FDA WARNING_LETTER - Herbal Amy Inc - February 18, 2020

The FDA and FTC issued a Warning Letter to Herbal Amy Inc. on March 6, 2020, after reviewing their website and social media in February 2020. The agencies found that Herbal Amy Inc. was offering "Coronavirus Protocol" products, including "Coronavirus Boneset Tea" and "Elderberry Tincture," 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 under section 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC also cited violations of the FTC Act (15 U.S.C. 41 et seq.) for advertising products to treat human disease without competent and reliable scientific evidence, as there are no approved products for COVID-19. Herbal Amy Inc. is required to immediately cease the sale of these unapproved products and making unsubstantiated claims. They must email both FDA and FTC within 48 hours detailing corrective actions. Failure to comply may result in legal action, including seizure, injunction, being added to FDA's public list of non-compliant firms, and potentially paying back money to consumers.