New York Nutrition Company / American Metabolix – FDA Warning Letter, Sep 14, 2021

The FDA issued a Warning Letter to Jason Duran and Markus Trillsch of American Metabolix on August 31, 2021, following a June 2021 review of their website, americanmetabolix.com. The letter identifies several products as unapproved new drugs and misbranded drugs, and others as adulterated dietary supplements.

Specifically, Muscle Test, Banish, Ketogenic Diet Aid, and Keto Friendly Collagen are deemed unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Act, due to website claims indicating their use for disease cure, mitigation, treatment, or prevention, without FDA approval. Muscle Test and Ketogenic Diet Aid are also cited as misbranded drugs under section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis or treatment, making adequate directions for layperson use impossible.

Furthermore, Exile Super Shock, Havok Hardcore, and Keto Pump (Watermelon and Grape Flavors) are classified as adulterated dietary supplements under section 402(a)(2)(C)(i) of the Act. This is because they contain Hordenine Hydrochloride (HCl) and, in the case of Exile Super Shock, Higenamine Hydrochloride (HCl). These ingredients are considered unsafe food additives as they are not generally recognized as safe (GRAS) and do not qualify as dietary ingredients.

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