FDA WARNING_LETTER - GlutaGenic - May 01, 2020

On May 6, 2020, the FDA and FTC issued a Warning Letter to the company operating www.glutagenic.com and www.advancedbiomecorp.com following website reviews on April 22 and May 1, 2020. The agencies found that the company was offering "Viral Protection Kits" for sale, claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 (21 U.S.C. § 352). Consequently, their introduction into interstate commerce is prohibited under sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC also cited the company for unlawful advertising under the FTC Act (15 U.S.C. 41 et seq.) for making disease claims without competent and reliable scientific evidence. The letter demands immediate cessation of sales for these unapproved and unauthorized COVID-19 related products. The company must email the FDA and FTC within 48 hours detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may lead to legal action, including seizure and injunction, and the firm will be added to FDA's public list of non-compliant companies.