For the first time, the Federal Trade Commission is issuing advertising guidelines aimed specifically at the nation's booming dietary supplement industry.
The guidelines are the commission's second action within a week on claims by the industry, which earned nearly $12 billion in 1997 and is growing at about 20 percent a year. Last week the commission e-mailed warnings to 1,200 Internet sites that it said had made "incredible claims" for drugs, devices and dietary supplements, including herbal remedies that purported to ward off AIDS or cure cancer.
In addition, the commission has taken legal action this year against seven supplement manufacturers over advertising claims for various products, including an impotence remedy called Vaegra and a shark cartilage product that supposedly cured cancer, rheumatism, arthritis, diabetes, fibroid tumors, bursitis, circulatory problems and cysts. Several weight-loss potions were also targeted by the commission.
The guidelines, which are being posted Wednesday on the commission's Web site and sent to trade associations for the supplement industry, do not amount to any change in policy, said Michelle Rusk, a lawyer for the commission. Basically the FTC requires that advertising be truthful, that it not be misleading and that advertisers be able to back up their claims. The new guidelines explain how those requirements apply to the supplement industry and spell out the kinds of claims that supplement manufacturers can and cannot make.
Jodie Bernstein, director of the FTC's Bureau of Consumer Protection, said that in recent years the commission had issued similar guidelines to define "low fat" for the food industry and terms like "recycled" and "recyclable" for other producers.
The new supplement guidelines were prompted by the tremendous growth of the industry, Ms. Bernstein said, and by confusion among manufacturers about what was allowed in advertising.
"There are a lot of new players," she said.
In addition, the Dietary Supplement Health and Education Act of 1994 limited the authority of the Food and Drug Administration to regulate supplements, and that change left many manufacturers wondering what the rules were.
Ms. Bernstein said the commission had worked with industry and consumer groups for a year to develop the guidelines.
Response from the industry has been favorable. Alan Raul, a lawyer at Sidley & Austin, a Washington law firm that represents the National Nutritional Foods Association, said: "The FTC has really reached out to the dietary supplement industry to provide assistance and guidance in the sort of advertising claims on dietary supplements that are appropriate. It looks like a thorough, helpful piece of guidance that will be useful to the public and to the industry."
Dr. Annette Dickinson, director of scientific and regulatory affairs for another trade association, said, "We think it's a very good idea, and a useful guide."
The guide, a 26-page document, explains that the Food and Drug Administration is responsible for claims on labeling, and the FTC for advertising claims, including those on the Internet. It provides 36 hypothetical examples of advertising claims, and explains how the law would apply to them.
Advertisers are responsible for implied claims as well as expressly stated ones, the guide says, so that if an advertisement cites "university studies" in support of a product, the studies must not only exist but also deliver on the implied message, which is that they are reliable studies.
Similarly, if an advertisement says that 90 percent of cardiologists take a certain product, the manufacturer must be able to demonstrate not only that fact but also the implied claim that the product is good for the heart.
Unlike FDA labeling rules, which forbid claims that supplements can treat or prevent disease, the FTC guidelines allow such claims in advertisements, provided that the manufacturer can substantiate them. What qualifies as substantiation is also explained in the guidelines: "competent and reliable scientific evidence," including tests, analyses, research and studies conducted and evaluated by qualified professionals.
But advertisers cannot, by picking and choosing among studies, present only those that back their claims. The guidelines say the advertisements must reflect "the totality of the evidence."
The commission also requires that advertisers disclose, clearly and prominently, "qualifying information" like side effects or the fact that a weight-loss product works only if the consumer also diets and exercises.
Companies must also disclose whether a person who endorses a particular product is being paid for the endorsement and whether the person is qualified to make such an endorsement. If, for example, a person identified as "Dr. Jones" speaks on behalf of vitamins but is a doctor of Romance languages rather than of medicine, the advertising is not acceptable.
Advertisers are also barred from implying that any food supplement has been approved by the FDA, which has no authority to regulate supplements unless they violate its labeling rules or become implicated in consumer illness.
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