The dietary supplement industry is a dynamic one. Scientific research on the associations between supplements and health is accumulating rapidly. The number of products and the variety of uses for which they are promoted have increased significantly in the last few years. The role of the Federal Trade Commission, which enforces laws outlawing unfair or deceptive acts or practices,is to ensure that consumers get accurate information about dietary supplements so that they can make informed decisions about these products.

The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) work together under a long-standing liaison agreement governing the division of responsibilities between the two agencies. As applied to dietary supplements, the FDA has primary responsibility for claims on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale. The FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials. Marketing on the Internet is subject to regulation in the same fashion as promotions through any other media. Because of their shared jurisdiction, the two agencies work closely to ensure that their enforcement efforts are consistent to the fullest extent feasible.

In 1994, the Dietary Supplements Health and Education Act (DSHEA) significantly changed the FDA role in regulating supplement labeling. These claims are commonly referred to as structure/function claims. Although DSHEA does not directly apply to advertising, it has generated many questions about the FTC approach to dietary supplement advertising. The answer to these questions is that advertising for any product including dietary supplements must be truthful, not misleading, and substantiated. Given the dramatic increase in the volume and variety of dietary supplement advertising in recent years, FTC staff is issuing this guide to clarify how long-standing FTC policies and enforcement practices relate to dietary supplement advertising.

The FTC approach to supplement advertising is best illustrated by its Enforcement Policy Statement on Food Advertising (Food Policy Statement). Although the Food Policy Statement does not specifically refer to supplements, the principles underlying the FTC regulation of health claims in food advertising are relevant to the agency approach to health claims in supplement advertising. In general, the FTC gives great deference to an FDA determination of whether there is adequate support for a health claim. Furthermore, the FTC and the FDA will generally arrive at the same conclusion when evaluating unqualified health claims. As the Food Policy Statement notes, however, there may be certain limited instances when a carefully qualified health claim in advertising may be permissible under FTC law, in circumstances where it has not been authorized for labeling. However, supplement marketers are cautioned that the FTC will require both strong scientific support and careful presentation for such claims.

Supplement marketers should ensure that anyone involved in promoting products is familiar with basic FTC advertising principles. The FTC has taken action not just against supplement manufacturers, but also, in appropriate circumstances, against ad agencies, distributors, retailers, catalog companies, infomercial producers and others involved in deceptive promotions. Therefore, all parties who participate directly or indirectly in the marketing of dietary supplements have an obligation to make sure that claims are presented truthfully and to check the adequacy of the support behind those claims.

CONTENTS

I INTRODUCTION
II APPLICATION OF FTC LAW TO DIETARY SUPPLEMENT ADVERTISING
A. Identifying Claims and Interpreting Ad Meaning

1. Identifying Express and Implied Claims
2. When to Disclose Qualifying Information
3. Clear and Prominent Disclosure

B. Substantiating Claims
Overview

1. Ads that Refer to a Specific Level of Support
2. The Amount and Type of Evidence
3. The Quality of the Evidence
4. The Totality of the Evidence
5. The Relevance to the Evidence to the Specific Claim

C. Other Issues Relating to Dietary Supplement Advertising

1. Claims based on Consumer Testimonials and Expert Endorsements
2. Claims based on Traditional Use
3. Use of the DSHEA Disclaimer in Advertising
4. Third Party Literature

III CONCLUSION

End Notes

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