How Dietary Supplements Are Regulated

The Dietary Supplement Health and Education Act, signed October 25, 1994, after a large public campaign by supplement makers and users, set supplements apart from drugs. Vitamins, minerals, herbs, amino acids, and similar products may be sold without FDA approval or proof that they work. Manufacturers are responsible for making sure their products are safe and accurately labeled, and they must notify the FDA before selling a new ingredient that was not on the market before 1994.

Supplements may not claim to treat or cure disease, but they may make structure and function claims, such as supports immune health, if they carry a disclaimer that the FDA has not evaluated the claim. Since 2007 makers have had to follow manufacturing standards, and since a 2006 law they must report serious adverse events. The burden is on the FDA to show that a product is unsafe before removing it, which the agency did with ephedra in 2004 after deaths linked to it. The Federal Trade Commission polices advertising claims. The market includes tens of thousands of products and most American adults use at least one supplement.

Critics, including many doctors and some members of Congress, say the system lets contaminated, mislabeled, or dangerous products reach consumers and have proposed requiring every product to be listed with the FDA. Supporters say supplements are generally safe, that consumers should be free to choose them, and that drug-style approval would drive useful products off the market. The health priorities announced by federal officials in 2025, which emphasized nutrition and skepticism of some pharmaceuticals, added to the debate over how supplements should be treated.