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FDA Center for Food Safety and Applied Nutrition
March 12, 2004
June 2, 2006: See also Questions and Answers on the Keystone Forum Report on Away-From-Home Foods: Opportunities for Preventing Weight Gain and Obesity
Q: What steps led to the formation of FDA's Obesity Working Group?
A: In support of the President's HealthierUS initiative, the Department of Health and Human Services (DHHS) established a complementary initiative, Steps to a HealthierUS, which emphasizes personal responsibility for the choices Americans make for healthy behaviors. One aspect of this initiative focuses on reducing the major health burden created by obesity and other chronic diseases. Following DHHS Secretary Tommy G. Thompson's July 2003 Roundtable on Obesity and Nutrition, Dr. Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs, established an Obesity Working Group (OWG) to prepare a report that outlines an action plan to cover critical dimensions of the obesity problem from FDA's perspective and authorities.
A: As a public health agency with responsibility for regulating the labeling of most packaged foods, FDA is addressing the pervasive public health problem of obesity in the United States. Since the late 1980s, adult obesity has steadily and substantially increased in the United States. Today, 64 percent of all Americans are overweight and over 30 percent are obese; up from 1988 through 1992, when fewer than 56 percent were overweight and fewer than 23 percent of American adults were obese. The trends for children are even more worrisome. Recent research by the Centers for Disease Control and Prevention (CDC) shows that 15 percent of children and adolescents aged 6 to 19 are overweight - almost double the rate of two decades ago.
Q: What other federal agencies are working as part of DHHS' obesity initiative?
A: Many components of DHHS, in addition to FDA, are involved in efforts to combat obesity. These include the Agency for Healthcare, Research and Quality, the Indian Health Service, CDC, the National Institutes of Health (NIH), the Health Resources and Services Administration, and the Office of the Surgeon General.
A: There is no simple answer. Achieving success in reducing and avoiding obesity will occur only as a result of multiple efforts over time by individuals as well as many sectors of our society. The OWG report recommendations, when carried out by FDA in concert with the complementary ongoing and planned efforts of other government agencies and organizations, along with private sector initiatives, have the potential to make a significant impact on current trends. It should be noted, however, that most associations, agencies, and organizations believe that diet and physical activity should be addressed together in the fight against overweight and obesity.
A: The recommendations in the OWG report are centered on the scientific fact that weight control is primarily a function of caloric balance. For this reason, the recommendations contained in the report focus on a "calories count" emphasis for FDA actions.
A: The OWG report provides a range of short and long-term recommendations to address the obesity epidemic. These recommendations are based on scientific facts and address multiple facets of the obesity problem under FDA's purview, including developing appropriate and effective consumer messages to aid consumers in making wiser dietary choices; establishing educational strategies and partnerships to support appropriate messages and teach people, particularly children, how to lead healthier lives through better nutrition; developing initiatives to improve the labeling of packaged foods with respect to caloric and other nutrition information; encouraging and enlisting restaurants in efforts to combat obesity and provide nutrition information to consumers, including information on calories, at the point-of-sale; developing new therapeutics for the treatment of obesity; designing and conducting effective research in the fight against obesity; and continuing to involve stakeholders in the process.
A: FDA intends to work expeditiously to implement the many recommendations in the report. Several of the recommendations call for rulemaking to make changes in the food label. FDA's Center for Food Safety and Applied Nutrition (CFSAN) will have the lead on these and other major recommendations in the report.
A: Obesity affects all age groups, children, as well as adults. FDA has an emphasis on children and adolescents for the education components of its recommendations. As part of a larger HHS effort, FDA is establishing relationships with youth-oriented organizations to provide educational outreach with an emphasis on caloric balance and proper diet, because establishing good dietary practices at an early age will decrease the likelihood of obesity into adulthood. Nevertheless, FDA believes that the overall focus of "calories count" is applicable to all age groups.
Q: What can FDA do to help consumers make better decisions about which foods are nutritious?
A: The OWG report provides recommendations to address the obesity problem, but the issue of making healthy food choices is more complicated than solely the question of obesity. The Federal government tries to provide long-term sound nutrition advice to consumers. For example, DHHS (including FDA) collaborates with the U.S. Department of Agriculture to establish and promote the Dietary Guidelines for Americans, which provide guidance on choosing a lifestyle that combines sensible eating with regular physical activity.
Q: What changes is FDA contemplating for the food label to help combat obesity?
A: The OWG recommends several main areas for FDA to consider - calories, serving sizes, carbohydrates, and comparative labeling statements. One of the calorie recommendations is to solicit comment on how to give more prominence to calories on the food label. For serving sizes, FDA will reevaluate the agency's regulations about serving sizes in order to give consumers the most accurate information about the serving size and caloric content of the packaged foods they purchase.
Q: What changes can FDA make to the Nutrition Facts panel (NFP) to emphasize calories?
A: The OWG report recommends that FDA publish an Advance Notice of Proposed Rulemaking (ANPRM) to request comments on how best to give more prominence to calories. Possible changes to the NFP might include: (1) increasing the font size for calories; (2) providing a percent Daily Value for calories; and (3) eliminating "calories from fat" listing as this takes the emphasis away from "total calories."
Accenting Calories (Muffin)
Possible changes.
Q: Is FDA considering allowing any health claims related to obesity?
A: Yes. Based on the recommendations in the OWG report, FDA will be publishing an ANPRM to consider whether to allow health claims on certain foods that meet FDA's definition of "reduced" or "low" calorie. (An example of such a health claim for a "reduced" or "low" calorie food might be: "Diets low in calories may reduce the risk of obesity, which is associated with type 2 diabetes, heart disease, and certain cancers.")
Q: Does FDA encourage the use of any dietary guidance statements concerning obesity?
A: Yes. The OWG report recommends that FDA encourage manufacturers to use dietary guidance statements. (Examples of dietary guidance statements are, "To manage your weight, balance the calories you eat with your physical activity"; "have a carrot, not the carrot cake.")
A: The serving size is critical to nutrition labeling since all the information on nutrient levels depends on the amount of the product represented. In addition, the accuracy of the information in the NFP is crucial for consumers who use this information to monitor their intake of calories and nutrients.
Labeling Example for a 20 oz. soda
Notice the difference in calories when
entire container is labeled one serving
A: The report recommends two separate actions. The first is to encourage manufacturers to take advantage of the flexibility in current regulations on serving sizes. This flexibility allows food packages to be labeled as a single serving if the entire contents of the package can reasonably be consumed at a single-eating occasion.
The second step is to solicit comment via ANPRMs on 1) whether to require additional columns in the NFP to list the quantitative amounts and percent Daily Value for the entire package or declare the whole package as a single serving for products that can reasonably be consumed at one eating occasion and 2) which, if any, reference amounts customarily consumed (RACCs) of food categories appear to have changed the most over the past decade and require updating.
A: FDA developed RACCs for 139 food categories that manufacturers use in developing serving sizes that are then expressed in household measures (e.g., teaspoons, cups, pieces). These serving sizes become the basis for reporting the amount of each nutrient present and enable consumers to compare the nutritional qualities of similar food products.
Q: Will FDA make any changes on the food label regarding carbohydrates?
A: The OWG report acknowledges American consumers' interest in restricting carbohydrates as a weight-loss method. The report further notes that the claims for carbohydrate content of foods have become increasingly common in the marketplace while, at the same time, the level of carbohydrates in foods marketed under the various carbohydrate claims appears to vary widely. FDA has filed petitions it has received that ask FDA to define such terms as "low carbohydrate," "reduced carbohydrate," and "carbohydrate free." FDA intends to initiate rulemaking proceedings to address these issues, as well as to provide guidance for the use of the term "net" in relation to carbohydrate content of food.
Q: What claims for carbohydrates are currently authorized on food labels?
A: Currently, terms such as "low," "reduced," or "free" carbohydrates are not defined in FDA's regulations. FDA has received petitions from industry asking FDA to define terms including "low carbohydrate," "reduced carbohydrate," and "carbohydrate- free." To ensure that such terms are consistently defined and that carbohydrate claims are not false or misleading, FDA has filed the petitions and intends to initiate rulemaking proceedings to address these issues. In addition, the agency intends to provide guidance to food manufacturers on the use of the term "net" in relation to the carbohydrate content of food.
Q: How long will it take before FDA responds to the petitions on carbohydrates?
A: Under the law, FDA has 90 days to respond to the petitions that were filed on March 11, 2004.
A: Consumers spend substantial sums on weight-loss diet plans and diet-related products. Such plans and products have the potential to affect food choices of some consumers. The long-term weight or health effects of these and other weight control measures remains unclear. The OWG report recommends that there be an exploration of the concept of third party certification of weight-loss diet plans and related products. The goal is to improve consumer information about the health consequences of their overall dietary choices.
Q: What steps can be taken to protect the public from weight loss products that make false or misleading weight-loss claims?
A: The OWG report recommends that FDA, together with the Federal Trade Commission, increase enforcement against weight loss products having false or misleading weight-loss claims.
Q: What steps will FDA take so that manufacturers list accurate serving sizes on food products?
A: To address this issue, the OWG report recommends that FDA highlight in the Food Labeling Compliance Program, enforcement against declarations of inaccurate serving sizes.
A: The serving size is critical to nutrition labeling since all of the information on nutrient levels, including calories, depends on the amount of the product represented. By statute, the serving size is to be based on the amount of the food customarily consumed. The accuracy of the information in the NFP is crucial for consumers who use this information to monitor their intake of calories and other nutrients.
Q: How does FDA plan to educate consumers about making healthy food choices?
A: The OWG report recommends that FDA focus its education strategy on influencing behavior, as well as imparting knowledge, in the context of healthy eating choices for consumers through the implementation of educational programs. These programs should be developed incrementally and be flexible in design so that new research findings, policy decisions and possible changes in the food label are included. These education programs should be simple to understand and apply, and should focus on showing consumers how to achieve a specific goal.
Q: Why does FDA intend to establish partnerships for educational outreach?
A: Given the resources and time that FDA would need to develop and implement new education programs, the OWG report recommends that FDA establish both private and public sector partnerships for educational outreach. Such partnerships will have the ability to reach larger and more diverse audiences on a more frequent basis and will enable calorie-focused education campaigns to begin more quickly.
Q: Is FDA establishing relationships with other organizations as part of a larger HHS effort?
A: Yes, as part of a larger HHS effort, FDA is working to establish relationships with youth-oriented organizations such as the Girl Scouts of the USA and the 4-H program. In addition, FDA, along with other components of HHS, is participating in the "Shaping America's Youth" initiative to identify actions being taken to address childhood and adolescent inactivity and excess weight. Information collected for this initiative in an on-line survey will be used by "Shaping America's Youth" to prepare a report that provides an overview of current public and private programs that target physical activity and nutrition in our nation's children.
Public sector relationships should have the goal of developing programs similar to the "Power of Choice" program FDA developed with the USDA, which teaches children who are 11-13 years of age how to make smart food and physical activity choices in real-life settings.
Q: Are restaurants required to provide nutrition information on their menu items?
A: Restaurants are not required by the Nutrition, Labeling and Education Act (NLEA) to provide nutrition information for a menu item or meal unless a nutrient-content claim (e.g., low, free, reduced) or a health claim (e.g., "diets low in saturated fat, trans fat and cholesterol may reduce the risk of heart disease") is made for the item or meal.
When such a claim is made, the restaurant need only provide information on the amount of the nutrient that is the basis of the claim. The restaurant may provide information about the nutrient for which the claim is made in various ways, including in brochures. In other words, restaurants need not provide such information on the menu or menu board.
A restaurant making such a claim also would not be required to provide complete nutrition information; its decision to provide nutrient content information about one nutrient does not trigger a requirement to disclose complete nutrition information for that item or meal.
Q: What steps can the restaurant industry take to help provide a solution to the obesity problem?
A: In light of the growing proportion of American meals consumed outside of the home, it is important to enlist the assistance and support of restaurants in addressing obesity. The OWG report recommends that in the short-term, FDA urge the restaurant industry to launch a nation-wide, voluntary, and point-of-sale nutrition information campaign for customers. The report also recommends that FDA encourage consumers routinely to request nutrition information in restaurants.
Over the long-term, the OWG report recommends: 1) the development of a series of options for providing voluntary and standardized nutrition information at the point-of-sale to consumers in restaurant settings; 2) FDA seek participating restaurants for a pilot program to study these options; 3) FDA provide incentives, if necessary, for voluntary industry participation in the pilot program; and 4) FDA evaluate results of the pilot program.
Q: What steps is FDA taking to facilitate the development of therapeutics for the treatment of obesity?
A: The OWG report recognizes that obese and extremely obese individuals are likely to need medical intervention to reduce weight and mitigate associated diseases and other adverse health effects. The OWG report recommends that FDA: (1) convene a meeting of a standing FDA advisory committee to address challenges, as well as gaps in knowledge, about existing therapies; (2) continue discussion with pharmaceutical and medical device sponsors about new obesity medical products; and (3) revise the 1996 "Guidance for the Clinical Evaluation of Weight-Control Drugs" draft guidance on developing obesity drugs and re-issue it for comment.
A: The draft guidance gives recommendations for the design and conduct of clinical studies aimed at demonstrating the effectiveness and safety of weight-loss medications. On January 26, 2004, FDA issued a Federal Register notice specifically to solicit comments on this previously published draft guidance. FDA is interested in incorporating the latest scientific advances in the field of obesity and drug development into a revised guidance document that the agency will, in turn, re-issue for comment.
Q: What drugs are currently approved to help with weight loss?
A: There are two drugs approved for the long-term treatment of obesity: sibutramine (Meridia) in 1997 and orlistat (Xenical) in 1999.
In addition, prior to 1996, FDA has approved two drugs for the short-term (e.g., a few weeks) treatment of obesity: phentermine (Adipex) and diethylpropion (Tenuate).
A: Many extremely obese patients, for whom no other measures have been effective in promoting weight loss, have opted for surgical or device-mediated gastroplasty. Despite serious complications, gastroplasty procedures as well as device implantations are effective for some individuals, with average durable loss of 35-40% of excess (over ideal) weight.
A: No. The OWG, however, was formed to help confront the current obesity epidemic and to develop new and innovative ways to help consumers lead healthier lives through better nutrition. One of the mandates of the OWG was to identify applied and basic research needs relative to obesity that include the development of healthier foods as well as a better understanding of consumer behavior and motivation.
A: The OWG report identifies five areas for obesity research: (1) information to facilitate consumers' weight management decisions, (2) the relationship between overweight/obesity and food consumption patterns; (3) incentives for product reformulation; (4) the potential for FDA-regulated products unintentionally to contribute to or result in obesity; and (5) the extension of basic research findings to the regulatory environment. In addition, the OWG report recommends that FDA pursue collaborations with other groups who are undertaking obesity research such as NIH, which has recently issued an obesity research agenda, and CDC.
The OWG report also recommends that as part of its research efforts, FDA collaborate with USDA's Agricultural Research Service on a national obesity prevention conference to be held in October 2004. The conference will draw on the expertise of both the public and private sector scientific communities to provide guidance for research agendas in the short- and long-term to address obesity prevention from a variety of scientific and other disciplines.
Q: What is the role of behavioral research in addressing the obesity problem?
A: Behavioral research is needed to learn more about consumer dietary behavior and attitudes toward weight management. It is also important in understanding how current food labeling is used by consumers to manage weight. The qualitative and quantitative research with an emphasis on consumer reaction to and efficacy of current food labeling as well as any changes to the food label (e.g., highlighting calories, listing the quantitative amounts for all nutrients in multi-size packages, and using "healthy" symbols, graphic devices, or caloric/nutrient density indicators) can affect future regulatory policy.
Q: What research does FDA recommend to better understand the potential for FDA regulated products unintentionally to contribute to or result in obesity?
A: In general, for both foods and drugs, weight gain or obesity has not consistently been measured, evaluated, or considered as an adverse effect in the design of study protocols or the evaluation of research results. Strategies to systematically evaluate this effect are needed as part of the safety assessment for FDA-regulated foods and drugs.
The OWG report recommends conducting research to investigate (1) the promotion of weight gain as an adverse side effect of FDA-regulated drugs and whether it is a factor that should be taken into account regarding drug safety, and (2) the development of animal model assessment strategies that encompass the evaluation of long-term effects on weight gain as a safety assessment parameter.
See also Questions and Answers on the Keystone Forum Report on Away-From-Home Foods: Opportunities for Preventing Weight Gain and Obesity June 2, 2006
