FDA WARNING_LETTER - Metamune Inc - September 09, 2021

The FDA and Federal Trade Commission (FTC) reviewed Bodymune's website, social media, and Amazon storefront in August 2021, identifying violations related to its "DiabetesSupport" product. The FDA determined that claims such as "Natural Diabetes Support" and "help maintain desired blood sugar level" classify the product as a drug under 21 U.S.C. 321(g)(1)(B). As it is not generally recognized as safe and effective, it is an unapproved new drug (21 U.S.C. 321(p)), and its introduction into interstate commerce violates 21 U.S.C. 331(d) and 355(a). Additionally, the product is misbranded under 21 U.S.C. 352(f)(1) because it lacks adequate directions for use, as it addresses conditions not amenable to self-diagnosis or treatment, violating 21 U.S.C. 331(a). The firm must respond to the FDA within fifteen working days with corrective actions. The FTC also issued a cease and desist demand, stating that disease claims require competent and reliable scientific evidence, warning of potential legal action, civil penalties up to $43,792 per violation, and consumer refunds for unsubstantiated claims. A separate response to the FTC is required within fifteen working days.