New York Nutrition Company

Warning LetterOpen

David Lovatt New York Nutrition Company American Metabolix 11427 W I 70 Frontage Rd Wheat Ridge , CO 80033 United States info@americanmetabolix.comIssued May 4, 2022Center for Food Safety and Applied Nutrition (CFSAN)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateMay 4, 2022

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: New York Nutrition Company
Location: David Lovatt New York Nutrition Company American Metabolix 11427 W I 70 Frontage Rd Wheat Ridge , CO 80033 United States info@americanmetabolix.com
FEI Number: N/A
Country: United States
Issue Date: May 04, 2022
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Dietary Supplements
Status: Open

Summary

New York Nutrition Company's dietary supplements "Lean Muscle For Her" and "Lean Muscle" were found to be adulterated because they contained 5-alpha-hydroxy-laxogenin, a substance that does not meet the FDA's definition of a dietary ingredient under the Federal Food, Drug, and Cosmetic Act. The company failed to demonstrate that this ingredient was either generally recognized as safe (GRAS) by qualified experts or approved as a food additive before marketing the products. By labeling and distributing these products without proper ingredient qualification or premarket approval, the company violated federal regulations governing dietary supplement safety and composition.

New York Nutrition Company FDA Warning Letter, May 4, 2022