FDA WARNING_LETTER - Renewal Supplements LLC - June 30, 2020

On August 25, 2020, the FDA issued a Warning Letter to Mr. Manzo concerning the product “Opi-Cure,” sold via www.opi-cure.com. An FDA review in June 2020 determined that website claims establish “Opi-Cure” as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, intended for the cure, mitigation, treatment, or prevention of diseases such as muscle aches, restlessness, and anxiety. The FDA found that “Opi-Cure” is an unapproved “new drug” under section 201(p) because it is not generally recognized as safe and effective for its intended uses. Introducing an unapproved new drug into interstate commerce violates sections 301(d) and 505(a) of the Act. Additionally, the product is misbranded under section 502(f)(1) of the Act because it lacks adequate directions for its intended use, as it addresses conditions requiring supervision by a licensed practitioner, making safe layperson use impossible (21 CFR 201.5). The introduction of this misbranded drug into interstate commerce violates section 301(a) of the Act. The firm must take prompt corrective action and notify the FDA in writing within fifteen working days, detailing steps taken and recurrence prevention. Failure to comply may result in legal action, including seizure and injunction.