Loading…
Performax Labs Inc was cited for marketing two dietary supplements, Brute BCAA and Predator Pro, containing 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 comply with dietary supplement regulations by including an unapproved food additive that lacks premarket safety approval and is not generally recognized as safe (GRAS) for human consumption. The products were deemed adulterated and their introduction into interstate commerce violated federal law.