From: Brian Williams [brian.williams@heart.org]
Sent: Friday, November 21, 2003 1:53 PM
To: 'FDADockets@oc.fda.gov'
Subject: Docket No. 2003N-0338 - Obesity Questions

American Heart Association Response to Questions Posed at FDA Public Meeting
on Obesity

Docket No. 2003N-0338

Federal Register Notice. October 8, 2003.

The October 23, 2003, meeting of the FDA's Obesity Working Group focused on
the following six (6) questions:

FDA: (1) What is the available evidence on the effectiveness of various
education campaigns to reduce obesity?

AHA:  Very few programs have focused on obesity prevention and some that
have had limited sample sizes and limited follow-up; thus the evidence for
the effectiveness of programs is limited. In a review of school-based
studies  to prevent obesity, Story (1999) reported that all of the studies
included both physical activity and nutrition education.  The results of the
school-based treatment programs were encouraging and showed positive but
modest, short-term results.  It was noted that intervening with children in
the pre-adolescent phase resulted in more success than when intervening
during the teenage years.  Three major components were recommended for use
in intervention programs:  classroom for health education, the school food
service, and physical education programs.  Most successful programs include
an emphasis on physical activity, often using dance among young females.
There are promising programs currently being conducted, for example the
community-based obesity prevention program for minority children called
Hip-Hop to Health Jr. is targeting preschool African-American and Latino
children in Chicago (Fitzgibbon et al, 2002).  Knowing the difficulty that
one faces in the treatment of obesity, it is advantageous to begin with
primary prevention.  Pre-school programs such as Head Start and K through 9
can take a population-based approach and use the schools to reduce the
number of children who become obese.

It is worth noting that programs that target cardiovascular disease (CVD)
target similar aspects of lifestyle and behaviors.  Two successful CVD risk
reduction programs were school-based and longer in length and warrant review
(Van Horn et al, 1994; the DISC Writing Group, 1995; Luepker et al, 1996).
The DISC Study included seeing elementary level school children with their
family and also telephone contacts in the second and third year. The CVD
risk reduction program reported by Luepker included school food based
service, physical education with physical activity comprising 40% of the
physical ed class, and a classroom curricula.  The DISC study lasted 3 years
and showed significant differences in fat intake between the treatment and
control groups, while Luepker also reported significant differences in fat
and cholesterol consumption among intervention group students in a large
sample that crossed four states.  

Weight loss to improve cardiovascular health is a high priority of the
American Heart Association because approximately 65% of the population is
overweight or obese. 

There is a great deal of public, commercial, and medical interest in
promoting long-term weight loss programs.  Several studies using behavioral
interventions and strategies to enhance compliance to weight loss treatment
show what measures are effective for losing weight and weight maintenance,
as long as the subjects continue to participate in active intervention, such
as a regular exercise regimen.  Long-term follow-up shows that physical
activity and exercise is the most important determinant of weight loss
maintenance. However, the biggest issue in these programs is that they are
time limited and the individual needs to maintain the lifestyle changes
without the support of the study team or others, which often results in
recidivism.   This highlights the issue of long-term care of a chronic
disorder.  Individuals who have been successful in losing weight are left on
their own to maintain that loss.  One can not refer them to a physician
because this problem is usually not addressed in medical practice.  Survey
have shown that less than 50% of physicians discuss physical activity and
diet with their overweight or obese patients, nurse practitioners are no
better in addressing this problem.  Without regular follow-up, patients slip
back into their previous habits and regain the weight.  This pattern
suggests that educating health care professionals on how to intervene with
patients facing a weight control problem may have an impact, especially with
the continuous increase in the prevalence of overweight and obesity.
Physicians relate that they do not feel comfortable discussing it and also
that they are not reimbursed for their services of dietary counseling.  This
suggests two campaigns that could be undertaken, first, similar to the
Cholesterol Education Program of the 1980's, we could develop an education
campaign targeting health professionals and educating them how to manage
this problem in everyday practice.  The fact is that addressing weight
control and weight management indirectly addresses dyslipidemia, diabetes
prevention, hypertension management and numerous other CVD risk factors.
This type of educational campaign has not been tried with obesity but was
successful in the improved management by physicians and nurses in
hypercholesterolemia.  

The second campaign that needs to be conducted is a movement towards
reimbursement for preventive services, which includes counseling about
eating and exercise habits.  Improving health professionals' skills to
deliver the service and providing incentives for the delivery of care could
have a major impact on the long-term management of this disorder.

Also, the FDA can build on the knowledge that has been gained from the
studies of behavioral weight loss and of professional education programs.
These studies show the strong influence of the environment on eating and
exercise behaviors.  Thus, we need to develop major public education
campaigns to educate the public about healthful eating and exercise habits
and the threats associated with obesity, similar to what has been done in
the past with hypertension and hypercholesterolemia.  

The AHA believes that some general, common-sense guidelines can serve as a
basis for recommendations to the general public. We believe that the
essential components of a safe and effective weight management program are:

Participant/patient information (informed consent)
Screening of all persons beginning a weight management program by use of an
appropriate medical history form to identify people who require a
physician's supervision
Guidelines for those who need to be evaluated by a physician before
beginning a weight management program
Staffing by individuals qualified by education, training, and experience to
provide these services
Identification of reasonable weight loss goals
Individualized nutritional, exercise, and behavioral components as needed
with the major part of treatment conducted through the group process
A maintenance program for at least 2 years

Evaluation of the long-term effectiveness and safety of the program by
review of weight loss and health status of all participants after completion
of the program and at 1, 2, and 5 years after program completion (i.e., data
on the number of participants who begin the program, the number who complete
the program, and participants' weight and health status [blood pressure,
blood lipids, and any health complications] should be reported, stratified
by gender, at these intervals; information on the number of participants who
restart the program should be reported separately)

Participants in most weight loss programs meet once a week during the
initial phase, which generally lasts from 12 to 24 weeks. Because
participants should be followed up for a full year, 12 contacts during the
first year appears to be a reasonable minimum number of contacts.

FDA: (2) What are the top priorities for nutrition research to reduce
obesity in children?

AHA: Although only about 1/3 of adult obesity begins in children, childhood
overweight is a significant problem in modern society. Among the many areas
of nutrition research which are helping to explain the dramatic rise in
childhood overweight, we believe the Food and Drug Administration can more
closely examine the effect of food and beverage marketing and advertising on
children. Coupled with increased television viewing time, as well as time
spent on the internet, we believe the "face time" of food and beverage
marketers with children has had an effect on the eating habits of children
and families. Other top priorities for nutrition research should include
examining school feeding programs, physical education programs, and
nutrition education classes that teach lifelong skills in nutrition and
physical activity.

FDA: (3) What is the available evidence that FDA can look to in order to
guide rational, effective public efforts to prevent and treat obesity by
behavioral or medical interventions, or combinations of both?

AHA: In addition to the recommendations provided in response to question #1,
the American Heart Association has been intrigued by the recent efforts of
the Centers for Disease Control and Prevention to use mass media to effect
behavior change. The Youth Media Campaign is a nation-wide media campaign
aimed at pre-teen children. It is designed to encourage physical activity.
The campaign is called: VERB, it's what you do. Likewise, the food and
beverage industry spends billions of dollars in mass media designed to
encourage product purchase. Virtually all of the largest U.S. corporations
use media as a way to change consumer behavior. We believe mass media has
been largely ignored by the government (and other organizations interested
in public health) as a way to prevent and treat obesity.

FDA: (4) Are there changes needed to food labeling that could result in the
development of healthier, lower calorie foods by industry and the selection
of healthier, lower calorie foods by consumers?

AHA: The American Heart Association believes that the upcoming addition of
trans-fat to the food labeling requirements will provide additional valuable
information to consumers who are trying to make healthy choices. A recurring
concern of the American Heart Association and others is the inconsistency of
the required food labels and other federal government nutrition education
tools, such as the Food Guide Pyramid. Furthermore, the Nutrition Fact Panel
itself is often confusing and difficult to interpret. The Fact Panel often
forces consumers to calculate the nutrition information by multiplying with
the number of servings. For instance, a bottle of juice from a vending
machine indicates 130 calories, but consumers must multiply 130 by the
number of servings in the bottle, which is often 1.5 or 2 or more.
Therefore, the total calories for the entire package as well as for a
serving size should be included. Other innovative labeling ideas might
include adding the amount of physical activity needed to burn the calories
contained in the food product.
One might also consider adding some footnotes to explain some of the items
on the label, as well undertaking a public education campaign to inform the
public about how to read the food label.  Making the label itself larger and
possibly more prominent on the package may help the public to pay more
attention to its contents.  In order to achieve improved portion size
control, it might be emphasized on the package when it contains more than
one serving.

The FDA should consider taking the labeling of foods beyond the package, for
example, have major chain restaurants include nutrient content on the menu,
and have hospitals and other large institutions include information on the
food that is being served in the cafeteria food line.  

FDA: (5) What opportunities exist for the development of healthier
foods/diets and what research might best support the development of
healthier foods?

AHA: Several newer technologies used by some food manufacturers should find
more and better ways to make healthier foods. As we learn more about
flavonols, phytochemicals, and so forth, opportunities should exist for
manufacturing more foods with these components. Challenges and opportunities
continue to exist for food technologists to produce food with less sodium,
but which taste good. Similarly, new technology should prompt food
manufacturers to make more trans-fat free foods. Furthermore, food
manufacturers can determine which foods lend themselves to supplementation
with vitamins and minerals while assuring the safety of the resultant
product. Achieving these goals requires preliminary research to determine
whether it is attainable, whether it is safe, and whether it is acceptable
to the consumer. Making foods more healthful often alters their taste, which
implies that the FDA needs to support research into taste. Since we are such
a diverse population, food manufacturers have the opportunity to develop
tastier and more healthful food products for different ethnic groups.
Finally, the FDA can do more consumer research designed to determine what
would motivate consumers to choose healthful foods.

FDA: (6) Based on the scientific evidence available today, what are the most
important things that FDA could do that would make a significant difference
in efforts to address the problem of overweight and obesity?

AHA: Obesity is clearly an emerging epidemic that must be addressed.
Examining cultural, social, and behavioral trends, and finding ways to
educate Americans about healthy eating and physical activity should be a top
priority of the FDA. Providing more information to consumers and educating
consumers about the meaning of food content, calories, and so forth, will
empower consumers to make healthy choices. Understanding the relationship
between food intake and energy expenditure will also help consumers make
healthy choices.
In addition, studies have shown repeatedly the importance of physical
activity.  Studies conducted outside the health care arena have shown the
impact of the community on physical activity, for example the impact of poor
and unsafe neighborhoods, suburbs without sidewalks, communities without
pedestrian walkways or overpasses, conditions that force individuals to not
exercise for safety reasons.  The FDA could facilitate the convening of
multiple groups, from city planners and building architects to food industry
representatives, to address this problem at the societal level since that is
where a big part of  the solution lies in the prevention of obesity and in
the maintenenance of weight loss among those successful in having reduced
their weight.