Weight loss/management: where is the market headed? Populations around the world continue to get fatter, as companies scramble to find solutions to overweight/obesity.
Despite the utter confusion amongst consumers as to the severity of the overweight/obesity issue, leading experts still consider it a real threat to Americans' present and future health. And reports from organizations like Trust for America's Health (TFAH), Washington, D.C., indicate the problem of overweight/obesity is likely to get worse before it gets better. "Obesity rates continued to rise last year in every state but one (Oregon), and government policies and actions to date offer little hope of countering the trend," the organization said in its most recent report. Shelley Hearne, DrPH, executive director of TFAH, believes we need more and better data to be able to make decisions to get out of the debate limbo in which we are stuck. "We have a crisis of poor nutrition and physical inactivity in the U.S. and it's time we dealt with it," she said.
Echoing these sentiments was obesity expert Rebecca Reeves, DrPH, RD, assistant professor at the Baylor College of Medicine, and the new president of the American Dietetic Association (ADA), Chicago, IL, who said, "Based on the latest data coming forth from the government, there is still an increase in the obese range. Those that are obese continue to get larger and new people enter the category on a daily basis. At this point, we don't see that rate slowing down. So all of the efforts made toward stemming the rise in overweight/obesity either haven't crystallized yet or haven't made a big impact."
But, Dr. Reeves said, help is on the way. "In response to this epidemic there are a lot of organizations banding together to take a harder look at finding solutions," she said. "Every organization in this country whether it is on the federal or state level has at least one component looking at obesity. People should take comfort in the fact that the public sector, the government and industry are really starting to come together on this issue."
Nina Likins, Tonalin CLA marketing manager, Cognis Nutrition & Health, agreed. "The good news is that the issue is front and center--the media, government officials and several other groups are focusing on the growing epidemic," she said. "The challenging part is, what happens next? Will Americans change their eating habits? Will they exercise more? We are all hopeful but reality suggests otherwise."
A study published in the October 4th issue of the Annals of Internal Medicine offered more bad news for overweight and obese Americans. Over the long term, researchers said nine out of 10 men and seven out of 10 women would eventually become overweight. The shocking part was that even if men and women in the study had made it well into adulthood without a weight problem they ultimately became overweight. The data for the study were gathered from 4000 white adults over a period of 30 years. Participants were between the ages of 30 and 59 at the start, and were examined every four years. By the end of the study, more than one in three had become obese.
Consumers in the past were more concerned with the stigma of being overweight or obese, so most chose to attack their weight issues purely from an appearance or vanity perspective. However, evidence clearly connecting overweight and obesity to chronic diseases like diabetes and cancer continues to surface on a daily basis. As a result, health is becoming a major driver in changing consumers' approach to weight loss/management. "People seem to be viewing weight loss not only from an appearance standpoint, but also based upon what that extra fat is going to do to their health down the road," said Mitch Skop, director of new product development, Pharmachem, Kearny, NJ.
As a result, Lynda Doyle, director, Business Development, DSM Nutritional Products, Inc., Parsippany, NJ, said there has been a major surge in dieting among shoppers that are concerned about obesity and weight loss. "According to a recent HealthFocus report, 40% of shoppers are concerned about being overweight and two-thirds of shoppers have dieted to lose weight in the past year," she said, adding, "Nearly 30% of shoppers want to lose 20 pounds or more and nearly a quarter of shoppers want to lose between 11 and 20 pounds."
But it will be education that separates one consumer from another when it comes to the types of weight loss products they purchase. Dr. Vladimir Badmaev, vice president, Scientific & Medical Affairs, Sabinsa Corporation, Payson, UT, explained his perspectives on this issue. "Consumers can be divided into two groups--one that consists of uneducated consumers, a tabloid fed group looking for immediate gratification (i.e., "energy on demand" or "instant" fat burning products), and the second one consisting of well educated, inquisitive customers who care more for their total health rather than quick-fix solutions," he said. "The latter group recognizes that a combination of factors, including lifestyle modification and nutritional intervention, contribute to a healthy and fit body. Incidentally, the well educated group is also less fixated on 'how do I look' and more focused on 'how healthy am I.'"
When the weight loss market--as it pertains to dietary supplements--lost its billion-dollar baby, ephedra, it took a serious dive and no product since has been able to fill that void. "The weight loss market in this post-ephedra era remains a large market, but has been struggling over the past year," said Scott Steil, vice president of sales and marketing, Humanetics Corporation, Minneapolis, MN. "In fact, it is off 20-22% since ephedra was taken off the market." Besides the impact of ephedra, he pointed to increased scrutiny by the FDA and FTC as another factor negatively affecting growth. "The good news is, consumers and regulatory agencies are more focused on science in today's market, which is causing companies to really buckle down and conduct research to show that ingredients truly show a benefit toward weight loss/management," he said.
In order for the market to substantially rebound, Todd Norton, president, Sabinsa, believes companies must stop "window dressing" their products. "There is a trend that continues to be heavily weighted on a certain fixed price point for weight management products that often have too little substance and too much hype," he said. "For those ingredients that have scientific support for use or application and are looked at as the active components in the product there is a well established pattern of using less than an efficacious dose in formulations."
For these and other reasons, Mr. Norton says some manufacturers feel the market is in dire need of resuscitation. "Some of the historic 'higher profile' weight loss supplement manufacturers I have talked to recently say the category is just not the same since the banning of ephedra," he commented. "One even described the category as 'near dead' at the moment and in need of something dynamic to bring it back to life."
He added, "Perhaps this sentiment is instructive in that 1) weight loss products as a category tend to exhibit an overabundance of marketing hype and fall short on substance, and 2) maybe it is time to look at this problem from a different perspective--as an opportunity. There is limited control to the credibility and sustainability of your economic engine if its flame is constantly being fueled by 'what's hot.' How about asking instead, 'what works?"
As consumers take a health rather than an appearance approach to shedding pounds, it is important to remember that they still want to receive positive messages about losing or maintaining weight. "According to recent research conducted by DSM Food Specialties, consumers in the U.S. react more favorably to a product message relating to their good intentions and time-pressured daily routine," said David Jobse, Fabuless product manager, DSM Food Specialities, Delft, The Netherlands. "In Germany, consumers appreciate that controlling satiety doesn't mean cutting out their favorite foods or changing their normal diet, it simply means eating less," he said. In the rest of Europe, DSM's research findings showed that an "anti-diet" message was the most effective. "Consumers don't expect to achieve drastic weight loss and are disillusioned with restrictive or fashionable diets, but they are very open to proven, uncomplicated weight loss products," said Mr. Jobse.
While not without its challenges, the weight loss/management market is also full of opportunities for companies that can help consumers make sense of the claims and mechanisms by which these products work. Currently, many nutraceutical companies offer ingredients that tackle the overweight/obesity issue through a variety of mechanisms, including boosting/regulating metabolism, appetite suppression, satiety (promoting fullness), improving body composition and fat absorption.
The Thermogenesis Factor
DSM Nutritional Products, Inc. became a player in the weight loss market from a thermogenesis perspective when it launched caffeine-free Teavigo, which is a highly purified epigallocatechin gallate (EGCG) isolated from green tea extract. To date, DSM's Ms: Doyle says the company has invested heavily in research on the various health aspects of Teavigo, particularly thermogenesis and enhanced metabolism. "Human clinicals on Teavigo and thermogenesis and abdominal fat are ongoing," she said. "Based on animal experiments and observational studies in humans, researchers believe that certain dietary compounds, such as EGCG, stimulate thermogenesis."
Further, Ms. Doyle pointed out, both animal and in vitro studies have been conducted by DSM scientists and collaborators on Teavigo brand EGCG, which have yielded positive results in various factors of obesity, including a reduction in body fat and weight, a reduction in body weight gain and increased metabolism and fat oxidation.
To boost consumer awareness for Teavigo, DSM recently implemented a marketing campaign incorporating print and radio ads to drive consumers to products containing Teavigo. In addition, it recently received generally recognized as safe (GRAS) status for its Teavigo product, which gives the company the "green light" to market it for use in a variety of food and beverage applications.
Even the best efforts to lose weight cannot reverse the fact that consumers will inevitably get fatter as they age. It is in this vein that Humanetics has positioned its 7-Keto product. In an effort to put to more substantiation behind its 7-Keto ingredient, a non-stimulant, thermogenic fat burner, the company dramatically strengthened its research center this year to carry out clinical studies. "The center is a wholly owned subsidiary of Humanetics and it performs IRB-approved clinical research," said Mr. Steil. "MARC (Minnesota Applied Research Center) just finished its 1000th patient visit for weight loss studies." Mr. Steil said the studies carried out by the center are designed according to a pharmaceutical model. The only difference is the study populations are not as big.
So far, studies indicate that aging has a negative impact on metabolism. "We know that aging will slow down the metabolic rate," explained Mr. Steil. "In fact, clinical studies have shown that metabolism slows down 2% each decade, beginning on average from age 30. So as you get older your body is not burning calories as efficiently as it used to." So how can 7-Keto play a role in this process? Mr. Steil said 7-Keto specifically enhances certain enzymes that help the body burn fat like it used to. "The enzymes that break down fat for energy also dramatically decrease with age. We have found that between ages 20 and 40 the activity of those fat burning enzymes decreases about 50%, and between the ages of 20 and 60 people lose about 75% of that enzymatic activity," he offered. "We are really starting to connect the dots through various studies showing that 7-Keto may play a role in reversing age-related declines in metabolism. As a result, clinical study participants have shown that 7-Keto produces three times greater weight loss than placebo, which was diet and excerise alone."
Another company that has been active on the thermogenesis front is Nutratech, Fairfield, NJ, which produces a product called Advantra Z, a bitter orange-based product. Bitter orange, or Citrus aurantium, contains a component called synephrine, which has been thrown into the spotlight due to its perceived ephedra-like effects. Over the years, Nutratech and other organizations have been actively working to dispel the negatives that have been associated with synephrine-based products.
A study conducted earlier this year concluded that Advantra Z contains only p-synephrine, a stable isomer of the synephrine alkaloid, not m-synephrine, which has the potential for raising blood pressure. In a more recent study conducted at the University of California, and published in the September issue of the American Journal of Medicine, researchers said ephedra-free weight loss supplements seem to have significant cardiovascular stimulant actions, similar to ephedra. But they also said, "These effects are not likely caused by C. aurantium alone, because an eightfold higher dose of synephrine (Advantra Z) had no effect on blood pressure, but may be attributable to caffeine and other stimulants in the multi-component formulation."
Bill Arthur, principal/owner of Nutraceutical Solutions Consulting (NSC), Miami Beach, FL, and a consultant to Nutratech, claims the studies on Advantra Z have repeatedly found that it produced a significant increase in the resting metabolic rate and was effective in inducing weight loss and reducing body fat more than diet and exercise alone--all without increasing heart rate or blood pressure or causing other adverse effects. Unfortunately, Mr. Arthur said, "Hype works both ways to either falsely pump up or denigrate a product/ingredient. For example, there has been a lot of conflicting negative hype out there about the safety of bitter orange." So how does a consumer separate false hype from fact? Mr. Arthur said the only way is to look at the research. "In the case of bitter orange, the truth is that in all the years bitter orange has been sold in the U.S., there has not been even one adverse event directly linked to it--a remarkable statistic, especially when compared with popular foods and prescription and over-the-counter drugs," he said.
The 10-subject study conducted at the University of California was subsequently picked up by major news outlets, including the New York Times. In an article that appeared in the October 11th edition, Michael McGuffin, president of the American Herbal Products Association (AHPA), Silver Spring, MD, was quoted as saying that the ingredient to be concerned about was caffeine, not bitter orange. The article also said that AHPA advocates special labeling for dietary supplements that contain caffeine, telling consumers how much the product contains by comparing it to cups of coffee. For example, a supplement that contains 200 mg of caffeine would be equivalent to two cups of coffee.
Given the hard fought efforts of industry to accurately portray bitter orange, FDA and other government agencies still remain concerned about its effects. For now, it seems, the future for this ingredient is uncertain at best.
Satiety & Appetite Suppression
Satiety is a relatively untapped area of weight loss/management. In fact, according to DSM Food Specialties, the concept of satiety only accounts for 1% of the ingredients market for supplements and food. This situation, however, will likely change in the future, as the ADA's Dr. Reeves feels this is the crucial component of weight loss/management that must be addressed. "If we could figure out a way to control hunger, we would have it. This is where a lot of researchers have been spending their time lately," she said.
A newcomer to the weight loss/management category is an ingredient called Fabuless, which was launched earlier this year by DSM Food Specialties. Promoted from a satiety standpoint, Fabuless is a patent protected combination of oat and palm oils that is formulated in a novel emulsion. According to the company, the oat oil extract contains a large quantity of polar lipids that function as a "coat" around the palm oil droplets. These prevent digestion of the palm oil in the stomach until it reaches the small intestine. Upon arrival in the latter part of the small intestine (the ileum), the oil is interpreted as undigested fat. This is recognized as a signal that the body has had enough food--a process called the "'Ileal Brake Mechanism." The brain then realizes there is no need for further calorie intake, and so suppresses the hunger signals that would normally be sent. Finally, the Fabuless fat is fully digested like normal fat. By activating the body's natural appetite control mechanism, DSM claims Fabuless reduces calorie intake.
The evidence behind Fabuless is based on four different published studies carried out at the Northern Ireland Centre for Diet and Health (Ulster University), which substantiate the product's claim on reducing calorie intake. Unlike many new diet products, Fabuless combines natural food ingredients so DSM says it is not subject to lengthy regulatory procedures.
Another ingredient category that has been propelled into the spotlight when it comes to feeling fuller longer is fiber. "The 2005 Dietary Guidelines for Americans recommends balancing calories from foods and beverages with calories expended in combination with regular physical activity to maintain body weight in a healthy range," said Kimmo Lucas, president and CEO, Cevena Bioproducts, Inc., Edmonton, Alberta, Canada. "Furthermore, high fiber intake has been found to affect body fat levels and contribute to weight loss. Increased satiety, reduced energy intake and loss of weight after fiber intake have been recorded in several studies." This is why the company is spending a significant amount of time with the weight loss/management market. Some of the claims that Cevena attributes to its Viscofiber product include:
* "Viscofiber helps support weight loss maintenance"
* "Viscofiber assists with weight loss by moderating glucose absorption thereby reducing cravings associated with consuming high glycemic foods"
* "Viscofiber assists with weight loss by reducing glycemic response and decreasing hunger cravings"
* "Viscofiber helps provide a sensation of satiety when taken prior to meals"
* "Viscofiber helps suppress appetite when taken prior to meals"
* "Viscofiber helps you feel full and more satisfied, reducing the temptation to overeat"
Orafti, Malvern, PA, is also exploiting the fiber angle for its inulin and oligofructose ingredients. This is because, according to Hilary Hursh, food and nutrition specialist, recent research underlines the value of fiber for maintaining a healthy weight. "A recent study published in the September issue of the Journal of the American Dietetic Association found that women consuming a high-fiber, low-fat diet had the lowest risk of being overweight or obese," she said. "As a result, the recommendations for increasing fiber as part of a healthy weight loss/weight maintenance plan are now even greater.
Ms. Hursh went on to say that fiber gained prominence in the weight control market following the rise and fall of low-carb products because consumers and food formulators realized the value of fiber for both replacing digestible carbohydrates and aiding digestive functions during a high protein diet. "This awareness of fiber in a healthy diet has remained and is gaining popularity as consumers realize the value of its satiating properties and the importance of maintaining digestive health," she commented.
When talking about staving off hunger it is impossible to leave out the issue of glycemic index or glucose metabolism. This hot button topic has motivated many companies to position products as having a positive influence on glycemic index. "I see a lot of trends focusing on stabilized eating to maintain glucose metabolism. The thought is that steady glucose levels will allow people to have more energy and burn more calories," said Pharmachem's Mr. Skop. "It makes senses as a new mechanism to monitor the glycemic index of foods and measure blood sugar." He added, "Coincidentally, our Phase 2 product seems to fit nicely into the picture as it relates to stabilizing blood sugar." In fact, Dr. Jay Udani, medical director, Northridge Hospital Integrative Medicine Program, and assistant clinical professor at the Department of Medicine, UCLA/Geffen School of Medicine, recently completed a clinical study assessing the impact Phase 2 on glycemic index. "The recent findings suggest that when consuming Phase 2 there is a significant reduction in the insulin spike accompanying high glycemic index foods," said Mr. Skop. "Phase 2 is currently being baked into products and it is our hope that more ingredients like it help the foods consumers eat to become more nutritious than they have ever been. (See more on glycemic index on page 46.)
In May 2005, Lipid Nutrition, Channahon, IL, launched a new ingredient called PinnoThin to the weight loss market. According to Patrick Luchsinger, marketing manager, North America, it stimulates the release of the hunger-suppressing hormone CCK (cholecystokinin), which not only helps the body digest fats better but also sends a "full" feeling to the brain, decreasing the desire to eat. "By reducing the desire to eat," he said, "it helps lower calorie intake."
Body composition has also been a major target for nutraceutical companies. According to Cognis' Ms. Likins, recent research confirms that taking conjugated linoleic acid (CLA) decreases body fat mass (BFM) and maintains lean body mass (LBM), and so also aids weight management, reducing the potential "yo yo" effect often associated with diet plans. She said the results of Dr. Jean-Michel Gaullier's study, published is the April issue of the Journal of Nutrition, were particularly exciting because the study was intended to confirm the safety of Tonalin CLA, but it went an important step further to demonstrate that subjects taking CLA also maintained LBM and didn't regain the body fat they'd lost. "It's hard enough to lose body fat and even more difficult to keep it off, so this research is welcome news to dieters and those formulating clinically proven products for this population," she said.
In the study, overweight subjects who took 3.4 grams of CLA per day lost body fat in the first 12 months of the study and were able to avoid regaining that fat in the second 12 months. "The results of the study corroborate and expand upon earlier findings published in the June 2004 issue of the American Journal of Clinical Nutrition, which revealed that CLA reduced BFM in overweight, but otherwise healthy adults by as much as 9%," she said. "The findings also revealed that people with the highest body mass index (BMI) and BFM, especially women, were more likely to lose body fat than those with lower BFM."
Also of note, said Ms. Likins, is that CLA supplementation helps lower levels of leptin. High levels of the hormone leptin are associated with increased body weight. Over the course of 24 months, leptin levels dropped 20-35% as study subjects lost body fat.
There are four claims that relate to Tonalin CLA:
* "Decreases the amount of fat that is stored after eating"
* "Increases the rate of fat breakdown in fat cells"
* "Increases the rate of fat metabolism"
* "Decreases the total number of fat cells"
Lipid Nutrition has also been active on the CLA front with regard to its Clarinol product. Mr. Luchsinger says the company recently increased the concentration level of the two active isomers for weight management to 95%. "This now makes Clarinol CLA the most highly concentrated form of CLA on the market with access to the WARF patents (Wisconsin Alumni Research Foundation)--allowing customers to make weight management claims on their products," he said. "Another big trend we see is the increased interest in CLA by the functional food segment. CLA is becoming more and more popular with functional food companies because of the proven track record in human clinical trials for body fat reduction and increasing lean muscle."
Also looking to effect positive results in body composition is Sabinsa with its patented ForsLean ingredient (derived from Coleus forskhlii). Mr. Norton says the company has completed eight clinical trials since 1999 to further substantiate its role in weight management. In addition, the company recently contracted with an internationally recognized toxicology group to review all available data on ForsLean's active component for safety. "We have done our own extensive safety studies and additional studies are planned," he offered. "At this point it seems we have only just scratched the surface, but with compelling data coming back we are encouraged to press on."
Mr. Norton claims the success of Sabinsa's ForsLean ingredient is based on a well-defined mechanism of action that is safe and effective in promoting lean body mass, which he believes is crucial in today's weight management market. "There must be a paradigm shift toward healthy, long-term weight management and a good place to start is by not focusing solely on the pounds one loses, but rather on what types of pounds should be targeted," he said.
The most recent study to examine the effects of ForsLean was published in the August issue of the Journal of Obesity Research. The 12-week randomized, double-blind, placebo-controlled study was conducted on 30 overweight and obese men. Study participants were given either 250 mg of 10% forskolin extract (as ForsLean) twice daily or placebo for 12 weeks, while they maintained their usual levels of physical activity and normal diet patterns. The results revealed a 3.98 kg (8.77 lbs) total increase in lean body mass in those subjects taking ForsLean. Results also showed a decrease in body fat by 4.52 kg (9.96 lbs), or 11% as compared to baseline. The placebo group showed no statistically significant changes in lean body mass (1.77 kg/3.90 lbs) or body fat (0.51 kg/1.12 lbs).
Receiving a lot of attention of late, claims Eric Bastian, director of R & D, Glanbia Nutritionals, Monroe, WI, is the relationship between dairy products and weight loss. He highlighted recent research that indicates, protein, peptide and mineral components from milk are important in weight management and weight loss. "Whey proteins and peptides are receiving a lot of attention in the weight loss area. A major issue connected to weight loss and dieting is that when people lose weight, they not only lose body fat, but also muscle mass. Loss of muscle is unhealthy, undesirable and, according to recent research, preventable," he said. "Consumption of whey protein and whey peptides in conjunction with calorie restriction helps people loose weight while maintaining lean body mass and reducing body fat content. Milk minerals also play a role in reducing body fat."
Today, Mr. Bastian claims, technology is available to isolate minerals, whey proteins and peptides to provide them in an enriched format and develop new ingredients for weight management. In fact, Glanbia's Prolibra whey mineral protein is an example of a product that is designed to take advantage of the various components in milk that influence weight management.
The most recent study touting the benefits of dairy in weight loss/management was published in the August issue of Obesity Research. Researchers at the Mayo Clinic found that obese adults could include up to four servings of dairy foods per day in a reduced-calorie diet, combined with moderate exercise, and still lose a significant amount of weight and body fat.
This randomized clinical trial compared the weight loss results of 72 obese adults following three different reduced-calorie diets: a "high-dairy" diet, which included four servings of dairy foods (milk, yogurt or cheese) each day; a "high-dairy/high-fiber/low-glycemic index" diet, which included four servings of dairy each day; and a "moderate-dairy" or standard diet, which included two servings of dairy foods each day.
After nearly one year (48 weeks), the participants in all three groups experienced significant weight loss and body fat loss--providing further evidence that dieters don't need to cut dairy from their diet to lose weight successfully, according to the National Dairy Council, Rosemont, IL.
While all groups lost similar amounts of weight and body fat, the participants in the high-dairy groups who most closely followed the prescribed diet and exercise plan also consumed four daily servings of dairy and about 100 to 150 more calories each day. Even with the higher calorie intake, these subjects still lost the same amount of weight as the dieters who consumed two servings of dairy a day and fewer calories.
Chitosan was an ingredient marked by rapid growth several years ago, but it seems the ingredient has fallen on hard times due to conflicting scientific evidence regarding efficacy. The most recent review of research on chitosan, published in the Cochrane Library in August, pointed out numerous flaws in the quality of chitosan studies that have been conducted to date. Fourteen trials, including a total of 1131 participants, were included in the review. Researchers found some evidence that chitosan was more effective that placebo in the short-term treatment of overweight and obesity. However, they said many trials were of poor quality and results were variable. Furthermore, results obtained from high quality trials indicated that the effect of chitosan on body weight was minimal and unlikely to be of clinical significance.
According to Nutraingredients.com, Iceland-based Primex, suppliers of the LipoSan brand of chitosan, is about to "make a mark on the weight loss category and create new demand for its product." The company's sales and marketing director, Thore Ivar Thorsen, said, "We are completing a turnaround from a generic product and using new clinical trials to make this year into a strong growth year." The article on Nutraingredients.com also indicated that the firm is currently funding a study to demonstrate the mechanism by which the product works. In fact, the scientific commitment has helped the firm in its discussions with a multinational partner that is planning to add the ingredient to a daily consumed food.
Another ingredient that has stepped up its role as a fat absorber is NeOpuntia, which is currently being positioned as a "green alternative" to chitosan. "NeOpuntia's balance of soluble and insoluble plant fiber makes it very easy to digest," said Greg Edmunds, vice president of marketing for Charles Bowman & Company, Holland, MI, which distributes the product in the U.S. "When bound to fats, it develops into a very soft matrix that passes through the body with ease. Historical data on the use of opuntia indicate the product is very well tolerated, even at higher doses."
For NeOpuntia, the market for functional foods seems to be a ripe one. "Functional foods in the weight loss/management category are starting to grow, and we see very significant opportunities arising," said Mr. Edmunds. "One advantage to food products is the ability to increase the dose of actives provided to the consumer per serving. With NeOpuntia, it is quite easy to provide our recommended serving of 1.5 grams in a food product."
By Rebecca Wright
RELATED ARTICLE: This article in a nutshell:
* Market trends
* The thermogenesis factor
* Satiety and appetite suppression
* Body composition
* Fat-absorbing ingredients
RELATED ARTICLE: The Hoodia Hoopla
Hoodia was seen as a rising star within the weight loss category a few years ago but due to market chaos and consumer confusion, its future remains unclear.
Formerly a weight loss category superstar, hoodia gordonii had the potential to bring the market out of the doldrums after ephedra had been removed from the market. But its future at the moment remains uncertain. After the widely viewed news piece on the television show "60 Minutes" catapulted the ingredient into the spotlight, many were excited about the potential of the ingredient in curbing the incidence of overweight/obesity worldwide. But confusion surrounding product claims and quality is dragging down the current market, which might eclipse its possibility for a very bright future.
In a recent interview with Anthony Almada, founder and chief scientific officer, Imaginutrition, Laguna Niguel, CA, he said there is a massive gulf between the promise and potential of hoodia. "Companies may be selling real hoodia but they have no data," he said. "Companies are playing with no science they can point to besides animal studies. In fact, there was only one study published on hoodia last year that identified its mechanism of action." Mr. Almada added, "Companies selling hoodia right now are all peddling generic hoodia of likely different chemical compositions and they are pirating unpublished science they can't point to. If these companies were taken to task by FDA to substantiate their claims they would fail miserably."
Furthermore, Mr. Almada pointed out, none of the products available on the market have been shown in human clinical studies to work the way Phytopharm's P57 product does. (It was Phytopharm's P57 product that was profiled on "60 Minutes" and it is currently the only hoodia-based product to have undergone well-designed human clinical trials.) "P57 is essentially a cocktail that contains hundreds of chemicals. One group of chemicals, the steroidal glycosides described in the patent, happen to be present in the extract in a known amount," he said. "But even if there was an ability for a company's hoodia product to induce weight loss, how would one go about communicating that in 2005? Given the massive amount of consumer and industry communications regarding hoodia being focused 100% on appetite suppression and weight loss, the consumer has linked hoodia with appetite suppression or weight loss in their own mind." In other words, even if a company comes out with a hoodia product and doesn't make any claims for appetite suppression or weight loss, there is an "implied use" that the consumer is buying it for weight loss. Mr. Almada cautioned, "If your hoodia extract contains the molecule described in the Phytopharm patents, even though a company may not making any claims for it, you could still be taken to court and charged with patent infringement."
The history of hoodia goes back several years. Long before Phytopharm signed an agreement with Unilever, it had an agreement in place with Pfizer to develop weight loss products based on the P57 cocktail. "Pfizer and Phytopharm conducted two clinical trials before they dissolved their relationship. The reason Pfizer backed off, according to Pfizer, was that it was no longer interested in pursuing the weight loss category." Mr.Almada said. "This is certainly suspect, considering that weight loss is the most hotly pursued category in drug development. Does it make sense that if the product worked the way it did in the study that Pfizer would have abandoned it?"
Now P57's fate is up to Unilever, which finalized a licensing agreement with Phytopharm last December. Following the Unilever/Phytopharm deal, it was expected that several letters would be sent to companies infringing on the patents held by Phytopharm.
Trevor Gorin, media relations manager. Unilever, London, U.K., believes the concern over the hoodia market is well placed. "There is a high risk in the market due to the unscrupulous traders praying on the vulnerability of those trying to lose weight," he said, adding, "If your product is a genuine product then get it validated by a regulatory authority and market it accordingly. At the same time, be aware that if it infringes on our intellectual property, we will protect it."
"Unilever is reportedly testing some of the products currently on the market--TrimSpa being the category leader for finished products claiming to contain hoodia--in order to send out infringement letters," Mr. Almada said. "Unfortunately, this is going to lead to an implosion of consumer interest in hoodia, which is something Unilever does not want to see happen. By the time it goes to market with its products, it does not want to deal with consumers who say they took hoodia and it didn't work for them."
Also hampering the hoodia category is the fact that three new dietary ingredient (NDI) submissions have been rejected, according Mr.Almada, which raises further questions. "If NDI submissions for hoodia have been rejected and companies continue to market it, then it raises the perennial issue of FDA not being a good gatekeeper," he said. "Additionally, if companies are arguing that hoodia is in fact an old dietary ingredient, then companies must have human intake data to prove that out. The question is, where would one get that information?"
One hoodia supplier finding it difficult to operate in a market characterized by chaos is Stella Labs, Washington Township, NJ. "Everyone knows about Hoodia gordonii," said Deborah Vickery, marketing director. "The problem is, consumers are looking for products they can trust, which is increasingly hard to do in a chaotic marketplace."
To clear up the confusion, she said, "We sell pure Hoodia gordonii. It is a whole ground plant, not an extract. Some companies are using an extract that contains the active ingredient but we believe that it is not only the active ingredient but also other constituents within the plant that are responsible for its health benefits."
As for clinical substantiation, Ms. Vickery said her company currently has a bioassay trial underway with a doctor at the University of Texas. "He is conducting metabolic studies on obese rats. He will assess the changes in the rats taking hoodia versus those eating regular rat pellets," she said. "Having this scientific substantiation will offer us a means of differentiating ourselves from others in the market."
While the future for hoodia will be challenging, there are exciting developments to think about. Speculating about Unilever's development of food/beverage products containing P57, Mr. Almada offered, "It makes sense to put it in a meal replacement like Slim-Fast because if someone who is small takes capsules of the product daily and they drop as many calories as seen in studies, it would amount to a significant, possibly harmful loss of calories for someone who is small but overweight." Mr.Almada said this is probably why Richard Nixon, CEO, Phytopharm, said at a conference late last year that P57 would be more suitable for food/beverage products. "They needed a product format that would deliver not only the active payload (the P57 extract) but also nourishment," he explained. "What better company to take this on than Unilever with its Slim-Fast products."
So how will this all play out? "Companies will start getting some infringement letters from Unilever, and unfortunately, a year or two from now hoodia will cease to exist like it does today," Mr. Almada commented. "When it comes down to it, consumers just aren't experiencing the results they heard about on 60 Minutes."
Will the relationship between Unilever and Phytopharm culminate in products that do work? Mr.Almada believes only if one or two more larger, long-term studies are conducted. "They need to establish what P57 will do in a Slim-Fast matrix over an extended period of time," he said. "If these studies yield positive results in relation to safety and efficacy, then I expect a fireworks show in December 2006 when Unilever is expected to launch its new products containing P57. If you don't see that fireworks show you will know what happened. Either it didn't work or it wasn't safe."--R.W.
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|Date:||Nov 1, 2005|
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