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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: Revision of the Nutrition and Supplement Facts Labels (FDA-2012-N-1210, RIN 0910-AF22) proposed rule. 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. 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,  emphasizing  a  variety of nutrient dense foods in appropriate portion sizes, are key in assisting individuals with diabetes to improve their overall health, and specifically to 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 is a key factor in preventing the onset of type 2 diabetes, even in individuals at high risk. Studies have shown individuals with prediabetes 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 The Association is pleased the Food and Drug Administration (FDA) has released this proposed rule to ensure the content and layout of the Nutrition Facts label helps individuals with diabetes and those at risk for developing diabetes maintain healthy dietary practices. The Association generally supports the changes FDA proposes, but respectfully offers these comments and recommendations to address key pieces of information which are of most importance to people with and at risk for diabetes.

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Added Sugars The  Association  strongly  supports  FDA’s  proposal  to  require  “added  sugars”  be  declared  on  the  Nutrition Facts label. There is great confusion in the general public between sugars added to food during processing and naturally occurring sugars. Eating a well-balanced diet, in addition to monitoring amounts of carbohydrate, is critical to people with diabetes. While it is true that naturally occurring sugars and added sugars have the same physiological impact, the difference is significant when considering dietary quality. Foods high in added sugars (such as sodas and sweets) are nutritionally inferior to foods high in naturally occurring sugar (such as fruit and milk). The need for Americans to consume less added sugar is represented in the 2010 Dietary Guidelines for Americans.3 Knowing how much added sugar a food or beverage contains is key in ensuring individuals are able to make dietary decisions to reduce their consumption. As such, the Association strongly supports requiring the declaration  of  “added  sugar”  on  the  Nutrition  Facts  label  to  ensure  individuals  with  and at risk for diabetes are able to follow the 2010 Dietary Guidelines for Americans. Increased  Prominence  of  “Calories” The  Association  supports  the  FDA’s  proposal  to  continue  to  require  "total  calories”  be  declared  on  the label and to increase the prominence of the calorie declaration. For overweight and obese adults with type 2 diabetes, reducing energy intake while maintaining a healthful eating pattern is recommended. In many cases, modest weight loss provides clinical benefits for individuals with diabetes. And as previously noted, weight loss is the key factor in preventing type 2 diabetes. To support individuals with diabetes and at risk for diabetes in selecting, preparing, and consuming foods and beverages with the appropriate number of calories to meet their needs for weight management, they must be able to easily see and understand the number of calories in a serving of a particular food or beverage. Therefore, we support  the  proposal  to  increase  the  type  size  for  both  the  “Calories”  heading  and  the  numerical  value  and  to require that the information be highlighted in bold or extra bold type. In addition to being able to easily identify the number of calories per serving, the Association believes it is also important for individuals with diabetes and those working to prevent diabetes to be able to easily identify and comprehend the serving size and number of servings per container. Therefore, we support the  proposal  to  increase  the  prominence  of  the  “Servings  per  container”  declaration  in  a  similar  manner  as  the  “Calories”  declaration. Replacing  “Total  Carbohydrate”  with  “Total  Carbs” The  Association  is  strongly  opposed  to  FDA’s  proposal  to  replace  “Total  Carbohydrate”  with  “Total  Carbs”  on  the  Nutrition Facts label. According to the preamble to this proposed rule, FDA is proposing this change as a means to maximize the amount of white space and maintain a simple format which enables the public to easily observe and comprehend the nutrition information presented. However, for individuals with diabetes, this change would result in confusion. 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 physically devastating and costly short- and long-term complications of diabetes. As such, it is essential

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that individuals with diabetes are able to accurately determine the carbohydrate content of the foods they consume. When learning about carbohydrate counting, millions of people with diabetes are taught to use either the grams of total carbohydrate to adjust insulin, or they can use carbohydrate “choices.”    A  carbohydrate  choice is defined as a serving of food that contains 15 grams of total carbohydrate. This is frequently referred to as a “carb  choice”  or  a  “serving  of  carb.”4 (See Appendix A). If the total carbohydrate content information  presented  on  the  Nutrition  Facts  label  is  labeled  as  “Total  carbs”  as  opposed  to  “Total  Carbohydrate”  it  could greatly  impact  individuals  with  diabetes’  ability  to  accurately  assess  the  carbohydrate content of their food and as such their ability to manage their diabetes will be negatively impacted. For example, if the Nutrition Facts  label  says  a  food  contains  5  “total  carbs,”  a  person  with  diabetes may interpret this to mean the food contains 5  “carb  choices”  and  therefore  contains  75 grams of total carbohydrate. Therefore we strongly urge FDA to continue to require the term “Total  Carbohydrate”  on  the  Nutrition  Facts label to avoid any confusion. The extra white space created by this change is not worth the great disservice this change would do for individuals with diabetes. Consumer Education The Association strongly believes a coordinated, multi-component consumer education campaign to promote and explain the new Nutrition Facts label is necessary to help consumers understand the information provided by the label and how they can use it to make healthier food and beverage choices. While it is important for all consumers to know about, understand, and use the revised Nutrition Facts label, the consumer education campaign should primarily target consumers who are least likely to understand and use the label, including low-income and low-education consumers more likely to suffer from many obesity- and nutrition-related chronic diseases, such as diabetes. The consumer education campaign should integrate with existing consumer education programs and initiatives, including SNAP-Ed, school-based nutrition education programs, and grocery store labeling and education initiatives. The education campaign should emphasize calories and serving sizes—since knowledge of both are important for rolling back the obesity epidemic—and nutrients that will be on the Nutrition Facts label for the first time, such as added sugars. Conclusion The Association appreciates the opportunity to provide comments on this proposed rule. We are pleased the FDA is proposing changes to the Nutrition Facts label to increase the prominence of the calorie declaration  and  require  declaration  of  “added  sugars.”    These proposed changes will help ensure the Nutrition Facts labels on packaged foods provide accurate and easily understandable information to help individuals with and at risk for diabetes follow their individualized eating plans and achieve their daily nutrition goals. However,  we  strongly  urge  FDA  to  reconsider  its  proposal  to  use  the  term  “total  carbs”  as  it will create confusion for consumers with diabetes.

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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 U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, December 2010. Available at http://www.health.gov/dietaryguidelines/dga2010/DietaryGuidelines2010.pdf. 4 National Agricultural Library, Carbohydrate Counting and Exchange Lists, U.S. Department of Agriculture, May 2014, available at http://fnic.nal.usda.gov/diet-and-disease/diabetes/carbohydrate-counting-and-exchange-lists.

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Appendix A Excerpt  from  “Count  your  Carbs:  Getting  Started”  

by the American Diabetes Association and the Academy of Nutrition and Dietetics

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