FDA WARNING_LETTER - The Jim Bakker Show - February 21, 2020

The FDA and FTC issued a Warning Letter to The Jim Bakker Show after reviewing their website and social media in February 2020. The agencies found the firm was offering products, including "Silver Sol Liquid," with claims to mitigate, prevent, treat, diagnose, or cure Coronavirus Disease 2019 (COVID-19). The FDA determined these products are unapproved new drugs, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a), and are misbranded drugs under 21 U.S.C. § 352. Their introduction into interstate commerce is prohibited under 21 U.S.C. § 331(a) and (d). The FTC also found that the firm's claims regarding COVID-19 efficacy are unsubstantiated by competent and reliable scientific evidence, violating the FTC Act, 15 U.S.C. 41 et seq., as no approved products currently treat or cure COVID-19. The firm must immediately cease selling these unapproved products and stop making unsubstantiated claims. Within 48 hours, they must email both the FDA and FTC, detailing corrective actions and prevention steps. Failure to comply may result in legal action, including seizure, injunction, being added to FDA's public list of fraudulent COVID-19 product sellers, and potential refunds to consumers for FTC violations. Imported products may also face detention and refusal of admission.