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Complete Nutrition was cited for marketing "DR1" as a dietary supplement containing 5-alpha-hydroxy-laxogenin, an ingredient that does not meet the FDA's legal definition of a dietary ingredient under the Federal Food, Drug, and Cosmetic Act. The company failed to establish that this substance qualified as a vitamin, mineral, amino acid, botanical, or other recognized dietary ingredient category. Because 5-alpha-hydroxy-laxogenin lacked Generally Recognized as Safe (GRAS) status and had not received premarket approval as a food additive, the product was deemed adulterated and unlawful for interstate commerce.