OrganiCare, LLC / OrganiCare Nature’s Science, LLC
FDA issued a warning letter to OrganiCare, LLC / OrganiCare Nature's Science, LLC (Austin, TX), the maker of 'HClear for him' and 'FemiClear Genital Herpes Symptoms,' finding both products to be unapproved new drugs marketed for the treatment of sexually transmitted infection symptoms. The products' website and social media claims — including killing 99.9% of herpes simplex viruses and providing fast-acting outbreak relief — established drug intent under the FD&C Act, while no FDA-approved applications exist for these OTC products. FDA warned that reliance on these products could cause consumers to forgo appropriate medical care, risking severe complications. The company was directed to respond within 15 business days with corrective steps, and FDA noted that failure to comply may result in seizure or injunction.
Flagged claims (8)
We know managing outbreak symptoms can be tough. The last thing you need is a price tag standing between you and relief. That's why we dropped the price of FemiClear for Genital Herpes Symptoms.
Looking for genital herpes symptom relief? Try the FemiClear topical ointment that kills 99.9% of the herpes simplex I & II viruses (HSV1 & HSV2) and works fast to relieve Itching & Tingling + Pain & Burning symptoms caused by a herpes outbreak.
Try the FemiClear topical ointment for men that kills 99.9% of the herpes simplex I & II viruses
>90% OF USERS REPORTED LESS SEVERE OUTBREAKS
Fast-acting ointment for recurring outbreak symptoms
Works like magic! I have had genital herpes for 35 years, and in the past 15 years, the outbreaks have been horrible and hard to get rid of. I won't take meds because they mess up my stomach. However, this ointment effectively eliminates the blisters within 24 hours. I have tried EVERYTHING, and this product truly works.
FAST-ACTING OUTBREAK SYMPTOM RELIEF ITCHING, TINGLING, PAIN & BURNING
Say goodbye to the discomfort of genital herpes symptoms with HClear for Him! This all-natural, organic ointment is designed specifically for men, targeting itching, tingling, and burning caused by herpes outbreaks. With a powerful formula that kills 99.9% of herpes simplex viruses (HSV1 & HSV2), you can trust HClear to bring fast relief. Over 90% of users reported milder symptoms, and over 50% experienced no blisters when used at the first sign.
Required actions (3)
Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address them and prevent their recurrence.
Failure to adequately address any violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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