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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.