FDA WARNING_LETTER - Alive By Nature, Inc. - May 04, 2020

The FDA and FTC issued a Warning Letter to Alivebynature.com after reviewing their website and social media on April 28 and May 4, 2020. The firm offers "NAD+" and "NMN" sublingual gel products with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. 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 are misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited under sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FTC also found the firm's advertising claims unlawful under the FTC Act (15 U.S.C. 41 et seq.) due to a lack of competent and reliable scientific evidence, including well-controlled human clinical studies, to substantiate COVID-19 related claims. The letter demands immediate cessation of sales for these unapproved products. Alivebynature must email the FDA within 48 hours detailing corrective actions and recurrence prevention steps, with supporting documentation. A separate 48-hour response is required for the FTC regarding advertising concerns. Failure to comply may lead to legal action, including seizure, injunction, placement on FDA's public fraud list, and potential consumer refunds for FTC violations.