When it comes to drugs and biological products for people, the Food and Drug Administration (FDA) must approve them before they can be marketed in interstate commerce. This means that a company must demonstrate that its drug or biological product is safe and effective for its intended use, and that it can manufacture the product according to federal quality standards. If the FDA grants an approval, it implies that the agency has determined that the advantages of the product outweigh the risks for its intended use. But what about dietary supplements? Where do they fit in?In the 1980s, food manufacturers began to make health claims.
This posed the question of where dietary supplements fit in. Drugs must be approved by the FDA before they can be sold or marketed, but supplements do not require this approval. Supplement companies are responsible for having proof that their products are safe, and the claims on the label are truthful and not misleading. However, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1999), the company does not have to provide these safety tests to the FDA before the product is marketed. The Dietary Supplement Health and Education Act (DSHEA) states that dietary supplements should not make health claims without testing or FDA approval.
This means that supplement companies must ensure that their products are safe before marketing them and meet other labeling and quality requirements, such as good manufacturing practices. Since dietary supplements do not need to be approved by the FDA before they are marketed, the agency often doesn't know when new products come to market. When public health concerns arise about the safety of a dietary supplement or ingredient, the FDA has the authority to take steps to protect the public. Some supplements may increase the risk of bleeding or, if taken before surgery, may change the response to anesthesia. Manufacturers must indicate the serving size of the food and the specific information about the nutrient content of each serving on the nutrition label (or on the “Supplement Information” label for dietary supplements). To be a dietary supplement, a product must also be labeled as such; that is, its label must include the term “dietary supplement” or equivalent.
Additionally, dietary supplements may include other statements on their labels that are not defined by law or regulation. Mammography centers must be FDA certified and show their FDA certificates where patients can view them.