In general, the FDA is limited to enforcing the law after marketing because, unlike drugs that must be proven to be safe and effective for their intended use before they are marketed, the law does not require the FDA to approve the safety of dietary supplements before they reach the consumer. The FDA does not authorize the sale of individual supplements. However, dietary supplement companies are only allowed to sell products that contain ingredients that are currently in the food supply or that were used in dietary supplements before 1994, when the Dietary Supplements Health and Education Act was passed. This law included very specific labeling requirements that included the statement of identity, the statement of the net quantity of the content, the nutritional information, the list of ingredients and commercial information.
The first two requirements on this list are apparently necessary to protect consumers against fraud. They contribute to obtaining a complete picture of the product and the manufacturer. Unlike drugs, dietary supplements are only for nutritional purposes. Because supplements aren't considered drugs, they aren't controlled in the same way. The FDA has regulations for manufacturing and labeling dietary supplements, but these have different guidelines for testing, safety, and efficacy than pharmaceutical drugs.
Unlike drugs, supplements do not require prior approval from the FDA before being offered for sale to consumers. This last requirement requires a little more effort because dietary supplements are not required to obtain FDA approval. Drugs must be approved by the FDA before they can be sold or marketed. Supplement companies are responsible for having proof that their products are safe, and that the claims on their labels are truthful and not misleading. However, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1999), companies do not have to provide these safety tests to the FDA before marketing their product. The Federal Food, Drug and Cosmetic Act (FD&C Act) was amended in 1994 by the Dietary Supplement Health and Education Act (often referred to as DSHEA), which defined the “dietary supplement” and established the authority of the FDA with respect to such products. When it comes to supplements, the FDA is a regulatory agency that dictates what statements are appropriate for supplement companies to make about their products.
This is why you might see inaccurate wording about what a supplement does: it does to comply with FDA guidelines on approved dietary supplement claims. Dietary supplement companies must report serious adverse events they receive from their dietary supplements to the FDA within 15 days. To file a general, non-serious complaint or concern about dietary supplements, contact your local FDA consumer complaint coordinator. The FDA has established good manufacturing practices (GMP) that companies must follow to help ensure the identity, purity, concentration and composition of their dietary supplements. If you experience an adverse effect while taking a dietary supplement, stop using it immediately, seek medical attention or advice, and report the adverse event to the FDA. So what exactly is the FDA's role in the supplement industry and what do those two little phrases mean? The Food and Drug Administration (FDA) does not determine if dietary supplements are effective before they are marketed.
To ensure public safety, they have defined good manufacturing practices (GMP) that they apply through inspections, and have authority to process, seize, and recall dangerous products from the market. In conclusion, while dietary supplements do not require prior approval from the FDA before being offered for sale to consumers, supplement companies must still adhere to certain regulations set forth by them. Companies must have proof that their products are safe and that their labels contain truthful information. Additionally, serious adverse events must be reported within 15 days.
By following these guidelines set forth by the FDA, you can ensure your business is compliant with all regulations.
