FDA Denies Metabolic Therapy OTC Petition

FDA has denied a 12/21/16 petition from Metabolic Therapy, Inc., asking that the agency amend the over-the-counter monograph for external analgesic drug products to indicate that melatonin and hexaphosphate (IP6) are safe and effective for external analgesic drug products. The denial letter says that the information provided in the petition “is not sufficient to establish the eligibility of melatonin and IP6 for evaluation for the requested use.” It says that to corroborate marketing conditions alleged in a citizen petition seeking to amend an OTC drug monograph, the agency typically must have actual product labeling or a copy of labeling that documents the conditions of marketing of a product in the U.S. before 5/1972.

Further, it says, even if there were enough information in the petition to establish eligibility of the two products, it is not supported by adequate accompanying data demonstrating general recognition of safety and effectiveness of the products for the requested use.