FDA WARNING_LETTER - jrb enterprise group inc. - March 27, 2020

The FDA and FTC issued a joint Warning Letter on March 30, 2020, to Antiagingbed.com after reviewing their website and social media on March 17 and 27, 2020. The letter addresses the sale of colloidal silver products marketed with unapproved claims to mitigate, prevent, treat, diagnose, or cure COVID-19, leveraging the ongoing public health emergency. 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 by sections 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 disease prevention/treatment claims without competent and reliable scientific evidence. The firm is required to immediately cease selling these products and respond within 48 hours to both FDA and FTC, detailing corrective actions and recurrence prevention. Failure to comply may result in legal action, including seizure, injunction, consumer refunds, and inclusion on FDA's public list of non-compliant firms.