FDA WARNING_LETTER - Vivify Holistic Clinic - February 29, 2020

The FDA and Federal Trade Commission (FTC) issued a Warning Letter to Vivify Holistic Clinic following a February 2020 review of their websites, https://coronavirusdefense.com and Facebook page. The agencies determined the firm was offering products for sale in the U.S. that claimed to mitigate, prevent, treat, cure, or diagnose COVID-19. The FDA found these products to be unapproved new drugs, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and misbranded drugs under section 502. Their introduction into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act. The FTC also identified that advertising claims for preventing, treating, or curing human disease lacked competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.). Vivify Holistic Clinic is required to immediately cease the sale of these unapproved products and stop making unsubstantiated claims. The firm must email both the FDA and FTC within 48 hours, detailing specific corrective actions taken. Failure to comply could lead to legal action, including seizure and injunction, placement on FDA's public warning list, detention of imported products, and potential orders to reimburse consumers.