Product claims are what often set one product apart from another. However, in the battle for retail shelves, companies may cross over the line separating legal claims from improper claims, putting them in the crosshairs of regulatory agencies and class action lawyers. Companies must evaluate their claims and understand what claims are permitted or they could end up spending time, energy, and, of course, money to defend their claims.
Types of Claims
FDA and FTC are the two primary federal agencies that regulate claims made by food, beverage and supplement companies. FDA regulates claims made on labels or in material accompanying products, known as “labeling," while FTC regulates advertising. There are three basic categories of claims that are allowed to be made for food, beverage and dietary supplement products: health claims, nutrient content claims, and structure/function claims. The focus below is on structure/function claims.
Structure/function claims are some of the most frequently used claims because they can be utilized to tout the unique benefits that a product may bestow upon the consumer and help set apart a company’s product from the myriad others available. To establish a proper structure/function claim (or, as a regulatory attorney, to properly review the legality of a claim), a two-step process should be utilized. First, a company must ensure the claim intended to be used is a permissible claim for the type of product to be promoted. As detailed below, this generally means, for a non-drug product, that a claim may not suggest that a product is intended to diagnose, treat, cure, mitigate or prevent any disease. Second, a company must ensure it has proper substantiation for each claim. Only after both steps have been met can a company feel more at ease about using the claim in its labeling and advertising.
Section 6 of the Dietary Supplement Health and Education Act of 1994 (DSHEA) established by regulation the right to make such claims in the labeling of dietary supplements (21 U.S.C. §343(r)(6)). Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans. Examples of such claims include claims such as “calcium builds strong bones," “melatonin promotes relaxation" or “green tea helps support a healthy cardiovascular system." In addition, structure/function claims may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, such as “fiber maintains bowel regularity" or “antioxidants maintain cell integrity."
The requirements for making proper structure/function claims are set forth by regulation in the Code of Federal Regulations at 21 CFR 101.93. Manufacturers of dietary supplements that make structure/function claims on labels or in labeling must submit a notification to FDA, no later than 30 days after marketing the dietary supplement, that includes the text of the structure-function claim (21 CFR 101.93(a)). In addition, a disclaimer that indicates the statements have not been evaluated by FDA and the product is not intended to “diagnose, treat, cure, mitigate or prevent any disease" must be placed on each label or piece of labeling on which a structure/function statement is made. This underlines the fundamental principle of a structure/function claim for a non-drug product, as mentioned above, namely that a company may not use a structure/function claim that suggests, in any way, that a product is going to address a disease. Knowing what constitutes a “disease" for the purposes of such statements, therefore, is critical.
“Disease" is defined is 21 CFR 101.93(g) as “damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition." To further assist the evaluation, 10 categories of potential disease claims are outlined in the regulation, ranging from claims that a product will treat signs or symptoms of diseases to claims suggesting a product is a substitute for a therapy for a disease, such as a replacement for chemotherapy (21 CFR 101.93(g)(2)(i)-(x)). When the final version of 21 CFR 101.93 was posted to the Federal Register, FDA included almost 50 pages of comments and discussion regarding the 10 categories of potential disease claims (65 FR 1000 [January 9, 2000]). While FDA’s discussion is not binding law, it is helpful in that it is instructive on how FDA is likely to view many claims and potentially exercise its enforcement powers.
Substantiate the Claims
While establishing the permissibility of a claim is critical, it is only half of the job. A company must also ensure that each material claim describing a health benefit is properly substantiated. FTC, which regulates all advertising, applies a substantiation standard of “competent and reliable scientific evidence" to claims about the benefits and safety of dietary supplements and other health related products, a standard which FDA has adopted as well. (See Dietary Supplements: An Advertising Guide for Industry for more information.)
What is “competent and reliable scientific evidence?" Unfortunately, there is no statutory definition of “competent and reliable scientific evidence," which provides for an ever-changing threshold for companies to meet. FTC has adopted a definition in FTC cases which includes “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." However, that definition does not really make it any clearer what evidence is actually required to establish “competent and reliable scientific evidence." The answer is not black-and-white. The standard is ever-fluctuating and takes into account a variety of factors, including the type of product at issue, the nature of the claims, the consequences of a false claim, and the quality and totality of the scientific evidence, to name just some of the factors. The “gold standard" is generally considered to be one or more double-blinded, placebo-controlled, well-designed clinical trials conducted on the specific product, although such studies are not mandatory to reach the threshold of “competent and reliable scientific evidence."
While the requirement for substantiation is strictly a regulatory requirement—there is no private right of action for “lack of substantiation"—the issue of substantiation has still made its way to the class action arena as plaintiff lawyers continue their assault on companies in the food, beverage and dietary supplement industry. Class action lawyers bring actions couched as false or misleading advertising actions, attempting to shift the burden of proof to defendants and make companies prove their products work. While litigation over “all natural" dominated the courtrooms for several years, litigation over functional claims and the scientific evidence, or lack thereof, has rapidly increased over the last year or two.
As the focus continues to be placed on the labeling and advertising of products from regulators, consumer advocacy groups, consumers and class action lawyers, it has never been more important for companies to ensure they are not only making legally permissible claims, but that they have the necessary substantiation to support such claims. Failure to do so could put companies in a deep hole, and it may be difficult to dig out.
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.