A manufacturer of a dietary supplement made a disease claim for its product in such a manner that the FDA deemed that the claim made the product a new drug. The manufacturer responded that it did not deny that the claim would make the product a drug; however, it contended the product is not a “new drug” and thus could be marketed without approval. The company claims it can submit enough evidence that its product is GRASE and has been used to treat the disease for more than 100 years. Discuss the merits of the manufacturer’s argument and whether it might prevail.