The FDA has a set of regulations that cover finished dietary supplements and dietary ingredients. These regulations are different from those that apply to conventional foods and pharmaceutical products. Dietary supplements are regulated by the FDA as foods, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or a medical condition you may have.
Products containing hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it is important to consult with a healthcare professional before using any dietary supplement. The FDA and the Federal Trade Commission regulate the marketing, manufacturing, labeling, and advertising of dietary supplements. The FDA recommends that consumers talk to their doctor, pharmacist, or other health professional before deciding to buy or use a dietary supplement.
The National Organic Program (NOP) is a federal regulatory program that develops and enforces consistent national standards for organically produced agricultural products sold in the United States. Generally, a company does not have to provide the FDA with the tests it relies on to demonstrate safety before or after marketing its products; however, there is an exception for dietary supplements that contain a new dietary ingredient (NDI) that is not present in the food supply. 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 the FDA containing the information on the basis of which the company has concluded that the dietary supplement containing NDI can be reasonably expected to be safe. The FDA wants consumers using dietary supplements to know that today's draft guidance, if finalized, will indicate to the dietary supplement industry that the agency intends to exercise its compliance discretion, for a limited time and under limited circumstances, to encourage manufacturers and distributors to correct any prior non-compliance by filing the mandatory NDI notification.
Advertising and other promotional material sent by mail are also subject to regulation by the U. S. Postal Service. To help consumers in their quest to become better informed, the FDA has prepared additional educational materials.
If you have any general complaints or concerns about food products, including dietary supplements, you can contact the consumer complaint coordinator at the nearest FDA district office. The FDA's role in regulating dietary supplements includes (among other things) inspecting dietary supplement manufacturing facilities, reviewing notifications for new dietary ingredients (NDI) and other regulatory requests for dietary supplements, investigating complaints, monitoring the dietary supplement market, and examining dietary supplements and dietary ingredients offered for import to determine if they comply with U. regulations. In addition to complying with a number of federal and state regulations governing dietary supplements and foods in the areas of manufacturing, quality control, labeling, safety and marketing, CRN member companies also adopt self-regulatory practices and adhere to a strict code of ethics and dosage recommendations, as well as voluntary guidelines and best practices.
There are three types of claims that are not approved by the FDA and do not require evaluation by the FDA before they are used in the labeling of dietary supplements: structure/function claims; health claims; and nutrient content claims. The Dietary Supplements Health and Education Act (DSHEA) amended the Federal Food, Drug and Cosmetic Act (Act FD&C) to create a new regulatory framework for dietary supplements. The Federal Trade Commission (FTC) regulates the advertising, including infomercials, of dietary supplements.