Academy Comments to FDA re Pre-Compliance Guidance for Menu Labeling for Covered Establishments' More Complex Issues

January 8, 2018

Scott Gottlieb, M.D.
Commissioner of Food and Drugs
c/o Division of Dockets Management
Food and Drug Administration
Room 1061, HFA-305
5630 Fishers Lane
Rockville, MD 20852

Re: Docket No. FDA-2011-F-0172; Menu Labeling: Supplemental Guidance for Industry

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and Dietetics (the "Academy") appreciates the opportunity to comment on the Food and Drug Administration's (FDA's) draft guidance "Menu Labeling: Supplemental Guidance for Industry" published in the November 9, 2017 issue of the Federal Register. 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 who 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of calorie information on menus and menu boards for food establishments of twenty or more locations, and believe the draft guidance will assist businesses in meeting the compliance date without delay. FDA's menu labeling initiatives are supported by legitimate research, but to be truly effective must include nutrition education and policy evaluation, and ensure calorie counts are accurate. The Academy strongly emphasizes that context and education are critical to making menu labeling a meaningful tool for consumers.

A. Academy's Principles for Nutrition Labeling

The Academy has developed a series of principles for nutrition labeling specified below, the bolded of which are relevant to the questions presented in the menu labeling draft guidance:

  1. Label claims should be clear and understandable to consumers; consumers' nutrition literacy is key to promoting understanding.
  2. The label must be truthful and not misleading.
  3. Content on the label should help consumers make informed decisions to build a healthy diet.
  4. Labels should help to provide understanding about the nutrient density and overall healthfulness of overall food rather than a focus on particular nutrients.
  5. Label content should have consistent type and format so products can be read and consumers can make product comparisons.
  6. Labeling should enhance consistency among the various government nutrition recommendations.
  7. 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.
  8. Consumer research is imperative before making changes to the label.
  9. 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 on nutrition labeling of standard menu items in restaurants and similar retail food establishments published in the May 4, 2017 issue of the Federal Register (82 FR 20825) 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 years to prepare to comply with the requirements, and we note that many covered food establishments have already changed their menus in anticipation of the compliance deadline. Indeed, the vast majority of the top restaurant, supermarket, and convenience store chains already are labeling calories, showing that posting calories as currently required is feasible. A recent scan of the top 50 restaurant chains (by revenue according to Nation's Restaurant News) found that all 50 had calorie information either on-line (e.g., posted per menu item, provided in PDF or other format, or via an online nutrition calculator) or in the restaurant.4 We encourage the FDA to finalize this draft guidance as soon as possible to facilitate implementation by May 7, 2018 (82 FR 20825).

More than two-thirds of American adults and one-third of American children and teenagers are overweight or have obesity,5 increasing their risk for many of the nation's leading chronic diseases, including cardiovascular disease, several types of cancer, and type 2 diabetes. These diseases are costly; America spends more than $147 billion annually in health care expenditures on obesity alone.6 With Americans consuming about one-third of their calories and half of their food budget on food prepared away from home,7 menu labeling is an important tool to help people to make informed decisions and help tackle the obesity crisis. National surveys show that 80 percent of consumers want menu labeling8,9 and studies show many use labeling when it is available, but it is not a panacea.10,11 A variety of restaurants, supermarkets, convenience stores, and other chains already are successfully and effectively providing calorie information, and the FDA continues to address many of the issues raised by covered establishments by providing various restaurant types with flexibility in how they label their products.

C. Specific Modifications to Draft Guidance

The issues raised in the draft guidance largely reinforce clarifications that have already been made through the final regulations, previous guidance, and technical assistance. We do, however, suggest a few modifications and offer recommendations below related to specific provisions of the draft guidance.

1. Clarify that Salad Bar Signage Be Visible to Consumers Selecting Any Item

The Academy encourages the FDA to revise the draft guidance to further clarify in Section 3 that if the establishment chooses to use a single sign or placard by the salad bar or hot bar, the sign must be visible from the whole bar (e.g., either/both sides) and that the sign must be located where a consumer can easily view the calories for a particular item while selecting it. We further encourage the FDA to specify that the preferred method for salad bar or hot bar calorie labeling is to label calories on a sign adjacent to the item (e.g., food tags) or attached to the sneeze guard.

2. Further Clarify the Definition of "Covered Establishments"

The Academy supports the FDA's answer to Section 8.2 of the draft guidance determining whether a convenience store is a covered establishment. Although franchisees should not be able to evade compliance with a merely superficial change in operating title, nor should the placement of a convenience store operating in 10 gas station locations be deemed a covered entity merely because it operates those ten stores at Exxon gas stations (and noting that there are more than 20 Exxon locations that could otherwise conceivably trigger recognition as a covered establishment).

3. Clarify that Consumers Must Be Able to View All Standard Menu Items at the Same Time When Making Combinations

In Section 5.3, the final Guidance should clarify that if establishments do not declare the calories for combined standard menu items, consumers must be able to view the calories for the standard menu items while choosing the combination (for example, by listing all of the standard menu items on the same menu or menu board (as shown in Figures 14 and 15)). Consumers may have more difficulty using the calorie information if standard menu items that can be combined are listed on separate menu pages or menu boards.

4. Support the Draft Guidance As Consistent with Rules Requiring Pizza Chains to Label Calories Inside the Restaurant

The draft guidance is consistent with applicable law and regulations (21 CFR 101.11) providing that calorie labeling is required inside pizza chains and other establishments offering delivery service if they use a menu board inside the covered establishment. Section 5.4 makes it clear that establishments that label calories online also must do so in-store, but only if an inside-menu board is used. As mentioned in Section 5.2, establishments are not required to have a menu board. Indeed, there are a variety of ways establishments can provide calorie labeling in lieu of a menu board (e.g., hand-held paper or laminated menus on the counter, or electronic devices such as in-store tablets or kiosks). However, if restaurants have a menu or menu board inside, calories must be posted on the menu or menu board.

Many pizza chains are already labeling different sizes, varieties, and toppings on menus and menu boards, demonstrating that labeling can be accomplished in a reasonable amount of space and at a reasonable cost. As mentioned in Section 5.6, the FDA has already provided establishments with the flexibility to declare calories for the pizza per slice, provided that the number of slices per pie is included on the menu or menu board in a manner that clearly associates the calories per slice and the number of slices for each size of pie offered by the establishment (e.g., pizza pie 200 Cal/slice, 8 slices) (21 CFR 101.11(b)(2)(i)(A)). It is helpful that the draft guidance provides seven additional examples for the pizza industry (Figures 16 through 22).

5. Support the Draft Guidance's Clear Distinction Between Menus and Advertisements

In Section 4.1, the FDA again clarifies the difference between menus or menu boards and advertisements. The FDA appropriately considers whether a consumer can use the document or other form of communication to order in determining whether it should be considered a menu. The Academy believes that a menu be understood to be a primary writing from which a consumer makes an order selection, and that nutrition information should be present on any and all consumer publications enabling an order selection, including take-out, delivery and Internet menus. Further, for any food advertisements making a health claim, the Academy supports the inclusion of nutrition information.

6. Reaffirm that the Type Size, Color, and Contrast of Calories Must be the Same or Similar to Standard Menu Items

The Academy encourages the FDA to add to Section 5 or 5.1 that the calorie declarations must be in a type size that is no smaller than that used for the name or price of the standard menu item (whichever is smaller), the same or similar color that is at least as conspicuous as the standard menu item, and the same or similar contrasting background as the standard menu item (21 CFR 101.11(b)(2)(i)(A)(1)). The succinct statement and statement regarding the availability of the additional written nutrition information also has similar conspicuity requirements. (21 CFR 101.11(b)(2)(i)(C)(1). These are all essential to ensure that calories are clear, legible, and provide the intended context for decisions by consumers. This comports with the Academy's labeling principle that "Label content should have consistent type and format so products can be read and consumers can make product comparisons."

7. The Draft Guidance Helpfully Reaffirms that Serving Sizes Must Be Easy to Understand and Items Be Listed as Typically Prepared and Offered For Sale

Section 5.7 is consistent with the law and regulations. For multiple-serving standard menu items that are not offered for sale in discrete units (e.g., "Family-Style Salad"), the calories declared must be for the entire standard menu item. In addition, an establishment can include the number of servings and the calories per serving as usually prepared and offered for sale (e.g., Family-Style Lasagna: 625 Cal/serving, 8 servings; 5,000 Cal). (21 CFR 101.11(b)(2)(i)(A)). This comports with the Academy's labeling principle that "Label claims should be clear and understandable to consumers. . . ."

8. Support Manner in Which the Draft Guidance Appropriately Addresses Enforcement Issues and Describes the Compliance Support that FDA Will Provide

The Academy is pleased that Section 6.1 is consistent with the FDA's previous position that the first year of menu labeling implementation will focus on education and technical assistance. Section 6.2 provides clear examples of minor violations that would not result in fines or criminal penalties, such as missing a calorie declaration for a buffet item, minimal variations in ingredients or inadvertent error such as adding extra slices of pepperoni on a pizza, and not rounding the calories correctly. For such concerns, the FDA indicates that it will work with covered establishments on an appropriate time-frame to make corrections.

9. Support Flexibility to Determine Nutrition Information and Recordkeeping

The Academy supports Section 7.1 of the draft guidance reaffirming that the 'reasonable basis' standard for determining calorie counts provides flexibility for natural variation in ingredients. The Academy supports this flexibility. There are many ways that an establishment may determine the nutrition information of its standard menu items in addition to laboratory testing (21 CFR 101.11(c)(1)) (Section 7.2). Establishments can also keep the records of their nutrient information on site or at the corporate headquarters and will have 4-6 weeks to provide the information following a request (Section 7.3). Recalculation of nutrient information is required only if a standard menu item changes (Section 7.4). This process comports with the Academy's labeling principle that "The label must be truthful and not misleading."

10. Support Labeling of Beer if Listed on Menus or Menu Boards

The Academy supports Section 10.1 of the draft guidance reaffirming that beer on tap is considered a food on display. Moreover, alcoholic beverages that are foods on display and are not self-serve are also exempt from labeling (21 CFR 101.11(b)(1)(ii)(B)). However, if a menu or menu board lists beers on tap as standard menu items, then the calories must be provided on that menu or menu board. The Academy supports these clarifications in the draft guidance with regards to caloric intake and other disclaimed nutritional information, as we strongly agree with the FDA's decision to include calorie counts of alcohol in the final menu labeling requirements.

D. 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.12 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 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.

E. Conclusion

The Academy supports the FDA's draft guidance and encourages the FDA to make the clarifications suggested above and to finalize the draft guidance quickly to facilitate implementation for food service establishments by May 7, 2018. Please contact either Jeanne Blankenship by telephone at 312-899-1730 or by email at jblankenship@eatright.org or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely

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 Center for Science in the Public Interest. Supplemental Comment on 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. August 2, 2017.

5 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. Available at https://www.cdc.gov/nchs/data/hestat/obesity_child_13_14/obesity_child_13_14.htm.

6 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.

7 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. Available at https://www.ers.usda.gov/webdocs/publications/43698/34514_summaryeib105.pdf?v=41270.

8 Caravan ORC International. Restaurant Calorie Content: ORC Study 721210, May 2012. Conducted for the Center for Science in the Public Interest. Accessed at: http://cspinet.org/new/pdf/restaurant-calorie-content.pdf.

9 AP-GfK Poll: Americans Support Menu Labeling in Restaurants, Grocery Stores. December 31, 2014. Available at http://ap-gfkpoll.com/featured/findings-from-our-latest-poll-11.

10 Lee-Kwan, SH, Pan L, Maynard, L, et al. Restaurant Menu Labeling Use among Adults – 17 States, 2012. MMWR 2014;63:581-584.

11 Healthy Eating Research. Impact of Menu Labeling on Consumer Behavior: A 2008-2012 Update. Research Review. June 2013. Available at http://healthyeatingresearch.org/wp-content/uploads/2013/12/HER-RR-Menu-Labeling-FINAL-6-2013.pdf.

12 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. Available at: http://www.ific.org/research/upload/IFICFdn2008FoodandHealthSurvey.pdf; Howlett E,