July 30, 2003

Department of Health and Human Services

Secretary's Roundtable on Obesity/Nutrition

Wednesday, July 30, 2003

10:00 a.m. -- 12:00 noon

Washington, D.C.

Public Docket 2003N-0338

The Department of Health and Human Services (HHS) has established a
public docket

2003N-0338 to receive additional information, perspectives, and
suggestions from participants who attended the Secretary's Roundtable on
Obesity/Nutrition on July 30, 2003.

Obesity is a growing and urgent public health problem in the United
States. To address this problem, HHS Secretary Tommy G. Thompson has led
the Department in its efforts to encourage healthy habits such as
healthy diets, more exercise, and making healthy choices. Secretary
Thompson continues to challenge HHS agencies and the leadership of the
public health

community to intensify their efforts to realize these improvements. The
Secretary's Roundtable on Obesity/Nutrition is intended to enhance an
HHS discussion with leading thinkers and experts in the public health
community on the role that HHS can play in reducing or reversing the
weight gain that leads to obesity. The Roundtable agenda included the
following five focus questions:

1.  What is the available evidence on the effectiveness of various
    education campaigns to reduce obesity?

2.  What are the top priorities for nutrition research to reduce obesity
    in children?

3.  What is the available evidence supporting whether public efforts
    should prioritize behavioral interventions to prevent obesity versus
    medical interventions to treat obesity?

4.  What changes to food labeling could result in the development of
    healthier, lower calorie foods and the selection of healthier, lower
    calorie foods by consumers? What opportunities exist for the
    development of healthier foods/diets and what research might best
    support the development of healthier foods?

5.  Based on the scientific foundation available today, what is the one
    thing that HHS could do that would make a significant difference in
    efforts to address the problem of obesity?

The Department has opened public docket 2003N-0338 to receive additional
information, references, or thoughts from Roundtable participants in
follow up to the July 30 discussion. We would appreciate receiving all
follow up information and views by *Tuesday, September 30, 2003*. You
should submit written comments to the Dockets Management Branch
(FDA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061,
Rockville, MD 20852. You may also submit comments electronically to
<http://www.fda.gov/dockets/ecomments> or by email to
<FDADOCKETS@oc.fda.gov> We request that you submit two copies of any
written comments; individuals may submit one copy. Please ensure that
you include the docket number 2003N-0338 in your submission. All
comments submitted to the public docket are public information and may
be posted to the FDA website ([http://www.fda.gov](http://www.fda.gov/))
for public viewing.

NAASO Public Affairs Committee -- Secretary's Roundtable on
Obesity/Nutrition

Public Docket 2003N-0338

Submitted by: Louis Aronne, MD Chair

Gary Foster, PhD

Karen Segal, PhD

Melinda Sothern,

William Dietz, MD

September 30, 2003

1.  What is the available evidence on the effectiveness of various
    education campaigns to reduce obesity?

At present, there is no evidence that any given education campaign is of
use in reducing obesity. Any educational campaign which is implemented
should have an attached research component in order to begin to answer
this important question.

2\. What are the top priorities for nutrition research to reduce obesity
in children?

1.  [Develop a better understanding of parental attitudes towards
    childhood obesity, the criteria by which parents define children as
    "obese," and parents' perceptions of the medical complications of
    childhood obesity]{.underline}. Existing research demonstrates that
    behavioral treatments for obesity in children can be effective,
    particularly when parents are involved. Lack of parental involvement
    presents enormous clinical challenges, as parents are the active
    agents of change (especially with young children). However, research
    and clinical experience suggests that many parents fail to define
    "overweight" children as being overweight and do not appreciate the
    problem. The reasons for this are poorly understood (cultural?;
    shame?; different criteria for defining obesity?). NIH studies of
    child weight control tend to recruit to most compliant and
    well-functioning families, who already perceive the problem.
    Research is needed to these issues. [Such research would ultimately
    lead to a better understanding of mechanisms for increasing the
    motivation of parents / families to perceive the problem and to
    enact changes]{.underline}.

2.  [Modifying and integrating existing behavioral treatment packages
    for "real world" pediatric offices and clinical
    settings]{.underline}. The most effective behavioral treatment
    packages place extensive requirements on families that are not
    practical for many families. By contrast, families have regular
    contact with their pediatricians especially during early childhood.
    Modifying and tailoring existing and efficacious interventions for
    clinical practice has not been attempted to date. Included under
    this topic is a more active role of pediatric nurses, who have much
    greater contact with families than physicians or school
    psychologists.

[Research into the development of comorbidities that co-occur with
childhood obesity. More specifically, what genetic and/or lifestyle
factors predict those children who will vs. those who will not have
comorbidities]{.underline}? Although an increasing number of studies
document comorbidities in obese vs. non-obese children, there is
considerable variability among obese children. There is currently
limited knowledge of those factors (e.g., genetic, body comp, lifestyle)
that increase the risk of vs. protect against comorbidity onset.

3\. What is the available evidence supporting whether public efforts
should prioritize behavioral interventions to prevent obesity versus
medical interventions to treat obesity?

Obesity prevention and treatment should both be supported by public
effort at the present time. Although focusing on prevention of obesity
would be optimal because it seems easier to accomplish than weight loss,
the fact that almost 2/3 of the adult population is overweight or obese
means that many Americans will be remain at excess risk of developing
comorbidities if no effort is made to treat their obesity.

Evidence from the NIH funded Diabetes Prevention Program has shown that
a weight loss of 7%, with 4% maintained after 4 years, reduced the risk
of developing Type 2 Diabetes by 58%(Diabetes Prevention Program
Research Group, 2002). A more recent study showed that further
reductions could be achieved with greater weight loss resulting from the
addition of pharmacologic therapy to dietary and behavioral
management(Sjostrom, IASO presentation, 2002).

Treatment of obesity is not currently a covered benefit, even for
patients with severe comorbidities unless bariatric surgery is
indicated. This is perhaps the result of bias against obesity, which
many still believe is a cosmetic problem caused by the gluttony and
sloth of the obese. Our current understanding of body weight regulation
clearly shows that obesity, like diabetes, hypertension, and
hyperlipidemia, is a disorder of a regulatory mechanism of the human
body. Once established, obesity should warrant the same treatment we
deliver to those with its comorbid conditions.

Development of obesity prevention programs is a worthy long-term goal.
Selective interventions in high-risk individuals have met with some
success compared to no treatment, but large scale trials have not been
performed. Obesity prevention should be a priority for research funding,
with the results applied in the future to community-wide programs.

4\. What changes to food labeling could result in the development of
healthier, lower caloric foods and the selection of healthier, lower
calorie foods by consumers.

Since 1970 marketplace food portions have increased in size and exceeded
federal standards (Young & Nestle, 2003). The Food and Drug
Administration (FDA) defines standard servings for food labels and the
United States Department of Agriculture defines standard serving size
for dietary guidance. Most portions of marketplace food items are double
that recommended by federal standards and, in some cases, are eight
times more than recommended amounts (Young & Nestle, 2003). This
increase in food portion size parallels the rise in the prevalence of
obese adults in the U.S. (Young & Nestle, 2002). In the past decade,
portion sizes of energy dense foods and beverages have increased
worldwide, as well, prompting researchers across the globe to promote a
focus on portion size in dietary guidelines and food labeling practices
(Matthiessen, et al, 2003; Young & Nestle, 2002). From 1984 to 1994
Americans, in particular, increased their caloric intake by an average
of 340 kilocalories per day (McCrory, et al, 2002). Athough research
continues in this area, there is sufficient data to suggest that
increased portion size is a contributing factor to the worldwide obesity
epidemic (Rolls, 2003; McCrory, et al, 2002). Studies show that both
adults (Rolls, et al, 2002) and children (Orlet Fisher, et al, 2003)
consume 30% and 25%, respectfully, more energy when given access to
large versus small food portions. Available data indicate that children
regulate their energy intake by adjusting portion size, as opposed to
increasing the number of eating occasions (McConahy, et al, 2002).
Studies also suggest that children who are allowed to determine serving
size consume fewer calories (Orlet Fisher, et al, 2003).

Current U.S. public policy allows manufacturers to package snack foods
in portion sizes 2.5 times that which is appropriate for young children
(Young & Nestle, 2003). In some states, school--aged children have daily
access to self-selecting snack portions in vending machines that are
more than twice recommended amounts for age (Hill, et al, 2002). Thus,
larger food portions may be one factor that helps to explain the
increased prevalence of childhood obesity, which is associated with a
2.4 increased risk for elevated cholesterol (Nicklas, 2001; Rolls,
2003). Since the economic burden of obesity-associated illness during
childhood has increased by 43% in the past 2 decades (Wang & Dietz,
2002), public health efforts that address portion control are essential
to curbing the growing epidemic of childhood obesity. Public policy that
requires the portion size of snack foods to comply with FDA standards
for single servings may have a significant impact on the morbidity and
economic burden of childhood obesity. Thus, research supports portion
control strategies, such as altering nutrition labels on marketplace
items and enforcing single serving packaging, to promote decreased
caloric intake and a reduction in the prevalence of obesity in adults
and youth (Bray, et al, 2003; Young & Nestle, 2003; Rolls, 2003).

5\. Based on the scientific foundation available today, what is the one
thing that HHS could do that would make a significant difference in
efforts to address the problem of obesity?

We believe that in the long run, making obesity research a priority, and
funding it at substantially higher levels than today is the best way to
make a significant difference in our efforts to address the problem of
obesity. We want to do something, but given the difficulty we have
experienced in treating obesity, what should we do? We need to
understand some of the basic steps in metabolism. What factors determine
whether excess nutrients will be stored or burned? How does a fat cell
know how much fat to store? What are the driving forces that lead to
weight regain after weight loss? It is critical for HHS to promote
research at all levels, from clinical to behavioral to basic if we are
going to solve the problem of obesity. As with the other chronic
diseases that predominate medicine, research will make inroads that will
ultimately lead us to the answers.

Finally, we must pass on to you one action item, contributed by Dr.
David Ludwig, Director of the Obesity Program at Children's Hospital in
Boston:

"Restrict food advertising to children. Approximately \$10 billion is
spent each year attempting to influence the eating patterns of children,
overwhelming for soft drinks, fast food, and other high calorie, poor
quality products. This figure dwarfs HHS expenditures to encourage a
healthful diet by a factor of 10,000 to 1. There is substantial evidence
(reviewed in: Ebbeling, Pawlak, and Ludwig, *Childhood obesity:
public-health crisis, common sense cure* , Lancet, 2002) that children
who see food ads tend to request the featured items, and eat less
fruits, vegetables and whole grains. Interestingly, the well-documented
relationship between television viewing and obesity may be largely
mediated by advertisement-influenced alterations in eating habits,
rather than changes in total activity level per se. Finally, the
American Academy of Pediatrics is on record as having said that
advertisement to young children is inherently manipulative and
unethical".