Are you considering taking a dietary supplement? If so, you may be wondering if the Food and Drug Administration (FDA) regulates these products. The answer is yes, 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 with a medical condition you may have. The Dietary Supplement 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.
According to the DSHEA, the FDA does not have the authority to approve dietary supplements before they are marketed. A company generally does not have to provide the FDA with the evidence 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 that is not present in the food supply, such as an item used as food in a form in which the food has not been chemically altered. At least 75 days before introducing such dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, the manufacturer or distributor must submit a notification to the FDA with information on the basis of which the company has concluded that it is reasonable to expect the dietary supplement containing NDI to be safe. In addition, FDA regulations require that those who manufacture, package, or preserve dietary supplements follow current good manufacturing practices that help ensure the identity, purity, quality, concentration, and composition of dietary supplements.
The FDA generally does not approve claims on dietary supplements or other labels before use.
Dietary supplements
are defined as products taken orally and containing a dietary ingredient intended to supplement the diet. Dietary ingredients include vitamins, minerals, herbs or other botanicals and amino acids. In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), an important piece of legislation that provided a regulatory framework to ensure the safety of dietary supplements. This legislation gave the Food and Drug Administration (FDA) authority to establish regulations on the manufacture of dietary supplements, regulate health claims and labeling.The marketing, manufacture, labeling, and advertising of dietary supplements are covered by regulations imposed by the FDA and the Federal Trade Commission. The FDA recommends that consumers talk to their doctor, pharmacist, or other health professional before deciding to buy or use a dietary supplement. The Federal Trade Commission (FTC) regulates advertising, including infomercials, of dietary supplements. However, manufacturers and distributors of dietary supplements should record, research, and send to the FDA any reports they receive about serious adverse events related to the use of their products.
Both the FDA and the FTC have the authority to take enforcement action against dietary supplements and companies if they identify violations. Before 1994, dietary supplements were subject to the same regulatory requirements as FDA foods. Whatever their form, the DSHEA classifies dietary supplements (DS) in a special category within the general scope of food and, therefore, the FDA remains responsible for helping to regulate the industry, albeit playing a minor role. In addition, any statement about food products must be truthful and not misleading, and must meet the regulatory requirements for the type of statement, as appropriate.
Anyone can report an adverse event considered related to a dietary supplement directly to the FDA by accessing the safety reporting portal. The FDA is responsible for protecting public health by regulating human and biological drugs, animal drugs, medical devices, tobacco products, foods (including animal foods), cosmetics, and electronic products that emit radiation. FDA regulations require that dietary supplement labels include the name of the product and a statement stating that it is a dietary supplement or an equivalent term that replaces “dietary” with the name or type of dietary ingredient in the product (e.g., vitamin). Because the FDA doesn't approve dietary supplements before they're marketed, the agency often doesn't know when new products come to market.
No, a product that is sold as a dietary supplement and that is explicitly or implicitly represented for the treatment, prevention, or cure of a specific disease or class of diseases meets the definition of a drug and is subject to regulation as a drug. To learn more about the FTC's role in regulating dietary supplement advertising, visit the FTC website. Supplements are often marketed now without being proven to work as claimed causing both agencies to update them once they have been distributed. We also investigate reports of adverse events and complaints from consumers, health professionals, other regulatory agencies and industry.
