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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.