Rebecca Madley-Wright09.01.04
When statistics surfaced this year putting obesity as the second leading cause of preventable death behind smoking, everyone took notice. That situation may soon change, however, as smoking is on the decline and overweight and obesity threaten to take the lead. But the tobacco message was simple: stop smoking. This new epidemic, however, has no single cause and therefore no simple solution; indeed many tools will be needed to fix this problem.
According to the Centers for Disease Control & Prevention (CDC), Washington, D.C., obesity is responsible for over 400,000 adult deaths in the U.S. each year. In addition, as the prevalence of overweight and obesity has increased in the U.S., so have direct and indirect related healthcare costs. According to Dr. Lester Crawford, Acting FDA Commissioner, "The current total cost of overweight and obesity is $117 billion per year, which is greater than 5% of the nation's total annual healthcare expenditures."
Long-term solutions have yet to surface from any industry or government around the world, attesting to the complexity of this situation. This "holy grail" has even escaped the grips of pharmaceutical R&D. Although "big pharma" has addressed successfully the conditions that arise from obesity-type 2 diabetes, cardiovascular disease, osteoarthritis, certain cancers-it has, according to Dr. Crawford, repeatedly failed to demonstrate the safety and efficacy of a remedy that addresses the underlying condition.
Greg Stephens, vice president, Sales & Marketing, Nurture, Inc., Devon, PA, agreed. "We're all aware of the R&D spend at pharmaceutical companies, all looking for a Prozac-like success. Drugs like Meridia and Zenical have not lived up to their expectations at all. Actually, if you look at 'Rx' sales for weight loss, the market is dominated by generic amphetamines," he said, adding, "Drugs are just one weapon in the battle against obesity."
Several entities have put forth ideas that may help in battling the bulge that Americans grapple with daily. The most visible has been the U.S. government, which has established several initiatives that aim to curb this epidemic by way of healthier food programs, exercise plans and, most recently, scrutinizing the dietary guidelines to see how they can be adjusted to create a healthier, leaner America. To the U.S. government, each step, however small, will make a big difference in the long run.
Every five years the dietary guidelines come up for reassessment by the United States Department of Agriculture (USDA), Washington, D.C., and the Department of Health and Human Services (HHS), Washington, D.C., which appoint a panel of experts to review current and emerging science, as well as comments from a range of stakeholders. In mid-August the advisory panel revising the guidelines held its final meeting. This meeting resulted in lumping sugar together with refined carbohydrates. In addition, it recommended that some refined grains be replaced with whole grains. The panel stood firm on its belief that "Calories Count" and that that measure should continue to be used by consumers in order to maintain weight.
This year the debate surrounding the guidelines was more heated than ever before, particularly because overweight and obesity has become an issue for an alarming 64% of Americans, 15% of which are children and adolescents. As several industries make a move to help rewrite the dietary guidelines, which form the basis for school lunch programs and other federal nutrition programs, in addition to the Food Guide Pyramid, the outcome may have far reaching implications on "nutrition thought" going forward. As we went to press, a public meeting was scheduled to determine the possibility of reshaping the Food Guide Pyramid, which in the end may not resemble a pyramid at all.
Scott Van Winkle, managing director, Adams Harkness, a Boston, MA-based investment bank, said revising the dietary guidelines and the Food Guide Pyramid is long overdue. "I do think the food pyramid is a little outdated and most people agree. What I see being talked about consistently is the Zone Diet as being one of the best diets to recommend amongst healthcare practitioners," he said. "There needs to be a push toward balance and for that to happen there needs to be a continued move away from carbohydrates, at least in the percentage of consumption, in favor of proteins and some of the better-for-you fats."
Jeff Nedelman, president, Strategic Communications, a food industry consultancy based in Vienna, VA, says for the most part, large food companies have lost their most important battles with the dietary guidelines. "With the exception of dairy, Walter Willet (of the Harvard School of Public Health, Boston, MA) got much of what he wanted and that was exactly what the food companies didn't want. Now the dietary guidelines are looking at reducing simple sugars, with an emphasis on fibers and good fats," he said.
What will not be mentioned in the dietary guidelines, however, is the role of glycemic index. Mr. Nedelman said he was surprised about this development. "I am convinced it had nothing to do with the science and everything to do with nutrition establishments not being able to effectively communicate the mechanics of glycemic index to consumers," he commented.
According to the Harvard School of Public Health, the information embodied in the Food Guide Pyramid does not point the way to healthy eating. Why not? Well, it says the blueprint for the Pyramid is based on shaky scientific evidence and hasn't appreciably changed over the years to reflect major advances in the understanding of the connection between diet and health.
As an alternative to the USDA's "flawed" pyramid, faculty members at the Harvard School of Public Health created a "Healthy Eating Pyramid," which resembles the original pyramid in shape only. The Healthy Eating Pyramid takes into consideration, and puts into perspective, the wealth of research conducted during the last 10 years that has reshaped the definition of healthy eating.
Taking the heat off the current Food Guide Pyramid and its connection with the overweight/obesity epidemic was an article published in the July issue of the Journal of the American Dietetic Association. The article said since its release in 1992, the Food Guide Pyramid has become one of the most recognized nutrition education tools in U.S. history. Because of this, the article said the Pyramid has been subject to criticism, particularly in several recent media reports that implicate it as the culprit in America's current obesity epidemic. The authors pointed out, "What these reports often overlook, however, is that the diets of many Americans do not adhere to the dietary guidelines illustrated by the Pyramid, refuting the notion that the Pyramid is the cause of the nation's obesity problem. Data indicate that the more likely causes of escalating obesity rates are increased per capita caloric consumption and larger portion sizes, along with a lack of adequate physical activity." Furthermore, the authors said abandoning the Food Guide Pyramid in favor of an alternate pyramid is not necessarily the answer to the nation's current nutrition problems, particularly in the absence of data to show that most Americans can and will actually eat according to any such alternate pyramid.
Pyramids and dietary guidelines aside, there have been several other initiatives in motion that address the overweight/obesity issue on multiple fronts. In a hearing held during the early days of June this year, Dr. Crawford, who is also the chair of FDA's Obesity Working Group, outlined these initiatives and programs, which revolve around counting calories and incorporating exercise. "Our report concludes there is no substitute for the simple formula that 'calories in must equal calories out' in order to control weight. We're going back to basics, designing a comprehensive effort to attack obesity through an aggressive, science-based, consumer-friendly program with the simple message that 'Calories Count.'"
Less is more to HHS Secretary Tommy Thompson as well. "Taking small steps to eat a more balanced diet and to stay physically active can go a long way to reversing the epidemic of obesity," he said. "Each small step does make a difference, whether it's taking the stairs instead of an elevator or snacking on fruits and vegetables. The more small steps we can take, the further down the road we will be toward better health for ourselves and our families."
In agreement with the "small steps" mentality was Van Hubbard, director, National Institutes of Health (NIH) Division of Nutrition Research Coordination, Bethesda, MD, who said, "We need people to realize that small steps can make major improvements over time. If we can curtail this problem then we as a nation can start down the road of success."
For the major food companies, the goal for now has been to remove components of foods deemed unhealthy (e.g., trans fats, sugars, carbs), rather than add functional ingredients to product formulations. According to Laurie Demeritt, president, The Hartman Group, Bellevue, WA, this may change in the future, but for now food companies are just trying to educate consumers on portion size and servings.
While governments, organizations, associations, companies and academia have all recognized that there is an epidemic of overweight and obesity permeating all populations of the world, consumers have yet to grasp that fact. According to research from the Hartman Group, it is not true that consumers lack basic nutrition information, or they somehow cannot seem to grasp the relationship between calories taken in and calories burned. The findings in its 2004 report, "Obesity in America: Understanding Weight Management from a Consumer Perspective," indicate that most consumers consider their weight to be fairly average despite the fact that 66% of study respondents were considered overweight or obese, according to body mass index (BMI) measurements. In fact, the Hartman Group found that most overweight people believe they are physically healthy.
The most interesting finding, however, related to how study respondents perceived the weight status of others. "The CDC's verdict that nearly two-thirds of the population is overweight or worse relies on objective measurements of height and weight, but most people believe that such statistics have very little, if anything, to do with themselves or their immediate social networks," the report stated. Instead, study respondents said the two-thirds statistic tends to relate to strangers, such as 'people I see at the grocery store.' "In sharp contrast to the way individuals see themselves, they generally hold others to a different, often higher, standard," the report said. "This propensity to use a double standard, rather than an inability to see ourselves accurately, is what makes our self-assessments generally less critical than our assessments of others." As such, the Hartman Group believes that policies aimed at educating the overweight and near overweight about how to "overcome their problem" are doomed to failure as long as they persistently ignore the fact that people have yet to agree they have a problem.
Similar findings were revealed through FDA's research as well. When Commissioner Crawford addressed the World Obesity Congress & Expo in July, he noted that the misperception of weight status continues to be an issue. "A large part of our population is not even aware that excessive weight gain is a health problem," he said, adding. "Our research indicates that both adults and teenagers frequently misperceive their weight status, and that this misperception cuts across gender, socioeconomic status, age and ethnicity. This is particularly true about individuals who regard themselves as overweight rather than obese. Recent focus group studies indicate that these men and women generally brush off the extra pounds as of minor significance, and therefore have little incentive to get rid of them."
A recent article in the Washington Post discussed the possibility of fat being contagious-that's right, fat caused by a virus. Whether or not it is caused by a virus is another article in itself, however, the "talk" of overweight and obesity certainly seems to be contagious. According to new research commissioned by the International Food Information Council (IFIC), Washington, D.C., the issue of obesity and weight management shot to the top of the charts in food reporting in 2003, accounting for nearly one of every six stories monitored in IFIC's survey. Furthermore, IFIC said consumers spend an estimated $37 billion a year on all types of weight loss/management products and programs, and it is estimated this figure will continue to grow at a rate of 6-7% per year.
Given the enormity of the overweight/obesity issue, agencies like FDA and the Federal Trade Commission (FTC) want to make sure that companies marketing products in this arena are not overstepping their bounds in labeling or advertising. Over the last year, both FDA and FTC have ramped up enforcement in this area, which is a welcome change according to some experts who feel increased enforcement is long overdue.
FTC has jurisdiction over advertising of weight loss products and services. Most recently the agency issued reports on weight loss advertising and held a workshop for the media in order to help them determine how to spot deceptive advertising. Commenting on these initiatives was Richard Cleland, assistant director for the Division of Advertising Practices at FTC, Washington, D.C. "Over the years a common response from media has been that 'we are not scientists and we can't tell which claims are false and which are not,'" he said. "So we invited members of the scientific community, the dietary supplement industry, weight loss products industry and the media to our workshop." As a result, Mr. Cleland said, seven common fraudulent weight loss claims ("Red Flag Claims") were identified and then published in a reference guide (Red Flag: Bogus Weight Loss Claims), which was issued to the media. These "Red Flag" claims included:
1. Lose two pounds or more per week (for a month or more) without dieting or exercise. Example: "Lose up to two pounds daily without diet or exercise."
2. Eat what you want! The more you eat, the more you lose and we'll show you how. Example: "Eat all the foods you love, and still lose weight (the pill does all the work)."
3. Weight loss will be permanent (even when the user stops using the product). Example: "Take it off! And keep it off."
4. Block the absorption of fat or calories, and lose substantial weight. Example: "This product blocks fat before your body absorbs it; the pounds will melt away effortlessly."
5. Consumers can safely lose more than three pounds per week for a period of more than four weeks. Example: "Lose 30-40-50 pounds. Yes! You can lose three pounds per week, naturally and without side effects."
6. The product causes substantial weight loss for all users. Example: "Lose excess body fat. You cannot fail, because no will power is required."
7. Diet patches, creams, wraps, earrings and other products worn on the body or rubbed into the skin cause substantial weight loss. Example: "Lose two to four pounds daily with the Neptune Diet Patch."
FTC has followed up this initiative by promoting the guide to the media as a way of identifying claims they should not be running. "As of right now," said. Mr. Cleland, "I believe that the response has been very positive, especially in the magazine media. We have seen a decrease in the types of claims being made-the outrageous, over-the-top claims-and we are in the process of conducting a survey of other types of media to determine what effect this campaign has had, which should be out this month."
With regard to dietary supplements in particular, Mr. Cleland said, "We are in the process of working with several different industry groups to develop specific guidelines for weight loss advertising, which can then be used as part of self-regulatory programs. However, this is a work in progress and we are not ready to release anything about it." He did reveal that FTC is presently working with industry groups such as UNPA (Utah Natural Products Alliance), AHPA (American Herbal Products Association) and CRN (the Council for Responsible Nutrition) on this initiative.
To organizations like the American Obesity Association (AOA), Washington, D.C., classifying obesity as a disease is a "no brainer." The organization says the current perception of obesity is one of failure of the individual, so its mission is to change that perception to one that recognizes obesity as a complex disease involving more than personal behavior. At the same time re-classifying obesity will help "de-stigmatize" the condition, health insurance allowances will also greatly help those afflicted obtain the necessary treatment.
Opponents, however, contend that obesity is merely a risk factor, which leads to an illness but is not an ailment in itself like cancer or heart disease. Nevertheless, the move to classify obesity as a disease appears to be accelerating, according to an article published in the Washington Post last November. In fact, the article stated, "The Internal Revenue Service ruled last year that, for tax purposes, obesity is a disease, allowing Americans for the first time to claim a deduction for some health expenses related to obesity, just as they can for those related to heart disease, cancer, diabetes and other illnesses."
The fact that not all insurance providers allow coverage for obesity treatment is quite perplexing. Many experts question why some of these organizations will cover the more expensive costs of something drastic like bariatric surgery (reducing the size of the stomach) instead of providing coverage for weight loss programs, such as Weight Watchers.
For Medicaid and Medicare, however, the time has come to make the call on whether or not to consider obesity a disease. In mid-July, it was announced by HHS' Centers for Medicare & Medicaid Services (CMS) that certain allowances would be made for those who are obese. The new policy specifically removes language in the Medicare Coverage Issues Manual stating that obesity is not an illness. This step allows members of the public to request that Medicare review medical evidence to determine whether specific treatments related to obesity would be covered by Medicare. This new development means that those who qualify for these services would be covered for approved obesity treatments instead of being diagnosed first with a condition like type 2 diabetes or cardiovascular disease in order to receive treatment.
Recognizing obesity as a disease, said Nurture's Mr. Stephens, has enormous cost implications for our healthcare system. But, he said, when/if coverage become available, it will be for those products/programs that have documented success; not weight loss success but weight maintenance success-loosing the weight and keeping it off.
Shil Kothari, product development manager, InterHealth Nutraceuticals, Benicia, CA, said people will continue to debate the "obesity as a disease" issue for a while. "I think obesity is a root disease that causes many other diseases, and if HMOs start to treat obesity first then they will be treating a lot less of type II diabetes and cardiovascular disease down the road," he commented.
Taking an optimistic look at the future, Suzanne McNeary, president, NutraGenesis, Brattleboro, VT, said she could envision government reimbursement for diet programs, functional foods and supplements as long as they provide clear medical and health benefits.
It cannot be said enough that there is no magic bullet or one-size-fits-all approach to weight loss or weight management. (Unfortunately, while consumers say they understand that fact, their actions frequently prove otherwise.) These days companies are positioning their products to serve as one of the many tools needed by consumers to lose or manage weight. This is where dietary supplements may play a new, more respectable role in this market moving forward.
Nurture's Mr. Stephens said each person is an individual and will require a variety of tools to accomplish the job of loosing weight and then keeping it off. "What is needed is a multidisciplinary approach to weight loss and weight management," he said. "I think companies marketing supplements will realize this and partner with other companies providing the behavioral component (anything from mental health facility staffs to Weight Watchers) and exercise (health clubs, rehab centers or personal trainers)."
Jocelyn Mathern, technical specialist, Acatris, Minneapolis, MN, agreed. "I think that there will always be people looking for the quick fix, but I think more companies are looking to develop products that don't serve as a single solution to weight loss, but rather as part of the solution," she offered. "Weight loss/management really has to incorporate lifestyle changes."
With the market becoming more competitive for weight loss/management products, Karen Todd, senior marketing manager, New Ingredients & Business Development, DSM Nutritional Products, Inc., Parsippany, NJ, says companies are looking hard at clinical studies, which is encouraging. "They are increasingly concerned about safety and they want products that work. Interestingly, a lot of the companies we have worked with recently are very interested in putting the 'efficacious dose' in their products and for a food company that is a huge step," she said. "This is a pretty big turn around from companies just sprinkling the ingredient in the product in order to get a label claim."
Scott Steil, executive director of marketing and sales, Humanetics Corporation, Minneapolis, MN, says that companies are looking at the science because regulatory bodies require it. "I think with FTC and FDA demanding more science that the burden for testing has really shifted to the shoulders of suppliers," he said. "This is an entry barrier now for products that want to get to market and stay on the market."
As stated previously, there are many options out there on both the food and supplement front that can serve as adjuncts to other weight loss/management products and services. Some products are geared toward increasing metabolism, some target satiety (the feeling fuller longer approach), some target calorie reduction and glycemic index and others are staking their claim in the low-carb segment.
Low-Carb Update. Many experts feel the low-carb trend has reached its peak, or at the very least is in a state of transition. Mr. Van Winkle of Adams Harkness offered, "I suspect we might have seen the peak already for low-carb products. However, they continue to evolve. What the low-carb trend did was trigger a change in nutrition thought, so I think you are going to see that spawn nutritional changes in consumers' diets in the future."
In time for the downturn of the trend will be the issuing of regulations from FDA on what exactly is meant by "low-carb" and what can be claimed on product labels. FDA Commissioner Crawford said in early August that guidelines will be issued later this year, which will shed some light on "low-carb", "reduced carb" and "carbohydrate-free" claims.
Mr. Van Winkle also sees other opportunities. "Due to the trends in the market, the vitamin category has really gotten a boost over the last 52 weeks, specifically with the growth of low-carb diets," he said. "As doctors start to positively receive the low-carb diets they will certainly be pushing for supplementation."
Cashing in on the low-carb craze from a supplement perspective most recently are Wyeth Consumer Healthcare, Madison, NJ, and Bayer Consumer Care, Morristown, NJ. These companies have launched supplements-Centrum Carb Assist (Wyeth) and One-A-Day CarbSmart (Bayer)-which claim to make up for nutritional deficiencies while on a low-carb regimen. According to a recent New York Times article, IRI data indicate that since its launch in April, CarbSmart has raked in $2.8 million in sales, while Carb Assist, which was launched a month later, has brought in $1.7 million.
Dairy. There is a growing body of evidence pointing to the inherent nutrients in dairy as somehow playing a role in weight loss or weight management. In fact, according to a recent article in Obesity Research, obese people who consumed three to four servings of milk, yogurt or cheese while on a balanced, reduced calorie diet, lost significantly more weight and fat than those who consumed equivalent amounts of calcium through supplements, or who consumed one or fewer servings of milk, yogurt or cheese per day. Several other articles published after 2000 also point to the positive effects of dietary calcium or dairy as being responsible for a favorable change in weight in subjects.
This research is precisely what prompted The International Dairy Foods Association (IDFA), Milk Processor Education Program (MilkPEP) and Dairy Management Inc. (DMI) to roll out their "Health Weight with Dairy" campaign last year. This campaign included national advertising and local marketing efforts to tout scientific research suggesting a link between dairy consumption and reduced body weight. According to IDFA, scientists are still studying why dairy is so important, but it says preliminary research suggests that calcium plays a role in the body's natural system for burning fat.
Serena Ball, RD, director of Nutrition Affairs and Communication, National Dairy Council, Rosemont, IL, said the "Healthy Weight with Dairy Campaign" is kicking off its official launch this month. "This is the big launch where we are going to be working more with retailers and WebMD," she said. "We were very conservative with our first wave of information, which started trickling out last October, because we really wanted to make sure we had sound science to back everything up. Once the science was there we felt we could really move forward with this and get the information out there."
Shedding some light on the milk and weight loss connection was Loren Ward, Ph.D., associate director of research at Glanbia USA, Monroe, WI. "Recent research shows mineral, protein and peptide components from milk are important in weight management and weight loss. Milk minerals help preserve bone density during weight loss and shift adipocyte metabolism toward the breakdown of fat (lipolysis) resulting in smaller adipocyte cells," she said. "Calcium is the key mineral in regulating adipocyte tissue, but other minerals in milk are important for maintaining bone health during weight loss." Dr. Ward said 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.
Hydroxycitric Acid (HCA). InterHealth's Mr. Kothari said its HCA product (Super CitriMax) inhibits the enzyme responsible for the conversion of carbohydrates to fat, which is the original premise of the product. However, in light of the complexity surrounding overweight and obesity, he said products should be able to tackle a variety of mechanisms. That said, Mr. Kothari revealed that additional work is being done to show that Super CitriMax works on a genetic level by modulating genes in the way they express certain proteins related to obesity. He also said there is evidence pointing to the increase of serotonin upon consumption of Super CitriMax. Lastly, he said, it works by way of fatty acid oxidation, which actually helps to break down fat that already exists in the body.
The Starch Blockers. The starch blockers have gained recognition in part due to the low-carb trend and also because there is a growing body of evidence attesting to their safety and efficacy. Mitch Skop, director of new product development at Pharmachem Laboratories, Kearny NJ, highlighted Pharmachem's Phase 2 Starch Neutralizer due to the depth of scientific research conducted on it, as well as its clinical efficacy at reducing carbohydrate calories. "Everyone knows the low-carb phenomenon is about to peak, and Phase 2 is one of the only ingredients that companies can formulate with to reduce the starch calories/glycemic index of starchy foods," he said. Most recently, Phase 2 found its way to the functional food market by way of French Meadow Bakery, Minneapolis, MN, which has unveiled a line of yeast-free, organic, reduced-carb baked goods containing the ingredient. The line will be marketed under the Carb Watcher label and will include sourdough and multi-grain dinner rolls, bread and tortilla shells.
Satiety. The issue of satiety has been raised as a way to get consumers to stop eating so much, so often. Active on this front is Nurture with its OatVantage product, which can be incorporated into supplements and foods. Going in this direction was important for Nurture, according to Greg Stephens. "A big and unchanging issue is that consumers are largely unwilling to change their eating habits. Healthcare professionals agree that for people to loose weight AND keep it off, positives changes to the diet must be made," he said. "Yet consumers are largely unwilling to give up unhealthy, fatty, salty or calorie-laden foods. The challenge for ingredient and food manufacturers is to provide substitutes that taste good and do not make the consumer feel deprived (hence a role for satiety ingredients)." According to Nurture, "The increased viscosity of the alimentary bolus caused by solubilized beta-glucan can delay nutrient absorption and result in reduced hunger and/or increased satiety. It is well known that oats, particularly the soluble fiber in oats (beta-glucan), readily induce very high levels of satiety. In a study, which quantified satiety, oats were found to have the third highest satiety rating among all foods tested."
Coming from the "good carb" angle was Hartley Pond technical sales manager, VDF Futureceuticals, Chicago, IL, who says his company's product, Nutrim, is positioned as a "good carb" that can help control weight from a satiety and glucose perspective. "Our Nutrim oat beta-glucan product, which was developed by the USDA comes with an FDA claim for reducing cholesterol," he said. "In addition, a lot of great tertiary work has been done on controlling glucose and insulin response." The company is also moving forward with some work to show Nutrim's benefits in controlling appetite. "Right now we know that the soluble fiber from oats helps slow gastric emptying, therefore slowing digestion," he explained. "It stands to reason, although this needs to be proven per ingredient, that if you slow down the digestion process you are actually making a person feel more satiated."
Discussing resistant starch in the context of satiety was Janine Higgins, PhD, who is a researcher at the University of Colorado Health Sciences Center, Center for Human Nutrition, Denver, CO. "More attention is being paid to resistant starch because it does act like fiber, so it could have the same satiety effect as traditional forms of fiber," she said. "Also, resistant starch can be incorporated into foods without giving the taste, texture and appearance of traditional fiber." Dr. Higgins said it is more likely that children and adults who prefer non-grainy breads in favor of more processed foods could ingest resistant starch very easily. Because resistant starch is not fully absorbed in the upper digestive tract, it passes right to the large bowel, so not all of the calories are absorbed. The theory, according to Dr. Higgins, is that by eating some of the same foods that have had resistant starch added will reduce some calorie intake.
Rather than "low carb," Acatris' Ms. Mathern said its fenugreek product is being positioned as "slow carb." "We have seen a lot of interest in FenuLife looking specifically at weight loss. When you eat FenuLife with a meal it slows down the absorption of sugar in the intestines, so you get less of a rise in blood sugar," she said. "Research indicates that low glycemic index foods can make you feel fuller longer." Recently, Ms. Mathern said, Acatris has commenced a study that looks at the role FenuLife plays in satiety. "There is a lot of documentation out there
According to the Centers for Disease Control & Prevention (CDC), Washington, D.C., obesity is responsible for over 400,000 adult deaths in the U.S. each year. In addition, as the prevalence of overweight and obesity has increased in the U.S., so have direct and indirect related healthcare costs. According to Dr. Lester Crawford, Acting FDA Commissioner, "The current total cost of overweight and obesity is $117 billion per year, which is greater than 5% of the nation's total annual healthcare expenditures."
Long-term solutions have yet to surface from any industry or government around the world, attesting to the complexity of this situation. This "holy grail" has even escaped the grips of pharmaceutical R&D. Although "big pharma" has addressed successfully the conditions that arise from obesity-type 2 diabetes, cardiovascular disease, osteoarthritis, certain cancers-it has, according to Dr. Crawford, repeatedly failed to demonstrate the safety and efficacy of a remedy that addresses the underlying condition.
Greg Stephens, vice president, Sales & Marketing, Nurture, Inc., Devon, PA, agreed. "We're all aware of the R&D spend at pharmaceutical companies, all looking for a Prozac-like success. Drugs like Meridia and Zenical have not lived up to their expectations at all. Actually, if you look at 'Rx' sales for weight loss, the market is dominated by generic amphetamines," he said, adding, "Drugs are just one weapon in the battle against obesity."
Several entities have put forth ideas that may help in battling the bulge that Americans grapple with daily. The most visible has been the U.S. government, which has established several initiatives that aim to curb this epidemic by way of healthier food programs, exercise plans and, most recently, scrutinizing the dietary guidelines to see how they can be adjusted to create a healthier, leaner America. To the U.S. government, each step, however small, will make a big difference in the long run.
Helping Consumers Battle Their Bulge: Back to Basics
Every five years the dietary guidelines come up for reassessment by the United States Department of Agriculture (USDA), Washington, D.C., and the Department of Health and Human Services (HHS), Washington, D.C., which appoint a panel of experts to review current and emerging science, as well as comments from a range of stakeholders. In mid-August the advisory panel revising the guidelines held its final meeting. This meeting resulted in lumping sugar together with refined carbohydrates. In addition, it recommended that some refined grains be replaced with whole grains. The panel stood firm on its belief that "Calories Count" and that that measure should continue to be used by consumers in order to maintain weight.
This year the debate surrounding the guidelines was more heated than ever before, particularly because overweight and obesity has become an issue for an alarming 64% of Americans, 15% of which are children and adolescents. As several industries make a move to help rewrite the dietary guidelines, which form the basis for school lunch programs and other federal nutrition programs, in addition to the Food Guide Pyramid, the outcome may have far reaching implications on "nutrition thought" going forward. As we went to press, a public meeting was scheduled to determine the possibility of reshaping the Food Guide Pyramid, which in the end may not resemble a pyramid at all.
Scott Van Winkle, managing director, Adams Harkness, a Boston, MA-based investment bank, said revising the dietary guidelines and the Food Guide Pyramid is long overdue. "I do think the food pyramid is a little outdated and most people agree. What I see being talked about consistently is the Zone Diet as being one of the best diets to recommend amongst healthcare practitioners," he said. "There needs to be a push toward balance and for that to happen there needs to be a continued move away from carbohydrates, at least in the percentage of consumption, in favor of proteins and some of the better-for-you fats."
Jeff Nedelman, president, Strategic Communications, a food industry consultancy based in Vienna, VA, says for the most part, large food companies have lost their most important battles with the dietary guidelines. "With the exception of dairy, Walter Willet (of the Harvard School of Public Health, Boston, MA) got much of what he wanted and that was exactly what the food companies didn't want. Now the dietary guidelines are looking at reducing simple sugars, with an emphasis on fibers and good fats," he said.
What will not be mentioned in the dietary guidelines, however, is the role of glycemic index. Mr. Nedelman said he was surprised about this development. "I am convinced it had nothing to do with the science and everything to do with nutrition establishments not being able to effectively communicate the mechanics of glycemic index to consumers," he commented.
According to the Harvard School of Public Health, the information embodied in the Food Guide Pyramid does not point the way to healthy eating. Why not? Well, it says the blueprint for the Pyramid is based on shaky scientific evidence and hasn't appreciably changed over the years to reflect major advances in the understanding of the connection between diet and health.
As an alternative to the USDA's "flawed" pyramid, faculty members at the Harvard School of Public Health created a "Healthy Eating Pyramid," which resembles the original pyramid in shape only. The Healthy Eating Pyramid takes into consideration, and puts into perspective, the wealth of research conducted during the last 10 years that has reshaped the definition of healthy eating.
Taking the heat off the current Food Guide Pyramid and its connection with the overweight/obesity epidemic was an article published in the July issue of the Journal of the American Dietetic Association. The article said since its release in 1992, the Food Guide Pyramid has become one of the most recognized nutrition education tools in U.S. history. Because of this, the article said the Pyramid has been subject to criticism, particularly in several recent media reports that implicate it as the culprit in America's current obesity epidemic. The authors pointed out, "What these reports often overlook, however, is that the diets of many Americans do not adhere to the dietary guidelines illustrated by the Pyramid, refuting the notion that the Pyramid is the cause of the nation's obesity problem. Data indicate that the more likely causes of escalating obesity rates are increased per capita caloric consumption and larger portion sizes, along with a lack of adequate physical activity." Furthermore, the authors said abandoning the Food Guide Pyramid in favor of an alternate pyramid is not necessarily the answer to the nation's current nutrition problems, particularly in the absence of data to show that most Americans can and will actually eat according to any such alternate pyramid.
Pyramids and dietary guidelines aside, there have been several other initiatives in motion that address the overweight/obesity issue on multiple fronts. In a hearing held during the early days of June this year, Dr. Crawford, who is also the chair of FDA's Obesity Working Group, outlined these initiatives and programs, which revolve around counting calories and incorporating exercise. "Our report concludes there is no substitute for the simple formula that 'calories in must equal calories out' in order to control weight. We're going back to basics, designing a comprehensive effort to attack obesity through an aggressive, science-based, consumer-friendly program with the simple message that 'Calories Count.'"
Less is more to HHS Secretary Tommy Thompson as well. "Taking small steps to eat a more balanced diet and to stay physically active can go a long way to reversing the epidemic of obesity," he said. "Each small step does make a difference, whether it's taking the stairs instead of an elevator or snacking on fruits and vegetables. The more small steps we can take, the further down the road we will be toward better health for ourselves and our families."
In agreement with the "small steps" mentality was Van Hubbard, director, National Institutes of Health (NIH) Division of Nutrition Research Coordination, Bethesda, MD, who said, "We need people to realize that small steps can make major improvements over time. If we can curtail this problem then we as a nation can start down the road of success."
For the major food companies, the goal for now has been to remove components of foods deemed unhealthy (e.g., trans fats, sugars, carbs), rather than add functional ingredients to product formulations. According to Laurie Demeritt, president, The Hartman Group, Bellevue, WA, this may change in the future, but for now food companies are just trying to educate consumers on portion size and servings.
The First Step is Admitting the Problem
While governments, organizations, associations, companies and academia have all recognized that there is an epidemic of overweight and obesity permeating all populations of the world, consumers have yet to grasp that fact. According to research from the Hartman Group, it is not true that consumers lack basic nutrition information, or they somehow cannot seem to grasp the relationship between calories taken in and calories burned. The findings in its 2004 report, "Obesity in America: Understanding Weight Management from a Consumer Perspective," indicate that most consumers consider their weight to be fairly average despite the fact that 66% of study respondents were considered overweight or obese, according to body mass index (BMI) measurements. In fact, the Hartman Group found that most overweight people believe they are physically healthy.
The most interesting finding, however, related to how study respondents perceived the weight status of others. "The CDC's verdict that nearly two-thirds of the population is overweight or worse relies on objective measurements of height and weight, but most people believe that such statistics have very little, if anything, to do with themselves or their immediate social networks," the report stated. Instead, study respondents said the two-thirds statistic tends to relate to strangers, such as 'people I see at the grocery store.' "In sharp contrast to the way individuals see themselves, they generally hold others to a different, often higher, standard," the report said. "This propensity to use a double standard, rather than an inability to see ourselves accurately, is what makes our self-assessments generally less critical than our assessments of others." As such, the Hartman Group believes that policies aimed at educating the overweight and near overweight about how to "overcome their problem" are doomed to failure as long as they persistently ignore the fact that people have yet to agree they have a problem.
Similar findings were revealed through FDA's research as well. When Commissioner Crawford addressed the World Obesity Congress & Expo in July, he noted that the misperception of weight status continues to be an issue. "A large part of our population is not even aware that excessive weight gain is a health problem," he said, adding. "Our research indicates that both adults and teenagers frequently misperceive their weight status, and that this misperception cuts across gender, socioeconomic status, age and ethnicity. This is particularly true about individuals who regard themselves as overweight rather than obese. Recent focus group studies indicate that these men and women generally brush off the extra pounds as of minor significance, and therefore have little incentive to get rid of them."
Obesity & Overweight: Everyone is Talking about it
A recent article in the Washington Post discussed the possibility of fat being contagious-that's right, fat caused by a virus. Whether or not it is caused by a virus is another article in itself, however, the "talk" of overweight and obesity certainly seems to be contagious. According to new research commissioned by the International Food Information Council (IFIC), Washington, D.C., the issue of obesity and weight management shot to the top of the charts in food reporting in 2003, accounting for nearly one of every six stories monitored in IFIC's survey. Furthermore, IFIC said consumers spend an estimated $37 billion a year on all types of weight loss/management products and programs, and it is estimated this figure will continue to grow at a rate of 6-7% per year.
Given the enormity of the overweight/obesity issue, agencies like FDA and the Federal Trade Commission (FTC) want to make sure that companies marketing products in this arena are not overstepping their bounds in labeling or advertising. Over the last year, both FDA and FTC have ramped up enforcement in this area, which is a welcome change according to some experts who feel increased enforcement is long overdue.
FTC has jurisdiction over advertising of weight loss products and services. Most recently the agency issued reports on weight loss advertising and held a workshop for the media in order to help them determine how to spot deceptive advertising. Commenting on these initiatives was Richard Cleland, assistant director for the Division of Advertising Practices at FTC, Washington, D.C. "Over the years a common response from media has been that 'we are not scientists and we can't tell which claims are false and which are not,'" he said. "So we invited members of the scientific community, the dietary supplement industry, weight loss products industry and the media to our workshop." As a result, Mr. Cleland said, seven common fraudulent weight loss claims ("Red Flag Claims") were identified and then published in a reference guide (Red Flag: Bogus Weight Loss Claims), which was issued to the media. These "Red Flag" claims included:
1. Lose two pounds or more per week (for a month or more) without dieting or exercise. Example: "Lose up to two pounds daily without diet or exercise."
2. Eat what you want! The more you eat, the more you lose and we'll show you how. Example: "Eat all the foods you love, and still lose weight (the pill does all the work)."
3. Weight loss will be permanent (even when the user stops using the product). Example: "Take it off! And keep it off."
4. Block the absorption of fat or calories, and lose substantial weight. Example: "This product blocks fat before your body absorbs it; the pounds will melt away effortlessly."
5. Consumers can safely lose more than three pounds per week for a period of more than four weeks. Example: "Lose 30-40-50 pounds. Yes! You can lose three pounds per week, naturally and without side effects."
6. The product causes substantial weight loss for all users. Example: "Lose excess body fat. You cannot fail, because no will power is required."
7. Diet patches, creams, wraps, earrings and other products worn on the body or rubbed into the skin cause substantial weight loss. Example: "Lose two to four pounds daily with the Neptune Diet Patch."
FTC has followed up this initiative by promoting the guide to the media as a way of identifying claims they should not be running. "As of right now," said. Mr. Cleland, "I believe that the response has been very positive, especially in the magazine media. We have seen a decrease in the types of claims being made-the outrageous, over-the-top claims-and we are in the process of conducting a survey of other types of media to determine what effect this campaign has had, which should be out this month."
With regard to dietary supplements in particular, Mr. Cleland said, "We are in the process of working with several different industry groups to develop specific guidelines for weight loss advertising, which can then be used as part of self-regulatory programs. However, this is a work in progress and we are not ready to release anything about it." He did reveal that FTC is presently working with industry groups such as UNPA (Utah Natural Products Alliance), AHPA (American Herbal Products Association) and CRN (the Council for Responsible Nutrition) on this initiative.
Should Obesity be Considered a Disease?
To organizations like the American Obesity Association (AOA), Washington, D.C., classifying obesity as a disease is a "no brainer." The organization says the current perception of obesity is one of failure of the individual, so its mission is to change that perception to one that recognizes obesity as a complex disease involving more than personal behavior. At the same time re-classifying obesity will help "de-stigmatize" the condition, health insurance allowances will also greatly help those afflicted obtain the necessary treatment.
Opponents, however, contend that obesity is merely a risk factor, which leads to an illness but is not an ailment in itself like cancer or heart disease. Nevertheless, the move to classify obesity as a disease appears to be accelerating, according to an article published in the Washington Post last November. In fact, the article stated, "The Internal Revenue Service ruled last year that, for tax purposes, obesity is a disease, allowing Americans for the first time to claim a deduction for some health expenses related to obesity, just as they can for those related to heart disease, cancer, diabetes and other illnesses."
The fact that not all insurance providers allow coverage for obesity treatment is quite perplexing. Many experts question why some of these organizations will cover the more expensive costs of something drastic like bariatric surgery (reducing the size of the stomach) instead of providing coverage for weight loss programs, such as Weight Watchers.
For Medicaid and Medicare, however, the time has come to make the call on whether or not to consider obesity a disease. In mid-July, it was announced by HHS' Centers for Medicare & Medicaid Services (CMS) that certain allowances would be made for those who are obese. The new policy specifically removes language in the Medicare Coverage Issues Manual stating that obesity is not an illness. This step allows members of the public to request that Medicare review medical evidence to determine whether specific treatments related to obesity would be covered by Medicare. This new development means that those who qualify for these services would be covered for approved obesity treatments instead of being diagnosed first with a condition like type 2 diabetes or cardiovascular disease in order to receive treatment.
Recognizing obesity as a disease, said Nurture's Mr. Stephens, has enormous cost implications for our healthcare system. But, he said, when/if coverage become available, it will be for those products/programs that have documented success; not weight loss success but weight maintenance success-loosing the weight and keeping it off.
Shil Kothari, product development manager, InterHealth Nutraceuticals, Benicia, CA, said people will continue to debate the "obesity as a disease" issue for a while. "I think obesity is a root disease that causes many other diseases, and if HMOs start to treat obesity first then they will be treating a lot less of type II diabetes and cardiovascular disease down the road," he commented.
Taking an optimistic look at the future, Suzanne McNeary, president, NutraGenesis, Brattleboro, VT, said she could envision government reimbursement for diet programs, functional foods and supplements as long as they provide clear medical and health benefits.
Creating a Systems Approach: Supplements are Only One Tool in the Toolbox
It cannot be said enough that there is no magic bullet or one-size-fits-all approach to weight loss or weight management. (Unfortunately, while consumers say they understand that fact, their actions frequently prove otherwise.) These days companies are positioning their products to serve as one of the many tools needed by consumers to lose or manage weight. This is where dietary supplements may play a new, more respectable role in this market moving forward.
Nurture's Mr. Stephens said each person is an individual and will require a variety of tools to accomplish the job of loosing weight and then keeping it off. "What is needed is a multidisciplinary approach to weight loss and weight management," he said. "I think companies marketing supplements will realize this and partner with other companies providing the behavioral component (anything from mental health facility staffs to Weight Watchers) and exercise (health clubs, rehab centers or personal trainers)."
Jocelyn Mathern, technical specialist, Acatris, Minneapolis, MN, agreed. "I think that there will always be people looking for the quick fix, but I think more companies are looking to develop products that don't serve as a single solution to weight loss, but rather as part of the solution," she offered. "Weight loss/management really has to incorporate lifestyle changes."
With the market becoming more competitive for weight loss/management products, Karen Todd, senior marketing manager, New Ingredients & Business Development, DSM Nutritional Products, Inc., Parsippany, NJ, says companies are looking hard at clinical studies, which is encouraging. "They are increasingly concerned about safety and they want products that work. Interestingly, a lot of the companies we have worked with recently are very interested in putting the 'efficacious dose' in their products and for a food company that is a huge step," she said. "This is a pretty big turn around from companies just sprinkling the ingredient in the product in order to get a label claim."
Scott Steil, executive director of marketing and sales, Humanetics Corporation, Minneapolis, MN, says that companies are looking at the science because regulatory bodies require it. "I think with FTC and FDA demanding more science that the burden for testing has really shifted to the shoulders of suppliers," he said. "This is an entry barrier now for products that want to get to market and stay on the market."
Weight Loss/Management Options
As stated previously, there are many options out there on both the food and supplement front that can serve as adjuncts to other weight loss/management products and services. Some products are geared toward increasing metabolism, some target satiety (the feeling fuller longer approach), some target calorie reduction and glycemic index and others are staking their claim in the low-carb segment.
Low-Carb Update. Many experts feel the low-carb trend has reached its peak, or at the very least is in a state of transition. Mr. Van Winkle of Adams Harkness offered, "I suspect we might have seen the peak already for low-carb products. However, they continue to evolve. What the low-carb trend did was trigger a change in nutrition thought, so I think you are going to see that spawn nutritional changes in consumers' diets in the future."
In time for the downturn of the trend will be the issuing of regulations from FDA on what exactly is meant by "low-carb" and what can be claimed on product labels. FDA Commissioner Crawford said in early August that guidelines will be issued later this year, which will shed some light on "low-carb", "reduced carb" and "carbohydrate-free" claims.
Mr. Van Winkle also sees other opportunities. "Due to the trends in the market, the vitamin category has really gotten a boost over the last 52 weeks, specifically with the growth of low-carb diets," he said. "As doctors start to positively receive the low-carb diets they will certainly be pushing for supplementation."
Cashing in on the low-carb craze from a supplement perspective most recently are Wyeth Consumer Healthcare, Madison, NJ, and Bayer Consumer Care, Morristown, NJ. These companies have launched supplements-Centrum Carb Assist (Wyeth) and One-A-Day CarbSmart (Bayer)-which claim to make up for nutritional deficiencies while on a low-carb regimen. According to a recent New York Times article, IRI data indicate that since its launch in April, CarbSmart has raked in $2.8 million in sales, while Carb Assist, which was launched a month later, has brought in $1.7 million.
Dairy. There is a growing body of evidence pointing to the inherent nutrients in dairy as somehow playing a role in weight loss or weight management. In fact, according to a recent article in Obesity Research, obese people who consumed three to four servings of milk, yogurt or cheese while on a balanced, reduced calorie diet, lost significantly more weight and fat than those who consumed equivalent amounts of calcium through supplements, or who consumed one or fewer servings of milk, yogurt or cheese per day. Several other articles published after 2000 also point to the positive effects of dietary calcium or dairy as being responsible for a favorable change in weight in subjects.
This research is precisely what prompted The International Dairy Foods Association (IDFA), Milk Processor Education Program (MilkPEP) and Dairy Management Inc. (DMI) to roll out their "Health Weight with Dairy" campaign last year. This campaign included national advertising and local marketing efforts to tout scientific research suggesting a link between dairy consumption and reduced body weight. According to IDFA, scientists are still studying why dairy is so important, but it says preliminary research suggests that calcium plays a role in the body's natural system for burning fat.
Serena Ball, RD, director of Nutrition Affairs and Communication, National Dairy Council, Rosemont, IL, said the "Healthy Weight with Dairy Campaign" is kicking off its official launch this month. "This is the big launch where we are going to be working more with retailers and WebMD," she said. "We were very conservative with our first wave of information, which started trickling out last October, because we really wanted to make sure we had sound science to back everything up. Once the science was there we felt we could really move forward with this and get the information out there."
Shedding some light on the milk and weight loss connection was Loren Ward, Ph.D., associate director of research at Glanbia USA, Monroe, WI. "Recent research shows mineral, protein and peptide components from milk are important in weight management and weight loss. Milk minerals help preserve bone density during weight loss and shift adipocyte metabolism toward the breakdown of fat (lipolysis) resulting in smaller adipocyte cells," she said. "Calcium is the key mineral in regulating adipocyte tissue, but other minerals in milk are important for maintaining bone health during weight loss." Dr. Ward said 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.
Hydroxycitric Acid (HCA). InterHealth's Mr. Kothari said its HCA product (Super CitriMax) inhibits the enzyme responsible for the conversion of carbohydrates to fat, which is the original premise of the product. However, in light of the complexity surrounding overweight and obesity, he said products should be able to tackle a variety of mechanisms. That said, Mr. Kothari revealed that additional work is being done to show that Super CitriMax works on a genetic level by modulating genes in the way they express certain proteins related to obesity. He also said there is evidence pointing to the increase of serotonin upon consumption of Super CitriMax. Lastly, he said, it works by way of fatty acid oxidation, which actually helps to break down fat that already exists in the body.
The Starch Blockers. The starch blockers have gained recognition in part due to the low-carb trend and also because there is a growing body of evidence attesting to their safety and efficacy. Mitch Skop, director of new product development at Pharmachem Laboratories, Kearny NJ, highlighted Pharmachem's Phase 2 Starch Neutralizer due to the depth of scientific research conducted on it, as well as its clinical efficacy at reducing carbohydrate calories. "Everyone knows the low-carb phenomenon is about to peak, and Phase 2 is one of the only ingredients that companies can formulate with to reduce the starch calories/glycemic index of starchy foods," he said. Most recently, Phase 2 found its way to the functional food market by way of French Meadow Bakery, Minneapolis, MN, which has unveiled a line of yeast-free, organic, reduced-carb baked goods containing the ingredient. The line will be marketed under the Carb Watcher label and will include sourdough and multi-grain dinner rolls, bread and tortilla shells.
Satiety. The issue of satiety has been raised as a way to get consumers to stop eating so much, so often. Active on this front is Nurture with its OatVantage product, which can be incorporated into supplements and foods. Going in this direction was important for Nurture, according to Greg Stephens. "A big and unchanging issue is that consumers are largely unwilling to change their eating habits. Healthcare professionals agree that for people to loose weight AND keep it off, positives changes to the diet must be made," he said. "Yet consumers are largely unwilling to give up unhealthy, fatty, salty or calorie-laden foods. The challenge for ingredient and food manufacturers is to provide substitutes that taste good and do not make the consumer feel deprived (hence a role for satiety ingredients)." According to Nurture, "The increased viscosity of the alimentary bolus caused by solubilized beta-glucan can delay nutrient absorption and result in reduced hunger and/or increased satiety. It is well known that oats, particularly the soluble fiber in oats (beta-glucan), readily induce very high levels of satiety. In a study, which quantified satiety, oats were found to have the third highest satiety rating among all foods tested."
Coming from the "good carb" angle was Hartley Pond technical sales manager, VDF Futureceuticals, Chicago, IL, who says his company's product, Nutrim, is positioned as a "good carb" that can help control weight from a satiety and glucose perspective. "Our Nutrim oat beta-glucan product, which was developed by the USDA comes with an FDA claim for reducing cholesterol," he said. "In addition, a lot of great tertiary work has been done on controlling glucose and insulin response." The company is also moving forward with some work to show Nutrim's benefits in controlling appetite. "Right now we know that the soluble fiber from oats helps slow gastric emptying, therefore slowing digestion," he explained. "It stands to reason, although this needs to be proven per ingredient, that if you slow down the digestion process you are actually making a person feel more satiated."
Discussing resistant starch in the context of satiety was Janine Higgins, PhD, who is a researcher at the University of Colorado Health Sciences Center, Center for Human Nutrition, Denver, CO. "More attention is being paid to resistant starch because it does act like fiber, so it could have the same satiety effect as traditional forms of fiber," she said. "Also, resistant starch can be incorporated into foods without giving the taste, texture and appearance of traditional fiber." Dr. Higgins said it is more likely that children and adults who prefer non-grainy breads in favor of more processed foods could ingest resistant starch very easily. Because resistant starch is not fully absorbed in the upper digestive tract, it passes right to the large bowel, so not all of the calories are absorbed. The theory, according to Dr. Higgins, is that by eating some of the same foods that have had resistant starch added will reduce some calorie intake.
Rather than "low carb," Acatris' Ms. Mathern said its fenugreek product is being positioned as "slow carb." "We have seen a lot of interest in FenuLife looking specifically at weight loss. When you eat FenuLife with a meal it slows down the absorption of sugar in the intestines, so you get less of a rise in blood sugar," she said. "Research indicates that low glycemic index foods can make you feel fuller longer." Recently, Ms. Mathern said, Acatris has commenced a study that looks at the role FenuLife plays in satiety. "There is a lot of documentation out there