FDA WARNING_LETTER - Usp Labs

This FDA Warning Letter, Case # 413065, addresses USP Labs, LLC regarding their dietary supplement products, Oxy Elite Pro and VERSA-1, which declare aegeline as a dietary ingredient. The FDA asserts that aegeline is a "new dietary ingredient" requiring notification under 21 U.S.C. 350b(a)(2) and 21 CFR 190.6, as there is no evidence of its marketing in the U.S. before October 15, 1994, or its presence in the food supply in an unaltered form.

The primary violation is the failure to submit the required new dietary ingredient notification, rendering the products adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a). Furthermore, the FDA states there is no history of use or other safety evidence establishing that aegeline is reasonably expected to be safe, leading to adulteration under 21 U.S.C. 342(f)(1)(B) and 350b(a) due to inadequate safety assurance.

The letter highlights a critical public health concern, noting an investigation into severe hepatotoxicity cases in Hawaii and elsewhere, with a strong causal link suggested between Oxy Elite Pro ingestion and these illnesses, including liver transplants and one death.

USP Labs, LLC is required to take