Weighing in on Weight-Loss Claims

The search for the magic pill" to achieve desired weight loss has become akin to the quest for the Holy Grail. Products touting hot" new ingredients for weight loss abound on afternoon talk shows, and companies chase new formulations and methods. The competition among weight-loss companies is fierce and leads to aggressive marketing and labeling claims. Companies in the dietary supplement industry must be aware of the legalities for making weight-loss claims so they do not run afoul of regulations enforced by state and federal agencies, or fall into the clutches of class action lawyers looking for the next big score.

Federal Supervision of Weight-Loss Claims

Both FDA and FTC regulate weight-loss claims made for food, beverage and dietary supplements. FDA has the primary responsibility for regulating claims made on product labeling, which includes product labels and other information accompanying products, such as inserts, brochures, other promotional materials and even websites. Meanwhile, FTC regulates all claims in advertising, including print, television and radio ads, catalogs and direct marketing materials. While FDA, pursuant to a memorandum of understanding between FDA and FTC, has primary responsibility for regulating materials that may constitute both labeling and advertising, oversight overlaps between the two agencies, especially with respect to material appearing on company websites.

FDA Review of Labeling

FDA reviews labeling claims made for conventional foods and supplements with the primary purpose of ensuring such claims fall into one of the permissible categories of claims (health, nutrient-content or structure-function claims) and that such claims are not disease claims. Claims promoting weight loss are usually made as structure-function claims, which describe the role of a nutrient or dietary ingredient on the normal structure or function of the human body.

The basic guideline to keep in mind when developing claims for a dietary supplement or a conventional food is that such products cannot be intended to diagnose, treat, cure or prevent a disease; otherwise, FDA will consider the product to be a drug. In the discussion of the Final Rule on Structure-Function Claims (21 CFR 101.93), published in the Federal Register in January 2000, FDA clarified that obesity is a disease, while the state of being overweight is not. Accordingly, companies marketing weight-loss products must confine their claims to the promotion of normal amounts of weight loss and not reference obesity or grossly overweight conditions. Terms like suppresses appetite" or increases satiety" are permissible, as long as it is made clear that the product is for ordinary weight loss and not for the treatment of obesity.

Companies often use consumer testimonials to tout the benefits of weight-loss products. However, companies must understand that FDA and FTC consider consumer testimonials used in labeling or advertising to be claims adopted by the company marketing or promoting the product. A company cannot use a consumer testimonial to make claims that the company could not make directly. Thus, consumer testimonials that reference the treatment or prevention of obesity or its resulting health effects, such as high blood pressure or cardiovascular health risks, will be considered disease claims in the same manner as if the company made the direct claims itself.

As the obesity epidemic continues to be discussed at length in the United States, products touting weight loss have drawn close scrutiny from FDA. FDA has identified the class of weight-loss products as one of the categories of high risk" products, along with body-building products and sexual enhancement products. FDA has dedicated a specific page on its website to weight-loss products, titled Beware of Fraudulent Weight-Loss Dietary Supplements."  FDAs primary concern regarding weight-loss products marketed as dietary supplements is the proliferation of products illegally containing undeclared active drug ingredients known for use in promoting weight loss, such as sibutramine. However, FDA has cited a number of warning signs" that may indicate tainted products, including claims promising quick action, such as lose 10 pounds in one week," or claims that suggest products are the herbal alternative to drug products.

The relatively few warning letters sent to companies promoting weight-loss products have generally identified obesity as only one of a host of disease conditions that were the subject of improper disease claims. For example, in the Nov. 19, 2012, letter to Emu Products and Management Inc., FDA cited other claims that one of the products would lower cholesterol" and counteract a number of other issues such as diabetes, fatigue, cardiovascular disease, weight gain and obesity." 

FTC Regulation of Advertising

While FDA has acted sporadically in its regulation of weight-loss claims, FTC has been more aggressive in its regulation of weight-loss advertising. Regulation of weight-loss advertising falls under FTCs general enforcement of Section 5 of the FTC Act and the Truth-in-Advertising Law. At its core, all advertising must be truthful and not deceptive or misleading. FTC has disseminated numerous materials to educate consumers on weight-loss claims, such as Weighing the Evidence in Diet Ads" found on FTCs website.  This FTC Fact Sheet for Consumers identified claims FTC believes the public should view with skepticism before accepting as true. Other consumer brochures address topics such as consumer testimonials, expert endorsements and miracle health" claims.

Advertisers must have adequate substantiation for all material claimsthe standard often referred to is competent and reliable scientific evidence," the meaning of which is often the subject of debate. While FTC indicated that the standard may include tests, studies, research, analyses or other evidence based on the expertise of professionals in the relevant area, the specific level of evidence required by FTC often depends on the claims being made. Further, if a company makes a statement that an ingredient or product is clinically proven" to cause weight loss or scientifically proven to increase the bodys metabolism," the substantiation standard bar is raised and evidence in the form of clinical studies or specific scientific research must be shown. Companies should review prior action taken by FTC or consult with knowledgeable people regarding scientific evidence to ensure that the necessary level of substantiation has been obtained.

Companies must also ensure that the scientific evidence offered to support the claims supports the actual levels of ingredients contained in the products. Too often, specific studies are referenced or claims such as clinically proven" are made when, in fact, the studies referenced do not support the particular level of ingredients or combination of ingredients. For example, a study that demonstrates the effectiveness of an ingredient at 1,000 mg does not likely substantiate claims for that same ingredient at 100 mg. In recent years, FTC has also been frequently requiring studies that demonstrate effectiveness for the particular combination of ingredients in a product, in order to adequately support material claims. Whatever that standard is determined to be, at least some level of scientific evidence is needed and companies should not make claims regarding weight-loss without such evidence.

In 2011, FTC took action against 10 different affiliate marketing operations for promoting acai berry supplements for weight loss. The complaints entered on the deceptive practices carried out by the affiliate marketers, including the formation of deceptive websites purporting to be created by real new channels. The websites contained fake news reports and completely fabricated testimonials from a reporter that allegedly tried the product and lost weight, therefore verifying" the claims made by the marketers of the products. In addition to the blatantly deceptive form of advertising, FTC also alleged the weight loss claims were completely unsubstantiated. While acai berries have been recognized as one of the superfruits" with numerous health benefits, FTC alleged no legitimate scientific studies or other scientific evidence supported the claims that ingestion of acai berries lead to weight loss, absent a change in diet and exercise. 

Class-Action Litigation

Of course, no discussion regarding labeling and advertising is complete, of late, without mentioning the  threat of class-action litigation over labeling claims. The wave of litigation against companies in the food, beverage and supplement spaces has included products in the weight-loss category. While some recent decisions indicate courts may be tiring of the continuous onslaught of litigation, companies must continue to be aware of the specter of litigation.

Cases, more often than not brought in California pursuant to one of the liberal state false advertising laws, have usually centered on alleged false or misleading statements promoting the products for weight loss. A plaintiff may allege he or she did not actually experience the benefits touted in the advertising or on the label of the product. Other plaintiffs asserted that celebrity spokespersons advertised products without scientific support or improperly attributed the product for weight loss achieved. Whatever the basis, such actions are a substantial drain on time, money and other resources.

In a multitude of forums, claims are being closely viewed by regulatory agencies, consumer advocacy groups and litigators skeptical of weight-loss claims. Companies must be careful to not overreach when making weight-loss claims and be prepared to provide substantiation for each and every claim or risk losing a lot more than the weight loss touted for their products. 

Justin J. Prochnow 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 and beverage, dietary supplement and cosmetic industries. He can be reached at (303) 572-6562 or [email protected], and 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.