SCS Direct, Inc.

Warning LetterOpen

Howard Greenspan CEO SCS Direct, Inc. 9 Trefoil Dr. Trumbull , CT 06611 United States howieg@scsdirectinc.comFEI 3012113857Issued Apr 6, 2023Center 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. To check it, open FDA's record for this establishment, listed under FEI 3012113857.

Violations0

Issue DateApr 6, 2023

Product TypeDietary Supplements

StatusOpen

Letter Details

Firm: SCS Direct, Inc.
Location: Howard Greenspan CEO SCS Direct, Inc. 9 Trefoil Dr. Trumbull , CT 06611 United States howieg@scsdirectinc.com
FEI Number: 3012113857
Country: United States
Issue Date: April 06, 2023
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Dietary Supplements
Status: Open

Summary

SCS Direct, Inc. was cited for distributing two dietary supplement products, Uplift Max and Shred Her Max, containing hordenine HCl, which does not meet the FD&C Act definition of a dietary ingredient and is not approved as a food additive. The company failed to comply with dietary supplement regulations by including an unapproved substance that lacks generally recognized as safe (GRAS) status, rendering the products adulterated under section 402(a)(2)(C)(i) of the FD&C Act. The violation involved introducing these non-compliant products into interstate commerce without the required premarket safety approval for the undeclared food additive.

SCS Direct, Inc. FDA Warning Letter, April 6, 2023