FDA WARNING_LETTER - Soda Pharm - March 08, 2022

The FDA and FTC issued a Warning Letter to sodapharmlife.com following reviews on February 7 and March 8, 2022, identifying products like the “Cold/Flu/COVID Pack,” “Goldenseal Extract,” and “Cool Down Loose Leaf Tea” being sold with unapproved claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under 21 U.S.C. § 355(a) and misbranded drugs under 21 U.S.C. § 352. Their introduction into interstate commerce is prohibited by 21 U.S.C. § 331(a) and (d). Additionally, the firm violated the FTC Act, 15 U.S.C. § 41 et seq., by making unsubstantiated claims about disease prevention or treatment without competent and reliable scientific evidence. The letter demands immediate cessation of selling unapproved COVID-19 products and making unsubstantiated claims. The firm must respond to both FDA and FTC within 48 hours, detailing corrective actions. Failure to comply could result in legal action, including seizure and injunction, inclusion on FDA's public list of fraudulent COVID-19 product sellers, and FTC penalties such as consumer refunds and civil penalties up to $46,517 per violation.