FDA Food and Dietary Supplement Labeling: What Health Claims Are Actually Allowed?

What Types of Health Claims Does the FDA Allow on Labels?

Under the Nutrition Labeling and Education Act of 1990 and the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA established a framework for regulating what manufacturers can say on product labels. Authorized health claims require "significant scientific agreement" among qualified experts — for example, the well-established link between calcium intake and reduced osteoporosis risk. These claims undergo the most rigorous FDA review before they can appear on packaging.

Qualified health claims, introduced following court rulings in the early 2000s, allow statements supported by emerging but not yet conclusive evidence, provided they carry qualifying language such as "some scientific evidence suggests." Structure/function claims — statements like "supports immune health" — require no FDA pre-approval at all. Manufacturers need only notify the FDA within 30 days of marketing and include a disclaimer that the product has not been evaluated by the agency. This tiered system creates a landscape where consumers encounter vastly different levels of scientific backing on labels that may look equally authoritative.

Why Are Dietary Supplement Labels Often Misleading?

Unlike pharmaceutical drugs, which must prove safety and efficacy before reaching consumers, dietary supplements are regulated more like foods under DSHEA. Manufacturers are responsible for ensuring their products are safe, but the FDA can only take action against a supplement after it reaches the market and is shown to be unsafe or mislabeled. According to the Government Accountability Office and various FDA reports, the agency has repeatedly noted challenges in monitoring the tens of thousands of supplement products on the US market with its available resources.

The Congressional Research Service report highlights several ongoing legal tensions, including disputes over what constitutes a "disease claim" versus a permissible structure/function claim. A statement like "maintains healthy blood sugar levels" is treated differently from "reduces risk of diabetes," yet the distinction can be opaque to consumers. Courts have also weighed in on First Amendment grounds, arguing that some FDA restrictions on qualified health claims may be overly restrictive, further complicating enforcement. Consumer advocacy groups, including the Center for Science in the Public Interest, have long called for stricter oversight and clearer labeling standards.

What Should Consumers Know When Reading Supplement Labels?

Health professionals recommend that consumers look for specific indicators when evaluating supplement labels. Products bearing authorized health claims have met the FDA's highest standard of scientific agreement. The presence of the standard disclaimer — "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" — signals a structure/function claim that has not undergone FDA review for efficacy. Third-party testing seals from organizations like USP (United States Pharmacopeia) or NSF International can provide additional confidence in product quality and ingredient accuracy.

The American Medical Association and other professional bodies advise patients to discuss supplement use with their healthcare providers, particularly because supplements can interact with prescription medications. The FDA maintains an adverse event reporting system (MedWatch) where consumers can report problems, and the agency periodically issues warnings about products found to contain undeclared pharmaceutical ingredients — a problem that has been documented particularly in weight loss and sexual enhancement supplements.