National Office 1701 North Beauregard St. Alexandria, VA 22311 703.549.1500

Diabetes Information 1.800.DIABETES (1.800.342.2383) www.diabetes.org

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

2

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

3

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

4

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.