ADA submitted comments on two proposed rules from the FDA modifying the Nutrition Facts label that appears on most packaged foods in the United States and gives consumers information on the nutritional content of the food. The FDA is proposing changes to the content and layout of the Nutrition Facts label.

1. National Office
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Diabetes Information
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June 4, 2014
Philip Spiller
Acting Director
Food and Drug Administration
Center for Food and Safety and Applied Nutrition
Office of Nutrition, Labeling, and Dietary Supplements
5100 Paint Branch Parkway
College Park, MD 20740
Dear Acting Director Spiller:
On behalf of the nearly 26 million Americans living with diabetes, and 79 million more with prediabetes,
the American Diabetes Association (Association) appreciates the opportunity to submit comments on the
Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion;
Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments (FDA 2004-N-0258, RIN 0910-
AF23) proposed rule.
A healthful eating pattern, regular physical activity, and often pharmacotherapy are key components of
diabetes management. For many individuals with diabetes, the most challenging part of the treatment
plan is determining what to eat. The Association recommends each person with diabetes be actively
engaged in self-management, education, and treatment planning with his or her health care provider,
which includes the collaborative development of an individualized eating plan.1
There is not a “one-size-
fits-all” eating pattern for individuals with diabetes. However, healthful eating patterns, and emphasizing
a variety of nutrient dense foods in appropriate portion sizes, are key components of overall health for
people with and at risk for diabetes. Specifically, healthful eating helps people with diabetes attain
individualized glycemic, blood pressure, and lipid goals; achieve and maintain body weight goals; and
delay or prevent complications of diabetes. In addition a healthy diet and weight loss are key factors in
preventing the onset of type 2 diabetes, even in individuals at the highest risk. Studies show individuals at
high risk for developing type 2 diabetes may be able to reduce their risk of progression to type 2 diabetes
by 58% with modest weight loss through a healthy, low-fat, low-calorie diet and increased physical
activity.2
Accurate and easily understandable food labels are essential in ensuring individuals with and at risk for
diabetes are able to follow their individualized eating plans and achieve their daily nutrition goals. As
such, the Association is pleased the Food and Drug Administration (FDA) has released this proposed rule
to guarantee serving sizes are based on current consumption data, and to provide consumers with serving
size information that will help them maintain healthy dietary practices. The Association applauds FDA
for using data from the National Health and Nutrition Examination Survey to determine amounts actually
consumed as the basis for these Reference Amounts Customarily Consumed (RACC) revisions, and for
RACC: The amount the average person is likely to eat at once.

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ensuring the recommended changes are based on science. We respectfully offer these comments and
recommendations to further improve the regulations.
Single-Serving Containers
The Association strongly supports the proposed revision of the definition of a single-serving
container requiring all foods packaged for individual sale containing less than 200% of the
applicable RACC to be considered a single-serving container and be labeled as one serving. In the
U.S., data compiled by the Centers for Disease Control and Prevention and the National Center for Health
Statistics show that total caloric intake increased from 2,450 kcal/day in the 1970s to 2,656 kcal/day in
the 2000s in males age 20 and over, and increased from 1,542 kcal/day to 1,811 cal/day in females age 20
and over during the same time period. Similarly, daily caloric intake for children increased during this
time as well. Portion size increases likely have contributed in part to the excess calorie intake seen in the
last few decades. Consumers may not understand that a package of food which seems packaged to be
eaten in one sitting is more than one serving. Ensuring the Nutrition Facts label information reflects
actual consumer eating habits will help individuals fully understand the nutritional content of the food
they are consuming.
In addition, as FDA mentions in the preamble to this proposed rule, many people may misunderstand the
serving size information on the Nutrition Facts label to be a recommendation of how much of a food to
eat. As such, it is imperative FDA conduct extensive consumer education regarding all proposed changes
to the Nutrition Facts label and the underlying calculations used to determine the quantities presented on
the labels. Without public education, consumers may not fully understand the meaning of that information
and may use it improperly.
Dual Column Labeling
The Association supports the proposed requirement that products packaged and sold individually
containing between 200% and 400% of the applicable RACC include an additional column within
the Nutrition Facts label with the quantitative amounts and percent daily values for the entire
container, in addition to the amounts for the serving size derived from the RACC. Since we know
some consumers may eat a full package of food regardless of its serving size, those consumer must be
able to easily understand the nutrition content of the full package of food as consumed.
In regard to the options FDA presented for the content of the Nutrition Facts label for the entire
container, the Association strongly urges FDA to require full nutrition information per serving and
per container. Because individuals with and at risk for diabetes have varying nutritional requirements to
maintain their health, access to the full nutritional information for a serving as well as the entire container
is necessary. However, if the FDA’s research determines consumers will be more inclined to use a dual
column labeling for a smaller set of nutrients, it is imperative that set of nutrients includes total
carbohydrates, as well as calories, saturated fat, and sodium.
People with diabetes have a particular interest in the way carbohydrates affect glycemic control and also
the way it affects their need for medications, particularly insulin. A key strategy in achieving glycemic
control for individuals with diabetes is monitoring their carbohydrate intake, including by carbohydrate
counting (grams of carbohydrate or carbohydrate choices). Glycemic control is imperative to avoid the

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physically devastating and costly short- and long-term complications of diabetes. As such, it is essential
that individuals with diabetes are able to accurately determine the carbohydrate content of the foods they
consume. Total carbohydrates must be included in both columns of nutrition information on
packages requiring dual columns.
The Association is strongly opposed to FDA’s proposal to exempt from the dual-column labeling
requirement products containing between 200% and 400% of the applicable RACC that require
additional preparation and voluntarily include two columns of nutrition information on the “as
purchased” and “as prepared” forms of the food. Nutrition information on the “as purchased” form of
food requiring additional preparation is not necessary, as consumers are highly unlikely to consume the
food as packaged. As such, we recommend FDA modify the regulations for all foods requiring additional
preparation to make inclusion of nutrition information on the “as prepared” form of the food required, and
information on the “as purchased” form of the food voluntary. In addition, we recommend foods
requiring additional preparation not be exempt from the dual column labeling requirement. These
changes would ensure the Nutrition Facts label on foods containing between 200% and 400% of the
applicable RACC and requiring additional preparation supplies all of the necessary nutrition information
for an individual who eats one serving of the prepared food, and for an individual who eats the entire
container of the prepared food.
In addition, the Association supports the proposed requirement that health claims for products with dual-
column labeling include a statement that sets forth the basis of the claim, including the amount of the
nutrient contained in a serving. We also support the proposed requirement that if the serving size on the
Nutrition Facts label is different from the applicable RACC, and the amount in the labeled serving does
not meet the requirements for a health claim, the claim must be followed by the criteria for the claim.
However, the Association strongly urges the FDA to ensure a product cannot contain a health claim
if a consumer has to eat larger servings than recommended in the Sample Meal Patterns for the
USDA Food Pattern at the 2,000 calorie level in order to achieve the benefit of the claim.
Reference Amounts Customarily Consumed
The Association is pleased the FDA used current consumption data to determine whether to modify
or add any RACCs. Many consumers do not typically measure the food they consume to ensure they are
eating only one serving. Adjusting the RACC for these products to reflect average consumption helps to
ensure individuals are aware of the nutritional content of the actual amount of food or beverage they
consume without measuring or calculating totals themselves. As previously discussed, people with
diabetes must have accurate nutrition information in order to manage their disease. Unfortunately, many
adults have limited numeracy or quantitative literacy skills. According to one study, over half of U.S.
adults are estimated to have Basic or Below Basic quantitative literacy skills.3
Ensuring the information
provided in the Nutrition Facts label reflects average consumption levels of foods and beverages
minimizes the need for mathematical calculations to determine nutrition information when a person
consumes more than one serving.
However, as previously discussed, research has found that people tend to eat more when the portion size
or serving container is larger.4
As such, we urge FDA to conduct consumer education to ensure these

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changes to the RACCs are not misunderstood by consumers as recommendations to consume larger
portions.
Conclusion
The American Diabetes Association appreciates the opportunity to provide comments on this proposed
rule. We are pleased the FDA has considered data regarding current consumer eating habits to inform the
proposed changes to the serving sizes and RACCs for certain foods. These changes and the
recommendations discussed in this letter, combined with robust consumer education will help ensure the
Nutrition Facts label on packaged foods provides accurate and easily understandable information to help
individuals with and at risk for diabetes follow their individualized eating plans, achieve their daily
nutrition goals and maintain their overall health.
If you have any questions, please contact Dr. LaShawn McIver, Managing Director Public Policy and
Strategic Alliances, at lmciver@diabetes.org or (703) 299-5528.
Sincerely,
Shereen Arent
Executive Vice President
Government Affairs & Advocacy
American Diabetes Association
1
Evert AB, Boucher JL, Cypress M, et. al, Nutrition Therapy Recommendations for the Management of Adults with
Diabetes. Diabetes Care, January 2014.
2
DPP Research Group, Reduction in the Incidence of Type 2 Diabetes with Lifestyle Intervention or Metformin,
New England Journal of Medicine, February 2002.
3
National Center for Education Statistics, Literacy Skills of Adults, by Type of Literacy, Proficiency Levels, and
Selected Characteristics: 1992 and 2003. Per Footnote 2: “Quantitative literacy refers to the knowledge and skills
required to identify and perform computations, either alone or sequentially, using numbers embedded in printed
materials. Adults at the Below Basic level, rated 0 to 234, range from being nonliterate in English to being able to
locate numbers and use them to perform simple quantitative operations (primarily addition) when the mathematical
information is very concrete and familiar. At the Basic level, rated 235 to 289, adults are able to locate easily
identifiable quantitative information and use it to solve simple, one-step problems when the arithmetic operation is
specified or easily inferred.” Available at: https://nces.ed.gov/programs/digest/d12/tables/dt12_450.asp.
4 Just
DR,
Mancino
L,
Wansink
B,
“Could Behavioral Economics Help Improve Diet Quality for Nutrition
Assistance Program Participants?” Report Number 43. Washington, DC: U.S. Department of Agriculture,
Economic Research Service, June 2007.