The Food and Drug Administration has proposed a new regulation to require current good manufacturing practices (cGMPs) in manufacturing, packing and holding of dietary supplements. The proposed rule would establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labelled to reflect the active and other ingredients in the product.
This proposed rule includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints related to cGMPs.
Under the cGMP proposal, manufacturers would be required to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements. FDA is soliciting comments from the public and industry on this proposed regulation