Questions and answers: The Food and Drug Administration's (FDA) obesity working group report
- Food Labeling
- Enforcement Activities
- Education Partnerships
- Reserach Activities
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
Q: Why is FDA concerned about obesity?
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'
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.
Q: What is the answer to fighting obesity?
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
Q: What is the focus of FDA's recommendations?
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
Q: What are the OWG report recommendations?
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.
Q: How will the OWG recommendations be implemented?
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.
Q: In what way does FDA's report focus on children?
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
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."
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.")
Q: Why is serving size information on the NFP important?
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.
Q: What actions is FDA considering regarding
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
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.
Q: What are RACCs?
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
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
A: Under the law, FDA has 90 days to respond to the petitions that were filed on
March 11, 2004.
Q: Will FDA certify weight-loss diet plans or programs?
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
Q: Why are accurate serving sizes important?
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
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
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
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.
Q: What does the 1996 draft guidance document
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
Q: What about surgery as an option to treat obesity?
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)
Q: Is FDA conducting research on obesity?
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.
Q: What research efforts does the OWG report
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
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.