Over the past several years, federal and state regulators have kept a close watch on the dietary supplement industry. Marketers of dietary supplements, such as weight loss products, detoxifying agents and energy supplements, must be aware of the regulatory landscape governing dietary supplements in order to avoid the legal pitfalls associated with high-risk marketing practices.
 
At the federal level, FTC and FDA are the principal regulators of advertising for dietary supplements. State and local regulators also police dietary supplement advertising. Additionally, advertising self-regulatory entities, in particular the National Advertising Division and the Electronic Retailing Self-Regulation Program, have also devoted considerable attention and resources to policing dietary supplement advertising.
 
FTC Substantiation Standards
 
The backbone of FTC’s consumer protection mission is Section 5 of the Federal Trade Commission Act (the “FTC Act”), which prohibits unfair or deceptive advertising and marketing. Most states have statutes modeled after the FTC Act known as “mini-FTC Acts,” and some of these statutes expressly provide that the mini-FTC Act is to be interpreted in accordance with FTC guidance and case law.
 
Under the FTC Act, all advertising and marketing practices, including those for dietary supplements, must be truthful, not misleading and substantiated before the advertising is disseminated. In 1998, FTC published “Dietary Supplements: An Advertising Guide for Industry” (the “Guide”) to help dietary supplement marketers comply with the FTC Act.
 
With regard to substantiation, FTC requires that dietary supplement marketers have competent and reliable scientific evidence supporting their efficacy and safety claims. FTC defines “competent and reliable scientific evidence” to include any “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” The FTC has stated that “[t]here is no fixed formula for the number or type of studies required or for more specific parameters like sample size and study duration.” However, competent and reliable scientific evidence that is adequate to substantiate a claim about a dietary supplement generally consists of information derived primarily from human studies. In deciding whether human studies substantiate a claim, the scientific quality of the studies is important, including the study type, study population, study design and conduct (e.g., presence of a placebo control), data collection, statistical analysis, and outcome measures. The “gold standard” is a randomized, double-blind, parallel group, placebo-controlled clinical trial. In general, both FDA and FTC will typically require clinical studies or other scientific studies on humans published in peer-reviewed journals.
 
The following additional types of information are generally considered background information, but alone may not be adequate to substantiate a claim: animal studies; in vitro studies; meta-analysis (the process of systematically combining and evaluating the results of clinical trials that have been completed or terminated); review articles; comments and letters to the editor; testimonials and other anecdotal evidence; or product monographs.
 
If an ad asserts that there is a specific level of support for a claim, the marketer must possess at least that level of support. If no specific level of substantiation is claimed, the FTC considers six factors in determining the appropriate level and type of substantiation that is required:
 
1. The type of product;
2. The type of claim;
3. The benefits if the claim is true;
4. The consequences if the claim is false;
5. The feasibility and cost of developing substantiation for the claims; and
6. The level of substantiation experts in the field believe is reasonable.
 
The FTC has observed in relevant guidance that studies on the efficacy of individual ingredients may not be sufficient substantiation for products with multiple ingredients if “there is reason to suspect that the combination of multiple ingredients might result in interactions that would alter the effect or safety of the individual ingredients.” In the event that the individual ingredients of a dietary supplement were tested but the supplement itself was not tested, the marketer must not make claims that the product, as opposed to the individual ingredients, was tested.
 
Heightened Substantiation Standards in FTC Consent Orders
 
In the past two years, FTC has entered into three consent orders imposing requirements that certain claims regarding dietary supplement products be supported by at least two well-designed clinical studies. The consent orders settled allegations against Nestlé Healthcare Nutrition, Inc., Iovate Health Sciences USA, Inc., and The Dannon Company, Inc., respectively. The requirement that certain claims be supported by at least two clinical studies represents a departure from the typical FTC substantiation standard for health claims.
 
By all indications, FTC has not adopted a new substantiation standard requiring a minimum of two supporting studies for dietary supplement claims. Nonetheless, if the agency believes a dietary supplement marketer has made unsubstantiated claims about its products, the agency may seek a consent order imposing the two-study standard with respect to certain types of claims.
 
Conclusion
 
As regulators continue to keep a watchful eye on the dietary supplement industry, marketers of dietary supplements should be mindful of relevant regulatory enforcement trends and standards. Dietary supplement companies should ensure that they have adequate scientific evidence supporting their claims. Such marketers should always keep substantiation for their claims on file so they are prepared to respond to a challenge by a regulator, class action attorney or competitor.          
 
References furnished upon request.