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As companies fight for a piece of the ever-growing weight-loss market, the desire to beat the competition leads to a proclivity for making increasingly spectacular-and outrageous-claims.
Americans are continually on the lookout for the next great solution to shed those unwanted pounds and get in shape. Ads for exercise programs incorporating every imaginable routine fill the radio and television airwaves. Products touting “amazing” weight-loss abilities in the form of patches, clips, body wraps, and elastic bands, among others, abound. As companies fight for a piece of the ever-growing weight-loss market, the desire to beat the competition leads to a proclivity for making increasingly spectacular-and outrageous-claims.
Food and supplement companies are not exempt from this penchant for “one-upmanship.” Companies in these industries must be aware of the legal parameters for making weight-loss claims so that they do not risk unwanted action from federal regulatory agencies charged with monitoring such claims.
Regulation of Weight-Loss Claims
FDA and the FTC work together to regulate claims made about conventional food and beverage products and dietary supplements. FDA is primarily responsible for claims made on product labeling, which includes labels, packaging, inserts, promotional materials, and even websites. The FTC, on the other hand, has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct-marketing materials.
There is often an overlap of oversight between the two agencies, as some forms of promotional material may fall under the definitions of both advertising and labeling-most notably, material appearing on company websites.
FDA Regulation of Labeling Claims
FDA’s analysis of content claims made for conventional food and supplements primarily focuses on ensuring that 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. Most of the claims promoting weight loss fall into the category of structure-function claims, which describe the role of a nutrient or dietary ingredient on the normal structure or function of the human body. So, the question then becomes: how far can a company go in describing the benefits of a particular product and its effect on the body?
The fundamental principle to remember when developing any claim for a dietary supplement or conventional food is that a product cannot be intended to diagnose, treat, cure, or prevent a disease; otherwise, FDA will consider the product to be a drug. In its final rule on structure-function claims published in the Federal Register in January 2000, FDA determined that while obesity is a disease, being overweight is not. Therefore, in order to be legally compliant, companies selling weight-loss products must confine their claims to promoting the loss of normal amounts of weight and not reference obesity or grossly overweight conditions. Terms such as “appetite suppressant” or “fat burner” are permissible, as long as it is made clear that the product is for ordinary weight loss and not for situations implying obesity.
One of the common methods employed by companies to make weight-loss claims about products is the use of consumer testimonials. It is important to recognize that regulatory agencies, such as FDA and the FTC, consider consumer testimonials used in labeling or advertising to be claims adopted by the company marketing or promoting a product. The company cannot use a consumer testimonial to make claims that the company could not make directly. Thus, consumer testimonials that reference obesity or extremely overweight situations will be considered disease claims in the same manner as if the company made the claims itself.
Despite the public stance taken by FDA regarding the growing obesity problem in the United States, FDA has taken relatively little regulatory action against companies for the use of overreaching or impermissible weight-loss claims. While FDA has taken actions against companies selling weight-loss products over the last year or two, such actions were primarily against companies selling products that contained tainted or undisclosed active drug ingredients-and not for unwarranted claims made about the products. In 2010, there have been only two warning letters issued and posted by FDA that reference obesity claims. In both cases, obesity was only one of a litany of disease conditions cited as being the subject of improper disease claims.
Instead, the regulatory agency that has taken the primary role of enforcing the law with respect to weight-loss claims is the FTC.
FTC Regulation of Advertising Claims
The FTC has taken a very public and aggressive stance with respect to weight-loss advertising and has implemented its enforcement strategy on several different fronts. It has brought high-profile actions against companies selling weight-loss products for making false, overreaching, or unsubstantiated claims.
Late last year, the FTC revised its Guides Concerning the Use of Endorsement and Testimonials in Advertising (Endorsement Guides), with a particular focus on weight-loss testimonials. The FTC has also devoted numerous pages on its website to weight-loss claims and published a variety of brochures for consumers, including Red Flag: Bogus Weight-Loss Claims, to educate the public on what it believes to be fraudulent or suspicious weight-loss claims.
There are no federal laws or regulations that specifically address weight-loss claims; regulation of such claims falls under the FTC’s general enforcement of the Truth-in-Advertising Law. Essentially, advertising must be truthful, not deceptive or misleading, and be supported by competent and reliable scientific evidence. In the area of weight-loss claims, the FTC has recommended “a healthy portion of skepticism.” The FTC has identified certain weight-loss claims that are presumptively false and suspect, such as “lose weight without diet or exercise,” “lose weight and eat whatever you want,” and “lose weight permanently and never diet again.” Use of words like “miracle” or “never seen before” also tend to elicit skepticism and closer scrutiny from the FTC.
The FTC has consistently taken the position that the only way to truly lose weight is to lower caloric intake and/or increase physical activity. Accordingly, it is a good practice for companies making weight-loss claims to combine such claims with a statement indicating that the product should be used in conjunction with a healthy diet and exercise program. The FTC will look at all of the claims together to determine what overall message is being conveyed to the consumer. If the overall message is that people can lose large amounts of weight without effort, meaning without making changes to diet and exercise, it is likely that the FTC will take issue with such claims. As such, it is important for marketers and advertisers to consider the overall message that is being conveyed when crafting claims to promote weight-loss products.
The FTC issued its revised Endorsement Guides in December 2009. While the Endorsement Guides are not law, they do provide a realistic view of how the FTC is likely to interpret the law. Practices inconsistent with the Endorsement Guides may very well lead to action by the FTC.
Weight-loss claims were one of the central focuses of revisions to the Endorsement Guides-specifically, consumer testimonials referencing specific amounts of weight loss. The FTC, through speeches by high-ranking personnel, as well as other communiquÃ©s, has indicated that consumer testimonials touting specific weight loss (such as “I lost 60 pounds”) are extremely influential and are likely to be interpreted as representative of what consumers will generally achieve by using a product. Furthermore, disclaimers such as “results not typical” are not considered to be effective in disclosing to consumers that such results are not typical of the average consumer.
The Endorsement Guides now clarify that testimonials describing specific results achieved through use of a product must be accompanied by a disclaimer that indicates what consumers can generally expect to achieve by using the product, or must sufficiently describe the specific conditions under which the results touted in the testimonial were achieved so that it is clear that such circumstances are likely to be different from the normal conditions in which the product is used.
Much of the FTC’s enforcement in the area of weight-loss claims centers on the substantiation element necessary for any claim made in advertising. An advertiser must have competent and reliable scientific evidence to support any weight-loss claim.
The issue of “competent and reliable scientific evidence” is always a subject of debate, as there is no statutory definition of this standard. Actions this year against companies promoting weight-loss products included claims made that products were “clinically proven” to cause weight loss and “scientifically proven to increase the body’s metabolism.” Such claims further raise the level of scientific evidence needed to support them. However, it is clear that some level of evidence is needed and that a company cannot make claims regarding weight loss without any concrete support for such claims.
Weighing the Claims
The “obesity epidemic” has received much attention this year. Whether it is the latest report portending the continued rise in obesity rates, new programs instituted by governmental agencies to combat obesity, or the latest products designed to lose weight fast, obesity is squarely on the radar of governmental agencies like FDA and the FTC.
While new scientific research has uncovered a number of beneficial ingredients that assist in achieving weight loss and staying healthy, weight-loss products are looked at with a cynical eye by those entrusted with regulating such products. Companies must be careful to not overreach when making weight-loss claims and be prepared to provide substantiation for each and every claim. Fundamentally, companies must evaluate their claims and consider whether it is the type of claim that is implicated by the FTC’s warning that “if the claim seems too good to be true, it probably is.” If so, food and supplement companies would be well-advised to readjust their claims-or risk unwelcome regulatory attention.
Justin J. Prochnow is an Of Counsel lawyer 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. He can be reached at email@example.com.
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