FDA WARNING_LETTER - U4Life LLC

The FDA issued a Warning Letter to U4Life, LLC dba Mitadone after reviewing their website, www.mitadone.com, in December 2017. The agency determined that the product "Mitadone Anti-Opiate Aid Plus Extra Strength" is marketed with claims establishing it as a drug intended for the cure, mitigation, treatment, or prevention of disease, including opiate withdrawal symptoms and cravings. These claims, found on the website, blog, and an embedded YouTube video, render the product an unapproved new drug under section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), violating sections 301(d) and 505(a) by being introduced into interstate commerce without prior FDA approval. Furthermore, the product is misbranded under section 502(f)(1) of the Act because it lacks adequate directions for use, as it addresses conditions not amenable to self-diagnosis or treatment without professional supervision. Introducing this misbranded drug violates section 301(a) of the Act.

Concurrently, the Federal Trade Commission (FTC) reviewed the marketing claims for potential violations of Sections 5 and 12 of the FTC Act, 15 U.S.C ?? 45(a) and 52, citing that health-related claims must be supported by competent and reliable scientific evidence, specifically randomized, controlled, human clinical testing for opiate withdrawal/addiction claims. The company is required to take prompt action to correct all cited violations. They must notify FDA and FTC in writing within fifteen working days of receipt of the letter, detailing specific corrective steps and providing documentation. Failure to comply may lead to legal actions, including seizure, injunction, and monetary judgments.