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Talk to a SpecialistTalk to a SpecialistExclusive Nutrition Products, LLC was cited for distributing two adulterated dietary supplements—Thermo Burn and 5-Alpha—that contained unapproved food additives (higenamine HCl and 5-alpha-hydroxy-laxogenin, respectively) not qualifying as valid dietary ingredients under federal law. The company violated the Federal Food, Drug, and Cosmetic Act by marketing substances that lack either dietary ingredient status or GRAS (generally recognized as safe) designation, requiring premarket approval that was not obtained. These products were deemed unsafe for introduction into interstate commerce due to the presence of undeclared or unapproved active components marketed as dietary supplement ingredients.