FDA WARNING_LETTER - pyrless group, llc - February 25, 2021

The FDA and FTC issued a Warning Letter to Dr. Fitt following reviews of their websites and social media since February 2021. The firm offers products including Buffered C Powder, Get Well 2 Day Vit A, Get Well 2 Day Vit D3, Robynzyme, and OMG Cell Protek, with claims 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). Their 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 COVID-19 claims lack competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.). The letter notes a prior Online Advisory Letter from November 2018 for similar violations. Dr. Fitt must immediately cease selling these products and respond to both FDA and FTC within 48 hours, detailing corrective actions and recurrence prevention. Failure to comply may result in legal action, including seizure, injunction, civil penalties up to $43,792 per FTC violation, and inclusion on FDA's public list of non-compliant firms.