SCS Direct, Inc. – FDA Warning Letter, Apr 18, 2023

On April 6, 2023, the FDA issued a Warning Letter to Mr. Greenspan regarding the dietary supplement products Uplift Max and Shred Her Max. The FDA determined these products are adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they contain hordenine HCl, which is not a dietary ingredient and is not generally recognized as safe (GRAS) for its intended use.

Hordenine HCl does not qualify as a dietary ingredient under section 201(ff)(1) of the FD&C Act. As a non-dietary ingredient, it must be used in accordance with a food additive regulation or be GRAS, neither of which applies to hordenine HCl in these products. Therefore, Uplift Max and Shred Her Max contain an unsafe food additive, rendering them adulterated under section 402(a)(2)(C)(i) of the FD&C Act. Introducing or delivering adulterated food into interstate commerce is a prohibited act under section 301(a).

The letter also noted a misrepresentation on the firm's website, www.nlaforher.com, which falsely claims affiliation with Optimum Nutrition, Inc.

The firm must respond within fifteen working days, detailing specific corrective actions, steps to prevent recurrence, and supporting documentation. Failure to address these violations may result in legal action, including seizure and injunction.