FDA WARNING_LETTER - Moy-Fincher Medical Group

The FDA issued a Warning Letter to Ronald L. Moy of DNA EGF Renewal following a December 2014 review of their website, dnaegfrenewal.com. The FDA determined that the "DNA Eye Renewal" product is promoted with claims that cause it to be an unapproved drug under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act. Specific claims cited include stimulating collagen, controlling inflammation, inhibiting muscle fibers, and stimulating new cell growth. Because the product is not generally recognized as safe and effective for its intended uses, it is considered a "new drug" under section 201(p) of the Act. Introducing or delivering such a new drug into interstate commerce without prior FDA approval via a New Drug Application (NDA), as required by section 505(a), violates section 301(d) of the Act. The FDA requires prompt action to correct all violations. The firm must notify the FDA in writing within fifteen working days of the specific steps taken to correct violations and prevent recurrence. Failure to comply may result in enforcement actions, including injunctions and product seizure.