FDA WARNING_LETTER - Valentus, Inc. - December 08, 2020

On November 30, 2020, the FDA issued a Warning Letter to Valentus, following a November 2020 review of their website, valentus.com. The FDA determined that Valentus was taking orders for products including Valentus Prevail Breakthrough AM/PM, Valentus Prevail eMulin M, Valentus Prevail eMulin C, and Valentus PrevailMAX.

The FDA found that claims on Valentus's website established these products as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1)(B), because they were intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of such claims included statements about reducing inflammation, supporting healthy blood sugar, and addressing various health conditions.

These products are considered "new drugs" under section 201(p) of the Act, 21 U.S.C. § 321(p), as they are not generally recognized as safe and effective for their stated uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355