February 25, 2004

Food Labeling and Qualified Health Claims

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The FDA is seeking comment on different approaches for regulating qualified health claims on conventional human food labels and dietary supplements.


The Nutrition Labeling and Education Act of 1990 gave the Food and Drug Administration (FDA) authority to permit health claims on food labels. A "health claim" is any claim that a substance in the food affects disease or other health conditions. Initially, the FDA permitted only those health claims that the agency determined were supported by "significant scientific agreement." Several court rulings, however, directed the FDA to explore ways of permitting producers to make "qualified" health claim--claims for which there may be some scientific evidence, but not significant scientific agreement. Courts stated that the agency should first consider if the claims could be presented in a truthful and non-deceptive way, such as by including disclaimers, before banning such claims.

The FDA is seeking comment on three options for permitting qualified health claims. Under Option 1, a producer would petition the FDA for permission to make a specific claim, and the FDA would determine what the appropriate disclaimer by assessing the strength of the scientific evidence underlying the claim. Under Option 2, each health claim would be subjected to a full notice-and-comment rulemaking to determine whether the wording of the claim accurately reflected the underlying scientific evidence. Under Option 3, producers would be free to make qualified health claims without prior FDA approval, but the FDA would investigate suspect claims to ensure that they were not false or misleading. Thus, the first two options involve pre-market review of all qualified health claims, while the third option focuses on post-market enforcement. The first two options are consistent with the FDA’s pre-market approval approach for new drugs, medical devices, and unqualified health claims on food labels. The last option is based on the Federal Trade Commission’s (FTC) approach to preventing false or misleading claims in advertising-- including advertising for products whose labeling is regulated by the FDA.

Based on the available information, Option 3 appears to be the alternative that best promotes consumer welfare by giving consumers the most access to truthful health claims while protecting them from false and misleading claims. In doing so, Option 3 also satisfies the courts’ directive that the FDA should deal with qualified health claims in a manner less restrictive than an outright ban.