The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) are responsible for regulating dietary supplements in the United States. The FDA regulates both finished dietary supplements and dietary ingredients under a different set of regulations than those that cover conventional foods and medications. The Dietary Supplement Health and Education Act (DSHEA) of 1994 created a very clear definition of dietary supplements and made it clear that they would be regulated as food. This law gave the FDA extensive authority to protect public health through a defined safety standard and new safety authorities.
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, companies also adopt self-regulatory practices and adhere to a strict code of ethics and dosing recommendations, as well as voluntary guidelines and best practices. The FDA does not approve dietary supplements, but they do have a role in regulating them. The DSHEA manufactures supplements subject to strict manufacturing standards and requires the FDA to “notify” new ingredients. This means that manufacturers must provide the FDA with information about each supplement, including the name and quantity of each ingredient, warnings and precautions for use, and allergen statements. The FTC regulates the advertising of dietary supplements as it does with all consumer products, by enforcing laws on truth in advertising and applies the same rules to all types of advertising, whether in newspapers, magazines, the Internet, by mail, or on billboards and buses.
Nonprofit organizations like Truth In Advertising and the Federal Trade Commission are consumers' main defense against fraudulent claims.
Proposed Legislation
In 2020, Senators Richard Durbin (D-IL) and Mike Braun (R-IN) proposed legislation to establish a mandatory list of products for supplements. This legislation would have provided Congress with a blueprint for a pragmatic, bipartisan policy that would strengthen oversight of dietary supplements. However, this legislation was not passed.Benefits of Dietary Supplements
Dietary supplements can be beneficial when taken correctly. For example, calcium and vitamin D can help strengthen bones, and fiber can help maintain bowel regularity.It is important to understand that supplements are only loosely regulated; in most cases, the Food and Drug Administration cannot step in to take a product off the shelf until it receives reports that the product has harmed consumers.
