The Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create a new regulatory framework for dietary supplements. Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed. Generally, a firm does not have to provide FDA with the evidence it relies on to substantiate safety before or after it markets its products; however, there is an exception for dietary supplements that contain a new dietary ingredient that is not present in the food supply as an article used for food in a form in which the food has not been chemically altered. At least 75 days before introducing such a dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, the manufacturer or distributor must submit a notification to FDA with the information on the basis of which the firm has concluded that the NDI-containing dietary supplement will reasonably be expected to be safe. In addition, FDA’s regulations require those who manufacture, package, or hold dietary supplements to follow current good manufacturing practices that help ensure the identity, purity, quality, strength, and composition of dietary supplements. FDA generally does not approve dietary supplement claims or other labeling before use., Questions and answers about dietary supplements, including regulations, information that must be disclosed on the label, new dietary ingredients, and safety issues., Important things to know about dietary supplements. Learn about their label information, effectiveness, safety, risk, quality, and regulation here..