FDA WARNING_LETTER - Peterson Research Laboratories LLC - September 30, 2020

The FDA and FTC issued a Warning Letter to Covercology (www.covercology.com and www.facebook.com/Hairreau) after reviewing their websites on September 8 and 30, 2020. The firm is offering "Simple Silver" for sale, claiming it can mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). Additionally, the FTC found the firm's advertising claims violate the FTC Act (15 U.S.C. 41 et seq.) because they lack competent and reliable scientific evidence, specifically for COVID-19. The letter demands immediate cessation of sales for these unapproved and unauthorized COVID-19 related products and all unsubstantiated claims. The firm must email FDA and FTC within 48 hours detailing corrective actions, including steps to prevent recurrence, and provide supporting documentation. Failure to comply may lead to legal action, including seizure, injunction, and consumer restitution, and the firm will be added to FDA's public list of non-compliant COVID-19 product sellers.