Business Guide For Dietary Supplement Industry Released by FTC Staff

The explosion of the dietary supplement market and changes in regulation have created uncertainty in the dietary supplement industry about how to abide by advertising law. To help ensure that advertising for dietary supplements is truthful and not misleading, staff of the Federal Trade Commission today released, "A Guide for the Dietary Supplement Industry." The plain-English guide describes the basic principles of the law and uses examples from the supplement industry to illustrate how those principles apply in practice.

According to the Business Guide, "[t]he dietary supplement industry [which includes vitamins, minerals, herbal products, hormones and amino acids] is a dynamic one. Scientific research on the associations between supplements and health is accumulating rapidly."

"Consumer use of dietary supplements has increased dramatically in the last few years," said Jodie Bernstein, Director of the FTC's Bureau of Consumer Protection. "This Business Guide will go a long way to ensure that consumers are getting information that is truthful and adequately substantiated. Good players in the industry will have the guidance they need. Others will continue to face vigorous enforcement by the FTC."

The guide also should help to resolve uncertainty about the interaction of FTC advertising policy and the Food and Drug Administration's regulation of labeling under the Dietary Supplement and Health Education Act (DSHEA), staff noted. The FTC and FDA operate under a longstanding liaison agreement that divides the responsibilities between the two agencies. The FDA has primary responsibility for labeling and the FTC has primary responsibility for advertising claims. Because of their shared jurisdiction, the two agencies work together to ensure that their enforcement efforts are consistent. The passage of DSHEA in 1994 created a new approach to FDA regulation of the labeling of dietary supplements and now permits certain types of claims in labeling without prior FDA authorization. Although, as noted in the Guide, DSHEA does not directly apply to advertising claims, the requirement that claims be truthful, not misleading and substantiated is common to both labeling and advertising laws.

The Guide follows a year of outreach meetings by FTC staff with industry groups, consumer organizations and government offices to identify the specific areas of uncertainty and how best to address them. The Guide is a restatement of longstanding FTC policies and is not intended to signal any change in the agency's approach to dietary supplement advertising, the staff pointed out.

The basic axiom of FTC advertising principles, the Guides points out, is that "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." Staff also noted that the agency's approach to substantiation of supplement claims is a rigorous but also flexible one. The amount and type of support needed will depend greatly on consumers' expectations, based on the specific claim being made, how it is presented in the context of the entire ad and how it is qualified. In evaluating the adequacy of support for a claim, the Commission consults with experts in a wide variety of fields, including those with a background in botanicals and traditional medicines.

The Guide is divided into three main sections. The first two sections explain how the FTC identifies the claims conveyed by an ad and how it evaluates the adequacy of the substantiation for those claims. The third section covers consumer testimonials, expert endorsements, and advertising claims based on historical or traditional use of supplements. It also addresses the relevance of certain specific provisions of DSHEA to advertising.

Bernstein and her staff underscored that the FTC will continue to maintain an active enforcement presence in the dietary supplement industry, giving priority to cases that present serious safety considerations or affect sick and vulnerable consumers. In the coming months, FTC staff will also be working with industry groups to encourage and support self-regulatory efforts. "I would like to see this industry use our Business Guide as a foundation for a broad-based and rigorous self-regulatory campaign against false and deceptive advertising. Industry has a critical stake here. Consumer trust in what they see and hear will determine the ultimate success or failure of the marketplace," said Bernstein.

The FTC also released a report on a research project conducted by the staff on a number of issues relating to how consumers interpret food and supplement advertising claims. Among the issues addressed in that report is how consumers interpret claims based on emerging science and what disclosures are effective in conveying the limitations of the scientific support for a claimed health benefit. "Supplement marketers will find this research instructive when attempting to craft claims that fairly and accurately describe the state of scientific knowledge on a particular product," said Bernstein. (See News Release dated November 18 on Food Copy Test.)

The Commission vote to approve release of the Business Guide was 4-0.

Copies of the Business Guide are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 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. 974506)