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November 13, 2023

Food and Drug Administration

Department of Health and Human Services

Attn: FDA-305

Docket# 2003N-0338

5630 Fishers Lane

Room 1061

Rockville, MD 20852

Dear Sir or Madam:

The American Dietetic Association (ADA) represents nearly 70,000 food
and nutrition professionals serving the public through the promotion of
optimal nutrition, health and well being. ADA appreciates this
opportunity to respond to questions posed by the Secretary's Roundtable
on Obesity/Nutrition and complement input provided by Susan Cummings,
RD, an ADA representative at the Department of Health and Human
Services' (HHS) July 30 discussion.

### General Comments

ADA is the nation's largest association of food and nutrition
professionals, guided by a reliance on sound science and evidence-based
practice. ADA members' unique education, supervised practical
experience, national registration examination and mandated continuing
professional education equip them to collaboratively identify, prevent
and treat obesity and its health consequences at all stages of the life
span and in a myriad of educational, community, medical, commercial and
research environments. Dietetics professionals translate complex
nutrition principles into a vast array of healthful and appealing food
options for millions of Americans daily. At nearly every level where
professionals and institutions attempt to deal with the health and
social consequences of obesity, dietetics professionals work both
individually and as part of teams to find individual and national
solutions to the problem.

ADA applauds HHS leaders for continuing the national dialogue on
obesity. The long term consequences of this alarming and growing
epidemic requires action now to turn the tide of the trends, help
individuals who have become overweight or obese manage their conditions
to achieve better health, and actually prevent overweight and obesity
among children, adolescents and adults.

Lifestyles that support and sustain the maintenance of a healthy weight,
for both individuals and the population as a whole, are a major focus of
ADA and its members. Data from the Centers for Disease Control and
Prevention (CDC) show that in the last 20 years, obesity rates have
increased, and more than 60 percent of American adults are classified as
overweight or obese. Perhaps more troubling is that rates have doubled
in children and tripled in adolescents since 1980. The rapid rise in the
prevalence of overweight and obesity among all segments of the U.S.
population is of grave concern, as the health and quality of life of
those afflicted plummets and health care costs and societal burdens
continue to soar.

Any meaningful attempts to address the obesity epidemic must take into
account the complex and pervasive nature of the problem. In the enclosed
ADA White Paper, five key premises for addressing obesity are
identified:

-   Obesity is a complex, multifactorial chronic disease state involving
    interactions between genetic, physiological, psychological,
    metabolic and environmental influences.

-   Both obesity/overweight prevention and treatment strategies are
    needed. Nutrition education for children and parents is the best
    long-term strategy for prevention and treatment of obesity.

-   Prevention and treatment of obesity/overweight must be addressed in
    a multidisciplinary team approach.

-   The nature and depth of work required to effectively intervene on an
    individual or community basis will require resources beyond those
    routinely provided today for promoting healthy lifestyles.

-   Public and private initiatives are needed to combat factors that
    contribute to the increase in obesity.

With these guiding statements in mind, several strategies should be
considered as means to address obesity.

#### Allocation of Resources

Critical to the issue of obesity is the allocation of adequate
resources. Unless the U.S. government and private sector entities find
ways to pay for research, education, intervention and health care
related to overweight and obesity, the outcomes will be predictable---we
will not make the necessary progress to have a healthy population in the
coming years. Obesity-related conditions will continue to consume a
large proportion of dollars spent on health care.

Funding for basic, translational and outcomes research is essential.

Resources must be committed to learn more about obesity as a highly
complex disease/condition, its etiology, and outcomes associated with
weight management. Advancements in the fields of biology, genomics,
psychology, pharmacology and nutrition as well as an understanding of
environmental factors, including economics, can lay the groundwork for
improved responses. Clinically useful outcome measures should be
developed to evaluate interventions. To achieve appropriate goals,
research is needed to support evidence-based practice and exploration of
economic incentives, as well as research for quality improvement
initiatives for successful prevention and treatment of obesity. Greater
funding should be directed to these and other facets of obesity in both
public and private research.

Another strategy that will require continued and additional resources
involves the identification of at-risk populations and definition of
factors contributing to the increased prevalence of overweight and
obesity. One method for accomplishing this is nutrition monitoring,
which is the tracking and benchmarking of what a population eats.
Through nutrition monitoring, data are collected that are vital to the
documentation of changes and in the development and implementation of
successful health and nutrition interventions. Funding for nutrition
monitoring through studies like the National Health and Nutrition
Examination Surveys has not kept pace with rising costs and inflation.
The data gleaned from this important program not only helps create and
enhance nutrition education and marketing campaigns, but also is used to
formulate nutrition labeling policies. ADA supports full funding of
these critical population-based studies.

**Designate obesity as a disease by federal agencies and insurers**

ADA urges that obesity be designated as a disease. This is a critical
first step to reverse this national epidemic. The designation would lead
to system changes for reimbursement and include sanctioned insurance
coverage for obesity treatment. This means that **all** categories of
obesity defined under the ICD-9 codes\-- not just surgical intervention
for the morbidly obese---but nutrition diagnoses, medical nutrition
therapy and other interventions would be covered.

Under the current health care reimbursement system, even the most
conscientious doctors calculate how they might screen and appropriately
refer for overweight/obesity in time frames of 90 seconds or less to
avoid spending time on a procedure that is not reimbursable.
Furthermore, most people afflicted by these conditions will never be
referred to a nutrition or other health care professional for a targeted
intervention. Appropriate recognition and subsequent reimbursement could
profoundly affect this process.

### Create and support nutrition education programs

Culturally appropriate, non-stigmatizing, and sensitive approaches are
needed, with the ability to gain access to programs and facilities
through numerous venues. Creative nutrition education programming should
be included in elementary and secondary schools' curricula, corporate
wellness, community and other programs appealing to a broad range of
individual interests.

### Promote healthy weight in children

ADA urges HHS to develop a comprehensive strategy for reducing the
number of overweight children, with particular emphasis on family and
community-based interventions that promote healthful eating practices
and daily physical activity. As effective programs and programmatic
elements are identified, family, school and community-based physical
activity and nutrition education efforts should be implemented and
expanded.

Research has shown that nutrition education early in life can positively
affect the choices people make with respect to diet and healthy
lifestyle practices as they grow older. One example of an existing
nutrition education program for children is Team Nutrition. This program
and its outcomes can be enhanced by the addition of a state-level
infrastructure and networking component to coordinate nutrition
education activities across child nutrition programs and conduct
evaluations to determine effectiveness and enhance program operations.
ADA is asking Congress to increase funding for Team Nutrition by \$50
million annually to fund the infrastructure component. HHS should
support efforts to expand and improve this program in the upcoming
reauthorization of the Child Nutrition Act.

**Conclusion**

No strategy to address obesity will be effective without adequate
funding. Public and private institutions both must assess needs and
direct resources appropriately. However, only the federal government has
the public mandate and resources to carry out research on human
nutrition needs, motivators, and biological, epidemiological, social and
environmental factors on a scale necessary to make a difference in this
tremendous problem.

Surgeon General Carmona, to an audience of ADA members in March 2003,
referred to obesity as "the terror within." Already, the total annual
cost of obesity in the U.S. is estimated to be \$117 billion and
growing. Yet, the IMPACT legislation currently under consideration in
Congress authorizes a mere \$60 million in funding to state and local
entities. Even if this legislation passes both chambers and is signed
into law, the appropriation of adequate funds is not guaranteed.
Resources deployed to address obesity must be allocated on a level more
closely aligned with the scope and impact of the problem.

ADA looks forward to a continuing dialogue with HHS, Congress and other
federal agencies on overweight and obesity, and we hope these comments
are useful as the agency moves forward with the development of
strategies to address this important public health issue.

Sincerely,

Marianne Smith Edge, MS, RD, LD, FADA

President