Honey Colony LLC – FDA Warning Letter, Apr 30, 2020

On May 4, 2020, the FDA and FTC issued a Warning Letter to HoneyColony after reviewing its website and social media in April 2020. The agencies observed the sale of products, including “Quicksilver Liposomal Vitamin C,” “Jigsaw Magnesium,” and silver-containing products like “Silver Excelsior Serum,” marketed 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)). The FTC also cited unlawful advertising under the FTC Act (15 U.S.C. 41 et seq.) due to a lack of competent and reliable scientific evidence for these disease claims. HoneyColony is required to immediately cease selling these unapproved products and making unsubstantiated claims. The company must respond to both FDA and FTC within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply could result in legal action, including seizure, injunction, inclusion on FDA's public fraud list, and potential monetary payback to consumers for FTC violations.