Weight-loss supplements have taken a drubbing in recent years from government officials, consumer groups, and the media. A key issue behind the controversy is the level of scientific substantiation for product claims. While researchers haven’t reached a consensus about the effectiveness and safety of most weight-loss products, many popular natural ingredients do have some supportive data, and the number of research studies generating useful information is growing.
Derived from the fruit of Garcinia cambogia, hydroxycitric acid (HCA) has a long traditional history of use as a medicinal ingredient. Studies on its effectiveness have been mixed; however, the disappointing results may be related to the form of HCA used in clinical trials. In a 2004 study by Harry Preuss, MD, a professor at Georgetown University’s (Washington, DC) department of physiology and biophysics, a bioavailable calcium-potassium salt of HCA was shown to lower body weight and body mass index (BMI) in human volunteers who followed a 2000-calorie-per-day diet and participated in a supervised exercise program.
In the study, 90 subjects received either a placebo or 900 mg of Super CitriMax, a patented form of HCA from InterHealth Nutraceuticals (Benicia, CA), three times per day. After eight weeks, Preuss found that volunteers in the treatment group experienced approximately a 5% decrease in body weight and a 7% decrease in BMI, compared with decreases of only 1.9% and 2% in the placebo group. According to Preuss, the study was the first time that a “comprehensive, well-monitored clinical study has definitively confirmed HCA’s effectiveness and safety in humans.”
Another study in 2004 evaluated HCA’s safety. The 90-day toxicology study, published in the journal Molecular and Cellular Chemistry and conducted by researchers at Creighton University Medical Center (Omaha, NE), found that Super CitriMax was safe in quantities 25 times greater than the recommended dose in experimental animals. Super CitriMax was also declared generally recognized as safe by the Burdock Group (Vero Beach, FL), further establishing its safety.
BITTER ORANGE EXTRACTS
Bitter orange (Citrus aurantium) is another natural ingredient with a long traditional history of use. Like HCA, bitter orange’s research record has been mixed, and like HCA, the results may be related to the form of bitter orange used in clinical trials. In 2006, Nutratech Inc. (Wayne, NJ), which manufactures a patented form of bitter orange called Advantra Z, launched a campaign to boost consumer and industry awareness of the different types of the ingredient. The differences may have a subtle effect on the ingredient’s performance.
“Advantra Z is a specially harvested extract of a citrus fruit that contains a family of indirect-acting adrenergic amines that facilitate utilization of energy substrates, stimulate metabolic processes, favor uptake of amino acids into muscle, increase lipolysis, and exert mild hunger-suppressant effects,” explains Danielle Thomas, director of sales and marketing for Nutratech.
According to Thomas, Advantra Z differs from other bitter orange extracts in several ways. First, it is a patented form of the ingredient that has been used in more than 10 clinical trials. Second, it contains all five adrenergic amines, giving it a more complete profile. Third, independent testing by Chromadex (Santa Ana, CA) in 2005 showed that it only contains the “p” form of synephrine, not the “m” form that can constrict blood vessels. Other extracts may contain different configurations of amines. “No generic bitter orange suppliers can make all these claims,” Thomas says.
7-Keto, a metabolite of dehydroepiandrosterone (DHEA) that may boost metabolism, has also been the subject of several efficacy and safety studies. “7-Keto is a nonstimulant, thermogenic fat burner that effectively allows the body to burn fat more efficiently,” says Scott Steil, vice president of sales and marketing at Humanetics Corp. (Eden Prairie). Steil says the ingredient’s mechanism of action is based on its ability to increase the activity of fat-burning enzymes.
According to Humanetics, two double-blind clinical trials showed that taking 100 mg of 7-Keto twice per day, in conjunction with diet and exercise, produced a threefold increase in weight loss and fat loss compared with a control of diet and exercise alone. In addition, 7-Keto has also undergone five safety studies.
Steil notes that while 7-Keto is a metabolite of DHEA, it acts differently in the body. “7-Keto will not produce increased testosterone or estrogen levels, whereas DHEA does,” Steil says. “Also, 7-Keto has several studies showing significant weight loss versus placebo, and DHEA lacks these studies.”
Researchers are also finding that other emerging ingredients may have a positive effect on weight loss and obesity. For instance, a study presented at the third annual International Society of Sports Nutrition Conference at Las Vegas last June found that ActivAli, a proprietary extract of Tongkat Ali (Eurycoma longifolia), decreased cortisol levels in athletes who participated in a 24-hour endurance mountain bike race. According to Jesse Lopez, president and CEO of Tongkat Ali distributor SourceOne Global Partners (Chicago), the placebo-controlled study showed that cortisol levels were 33% lower in the treatment group than in the placebo group.
“This placebo-controlled study bodes well not only for athletes but for dieters alike because the incidence of visceral obesity is directly associated with high cortisol output that contributes to the deposition of fat in adipose tissue that surrounds the stomach,” says study coauthor James Roza, SourceOne’s vice president of business development, technology, and science.
Perhaps one of the most intriguing new weight-loss ingredients is Lipid Nutrition’s (Channahon, IL) PinnoThin (Pinus koraiensis), a Korean pine nut extract that promotes satiety and suppresses appetite by enhancing the release of the compounds cholecystokinin (CCK) and glucagon-like peptide (GLP1). In a double-blind study involving 18 women who received either 3 g of PinnoThin or a placebo containing 3 g of olive oil, volunteers who received the supplement experienced less desire to eat and their CCK levels significantly increased, according to Lipid Nutrition.
In addition, PinnoThin also won two prestigious awards in 2006: the Silver Award at Health Ingredients Europe (Frankfurt, Germany), and Frost & Sullivan’s (New York City) Product Innovation Award.
Scientists may not have reached a consensus about the risks and benefits of natural weight-loss ingredients, but consumers seem to be a different story. Recent survey data from the Partnership for Essential Nutrition (Washington, DC) suggest that 49% of consumers use over-the-counter diet aids and 45% went on at least one diet during the last five years. Moreover, a new commentary published in the January 6 issue of the Lancet that calls for more long-term data on prescription antiobesity drugs may make natural products that boost metabolism or promote satiety even more appealing to consumers.
“Current trends in the weight-loss marketplace clearly indicate that the appetite suppressant and thermogenic fat-burner categories are the desired choice of consumers,” says Steil, who notes that natural ingredients such as hoodia, conjugated linoleic acid (CLA), green tea, and 7-Keto have helped to fill in the void caused by the ephedra ban.
“Consumers are looking for ingredients that work,” adds Thomas. “They also realize that unless they can burn more calories than they take in, they will not lose weight. That’s why if you look at the top-20 weight-management supplements as reported by Information Resources, 17 of them contain a thermogenic ingredient.”
FTC Crackdown on Weight-Loss Products Nets More Than $25 Million
FTC settled four major cases involving the marketing of diet products, recovering more than $25 million in consumer redress, commissioner Deborah Platt Majoras announced at a January 4 press conference. The $25 million figure includes money already obtained by FTC through previous legal actions.
“Unsubstantiated weight-loss claims rake in millions of dollars for promoters, but they are costing consumers dearly,” Majoras said, estimating that some of the companies had made millions or even hundreds of millions on the products.
FOUR MAJOR SETTLEMENTS
According to Majoras, two marketers of Xenadrine EFX will pay up to $12.8 million to settle allegations that the product’s weight-loss claims were false and unsubstantiated. Majoras noted that the marketers of Xenadrine, which contains green tea extract, caffeine, and bitter orange (Citrus aurantium), also agreed to pay an additional $22.75 million to settle claims in a bankruptcy case involving creditors and consumers.
FTC said it objected to claims that Xenadrine EFX was clinically proven to cause rapid and substantial weight loss and clinically proven to be more effective than ephedrine-based diet products. Majoras said that one 10-week company-commissioned study found that the product actually caused less weight loss than a placebo. Majoras also noted that some ads for the product featured endorsers who were paid up to $20,000 for their testimonials.
Meanwhile, seven parties involved with the marketing of the products CortiSlim and CortiStress agreed to surrender assets worth at least $12 million, including $8.4 million in cash. According to FTC, ads for CortiSlim claimed the product would cause “rapid, substantial, and permanent weight loss in all users” and ads for CortiStress claimed the product would reduce the risk of Alzheimer’s disease, cancer, and other illnesses. The commission also argued that the ads were “deceptively formatted” to appear to be talk shows.
Majoras said that four companies and individuals that marketed TrimSpa agreed to pay $1.5 million to settle charges that they did not have adequate scientific evidence to support claims that the product causes rapid and substantial weight loss and that one of its ingredients, Hoodia gordonii, suppresses appetite. Majoras singled out claims such as “It makes losing 30, 50, even 70 pounds (or however many pounds you need to lose) painless” as being over the line.
In the fourth settlement, Bayer Corp. (Morristown, NJ), which manufactures One-a-Day WeightSmart multivitamins, agreed to pay $3.2 million to settle charges that it violated a 1991 consent order requiring all claims to be substantiated by competent and reliable scientific evidence. Specifically, FTC objected to ads that claimed the product increases metabolism, enhances metabolism via green tea extract, helps prevent weight gain associated with metabolic decline in people over 30, and helps users control weight by enhancing their metabolism.
According to Majoras, one ad for the product suggested that the “lifting, twisting, and bending” needed to open the bottle was the only exercise required to lose weight.
But in a statement issued the same day as the press conference, Bayer said it stood behind its product and “fully believes that all claims made in the marketing of the product are well substantiated and supported.” The company said it agreed to settle the case without any admission of guilt or wrongdoing to expeditiously resolve the FTC complaint. Bayer said it also took issue with FTC’s description of the company as “a major marketer of weight-loss pills,” adding that One-a-Day WeightSmart is “not a weight-loss product.”
TrimSpa (Whippany, NJ) also issued a statement saying that the case was “amicably resolved” and adding that the company disagreed with FTC’s inference that the product has no scientific support.
In a question-and-answer session with reporters following the press conference, Majoras said the settlements were a “wake-up call to any legitimate company or company that might be on the edge” when it comes to making unsubstantiated claims. She acknowledged, however, that some “fly-by-night” companies may not be deterred by the settlements.
Majoras also brushed off suggestions from reporters that the penalties didn’t go far enough. “Legitimate companies know that they will lose business over time if their claims can’t be trusted,” Majoras said. “I’m not sure increased penalties would actually have a greater deterrent effect on those who are bent on deceiving customers.”
Majoras added that FTC did not feel that any of the products posed a danger to consumer health that would justify their removal from retail stores. “Whether or not the products remain on store shelves depends on whether the companies want to keep making the claims,” Majoras explained. “If we had determined that any of these products were actually dangerous to a person’s health, then we would have gone to FDA, with whom we work very closely in these matters.”
The FTC chairman also hinted that future FTC actions might target media companies that accept ads with dubious claims. “In the past, we have not brought legal challenges against the media for running these ads,” Majoras said. “Truthfully, after today, we may have another flurry of activity in that regard.”