Globally, the World Health Organization (WHO) predicts there will be 2.3 billion overweight adults by 2015; more than 700 million of them will be obese. Moreover, at least 20 million children under the age of 5 were overweight in 2005, according to the WHO. While a report last year found the U.S. childhood obesity epidemic leveled off this decade-after surging for about 20 years-nearly 20% of children and adolescents remain overweight. Additionally, the rate of "severe obesity" among U.S. children and teenagers more than tripled over the past three decades, according to a study published in the journal Academic Pediatrics, with nearly 4% of 2- to 19-year-olds in the U.S. classified as severely obese-defined as having a body mass index (BMI) in the 99th percentile for one's age and gender-as of 2004.
"Until people begin to eat a healthy diet and maintain a physically active lifestyle, obesity will continue to plague our society," said Paul Dijkstra, CEO, InterHealth Nutraceuticals, Benicia, CA. "If there is a silver lining, it is the fact that more attention is now being given to the connection between obesity and poor health and many in the food and beverage industry have started to take notice, developing well-formulated, healthy alternatives that fit into a healthy lifestyle regimen."
According to the CDC report, published in the journal Health Affairs, the proportion of all annual medical costs due to obesity increased from 6.5% in 1998 to about 9% in 2006. This total includes payment by Medicare, Medicaid and private insurers, as well as prescription drug spending. Overall, people who are obese spent $1429 (42%) more for medical care in 2006 than those of normal weight.
Alongside a clear association between obesity and related health issues like diabetes and cardiovascular disease, people who are "actively managing" their weight are also dealing with a host of other health conditions. According to the Natural Marketing Institute (NMI), Harleysville, PA, "2008 Health & Wellness Trends Survey," weight managers are also dealing with high cholesterol (39% vs. 30% in the general population); hypertension (35% vs. 26%); stress (30% vs. 22%); lack of energy (30% vs. 20%); and depression (23% vs. 16%).
Given the sheer size of so many consumers, manufacturers of dietary supplements for weight loss have pulled in a hefty profit over the years. U.S. consumers spent $1.67 billion on weight-loss supplements in pill form in 2007, down slightly from $1.69 billion the year before, according to Nutrition Business Journal (NBJ), Boulder, CO. Meanwhile, weight loss meal replacement supplements brought in nearly $2.15 billion in 2007, up from $2.07 billion in 2006.
Credibility in Question
In such a lucrative market, credibility has become a major concern in the weight loss/management segment. "During the past few years, several developments have significantly impacted how marketers view the 'weight loss' category," said Chris Lindstrom, product manager, Kemin Health, Des Moines, IA. "In 2004, FDA banned the sale of dietary supplements containing ephedra. In 2007, the FTC recovered $25 million as a settlement in its cases alleging deceptive advertising against marketers of Xenadrine EFX, CortiSlim, TrimSpa and One-A-Day WeightSmart. And in 2009, FDA warned consumers to immediately stop using Hydroxycut products."
With regard to the latter, after at least 23 adverse event reports suggested a potential link between Hydroxycut and liver damage, Iovate Health Sciences Inc., Oakville, Ontario, Canada, recalled 14 of its product lines in May. In 2008, the company sold more than 9 million units of the brand, which consists of products marketed for weight-loss as fat burners, as energy-enhancers, as low-carb diet aids and for water loss. Products contain herbal combinations, along with hydroxycitric acid (HCA) from the South Asian fruit Garcinia cambogia and green tea. Authorities continue to investigate which ingredient or combination may have caused the liver problems.
Looking at the bright side, Joseph O'Neill, executive vice president of sales and marketing for BENEO-Orafti Inc. in North America, Morris Plains, NJ, said "The Hydroxycut warning and recall is an example of the FDA exercising the necessary controls and authority to enforce supplement regulations, which are vital to safeguarding the consumer."
Prior to the Hydroxycut recall, FDA stepped up its oversight of weight loss supplements earlier this year, identifying more than 70 products found to contain undeclared active pharmaceutical ingredients. The agency has warned of possible criminal charges against companies marketing such "tainted" products.
"It's no surprise that government agencies are skeptical," said Bob Green, president, Nutratech, West Caldwell, NJ. "Many of their concerns are legitimate and justified. Exaggerated or false claims might generate sales in the short term, but if our industry is to build real credibility and staying power, ingredient suppliers, manufacturers and retailers must work together to break the myth that there could be a magic bullet out there for weight loss."
Sharrann Simmons, senior marketing manager, Cognis Nutrition & Health, La Grange, IL, said she anticipates greater enforcement of current regulations from federal agencies. "If someone makes an outrageous claim I think they're much more at risk today than they were five years ago. There's also more self-policing going on. The majority of players in dietary supplements recognize who the 'bad apples' are. But I think in general people realize there is someone looking over our shoulder."
To combat negative associations with the category, Scott Steil, president, Nutra Bridge, Shoreview, MN, said that ingredients must be backed by sound clinical data."Large investments in science by ingredient suppliers are paying off in today's weight loss arena," he said.
Gary Brenner, marketing director, Israel-based Solbar Plant Extracts, concurred, saying, "The market demands better and better science, and regulatory agencies are making stricter demands to demonstrate efficacy and safety. The challenge for the health ingredients industry is how to develop sustainable products with good science while facing increasing raw material costs on one side and under-cost pricing from China and elsewhere."
A Mature Market
In spite of increased scrutiny, this market segment has matured, translating to better, more efficacious products overall, according to Mitch Skop, director of new product development, Pharmachem Laboratories, Kearny, NJ. "Consumers seeking to modify their behavior and get some extra help through quality supplements now have a better chance than ever to accomplish their long-term goals."
Mr. Skop noted sizeable interest in carb controlling, starch blocking ingredients "because it gets to the core of why we gain weight and also addresses the growing issue of blood glucose control. We've seen Phase 2 Carb Controller continue to grow in acceptance and sales by positioning it as the first studied and most trusted carb control ingredient. Through our research efforts, it is the only weight control ingredient with two structure/function claims for starch reduction and weight control. Natural products that offer benefits of carb control, satiety, insulin-regulating, we think will be well received in the weight control category."
Alongside carb controlling ingredients, Hiren Doshi, business development director, OmniActive Health Technologies, Short Hills, NJ, said thermogenesis has become a trusted mechanism of action for weight loss. "The highest interest in the market continues to be thermogenesis and associated weight loss, because calorie expenditure is the number one interest, especially considering our lifestyles."
"Tools for obesity management include thermogenic agents such as caffeine, capsaicin and green tea," said Jayant Deshpande, PhD, chief technology officer, OmniActive. "These thermogenic agents have been proposed as strategies for weight loss and weight maintenance, since they may increase energy expenditure and have been proposed to counteract the decrease in metabolic rate that is present during weight loss."
The company's Capsimax red hot chili pepper extract increases energy expenditure to help burn more calories while decreasing appetite, Mr. Doshi said.
"Capsaicinoids, the active ingredient of Capsimax, are associated with a multi-pronged effect for promoting weight loss, including marked decrease in appetite and food intake, increased energy expenditure, reduction in body mass, reduction in fat percentage and reduction in waist circumference," said Abhijit Bhattacharya, COO with OmniActive. "Capsimax capsicum extract beadlets in a proprietary formulation (available as Capsimax Plus Blend) have been tested in a double-blind, placebo-controlled clinical study, which showed the blend helped burn 278 more calories combined with exercise compared to placebo."
Nutratech's Advantra Z bitter orange extract has also demonstrated thermogenic properties, according to the company's Mr. Green, and is backed by more than 15 studies supporting its safety and efficacy.
7-Keto from Humanetics is another non-stimulant, thermogenic fat burner that allows the body to shed fat more efficiently, according to Mr. Steil, of Nutra Bridge. "Multiple clinical studies have shown that 7-Keto produces three times greater weight loss than placebo (diet and exercise). This translated to an average additional five pounds of weight loss above that produced by diet and exercise alone. Additionally, 80% of the weight loss was pure body fat. 7-Keto also increased metabolism by more than 5% compared to placebo, which was a restricted calorie diet."
Body composition and promoting lean body mass has become another noteworthy product position. A recent study published in the American Journal of Clinical Nutrition found that Tonalin CLA (conjugated linoleic acid) from Cognis reduced body fat mass and preserved lean muscle mass in post-menopausal women with type 2 diabetes. Research indicates that daily supplementation of 6.4 grams of Tonalin CLA significantly lowered body weight, BMI and total adipose mass without affecting lean muscle mass in postmenopausal women with type 2 diabetes who were not on a weight-loss diet and activity plan.
Researchers gave the 55 obese and menopausal participants with type 2 diabetes (average 10 years of diabetes history) safflower oil or Tonalin CLA for 16 weeks in this randomized, placebo-controlled crossover study. CLA supplementation reduced body weight (1-1.6 kg), BMI and total adipose mass without altering lean mass.
Among a host of other ingredients and product positions, Kemin's Slendesta, standardized to proteinase inhibitor II (PI2), has been shown to promote the body's own release of CCK, a natural peptide and known satiety factor.
"It works naturally with the body to provide satiety and manage hunger, and has been clinically-proven to support reductions in weight, waist and hip measurements," said the company's Mr. Lindstrom. "Clinical studies with more than 500 participants have collectively demonstrated PI2's benefits to promote satiety and healthy weight loss."
Generally, Lakshmi Prakash, PhD, vice president of innovation and business development, Sabinsa Corporation, Piscataway, NJ, said companies are looking "to comprehensively address weight management support through fat breakdown, lean body mass build up and satiety support. Since metabolic syndrome is often linked with obesity, phytonutrients such as fiber that potentially reduce risk factors for cardiovascular disease and support the maintenance of healthy blood sugar levels are also included in weight management support measures."
She noted that Sabinsa's LeanGard contains three phytonutrient ingredients: Forslean, a natural extract of Coleus forskohlii roots that supports lean body mass and healthy body composition, as well as GarCitrin natural extracts from the fruit rind of Garcinia cambogia (Malabar tamarind) to support satiety, healthy body composition and carbohydrate metabolism. LeanGard also contains Bioperine, an extract from black pepper fruits that enhances the bioavailability of the other two nutrients.
Given the Hydroxycut recall, Sabinsa recently issued a position paper analyzing the safety of Garcinia cambogia, its active component hydroxycitric acid (HCA) and its salts. While the company's ingredients do not appear in Hydroxycut, Sabinsa developed the paper to dispel reservations about its Citrin range of extracts.
"There is no direct epidemiological or clinical evidence linking Garcinia cambogia fruit rind extract with hepatotoxicity," said Dr. Prakash. "Further, an exhaustive safety review by an independent panel of experts established GRAS [Generally Recognized as Safe] status for Citrin K, the potassium salt of hydroxycitric acid, in 2007."
Super CitriMax, from InterHealth, also contains HCA, which is bound to essential minerals calcium and potassium. Peer-reviewed clinical research demonstrates that Super CitriMax increases weight loss partly because of its ability to increase satiety and reduce calorie intake. A randomized, placebo-controlled study showed that Super CitriMax taken in beverages for two weeks significantly decreased daily energy intake by 25% and calories from snacking by 40% compared to placebo, leading to reduced body weight.
Also, the company's ChromeMate, a bioavailable form of chromium, safely and effectively supports normal insulin function and healthy body weight. Normal insulin function supports balanced blood sugar levels, which in turn assist appetite control and reduce food cravings. Randomized, double-blind, placebo-controlled research shows that ChromeMate increases fat loss and lean body mass, according to the company.
A 'Functional' Future
Whereas dietary supplements typically target weight loss, functional foods and beverages have evolved as a viable means of maintaining a healthy weight. "Consumers acknowledge the fact that in order to achieve a healthy body weight, adopting a healthier lifestyle is critical," said InterHealth's Mr. Dijkstra. "That's where many functional foods and beverage products come in. Food and beverages are an excellent way to deliver weight management benefits since they naturally fit within consumers' normal lifestyles."
Jeff Wuagneux, president and CEO, RFI Ingredients, Blauvelt, NY, agreed, saying that while the market for weight loss products has been dominated by dietary supplements in the past, functional foods are gaining momentum. "With the introduction of many new products like Chocamine [RFI's patented cocoa extract, which promotes sustained energy and satiety], modified starches (that enhance the feeling of satiation) and new energy products (teas, guarana and coffee especially) that have traditional food and beverage applications, the movement toward functional foods and beverages is hard to contain. This trend is amplified with a movement toward softer, more lifestyle oriented claims and promises."
Recognizing consumer demand for products that make them feel fuller longer, major food manufacturers in the U.S. have been appealing to health conscious shoppers by adding fiber to packaged goods. According to Datamonitor's Product Launch Analytics, the percentage of new food products in the U.S. claiming to be "high in fiber" hit 6% in 2008, up from 5% in 2006. Multinational companies jumping on this trend include PepsiCo, Kraft, Campbell Soup, Kellogg, General Mills and Dannon.
Consumers recognize the value of fiber as it relates to weight loss/management, according to NMI statistics, with 42% of weight managers making this association compared to 32% of the general population. Alongside fiber, consumers associate protein as a means of managing their hunger, with 28% of weight managers and 24% of the general population making this connection.
Moreover, two-thirds of consumers (67%) say that satiety is an important factor in their food and beverage choices, according to a survey from NPD Group conducted on behalf of Dairy Management Inc. (DMI), Rosemont, IL. Feeling full after breakfast is especially important, 42% of responders stated. In this survey, 54% also agreed that protein-based foods are the best at satisfying hunger.
"We know that a higher-protein diet can be an excellent way to feel fuller longer, which may help reduce the desire to reach for unhealthy snacks between meals," said Matt Pikosky, PhD, registered dietitian and director of research transfer at the National Dairy Council. "Whey protein added to foods and beverages can help increase daily protein intake to achieve a higher protein diet, which can help promote a feeling of fullness."
Josh Hosking, business development manager, Fonterra USA, Rosemont, IL, agreed that protein has attractive qualities in the weight management arena. "Established research over many years has shown that protein in general delivers superior satiety compared to other macronutrients such as carbohydrates, and we're seeing increased consumer awareness that protein-and more specifically milk or whey protein-can effectively control appetite and boost nutrition." Fonterra recently launched Whole satiety water, which contains the branded whey protein isolate ClearProtein, offering 5 grams of protein and 1.5 grams of fiber.
At a fundamental level, the main principle behind weight management is to balance caloric intake and expenditure, according to Catherine Lecareux, global communication manager, IRANEX, which includes Bio Serae Laboratoires SA and Colloïdes Naturels International. "Various solutions could be interesting for that purpose, including glycemic index for blood sugar maintenance, as well as satiety solutions."
Specifically, she said lipophilic fiber helps reduce the absorption of fat. Bio Serae's NeOpuntia (developed from the cactus Opuntia ficus indica) interacts in the stomach with ingested fats to impede their digestion and eliminate them naturally. "This ingredient provides sensible help for natural weight management," she said. In addition, Bio Serae's ID-alG brown algae extract limits efficiency of digestive enzymes (amylase and lipase) so the body doesn't fully absorb fat and sugar. It also activates thermogenesis, she added.
Managing blood glucose levels is another component of the weight management category. Alongside blocking alpha-amylase and alpha-glucosidase enzymes at a high potency level, InSea2, a wild brown seaweed from InnoVactiv, reduces peak glucose levels by 90% and peak insulin levels by 40%, 30 minutes after consuming a high starch meal, according to Nutra Bridge's Mr. Steil. The product has also been shown in studies to help convert meals from a high to low glycemic index, he noted.
Prebiotics also present a viable option for managing blood sugar levels. "Inulin and oligofructose are all-natural prebiotics used not only for fiber enrichment but also for their low caloric properties," said BENEO-Orafti's Mr. O'Neill. "They are low glycemic and do not trigger an insulin or glucagon response-important measures in blood sugar control. They are widely used to replace sugar and fat and to lower the energy density of foods."
"The low insulinemic effect of Palatinose helps to promote metabolic fat oxidation in consumers engaged in some form of physical activity and who follow a healthy diet," said Stephan Hausmanns, head of new business development & management, BENEO-Palatinit, Mannheim, Germany. "This means Palatinose helps to promote a higher expenditure of energy derived from fat and fatty acids compared to other sugars."
Sarah Staley, vice president of business development, Friesland Foods Domo USA Inc., Chicago, IL, said there is already a healthy halo surrounding dairy and key components such as protein and milk calcium, which are linked to weight management applications-mainly satiety-including influencing hormonal response, promoting thermogenesis and prolonging gastric emptying. "One of the newer components we have launched that can be used for weight management products is Vivinal GOS dairy-derived prebiotic galacto-oligosaccharides," Ms. Staley said.
She noted two hypotheses on prebiotics' mechanism of action for promoting satiety: "They cause a full sensation due to bulking in the intestinal tract; and they are fermented in the colon, resulting in the production of short chain fatty acids, which leads to a higher production of satiety hormones like PYY and Ghrelin."
Overall, RFI's Mr. Wuagneux said that since "hard" claims for weight loss are difficult to substantiate and the regulatory environment is tightening, "products that support healthier lifestyles and have the look, feel and flavor of foods should continue to grow."
Moreover, given the complex dynamics of the weight loss/management category, Cognis' Ms. Simmons said it is important to note that the economic recession will continue to impact consumer purchasing habits. "I think there's still a very strong demand to provide value," she said. "Every product launched today is going to have to have a certain value element to be successful."