FDA WARNING_LETTER - TaperAid

The FDA issued a Warning Letter to Richie Ogulnick after reviewing www.taperaid.com and www.facebook.com/TaperAid in December 2017, concerning the products “TaperAid” and “TaperAid Complete.” The FDA determined that claims on these websites establish the products as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease treatment and are not generally recognized as safe and effective. Introducing these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the Act. Additionally, the products are misbranded under section 502(f)(1) of the Act due to a lack of adequate directions for use, as their intended purposes require professional supervision, making their introduction into interstate commerce a violation of section 301(a). The Federal Trade Commission (FTC) also found the marketing claims unsubstantiated, violating Sections 5 and 12 of the FTC Act, which mandates competent and reliable scientific evidence for health claims. The firm must notify FDA and FTC within fifteen working days of specific corrective actions taken, including documentation. Failure to comply could result in legal action, including seizure, injunction, and monetary penalties.