July 2011/NutraSolutions -- The proliferation of weight-loss products continues, as each new national health report further attests to the mounting weight problems in the U.S. As the demand from consumers for weight-loss products to combat weight issues rapidly increases, the promotion of weight-loss products has spread to include a wide range of food and beverage products—an area that has been heavily trodden by the dietary supplement industry. Industry companies are studying new ingredients and combinations of ingredients, as well as devising innovative methods for achieving weight loss, to meet this growing demand. Recently, this research and development has led to an increase in weight-loss claims emphasizing satiety and appetite suppression, as opposed to the historical fat-burning claims. As these novel methods are explored and utilized, companies must remember that proper substantiation is essential for each of their weight-loss claims.
Trendy Ingredients and Popular Claims

Ephedra was the “wonder ingredient” of weight-loss products in the 1990s and early 2000s.  Ephedra was notable for its role as both a stimulant and a thermogenic, causing an increase in heart rate and metabolism, both of which can facilitate rapid weight loss. Unfortunately, ephedra was also notorious for the number of adverse events associated with ephedra-containing products, resulting in the eventual ban by the FDA of its use in dietary supplements in 2004.  Immediately after the ban, dietary supplement companies focused tremendous energy on finding a legal and safe replacement for ephedra. Bitter orange was one of the popular natural ingredients put forth as a possible replacement to ephedra, although similar concerns about potential side effects swirled around this ingredient. Various forms of caffeine were also touted as potential substitutes that could produce results similar to products containing ephedra. However, in recent years, the direction of many weight-loss products and claims has shifted away from the emphasis on increasing energy and heart rate. Instead, many weight-loss products have moved towards claims with a focus on satiety, appetite suppression and thermogenesis.        Satiety is the condition of being full or gratified beyond the point of satisfaction; or, simply put, the absence of hunger. Essentially, if someone feels full, the physical urge to eat is generally reduced. Research indicates that satiety is regulated by hormones. The hormone leptin increases as one eats, typically resulting in a reduction of one’s motivation to eat. After satiety has been achieved, and leptin production stops, leptin levels drop over a period of time, causing the release of a secondary hormone, ghrelin, which initiates the feeling of hunger. Accordingly, some ingredients that affect the production of these hormones have been identified as effective for use in weight-loss products. 

Proteins are one category of ingredients thought to affect hunger hormones. In particular, some studies have shown protein extracts from potatoes promote satiety and weight loss. Increased fiber intake has also been linked to satiety. Glucomannan, which comes from the root of the konjac plant, has been purported to be effective in promoting weight loss, although the Federal Trade Commission (FTC) did bring actions against several marketers of weight-loss products in 2005, for making weight-loss claims regarding products containing glucomannan without substantiation. Fatty acids, such as Korean pine nut oil, have also been recently touted for their role in controlling hunger and promoting satiety by regulating hormones.

When considering popular weight-loss claims, appetite suppression goes hand-in-hand with satiety. At the forefront of ingredients for which appetite suppression claims are made are two cactus-like plants, predominantly found in Africa and India. Hoodia gordonii has been highly publicized as an appetite suppressant containing glycosides, which reduce food intake. The active ingredient, P57, “tricks the brain” into thinking a person is full, even if he has not eaten.  Similarly, caralluma fimbriata has also been studied for its appetite-suppressant qualities.

Claims related to thermogenesis have also become increasingly trendy. Thermogenesis is the process of heat production in organisms. While thermogenesis formulations are most prevalent in bodybuilding products, ingredients with thermogenic properties have been finding their way more frequently into weight-loss products, as research continues to see whether thermogenesis can be stimulated to increase energy expenditure and fat oxidation. An ingredient widely hailed for its thermogenic properties is green tea, which contains the ingredients epigallocatechin gallate (EGCG) and caffeine that interact to provide the thermogenic action. Capsaicin, the active component of chili peppers, has also been studied and promoted for its thermogenic qualities.

A nationally certified eating disorders specialist, Alex Schauss, Ph.D., FACN, CEDS, senior director of research and CEO of AIBMR Life Sciences, a natural products consulting firm, believes there are some exciting new products currently in the pipeline undergoing clinical and safety studies. Evidence provided by such studies is often crucial to substantiating weight-loss claims. However, companies must ensure the clinical and safety studies actually support the claims being made about products. “Companies must make products at levels for which there is substantiation for claims,” stresses Schauss. Simply adding “pixie dust” levels of ingredients does not allow companies to make claims, unless there is support for the specific amount of the ingredients contained in the products. This important requirement of substantiation for claims, especially with respect to weight-loss claims, is an area to which the FTC has been paying particular attention of late.

Regulation of Weight-loss Claims
Regardless of the nature and form of the weight-loss claims, there is a strong likelihood that claims will be closely scrutinized by state or federal regulatory agencies, industry watchdogs, consumer advocacy groups or others skeptical of weight-loss claims. From a federal standpoint, the FDA and the FTC work together to regulate food, beverage and supplement products that are offered to promote weight-loss. While the FDA has primary responsibility for ensuring products are properly categorized as a food, beverage, supplement or drug, and regulates claims made on product labels and labeling, the FTC has primary responsibility for claims made in advertising, including print and broadcast ads, infomercials, catalogs and similar direct-marketing materials.  There is often overlap 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. 

The FDA’s primary concern is to ensure such products are not being sold to diagnose, treat, cure or prevent a disease. “Disease,” in the case of weight-loss products, generally means extreme cases of overweight or obesity. In reality, the FDA has taken little action recently against companies for making impermissible weight-loss claims, issuing only a handful of warning letters to companies for making obesity claims. The FDA has deferred to the FTC to take enforcement action for false, misleading or unsubstantiated weight-loss claims.

FTC Regulation
Regulation of weight-loss advertising falls under the FTC’s 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. The FTC has disseminated numerous materials to educate consumers on weight-loss claims, such as the section titled “Weighing the Evidence in Diet Ads” found on the FTC’s website. This “FTC Fact Sheet for Consumers” identifies claims the FTC believes the public should view with some skepticism, before accepting them as true. Other consumer brochures address topics such as consumer testimonials, expert endorsements and “miracle health” claims. 

Additionally, advertisers must have adequate substantiation for all material claims, the standard often referred to as “competent and reliable scientific evidence.” The standard of “competent and reliable scientific evidence” is often the subject of debate. While the FTC has indicated  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 the FTC often depends on the claims being made. Furthermore, if a company makes a statement that an ingredient or product is “clinically proven” to cause weight loss or “scientifically proven to increase the body’s metabolism,” the substantiation standard bar is raised to at least that level of scientific evidence implied by the claims. 

Companies must also ensure 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 a level of 100mg/serving size may not substantiate claims for that same ingredient at a level of only 10mg/serving size. In recent years, the FTC has also been requiring, on a more frequent basis, 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. 

While the FTC has filed numerous actions against companies for a wide array of deceptive advertising promoting weight loss, recent enforcement action in the area of weight-loss claims has frequently included allegations that companies lack the necessary substantiation for those claims. Last year, actions brought by the FTC included allegations of lack of substantiation against a marketer of an açai berry supplement promoted for weight loss, as well as the manufacturer of a weight-loss product that claimed the product was “clinically proven” to cause weight loss. In April 2011, the FTC announced actions against 10 different affiliate marketing operations that were marketing and promoting açai berry weight-loss products. While the allegations included numerous deceptive practices carried out by the affiliate marketers, including the creation of deceptive websites, phony news reports and fake testimonials, the FTC also alleged the weight-loss claims were completely unsubstantiated. While açai berries have been recognized as one of the Superfruits with numerous health benefits, the FTC alleges there are no legitimate scientific studies or other scientific evidence that supports claims that ingestion of açai berries causes weight loss, absent a change in diet and exercise.

Search Continues

The search continues for innovative ingredients and products that produce significant and lasting weight-loss results. Ingredients are being persistently tested to study their effectiveness for weight loss, and novel processes are constantly being evaluated. As these novel weight-loss strategies are implemented, it is critical for companies to remember that adequate substantiation must exist in order to legally make such claims. While the demand for weight-loss products continues to rise, and the allure to market such products continues to grow, failure to adhere to advertising laws and regulations enforced by the FTC and other agencies could result in costly forays into the world of weight-loss products. NS