FDA WARNING_LETTER - 1 Party At A Time - August 28, 2020

The FDA and FTC issued a Warning Letter to reternity.org on September 1, 2020, after reviewing their website on August 4 and 28, 2020. The firm was found to be offering "BetterFly," a niacin-containing product, for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 of the FD&C Act (21 U.S.C. § 352). Its introduction into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)). Additionally, the FTC found that advertising claims for preventing or treating human disease without competent and reliable scientific evidence is unlawful under the FTC Act (15 U.S.C. 41 et seq.). The firm was instructed to immediately cease the sale of these unapproved and unauthorized products and to correct all violations. They must email both FDA and FTC within 48 hours detailing corrective actions and steps to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction, addition to FDA's public warning list, and potential orders to pay back consumers for FTC violations.