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FDA Issues Guidance on CAM Regulation
March 12, 2007
1 Min Read
WASHINGTONThe Food and Drug Administration (FDA) released a draft guidance for industry, entitled Complementary and Alternative Medicine [CAM] Products and Their Regulation by the Food and Drug Administration, which is intended to clarify which CAM modalities and products fall under the Federal Food, Drug and Cosmetic Act (FFDCA) or the Public Health Service Act (PHSA).
The draft guidance makes two main points:
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.
Neither the FFDCA nor the PHSA exempts CAM products from regulation. Comments can be submitted to FDA (www.fda.gov) through May 28, 2007.
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