New Criteria for Disease-Related Claims on Dietary Supplement Labels

FDA uses new guidelines to authorize and deny health-related claims.

FDA has come out with changes to how it evaluates disease-related claims on dietary supplement labels. An interim enforcement strategy has also gone into effect, after a federal court ruled that part of the agency's previous process was unconstitutional.

The agency ruled in 1993 that dietary supplement manufacturers could not include on their labels health claims for the disease-substance relationships between dietary fiber and cancer, between antioxidant vitamins and cancer, and between omega-3 fatty acids and coronary heart disease. FDA also ruled that while a health claim could be made for the relationship between folate and the reduced risk of neural tube defects, claims that folate from one source (dietary supplements) is more effective than folate from another source (food) would not be allowed.

Several dietary supplement marketers and nonprofit organizations sued to overturn those rulings. The agency won the case, Pearson v. Shalala, in U.S. District Court in 1998, but the following year the U.S. Court of Appeals for the DC Circuit reversed the decision. The appellate court said the First Amendment does not permit FDA to reject health claims that it determines to be potentially misleading unless the agency determines that no disclaimer would resolve the potential confusion.

So the appellate court invalidated the regulations codifying FDA's decision in those four cases, and instructed the agency to reconsider them. That did not mean the four claims were now approved. The court also mandated that FDA clarify its "significant scientific agreement" standard for authorizing health claims on labels. It said the agency could issue a regulatory definition of the term or define it on a case-by-case basis.

Since then, the agency has conducted a review of scientific literature dating back to 1993 to determine if any relevant information regarding the four claims had been published; convened a public meeting to solicit input on potential changes to the regulations; and, in December 1999, issued a guidance clarifying "significant scientific agreement." The key phrase in the guidance is: "The assessment of significant scientific agreement... derives from the conclusion that there is a sufficient body of sound, relevant scientific evidence that shows consistency across different studies and among different researchers and permits the key determination of whether a change in the dietary intake of the substance will result in a change in a disease end point."

A rule outlining how the new "significant scientific agreement" process will be implemented must be made. It has not surfaced yet.

On October 3, 2000, the agency issued in the Federal Register [65 FR: 58917–58918] a rule revoking the four decisions. The portions of 21 CFR Sec. 101.71 and Sec. 101.79 that specifically disallowed the four claims were removed.

In the October 6, 2000, Federal Register [65 FR:59855–59857], FDA outlined how it will enforce provisions against inappropriate claims absent a new "significant scientific agreement" ruling for the time being. If the agency used the old "significant scientific agreement" process, it might be subject to more First Amendment challenges.

So the agency said it "intends to exercise enforcement discretion in appropriate circumstances." Claims will be considered for approval if the petition meets the requirements of 21 CFR Sec. 101.70 and the claim meets the general requirements for health claims in 21 CFR Sec. 101.14 (that were not overturned by the October 3 rule); if consumer health and safety are not threatened; if the scientific evidence in support of the claim outweighs that against it; and if the claim is appropriately qualified and each statement is consistent with the weight of the scientific evidence.

If "significant scientific agreement" is achieved, the claim will be authorized. If the standard is not met but positive scientific evidence outweighs negative evidence, and all other criteria for approval are met, the agency will consider authorizing the claim if appropriate qualifying language is included. If the standard is not met and the negative evidence outweighs the positive, or the substance poses a threat to public health, or any other criteria for approval are not met, the claim will be denied.

On October 10, 2000, using the new criteria, the agency denied the petitions for the folate–neural tube claim and the dietary fiber–cancer claim. The agency said the former could not be appropriately qualified without being misleading, and the latter's negative scientific evidence outweighed its positive evidence. Decisions on the other two claims had not been made at press time.

For further information, contact James E. Hoadley, Center for Food Safety and Applied Nutrition (HFS-832), 200 C St. N.W., Washington, DC 20204, 202/205-5372.

No votes yet