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Key considerations when evaluating whether adequate substantiation exists for a claim includes type of product, the type of claim, the benefits of a truthful claim weighed against the cost of developing substantiation, the consequences of a false claim, and the amount of science.
June 9, 2017
Advertising and labeling claims are a primary way companies try to grab consumer attention and distinguish one product from another. As the market becomes crowded, competition has increased and claims have become increasingly aggressive and, sometimes, overreaching. Companies must balance the desire to sell products against the fundamental principle that material claims must be substantiated with the appropriate level of support. If not, companies are at risk of action from regulatory agencies such as FTC and FDA, offices of state attorneys general, local district attorneys, competitors and, of course, plaintiffs’ lawyers.
The primary regulator of advertising claims is FTC. To assist the industry in understanding how it regulates advertising of dietary supplements, FTC issued a guidance document in 2001, “Dietary Supplements: An Advertising Guide for Industry;" reflecting just how important substantiation is to FTC, approximately half of the guidance is dedicated to the topic of substantiation.
Advertisers must have a reasonable basis for making express and implied claims about a product. However, the level of substantiation needed is not uniform—it varies greatly depending on a variety of factors. The standard of substantiation for efficacy, safety and general health claims is one of “competent and reliable scientific evidence." FTC has defined this as “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." Now, raise your hand if you have a better understanding of what “competent and reliable scientific evidence" is. I thought not.
So, how are the appropriate amount and type of substantiation to be determined? FTC identified factors to consider, such as the type of product, the type of claim, the benefits of a truthful claim weighed against the cost of developing substantiation, the consequences of a false claim, and the amount of science that experts in the appropriate field believe is reasonable. The interplay of these factors, along with other considerations, shape the level of science needed to support each claim. The following are a few of the common issues companies must resolve when determining whether the appropriate substantiation exists for their claims.
One important caveat to keep in mind is that, if an advertiser expressly states or implicitly suggests a certain level of scientific evidence exists, it must have at least that level of evidence. So, statements like “clinically proven" or “scientifically shown" require at least one or more clinical trials to support the claim. Additionally, an advertiser should not suggest a clinical trial has been conducted on the product if the study relied upon was conducted on a single ingredient or on another product. In such cases, the claim must be appropriately qualified to make the subject of the clinical trial clear, such as “10 g of whey protein has been clinically shown to …" or “[X supplement], a proprietary form of curcumin, was studied for …." Absent such clarification, the claim can be misinterpreted as meaning the advertised product was the actual subject of the clinical trial.
The type of science needed is not standardized. Generally, the “gold standard" is a well-designed, double-blinded, placebo-controlled clinical trial appropriately conducted on the actual product. FTC has often required this standard in consent decrees, requiring two such studies for future claims made by companies governed by such decrees. Of course, these studies do not come cheaply, and most companies have not conducted such a study, especially in the early stages, on their own products. Studies on one or more ingredients used in the product may provide support, although a careful analysis of how those ingredients will interact with other ingredients in the product may also be necessary to ensure the studies properly support the claims for the specific products. Animal and in vitro studies may also be used in support, especially when human research is infeasible, although such studies do not usually constitute sufficient evidence as the primary support for claims. Anecdotal evidence in the form of endorsements and testimonials does not qualify as substantiation.
In some instances, one study may be sufficient; in others, more may be required. In general, more is better, although the quality of the studies often is more important than the quantity. While there is no protocol for how to conduct research, FTC identifies principles that are generally accepted to yield reliable test results. A well-designed and carefully controlled study with the blinding of both subjects and researchers is generally viewed as more likely to yield reliable results. Studies of longer duration can provide better evidence of results over a period of time and resolve safety issues. More test subjects are also typically viewed as likely to yield more meaningful results, although it is important to have statistical significance of findings, regardless of the size—a difference between control and test subjects will show that the results are more than just a placebo effect. Further, a well-written report can also make a difference in how a study is viewed, and the publication of a peer-reviewed study in a reputable journal indicates the research has undergone some scrutiny.
Finally, from a practical standpoint, one of the biggest ways companies err is to rely on studies that tested levels of the studied ingredients not present in the product. For example, if there are only 90 mg of vitamin C per serving in a product (100 percent of the DV under the new revisions to the federal labeling regulations), scientific studies on 500 mg of vitamin C, while perhaps informative, do not substantiate claims made for 90 mg.
The above points are just a few of the factors to evaluate when substantiating claims. Advertisers must carefully consider each claim and ensure that proper support exists. Otherwise, in this era of “claims litigation," a company may find itself on the receiving end of unwanted action from a variety of sources.
Justin J. Prochnow ( 572-6562, [email protected]) is an attorney and Shareholder in the Denver office of the international law firm of Greenberg Traurig LLP (gtlaw.com). His practice concentrates on legal issues affecting the food & beverage, dietary supplement and cosmetic industries. He can be followed on Twitter at @LawguyJP.
This article is issued for informational purposes only and is not intended to be construed or used as general legal advice. The opinions expressed are those of the author exclusively.
Attorney, Greenberg Traurig LLP
Justin J. Prochnow is an attorney and shareholder in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the food and beverage, dietary supplement and cosmetic industries.
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