Creatine

Under the Federal Food, Drug, and Cosmetic Act, an orally ingested creatine product is a dietary supplement only when the finished product meets the ingredient, presentation, and labeling requirements of 21 U.S.C. § 321(ff). Such products are not subject to FDA premarket approval, but manufacturers and distributors remain responsible for safety, labeling, and compliance, including current good manufacturing practices. For a product containing a new dietary ingredient that is not exempt under 21 U.S.C. § 350b(a)(1), the manufacturer or distributor must provide the Secretary with the statutory safety information at least 75 days before introduction or delivery for introduction into interstate commerce.