Just how bad is the trend toward overweight and obesity in the U.S. today? Well, says Frank DeJianne, senior marketing manager for Parsippany, NJ-based DSM Functional Foods, "You know you have a problem when McDonald's has to offer fruit and is willing to re-evaluate healthier options for its menu."

The statistics don't lie. Patrick Luchsinger, marketing manager-North America for Lipid Nutrition, Channahon, IL, cites numbers issued by the Centers for Disease Control and Prevention (CDC), showing that more than one-third of U.S. adults (72 million-plus) were clinically obese between 2005 and 2006, and that instances of obesity doubled between 1980 and 2004.

The Problem

Obesity, however, is only the tip of the iceberg. Less visible, but also dangerous, is the more massive problem of people who may be less than obese, but still pack too many pounds. Bob Green, president of Nutratech, West Caldwell, NJ, pointed out that "two-thirds of American adults are officially overweight."

He added, "According to the Wellness International Network, more than three out of four Americans are not meeting basic activity level recommendations. That's a recipe for healthcare disaster. More and more children are overweight, up from 4% in 1982 to 16% in 1994. All that extra weight brings with it healthcare issues, such as massive increases in both childhood and type 2 diabetes, more heart disease, increased risks for colon and breast cancers and more."

There is an economic burden as well. Daniel Fabricant, PhD, Washington, D.C.-based vice president of scientific and regulatory affairs for the Natural Products Association (NPA), says the overweight not only incur added healthcare costs, but often may be responsible for lowering workforce productivity.

We live an "oxymoronic lifestyle," suggests Mitch Skop, director of new product development for Pharmachem Laboratories, located in Kearny, NJ. On the one hand, we are too sedentary, and on the other, we are always on the go, causing many people to eat less nutritiously. Working all hours, running to meetings, always feeling the tug of unfinished responsibilities-while not exercising regularly-adds up to "high stress, poor sleep and increased potential for developing metabolic syndrome, cardiovascular disease and a fatty liver. Obesity and poor lifestyle cause tremendous damage throughout the body, leading to systemic and or­gan degradation."

How hopeless is the situation? Is there any way out of the big fat hole we are digging for ourselves?

The answer, sources say, is a re­sounding "Yes!" But, they add, it won't happen without major changes in how we as a society eat, move and rest. Diet, exercise and sleep are critical to weight management. There also is a role to be played by supplements, most would agree, but it would be a dreadful mistake to think that these products can replace or even come ahead of the other three.

Here's how Ron Udell, president of Los Angeles, CA-based Soft Gel Technologies, Inc. (SGTI) sums it up: "A complete weight-control program involves three components: 1) a balanced nutritional plan with reduced caloric intake; 2) an aerobic exercise program to increase the burning of calories; and 3) behavior modification to make sure you implement the first two items. It is a simple concept of energy balance-too much food input or too little exercise output can result in weight gain; decreased food intake or increased physical activity can result in a negative caloric balance or weight loss. Think in terms of lifelong eating patterns. Small changes made in permanent eating habits, like gradually cutting back on portion size and planning your meals, can have big long-term effects."

Mr. Udell continues, "Food, supplements and exercise are only part of one's overall wellness. It's also important to drink at least eight to 10 8-oz. glasses of water each day and limit the amount of caffeine and carbonated beverages consumed. Sleep is also crucial for total health; at least eight hours a night helps you heal and rejuvenate. Finally, the way we deal with stress will affect our health; it should be managed in a healthful way that includes deep breathing and/or meditation."

This is such a tall order of change, it's not surprising that so many fail. Scott Hagerman, president and CEO of Chemi Nutra, White Bear Lake, MN, reports, "One-third of people drop off their diets in the crucial first few weeks. As a result, they experience little if any success. In many cases, they actually end up in worse shape from both psychological and metabolic standpoints."

Ken Wheeler, global marketing manager-Innovations for Des Moines, IA-based Kemin Health LLC, cites USDA statistics showing that fewer than 3% of the population eats according to the Food Pyramid. This, he asserts, signifies that nutrients are not being consumed in appropriate volume or proportion to the overall diet. And this is where and why supplements are important. Weight management supplements, in particular, can help motivate and mobilize overweight and obese individuals to seek improvement and to stick with it when the going gets rough.

Ingredient Solutions

Most weight management supplements rely on one or more of five mechanisms of action (Table 1).

Benicia, CA-based InterHealth Nu­traceuticals, for example, points out that its Super CitriMax ingredient was granted a patent (No. 7,335,651 B2) this past February for its ability to promote fat oxidation (fat burning).

Satiety (fullness) is the prime target of Fabuless, a lipid emulsion marketed by DSM. Mr. DeJianne says its effectiveness has been confirmed in five human clinical studies.

Cognis Nutrition & Health, headquartered in La Grange, IL, positions its Tonalin CLA ingredient "more for fat reduction than for weight loss," according to Sharrann Simmons, senior marketing manager. CLA is a polyunsaturated, conjugated linoleic acid sourced from safflower oil that offers four modes of action: 1) decreasing the amount of fat stored after eating; 2) increasing the rate of fat metabolism; 3) increasing the rate of fat breakdown in fat cells; and 4) decreasing the total number of fat cells.

At Humanetics Corporation, Eden Prairie, MN, the leading ingredient product is 7-Keto. Scott Steil, vice president of sales and marketing, describes it as "a non-stimulant, thermogenic fat burner that effectively allows the body to burn fat more efficiently-specifically, 7-Keto increases the activity of key fat-burning enzymes. 7-Keto is naturally found in the body, but declines dramatically with age. Typically, a person loses about 50% of his or her endogenous 7-Keto levels by age 40. "This results in the body's inability to burn fat as it used to when we were younger."

Allendale, NJ-based Lonza, Inc. indicates that its Carnipure brand of L-carnitine addresses many specific market segments, including not only weight management, but also sports nutrition and cardiovascular health. Citing previous studies, the company explains, "In obese adolescents, L-carnitine supplementation promotes weight loss, and decreases BMI and body fat content." Nevertheless, Lonza offers this disclaimer: "It is important to bear in mind that the dietary supplement L-carnitine is not recommended to treat obesity. This is a disease that requires intervention by a health professional."

Sabinsa Corporation's (Piscataway, NJ) leading entry in the weight management category is LeanGard, a blend of three of the company's leading ingredients-Forslean, a Coleus forskohlii root extract containing 10% forskolin; Garcitrin from Garcinia cambogia (Malabar tamarind) containing hydroxycitric acid and garcinol; and Bioperine, a patented standardized extract from black pepper fruit containing 95% piperine. Forslean and Garcitrin are phytonutrient extracts that work to support lean body mass and healthy body composition, promote satiety and provide antioxidant support; Bioperine is an extract of piperine, which functions as a bioavailability enhancer. Lakshmi Prakash, PhD, vice president of innovation and business development, says, "Supplementation with the proprietary ingredient blend led to a 6% greater weight loss, and a 7% greater loss of body fat than placebo in a randomized, double-blind, parallel-controlled study."

Introduced in 2001, Phase 2, a product from Pharmachem, is a proprietary extract of the white bean, which acts in the body as an alpha-amylase inhibitor. Citing research studies, the company's Mitch Skop commented, "The GI (gly­cemic index) is becoming an important measure of a healthy diet, and now we can show that in proper dosages Phase 2 Carb Controller will not only reduce the absorption of starch calories, but can also lower the GI of starchy foods."

SGTI and its sister company Opti­Pure have several entries aimed at weight management, including GlucoFit, CaféVerdeX and Loquoro. GlucoFit's formula contains corosolic acid derived from the banaba plant (Lagerstroemia speciosa, L.), which, SGTI reports, is "clinically proven to help balance blood glucose levels." CaféVerdeX is a green coffee bean extract (GCBE) with considerable amounts of hydroxyl-cinnamic acid derivatives, including chlorogenic acid, quinic acid and caffeic acid. In an in vitro study, GCBE at 1000 μg/ml showed a higher inhibition of lipase activity compared to chlorogenic acid. Loquoro, derived from the leaves of Eriobotrya japonica, otherwise known as loquat, is said to provide a targeted approach for balancing low blood sugar and chronic hypoglycemia.

Suggesting that hunger is "dieting's biggest enemy," Kemin is offering Slendesta, an ingredient extracted from potatoes, which sends the brain a signal that it's time to stop eating. The company says the key to Slendesta's effectiveness is the satiety factor cholecystokinin (CCK), a peptide first discovered in 1928. According to Kemin, the product utilizes Proteinase Inhibitor II (PI2), which it has been researching for more than 20 years, to enhance the release of CCK. In one randomized, placebo-controlled, crossover clinical study involving 45 participants, Slendesta was shown to prompt a sense of "significantly greater fullness and decreased motivation to eat."

Fibersol-2 from Matsutani America, which has its main U.S. sales office in Itasca, IL, is a digestion-resistant maltodextrin (90+% water-soluble dietary fiber). The company describes it as "a highly dispersible, soluble, tasteless, colorless, and odorless prebiotic ingredient" that has been studied for its effect on satiety and hunger, as well as for secondary effects on intestinal function, blood lipids and blood sugar/insulin.

Slimaluma (Caralluma fimbriata), from Anaheim, CA-based Gencor Pacific, is a water-soluble standardized extract that is positioned as an appetite suppressant. According to the company, it may also inhibit the growth of preadipocytes, which are the base of fat storage tissues. Sales director Dr. Jit Maheshivari claims seven toxicity studies have demonstrated its safety. Today the ingredient is featured in many formulations being sold in stores, such as GNC, Vitamin Shoppe, CVS, Rite Aid, Walgreen and Longs.

Rob Minnee, an adviser to Artemis International, located in Fort Wayne, IN, says, "Satiety is often called the holy grail of weight management." Among several promising approaches, he lists peptide mixtures, gelling agents in the stomach, or fats that trigger an ileal brake mechanism. Noting that Artemis is exploring the weight management potential of berries or other sources of anthocyanins such as purple corn, he adds, "Anthocyanins influence adipocytokine expression and show exciting anti-obesity potential in animal trials."

According to Lipid Nutrition's Mr. Luchsinger, Clarinol CLA improves body composition, reduces body fat, and helps increase lean muscle, while its PinnoThin ingredient works as a satiety agent that stimulates the release of the hunger-suppressing hormone CCK and GLP1 (glucon-like peptide 1). These not only help the body digest fats better, but they also send a "full" feeling to the brain, decreasing the desire to eat.

Chemi Nutra's Mr. Hagerman cited a recent study showing that his company's PhosphoLean "significantly im­proved diet compliance in a group of healthy, overweight or obese subjects, as demonstrated by dropout rate. It also increased satiety, decreased depressive symptoms, decreased binge eating severity, and provided favorable changes in insulin resistance and lipids," he said. The study included 138 subjects who were studied over a period of eight weeks. The findings were published in the July 2008 issue of the British Journal of Nutrition. Key components of PhosphoLean include a proprietary mixture of N-oleoyl-phosphatidyl-ethanolamine (NOPE), de­rived from soy phospholipids, and epigallocatechin gallate (EGCG) from standardized green tea extract.

Fat burning is the primary mechanism of Nutratech's Advantra Z, which the company claims is "the only patented form of Citrus aurantium (bitter orange) on the market, [and] has been proven in studies to help stimulate thermogenesis." According to the company's Mr. Green, Advantra Z contains a family of indirect-acting adrenergic amines (B-sympathicomimetics), which facilitate utilization of energy substrates, stimulate metabolic processes, favor uptake of amino acids into muscle, increase lipolysis (breakdown of fat) and can exert mild hunger-suppressing effects. Meanwhile, he added, "Since the amines in Advantra Z are not as lipophilic as those in ma huang/ephedra, they do not readily cross the blood/brain barrier."

Monroe, WI-based Glanbia Nutritionals describes its Prolibra 190 as a whey-derived ingredient that has been "clinically proven to target fat loss and retain lean mass." When combined with fruit concentrates, flavors, sweeteners and water, it blends into a homogenous smoothie. The company recommends ad­ding citric acid and adjusting pH to 3.85 with phosphoric acid as a finishing touch before heating to sterilize and cooling for consumption.

Nutraceuticals International, Elmwood Park, NJ, offers fucoxanthin, one of the newer ingredients on the weight management scene. It de­scribes fucoxanthin as a "totally innovative approach to weight loss," that "has been scientifically proven to burn fat-particularly abdominal fat-by adaptive thermogenesis within white adipose tissue." According to the Fucopure website, "Fucoxanthin works by breaking apart protein families and allowing the body to naturally metabolize fat, which is usually the last thing the body burns when expending energy.'

The Industry vs. GSK

Clearly, there is no shortage of ingredients vying for a slice of the lucrative weight management category. If pharmaceutical giant GlaxoSmithKline (GSK) and three co-petitioners have their way, however, this sector, which is estimated at about $1.3 billion in annual sales, could dry up during the next several years.

On April 17th, GSK and three other organizations-the American Dietetic Association, The Obesity Society and Shaping America's Health-formally asked FDA to "determine that dietary supplements bearing claims that they promote, assist, or otherwise help in weight loss are 'disease claims' under Section 403(r)(6) of the FDCA [Federal Food, Drug, and Cosmetic Act]."

Disease claims for supplements are, as virtually everyone knows, not permitted under the Dietary Supplement Health & Education Act of 1994 (DSHEA). Curiously, however, GSK and its fellow petitioners are not arguing that being overweight is in itself a disease. Instead, they declare, "Such statements purport to prevent or treat an abnormal or unhealthy condition that, while not itself a disease, is a significant risk factor for disease."

The rationale for the petition, as stated in the document, is an assertion that "more consumers are defrauded by weight-loss products than any other product" evaluated by the Federal Trade Commission (FTC), the government agency charged with enforcing truth in advertising.

Meanwhile, GSK is not a disinterested party in this action; it does have a dog in the fight. The company's over-the-counter weight-loss drug alli works by inhibiting the lipase enzyme, thereby blocking 25% of fat from being absorbed. One disadvantage of using alli, according to SGTI's Mr. Udell, is that, "Like its prescription counterpart, Xenical, alli can cause oily or loose stools if too much fat is consumed in one sitting."

Moreover, this past June, GSK announced figures suggesting that 2008 sales of alli may not be as strong as expected. The company reported that, to date, a total of four million people have tried alli. According to NutraAnalyst, Inc., Salt Lake City, UT, "Stock analysts have said this number is disappointing given the significant marketing efforts behind the product, but GSK took a longer-term view and said the numbers show a solid foundation for its future.

"The company said its 2007 sales for alli reached $304 million, and that it spent $150 million promoting the drug," NutraAnalyst continued. "These figures included a buildup of initial inventory in retail outlets though, and the company said its Q1 sales so far have only reached $17.5 million. According to IRI, alli accounted for half of all weight-loss product sales when it recorded $32 million in retail sales, but by May sales had fallen to $9 million, putting its share closer to 13%-14%." Under these circumstances, it is not hard to understand why GSK might want to take away those pesky dietary supplements.

Whether FDA ultimately will or won't smile on the GSK petition, there is no denying that it has caught the nutrition industry's attention.

Attorney Marc Ullman, of New York, NY-based Ullman, Shapiro & Ullman, LLP, suggests that FDA approval "would essentially convert all weight-loss supplements into unapproved new drugs, forcing them off the market." Overnight, all of alli's nonprescription competition would disappear.

NPA's Mr. Fabricant calls the petition "misguided and ultimately without legal basis." In his view, "FDA's definition of disease is premised on 'damage to an organ or body' and draws a distinction between 'healthy function and preventing or treating abnormal function.'"

Emphasizing his organization's determination to oppose the petition, Steve Mister, president and CEO of Washington, D.C.-based Council for Responsible Nutrition (CRN), said, "We believe weight-loss claims are legitimate and appropriate claims for products in the dietary supplement category, provided these products have substantiation to support the truthfulness of these claims."

CRN also has won endorsement of a sort from FTC for its 2006 initiative, undertaken in cooperation with the National Advertising Division of the Council of Better Business Bureaus (NAD), to increase monitoring of advertising for dietary supplements. Indicating that the agency "strongly supports effective self-regulation," Lydia Parnes, director of FTC's Bureau of Consumer Protection, calls the initiative "a positive step forward," and adds, "industry members have a real opportunity to learn from NAD decisions and build consumer confidence."

Loren Israelsen, executive director of the United Natural Products Alliance (UNPA), Salt Lake City, UT, remains optimistic, believing that the chances of the GSK petition being approved are "remote," or "modest, at best." But if it does succeed, he says it will "officially open the door for even greater competition between pharmaceuticals and dietary supplements, spanning a variety of already accepted disease claims." These might include such areas as blood pressure, cholesterol and blood sugar levels, all of which, like excess weight, are "surrogate markers of diseases." He adds, "Approval of this petition would suggest that the definition of disease has been changed. This would clearly be a victory for pharmaceutical products and a major loss for supplements."

So the stakes are high. Sources for this article-conscious of what could be lost-are candid in admitting that there is a fringe element making overblown, probably unjustified, and possibly actionable claims for weight-loss products. There is no escaping the fact that since 1927 FTC has brought more than 200 cases involving weight loss, collected over $100 million in consumer redress and assessed substantial fines.

Richard Cleland, assistant director of the agency's Division of Advertising Practices, charges, "Promoters of these diet products make billions of dollars. Under the current system, virtually none of that money goes to scientific research." This creates a situation, he claims, in which not only consumers but honest, research-minded manufacturers also are being hurt. For one thing, exaggerated promises lead to a lack of credibility. For another, Mr. Cleland said, "It's impossible to compete against competitors who have no regard for the truth of their claims, unless you lower your own standards."

Many if not most of the industry sources cited in this article would agree with this view. Cognis' Ms. Simmons observes, "We actually believe responsible suppliers would be better off if the government stepped up efforts in this area. Enforcement of existing regulations is what's needed."

Humanetics' Mr. Steil offered a similar point of view. "My opinion is that less than 50% of all of the products currently available to consumers today in the weight management area will produce a positive experience for consumers. Many products still lack any human clinical data showing that they will produce statistically significant weight loss," he said. "This, combined with the large numbers of consumers who are looking for the magic bullet that causes 20 pounds of weight loss without diet and exercise, only makes the issue more severe."

Still, Mr. Steil says, "The weight loss market has made major progress in the past two years in terms of converting from strong marketing hype to more science-based solutions. We have seen a dramatic increase in companies requiring that the ingredients they use possess a good clinical trial pedigree."

Judy Blatman, CRN's senior vice president for communications, sums it up neatly. "This category is particularly vulnerable to over-reaching claims be­cause consumers are so caught up in wanting a quick and simple solution to losing weight. It is unfortunate that there are some companies, however, that take advantage of consumers' desire to lose weight by promising miracle results that are not legitimate-and these are the companies and products that get so much attention and give the supplement industry a bad reputation," she said. "Supplements can play a role in weight loss and weight management, but the bottom line is you cannot sit on the couch and click the remote control for exercise, then eat anything and everything you want, pop a pill and safely lose weight. Supplement companies that make those kinds of promises are doing consumers and the supplement industry a disservice."

Ms. Blatman urges companies that see ads making claims that go beyond what can be substantiated to consider filing a competitive challenge with the CRN/NAD ad-monitoring effort. For the future, she said, "This kind of self-regulatory initiative will serve to improve consumer confidence and help improve the dietary supplement industry's reputation."

About the author:
New Jersey-based freelance writer Alan Richman, former editor/associate publisher of Whole Foods Magazine, specializes in coverage of the nutrition industry. He can be reached at arkr@optonline.net.