Previously published in DRTV News
In mid-November, the Federal Trade Commission released "A Guide for the Dietary Supplement Industry", which is designed to provide the dietary supplement industry with a clear understanding of the standards the FTC will use to evaluate dietary supplement advertising and labeling.
The guide describes basic principles of advertising and labeling law and uses examples from the supplement industry to illustrate how those principles apply. The release of this guide is an important step by a key regulator because the dietary supplement industry is one of the most rapidly emerging markets for direct response television.
Many observers have noted that Americans' interest in - and spending for - herbs, vitamins and other "natural" supplements has increased exponentially in recent years. The passage of the Dietary Supplements Health and Education Act (DSHEA) in 1994 significantly changed - most would say, reduced - the role of the Food and Drug Administration in regulating supplement labeling.
With the passage of DSHEA, advertisers can make "structure/function" claims about nutritional supplements. Such structure/function claims permit a marketer to make representations about a dietary supplement's effect on the structure of function of the body for maintenance of good health and nutrition. Marketers, however, are still prohibited from making any labeling claim about the diagnosis, mitigation, treatment or cure of a disease in the absence of express permission of the FDA.
Truth in Advertising
The purpose of the FTC's releasing the Dietary Supplement Guide is to forcefully remind marketers that compliance with DSHEA is only half the story. The other half is the usual requirement, enforced by the FTC in all areas of the economy, that claims in advertising for products be both truthful and substantiated.
The primary utility of the guide is in the application of this well-understood, two-step process to the rapidly evolving world of dietary supplements, an industry where this week's story in a medical journal suggesting a link between a particular herb or vitamin and a health benefit can generate next month's wave of DRTV marketing.
The Commission reminds us that advertisers must have substantiation, not only for the express claims they make in an advertisement, but also for any implied claims that a reasonable consumer could take away. For example, the Guide observes that an advertisement for a vitamin supplement claiming that 90 percent of cardiologists regularly take the product would be understood as making both the literal claim about the percentage of cardiologists who use the product, and an implied claim that the product offers some benefit for the heart. Consequently, the advertiser would need to have substantiation for both claims.
The guide also is specific on the question of when to disclose qualifying information. Among the examples used to illustrate this point is an advertisement for a multivitamin-mineral supplement which claims that the product can eliminate a specific mineral deficiency that results in fatigue. The example hypothesizes that less than 2 percent of the general population to which the ad is targeted suffers from this deficiency and observes that the advertiser must disclose the fact that only a very small percentage of people who suffer from the actual mineral deficiency are likely to experience any reduction in fatigue from using the product.
Clinical Studies Most Reliable
Perhaps the most useful part of the Guide is the discussion of substantiating claims in the context of dietary supplements. The Guide reiterates that advertisements that refer to a specific level of support must, in fact, have that support. This may seem like an obvious point, but the key issue is to avoid making an "establishment" claim - that is, one that claims that the advertiser possesses a level of substantiation that would convince even an expert in the field - unless you do, in fact, have that kind of proof. And that's a pretty high hurdle.
The guide states that, in general, "well-controlled human clinical studies are the most reliable form of evidence," but results obtained in animal or in vitro studies will also be examined where human research is infeasible. The guide states that, in most cases, the quality of the studies will be more important than quantity. When a clinical trial is not possible - for example, in the case of a relationship between a nutrient and a condition that may take decades to develop - epidemiological evidence may be an acceptable substitute for clinical data. This is especially true when that evidence is supported by research that purports to explain the biological mechanism underlying the claimed effect.
In any event, the Commission is clear that anecdotal evidence about the individual experience of consumers, such as may be reflected in testimonials from satisfied users, is not sufficient to substantiate claims about the effects of a supplement.
Substantiating Health Claims
The question most frequently asked of the FTC by an advertiser who has a study is whether there are any set guidelines as to what qualifies as a valid study. The answer, unfortunately, is "no." The kind of substantiation that an advertiser must have depends largely on the kind of claims it wishes to make.
If the advertiser wishes to claim that a particular result has been proven, it must be prepared to demonstrate a level of substantiation that would convince a medical expert that this is the case - usually two or more well-controlled, double blind studies. Lesser levels of claim require lesser levels of proof. But the Commission emphasizes in the Guide that an advertiser cannot consider only favorable studies and, if the advertiser knows or should be aware of other studies that do not support its advertising claims, it must tone down its claims, disclose the existence of conflicting information, or take similar steps to avoid a misleading impression being given to the consumer.
Finally, the guide emphasizes that an advertiser must ensure that the substantiation on which it relies is, in fact, relevant to the specific claim being made. One example in the guide hypothesizes that an ad for a supplement claims that a particular nutrient helps maintain healthy cholesterol levels and - while there is a substantial body of evidence suggesting the foods high in that nutrient are associated with lower cholesterol levels - there is no science demonstrating a relationship between the specific nutrient and cholesterol. If one could argue that lower cholesterol is attributable to other components of the food, or a combination of various components, the claim about the relationship between the specific nutrient and cholesterol levels would not be considered substantiated.
In summary, the guide may prove invaluable to those who wish to market in this increasingly dynamic field. As mentioned above, it is not new law, nor does it break new theoretical ground concerning interpretation of advertising claims or the need for substantiation. It is the numerous specific examples of the application of these well-known principles to frequently occurring issues of dietary supplement advertising that make this document so valuable.