August 2, 2017
Scott Gottlieb, M.D.
Commissioner of Food and Drugs
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Re: Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date; Request for Comments (Docket No. FDA-2011-F-0172)
Dear Dr. Gottlieb,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to comment on the Food and Drug Administration's (FDA's) interim final rule (Docket No. FDA-2011-F-0172) pertaining to the extension of the compliance date for "Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments. Representing over 100,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs),2 and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States committed to a world where all people thrive through the transformative power of food and nutrition. Academy members provide professional services such as nutrition education and medical nutrition therapy (MNT)3 and regularly use point of purchase nutrition information when working with clients, patients, and businesses to encourage healthy eating and prevent and treat a wide variety of disease states and chronic conditions.
The Academy supports Americans' ability to know what is in their food so that they can make healthy choices at the point of purchase for themselves and their families. Specifically, we continue to strongly support the declaration of calorie information on menus and menu boards for food establishments of twenty or more locations, and urges the FDA to implement its longstanding final menu labeling rule without delay.
A. Academy's Principles for Nutrition Labeling
The Academy developed a series of principles for nutrition labeling specified below, the bolded of which are relevant to the questions presented in the menu labeling final rule:
- Label claims should be clear and understandable to consumers.
- The label must be truthful and not misleading.
- Content on the label should help consumers make informed decisions to build a healthy diet.
- Label content should have consistent type and format so products can be read and consumers can make product comparisons.
- All claims should include labeling of accurate quantitative information about the dietary substance, including percent of Daily Value in a single serving of the products, when known, or the daily dietary intake necessary to achieve the claimed effect.
- Consumer research is imperative before making changes to the label.
- The label is only a source of information, and thus sustained support for educational programs and individual counseling by registered dietitian nutritionists is essential.
B. Menu Labeling Is Needed, Wanted, and Overdue
The final rule was the result of a deliberate multi-year process that included input from a range of stakeholders across industry, government, and public health. Chain food service establishments have had more than two years to prepare to comply with the requirements, and we note that many have already changed their menus in anticipation of the May 5, 2017 compliance deadline (which itself was the result of two previous delays from the original compliance deadline of December 1, 2016).
More than two-thirds of American adults and one-third of children and teenagers are overweight or have obesity,4 increasing their risk for many of the nation's leading chronic diseases, including cardiovascular disease, several types of cancer, and type 2 diabetes, which cost more than $147 billion annually in health care expenditures.5 With Americans consuming about one-third of their calories from food prepared away from home,6 menu labeling is an important tool to help people to make informed decisions. National surveys show that 80 percent of consumers want menu labeling ,7,8 and studies show many use labeling when it is available.9,10 A variety of restaurants, supermarkets, convenience stores, and other chains already are successfully providing calorie information, and the FDA has repeatedly addressed many of the issues raised in the request for comments by providing various restaurant types with flexibility in how they label their products.
The Academy opposes changes to the menu labeling requirements that would make it more difficult for consumers to access and use information on menu labels when they purchase ready-to-eat foods away from home. Specifically, we urge the FDA to maintain the following requirements as established in the 2014 final rule and subsequent guidance documents:
- Menu labeling should apply to ready-to-eat foods and beverages purchased at all chain food service establishments, including restaurants, supermarkets, and convenience stores, and closed-environments where one cannot bring their own food, such as movie theaters and stadiums.
- Calorie labeling should be required on all menus from which customers make food selections. This should include in-store, drive-through, printed takeout and delivery, and online menus.
- Calorie disclosures must be at the point of decision-making to be useful; the information should be located on or adjacent to the name of the food and price on a menu, menu board, or food label for self-service foods or foods on display and not in a separate location in the establishment.
C. Additional Consumer Research and Robust Nutrition Education Are Needed
Consumers' confusion over their calorie needs and their need to place calorie information into context necessitates enhanced nutrition education initiatives. To make the FDA's proposed labeling changes fully meaningful for consumers, the Academy continues to recommend implementing a sustained, adequately funded nutrition education initiative empowering consumers to use menu labels and the additional information available behind the counter to make informed decisions to eat healthfully. In addition to arming consumers with information on the amount of added sugars, sodium, saturated fat, and calories in food products, public education on the food sources and health consequences of excessive added sugars intake is needed.
Education and promotion strengthen the effect of point of purchase nutrition labeling. Research has shown that the use of education with the increased availability and visibility of nutrition information increases the use of the information beyond the effect of only making the information available and visible.11 This research indicates that merely providing information is not as effective unless provided with an educational component. Emphasis on factors such as nutrient-density rather than calorie per se, may help improve food selection at restaurants as well as in the retail marketplace.
This lack of public awareness drives the need for a complementary educational program where consumers receive information through various mediums (pamphlets, electronic media, and social networking sites) concerning nutrition labeling. Because many consumers do not know the appropriate amount of calories necessary for their body types, gender and age, these educational programs and messages must emphasize the utmost significance of considering a food or meal in terms of its contributions to the total diet. Merely providing consumers the number of total calories or sodium will not impact their behavior unless consumers are also educated about how each nutritional component impacts the body. Consumers only will change their behaviors once they understand the various facets in the decision-making process and which nutrients comprise a well-balanced diet.
Today, consumers are exposed to an abundance of nutrition information that may be hard to interpret. FDA should develop materials, for example, to explain that consuming foods high in added sugars makes it difficult to meet nutritional needs and stay within calorie requirements. Such an education program should emphasize that naturally-occurring sugars in fruits, vegetables, and dairy products do not pose any health problem, and, indeed, people should choose and consume more fruits, vegetables, and low-fat dairy products. We welcome the opportunity to work with both FNS and the Food and Drug Administration as they develop and test these initiatives.
We recognize the complexity in developing effective, balanced, evidence-based solutions to provide Americans with the nutrition information needed to make healthy dietary choices, and the Academy offers our assistance and evidence analysis regarding implementation of this important menu labeling initiative. Please contact either Jeanne Blankenship by telephone at 312-899-1730 or by email at email@example.com or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, JD
Sr. Director, Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 NDTRs are educated and trained at the technical level of nutrition and dietetics practice for the delivery of safe, culturally competent, quality food and nutrition services. They are nationally credentialed and are an integral part of health care and foodservice management teams. They work under the supervision of a registered dietitian nutritionist when in direct patient/client nutrition care; and often work independently in providing general nutrition education to healthy populations.
3 Medical nutrition therapy (MNT) is an evidence-based application of the Nutrition Care Process focused on prevention, delay or management of diseases and conditions, and involves an in-depth assessment, periodic re-assessment and intervention. [Academy of Nutrition and Dietetics' Definition of Terms list, http://www.eatright.org/scope/, accessed 2 April 2014.] The term MNT is sometimes used interchangeably with, but is sometimes considered different from, nutrition counseling in health insurance plans.
4 Fryar CD, Carroll MD, and Ogden CL. Prevalence of Overweight and Obesity Among Children and Adolescents Aged 2-19 Years: United States, 1963-1965 Through 2013-2014. Centers for Disease Control and Prevention, National Center for Health Statistics. July 18, 2016.
5 Finkelstein EA, Trogdon JG, Cohen JW, and Dietz W. Annual Medical Spending Attributable to Obesity: Payer-and Service-Specific Estimates. Health Aff 2009;28(5):w822-831.
6 Lin B-H and Guthrie J. Nutritional Quality of Food Prepared at Home and Away from Home, 1977-2008. U.S. Department of Agriculture Economic Research Service. December 2012.
7 Caravan ORC International. Restaurant Calorie Content: ORC Study 721210, May 2012. Conducted for the Center for Science in the Public Interest.
8 AP-GfK Poll: Americans Support Menu Labeling in Restaurants, Grocery Stores. December 31, 2014.
9 Lee-Kwan, SH, Pan L, Maynard, L, et al. Restaurant Menu Labeling Use among Adults – 17 States, 2012. MMWR 2014;63:581-584.
10 Healthy Eating Research. Impact of Menu Labeling on Consumer Behavior: A 2008-2012 Update. Research Review. June 2013.
11 O'Dougherty M, Harnack L, French S, Story M, Oakes J, Jeffery R. Nutrition labeling and value size pricing at fast-food restaurants: A consumer perspective. A J Health Promot. 2006;20:247-250; 2008 Food & Health Survey: Consumer Attitudes toward Food, Nutrition & Health International Food Information Council Web site. http://www.ific.org/research/upload/IFICFdn2008FoodandHealthSurvey.pdf; Howlett E, Burton S, Kozup J. How modification of the Nutrition Facts Panel influences consumers at risk for heart disease: The case of Trans fat. J Public Pol Marketing. 2008;27;83-97.