for its copper-infused compression clothing. The case was filed as a federal injunction proceeding under civil action number 7:15-cv-09304-VB. The enforcement action targeted health-related marketing claims about the therapeutic benefits of the apparel. The matter resulted in a federal injunction proceeding, consistent with FTC enforcement against unsubstantiated health claims in consumer product advertising.

Alcoholism Cure Corporation, also d/b/a Alcoholism Cure Foundation, et al.

The FTC, jointly with the Florida Attorney General, brought a civil action against Alcoholism Cure Corporation (also d/b/a Alcoholism Cure Foundation) and its officer Robert Douglas Krotzer for deceptive health marketing claims related to an alcoholism cure. The case centered on unsubstantiated and misleading claims that the company's product or program could cure alcoholism. As a federal court case in the Middle District of Florida, this enforcement action represents a critical-level proceeding with potential for injunctive relief and civil penalties.

IAB Marketing Associates, LP, d/b/a IAB, et al.

The FTC brought a civil action against IAB Marketing Associates, LP and related entities (doing business as IAB and Health Service Providers) along with multiple individual defendants for deceptive telemarketing practices. The case involved consumer protection and Do Not Call violations in the marketing of health-related products or services. The matter resulted in a consent order with consumer refunds as a remedy. No specific flagged marketing claims or verbatim required-action language were available in the provided document text.

Icon Health and Fitness, Inc.; IHF Holdings, Inc.; and IHF Capital, Inc.

The FTC brought an action against Icon Health and Fitness, Inc., IHF Holdings, Inc., and IHF Capital, Inc. (Matter No. 962-3045, Docket C-3765) concerning advertising and health claims made in connection with their fitness products. The available document record is minimal, providing only docket identifiers and tags indicating the matter involved advertising, marketing, and health claims. No specific verbatim marketing claims or detailed enforcement actions are extractable from the provided text.

Skechers U.S.A., Inc., d/b/a Skechers

The FTC brought an action against Skechers U.S.A., Inc. in the Northern District of Ohio (FTC Matter 102-3069) over health claims made in the marketing of its toning footwear products. Skechers made unsubstantiated claims that its shoes could help consumers lose weight, tone muscles, and improve cardiovascular health. The case resulted in a consent order and a significant civil penalty/consumer redress settlement. This is a consumer protection enforcement action focused on deceptive health-related advertising claims for a footwear product.

Centro Natural Services, Inc., Xavier Rodriguez, and Rocio Diaz

The FTC brought a federal court action in the Central District of California against Centro Natural Services, Inc. and its officers Xavier Rodriguez and Rocio Diaz for deceptive health claims in advertising and marketing. The case, filed under civil action SACV06-989, falls under the FTC's Consumer Protection mandate targeting unsubstantiated health claims. The full text of the complaint and specific marketing claims are not provided in the available document excerpt, but the matter was litigated as a formal federal enforcement action. The case record was last updated January 30, 2008.

Barnekow, Merilou; d/b/a Womens Menopause Health Center.

The FTC entered a consent order against Merilou Barnekow, doing business as Womens Menopause Health Center, in November 2007. The matter (FTC File No. 072-3143, Docket C-4208) involved marketing claims related to menopause health products or services. The full text of the consent order is not provided in the available document, so specific flagged claims and detailed enforcement actions cannot be extracted verbatim.

Elation Therapy, Inc. and Robert Rutledge.

The FTC brought an action against Elation Therapy, Inc. and its officer Robert Rutledge in November 2007 (Matter No. 072-3142). The available document text does not include the full complaint or consent order details, so specific marketing claims and required actions cannot be extracted verbatim. The matter resulted in a consent order, indicating the FTC found sufficient cause to require corrective action from the respondents.

SG Institute of Health & Education, Inc., et al.

The FTC brought a civil action against SG Institute of Health & Education, Inc. and its principals Pedro Salas and Vanessa Salas in the Southern District of Florida. The case (FTC Matter 032-3253, Civil Action 04-61627) resulted in a consent order finalized December 13, 2005. The limited available text does not detail specific marketing claims, but the FTC's pursuit of a formal consent order indicates deceptive or unsubstantiated health-related advertising practices. The consent order represents a binding resolution requiring the defendants to comply with FTC mandates.

Creative Health Institute, Inc., and Kyl L. Smith

The FTC brought an action against Creative Health Institute, Inc. and Kyl L. Smith (Matter No. 012-3248, Docket C-4108) related to consumer protection concerns in advertising and marketing, including issues around endorsements and reviews. The available document text does not provide specific verbatim marketing claims or detailed required actions beyond the case filing metadata. The matter was resolved via consent order finalized on May 4, 2004.

Alternative Medical Technologies, Inc., and Jose Fernandez

The FTC brought a federal court action in the Southern District of Florida against Alternative Medical Technologies, Inc., and Jose Fernandez. The case resulted in a consent order finalized on April 27, 2004. The full text provided is minimal, so specific marketing claims and detailed enforcement actions cannot be extracted from the available document excerpt.

Physicians Healthcare Development, Inc., et al.

The FTC brought an enforcement action against Physicians Healthcare Development, Inc. (and related entities/individuals including Antonio Echavez) for deceptive practices. The case was docketed as C-3909 and assigned FTC matter numbers 012-3231 and X020075. The full text of the document provides only case identification details without specifying the precise marketing claims or remedies, but the FTC's formal case-and-proceeding designation indicates a consent order or adjudicative action was pursued. Given the physician-branded healthcare development framing and FTC enforcement, the matter likely involved deceptive health or billing-related marketing representations.

American College for Advancement in Medicine

The FTC brought an action against the American College for Advancement in Medicine (ACAM), a professional organization associated with alternative and integrative medicine practices, resulting in a consent order (Docket C-3882) finalized July 13, 1999. The available record is minimal, providing only docket identifiers without detailed claim text or specific required actions. Based on the organization's known focus on chelation therapy and integrative medicine, the matter likely involved unsubstantiated health claims, though no verbatim marketing copy or penalty amounts are extractable from the provided document.

Magnetic Theraputic Technologies, Inc. (Operation Cure All)

The FTC took action against Magnetic Theraputic Technologies, Inc. as part of its 'Operation Cure All' initiative, targeting companies making unsubstantiated health claims for magnetic therapy products. The case, filed under FTC Matter/File Number 982 3150, challenged marketing claims that magnetic devices could treat or cure various medical conditions without adequate scientific substantiation. The full text available is minimal, but the Operation Cure All context indicates this was a coordinated enforcement sweep against fraudulent health product marketers.