Jay Cohen
Nutritional Sales and Customer Service, LLC
10450 West McNab Rd.
Tamara , FL 33321
United States
metabolicnutrition.comFEI 1052277Issued May 4, 2022Center for Food Safety and Applied Nutrition (CFSAN)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1052277.
Violations1
Issue DateMay 4, 2022
Product TypeDietary Supplements
StatusOpen
Letter Details
Firm
Nutritional Sales and Customer Service, LLC
Location
Jay Cohen
Nutritional Sales and Customer Service, LLC
10450 West McNab Rd.
Tamara , FL 33321
United States
metabolicnutrition.com
FEI Number
1052277
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
Nutritional Sales and Customer Service, LLC was cited for marketing Synedrex as a dietary supplement containing three undeclared new dietary ingredients—octopamine, hordenine, and higenamine—that were not present in the U.S. food supply before October 15, 1994. Under federal law, dietary supplements containing new dietary ingredients must meet specific safety and notification requirements unless the ingredients were already marketed in the United States prior to that cutoff date. The company failed to comply with these pre-market notification requirements, rendering the product adulterated and illegal to sell in interstate commerce.
Nutritional Sales and Customer Service, LLC FDA Warning Letter, May 4, 2022
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