04.01.07
FDA has made available a draft guidance for industry entitled, “Complementary and Alternative Medicine Products and Their Regulation by the Food & Drug Administration.” In recent years, the FDA claims it has seen the practice of complementary and alternative medicine (CAM) increase in the U.S. As a result, the agency has also noticed that there is increased confusion as to whether certain products used in CAM are subject to regulation under the Federal Food, Drug and Cosmetic Act (the act) or Public Health Service Act (PHS Act). FDA claims to have also seen an increase in the number of CAM products being imported into the U.S. Therefore, the draft guidance discusses when a CAM product is subject to the act or the PHS Act. The draft guidance makes two fundamental points:
• First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device or food (including food additives and dietary supplements) under the act or the PHS Act.
• Second, neither the act nor the PHS Act exempts CAM products from regulation. The draft guidance when finalized will represent FDA’s current thinking on the regulation of CAM products by FDA.
• First, depending on the CAM therapy or practice, a product used in a CAM therapy or practice may be subject to regulation as a biological product, cosmetic, drug, device or food (including food additives and dietary supplements) under the act or the PHS Act.
• Second, neither the act nor the PHS Act exempts CAM products from regulation. The draft guidance when finalized will represent FDA’s current thinking on the regulation of CAM products by FDA.