FTC Staff Files Comment with FDA About Substantiation of Dietary Supplement Claims

The staff of the Federal Trade Commission today filed comments with the Food and Drug Administration suggesting that FDA highlight, in its proposed rule on dietary supplement claims, the requirement that such claims be substantiated. The comment also suggests that FDA incorporate into the rule guidance about how it will apply the substantiation requirement. The FDA is soliciting comments on a proposal to clarify the distinction between permissible labeling claims about a dietary supplement's effect on a normal structure or function of the body and impermissible labeling claims about a supplement's ability to diagnose, cure, mitigate, treat, or prevent disease.

The FTC and FDA have complementary jurisdiction over the marketing of dietary supplements and, under the terms of a 1971 liaison agreement, the FTC has primary responsibility for regulating advertising and the FDA has primary responsibility for labeling.

In its comment, FTC staff note that the principles for substantiation of labeling claims, as outlined in the November 1997 Report of the Commission on Dietary Supplement Labels and embraced by FDA in its response to that report, correspond in many ways to the FTC's approach to substantiation of advertising claims. For example, the comment states, "Both approaches apply a flexible standard governed in large part by the way the claim is presented." Also consistent with the approach set out in the Report of the Commission on Dietary Supplement Labels, "the FTC looks at studies in the context of the entire body of scientific literature, considers all relevant evidence, including contrary evidence, and has indicated that the weight of the evidence should support the claim."

The Commission vote to approve the staff comment was 4-0.

The comment reflects the views of the staff of the Bureau of Consumer Protection. They do not necessarily represent the views of the Commission or any individual Commissioner.

Copies of the full text of the comment are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 6th Street and Pennsylvania Avenue, N.W., Washington, D.C. 20580; 202-FTC-HELP (202-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.

(FTC File No. V980023)