September 10, 2015
The Honorable Sylvia M. Burwell
Secretary of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Re: Information Collection for Examining Consumer and Producer Responses to Restaurant Menu Labeling Requirements: Survey Protocol—OMB No. 0990-XXXX—New
Dear Secretary Burwell:
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the U.S. Department of Health and Human Services (HHS) related to its July 10, 2015 information collection "Examining Consumer and Producer Responses to Restaurant Menu Labeling Requirement: Survey Protocol" ("information collection"). Representing over 75,000 members comprised of registered dietitian nutritionists (RDNs)1, nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States committed to improving the nation’s health through food and nutrition across the lifecycle. The Academy’s members independently provide expert nutrition care services, including nutrition education and Medical Nutrition Therapy (MNT)2, to individuals as prevention and treatment for a wide range of disease states and chronic conditions.
The Academy strongly supports the proposed information collection for purposes of conducting a study about calorie labeling on restaurant menus and offers the below recommendations regarding the value and utility of the study to aid HHS in developing the study.
I. Necessity and Utility of the Proposed Information Collection
The proposed information collection is necessary to effectively implement the department's final menu labeling regulation (the "final rule") and achieve its intended goals of providing Americans with nutrition information to make educated choices when dining outside the home. Although the Academy notes that conducting the study prior to finalizing the rule could have helped FDA determine the most accurate cost benefit analysis and provide insight into consumers' perception of the information and their behavioral response, it is still timely given flexibility in the final rule's implementation timetable.
Utility of the information will be enhanced if the Food & Drug Administration (FDA) conducts surveys to determine behavioral responses on a regular basis after implementation of the final rules to inform end users of the collected information. All messaging developed should be science-based, and credentialed experts in nutrition and dietetics should be included in the evidence-based analysis and development of messages for target audiences. Regulated industries and retailers should also be included in all decision-making and outreach messaging. Although it may generally be assumed that the end users of the collected information will be consumers, other expected end users include (a) professionals tasked with educating consumers on effective use of the information (largely RDNs3) and (b) individuals who develop and prepare recipes in the foodservice marketplace who may begin to change formulations to meet consumer expectations.
The Academy questions how FDA will utilize the collected information, given that it has promulgated a final rule. Does FDA propose to update the final rule, or instead issue guidance to aid food retailers and end users in compliance and use?
II. Enhancing the Quality, Utility, and Clarity of the Collected Information
The Academy offers the below suggestions for ways in which FDA can enhance the quality, utility, and clarity of the information to be collected on consumer and producer responses to restaurant menu labeling requirements.
A. Ensure Consistency in Nutrition Education Information
FDA should make every effort to make the nutrition information provided on display and available upon request conforms as much as possible with the Nutrition Facts panel so that consistent nutrition education information can be provided. Consistent and simple information is critical for consumers. Consistency also makes compliance easier on the industry from an analytical and reporting perspective. Consumers can become confused by seemingly counterintuitive and conflicting nutrition messages, including some from the federal government. The Academy recognizes that, for example and as detailed below, the FDA is statutorily required to define “serving size” in a descriptive rather than aspirational manner.
B. Incorporate and Evaluate Current Research in Developing Study
The Academy respectfully suggests that FDA develop the study after consideration and evaluation of current research, including availing itself of existing consumer data from local jurisdictions that already mandate the provision of calorie and nutrition information. The information collection should be inclusive of a thorough review of the findings of recent consumer health and decision-making research published in the peer-reviewed literature and a wide variety of restaurant menus (e.g., casual, fast casual, quick service, drive-throughs, and food trucks for chain retailers), as well as entertainment venues and grocery stores — two fast-growing markets for meals purchased away from home. FDA should incorporate research consistent to the broadest reasonable interpretation of the final rule's provisions.
In addition, an open review of the survey instrument would ensure educators and producers are able to determine whether the survey will answer questions that will enable them to effectively implement the final rule and help consumers make healthy choices.
C. Ensure Consumer Comprehension by Clarifying Behavioral Aspects
Notwithstanding statutory and regulatory complexities, the Academy agrees with the 2015 Dietary Guidelines Advisory Committee (DGAC) that, "food and calorie label education should be designed to be understood by audiences with low health literacy, some of which may have additional English language fluency limitations."4 Academy members are recognized for their expertise in translating scientific information that consumers can understand and apply to self-directed goals to improve their overall health. Our members use the label in client education and counseling in the community, in the media, and one-on-one with consumers.
Research indicates that an individual's socio-economic status, educational attainment, numeracy, English literacy, and health status impact what elements of the Nutrition Facts label are used and the extent to which an individual is able to more broadly incorporate a variety of nutrient content data into the context of a healthy daily diet.5 While it would be important for all consumers to know about, understand, and use the menu label information, consumer education campaigns should primarily target consumers who are least likely to understand and use the label, including low-income and low-education consumers, who are more likely to suffer from many obesity- and nutrition-related chronic diseases.
Survey respondents should be able to view sample menu labels to assess clarity of the information presented, readability of the label, and utility of the information. The Academy encourages FDA to consider the following specific behavioral aspects of menu labeling issues requiring clarification.
- How is the term "menu" interpreted where there may be no formal menu, such as for buffets, salad bars and dessert trays? These areas require appropriate point-of-purchase labeling.
- How do panelists interpret information provided as a range? This is not consistent with current product labeling and may be difficult to understand on a menu.
- How do panelists respond to total product labeling compared to the labeling of meal components? Restaurant foods are often served in combination, such as salad with dressing. It would be helpful to seek information on the utility allowing menus to provide additional information on meal components, such as giving information on sauces and salad dressings separately so that consumers can decide whether to eat all of the meal components. For example, a menu could include calorie counts for each salad dressing option separately. However, this should not take the place of providing a total value for foods served in combination, such as a pizza; consumers should not be required to add disparate ingredients to obtain a total.
- How do consumers interpret choices for combinations on menus? For example, if a mixed entrée can be ordered with beef, shrimp, chicken or tofu, how will the product be labeled and will consumers be able to differentiate the values easily?
- How can table condiments, such as salt, mayonnaise, ketchup, and syrup, be labeled to inform consumers? If condiments are not labeled, the product consumed may have a significantly different profile from the product described on the menu.
(a) Serving Size
The Academy, as a matter of nutrition policy, does not support defining serving size as the Reference Amount Customarily Consumed (RACC), because these sizes increase when consumption practices increase over time and consumers perceive the RACC to be a recommended serving size for a particular food product. Increasing the RACCs as portion sizes grow is contrary to the intended use of the label as an educational tool that consumers can use to adopt healthier dietary practices. However, we recognize that the Nutrition Labeling and Education Act of 1990 (NLEA) specifically requires that food products' serving sizes must be descriptively set as the "amount customarily consumed," despite evidence that consumers mistakenly perceive these serving sizes as recommended portions.6 Given the significant confusion, the Academy encourages FDA to address several concerns in the study.
- How can menus reflect accurate information on items designed as more than a single serving?
- Is serving size on menus clearly understood? Since Nutrition Facts panels provide information on a per serving basis, would it be helpful for the menu items to clearly describe the serving size, number of servings and calories/serving for items that are designed to include more than one serving, such as a large pizza? If not, we note that the entire item will be labeled as a single serving, which may be misleading.
(b) Font Size
The Academy encourages FDA to study how font size impacts the use and comprehension of nutrition information on menus. We recognize that this is an issue that affects all labeling, since space is limited on menus and menu boards, but we encourage FDA to make this a factor that can be tested in a survey by allowing review of information at different font sizes. We note several conflicting needs for this issue.
- The current size/type/font requirements for calorie labeling on menus are quite specific. As companies began laying out menus that meet the current requirements, we understand many have found that their menus were no longer readable with all of the copy and calorie numbers. We question whether restaurants could achieve the same transparency, while keeping menus functional as a marketing and ordering tool, if given some flexibility of size/type/font of nutrition information.
- Low vision is a visual impairment that interferes with the ability to perform everyday activities, including reading, driving, shopping, and food preparation. Low vision cannot be corrected with glasses, contact lenses, or surgery; therefore, people living with low vision must learn ways to adapt so they may continue living independently. Approximately 3.5 million Americans have low vision, and the number of people affected is expected to double in coming years. Among a sample of visually impaired people, an older study found 40 percent of evening meals were purchased outside of the home (2009). These numbers have likely increased, both in numbers of individuals that live with low and vision (with the greying of America), and also, as an increasing number of meals are consumed outside of the home.
- Considerations of including persons with special needs on the panel would be useful. We recommend including individuals with low vision and individuals with medical needs, who comprise a substantial subset of the population.
(c) Providing Context and Education is Critical
The label should optimally not just be a mechanism for providing information to consumers, but should be a tool to help them make healthier food choices for themselves and their families. Beyond merely presenting data, menu labels should be used to normatively educate the public about establishing healthy eating behaviors. The Academy has deep reservations about nutrition information initiatives that are not matched with well-designed, adequately funded, and sustained nutrition education efforts. Information and education are not synonymous—they are complementary and synergistic. The educational effort will determine how successfully consumers can understand and utilize the information to enhance and maintain healthy dietary practices.
Educational interventions designed and implemented by Academy members can improve purchasing behavior.7 Many retailers, recognizing RDNs effectiveness and the value in helping their customers make healthy purchases, are employing these experts on their retail management teams. Adding an integrated intervention where nutrition and dietetics practitioners provide community members with skill sets to best take advantage of the improved access can multiply the initial investment and facilitate the long-term success and viability of the programs.
The Academy encourages FDA to address a number of specific contextual issues:
- How does context affect usefulness of information? What information on a menu provides the best context, recognizing conflicting needs for presentation of information. We note that numerous studies systematically reviewed by Campos and colleagues (2011) reported that consumers especially have a difficult time grasping concepts such as percent daily values or other forms of reference information listed on labels.8 Reports of consumer desire for simpler presentation of nutrition information are important to keep in mind as means of nutrition reporting to consumers evolve.9 For example, researchers at the University of North Carolina found that consumers ordered less median calories only if the menu listed both calories and minutes to physical activity required to burn those calories.10 Since label information is neither intuitive nor well-understood by most consumers, it is important to provide opportunities and funding for appropriate education.
- How are health claims and content claims on menus understood? Will menus be held to the same standards as packaged products? For example, will the FDA definition for "healthy" (as used for product labels), be used the same way on menus? Will "gluten free" describing a bread product be interpreted to mean that there will be no cross-contamination from other products prepared in the kitchen?
III. Use of Automated Collection Techniques and Information Technology
The Academy suggests that FDA can effectively employ certain automated collection techniques or other forms of information technology to minimize the information collection burden:
- Automated collection techniques that allow simulated menus with different information presentations, font sizes, and the like is a wise use of information technology.
- Recognizing that high-speed internet may be limited in some rural areas and forsome populations, the limitations of using a panel — especially a trained panel — that has good internet access may not represent the population as a whole. Some additional testing or oversampling for other populations would be inclusive.
- Development of a mobile app for consumer reporting on menu confusion could be a useful adjunct to more formal surveys. With today’s simple-to-use technology, consumers could send pictures of menus that are (a) particularly easy to use, (b) confusing to consumers, or (c) do not meet guidelines. Such an effort would be consistent with FDA's programs to report adverse events, side effects, and allergens.
We recognize the complexity of this topic and offer our assistance and expertise in designing the study and working with consumers on nutrition education initiatives as the final rule is implemented. Please contact either Jeanne Blankenship at 202/775-8277, ext. 1730 or by email at firstname.lastname@example.org or Pepin Tuma at 202/775-8277, ext. 6001 or by email at email@example.com 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, Esq.
Senior Director, 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 "Medical Nutrition Therapy is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/re-assessment, nutrition diagnosis, nutrition intervention, and nutrition monitoring and evaluation that typically results in the prvention, delay, or management of diseases and/or conditions." CITE definition of terms list
3 The expertise of registered dietitian nutritionists is unique; the Academy highly recommends that the FDA leverage these nutrition professionals throughout the process of survey development, interpretation, and utlization. Inclusion of one or more members of the Academy is essential to ensure accurate and optimal articulation of menu labels.
4 Scientific Report of the 2015 Dietary Guidelines Advisory Committee (DGAC Report). Part D. Chapter 3, Page 25. Dietary Guidelines website. Released February 23, 2015. Accessed May 8, 2015.
5 See, e.g., Rothman RL, Housam R, Weiss H, et al. Patient understanding of food labels: the role of literacy and numeracy. Am J Prev Med. 2006;31(5):391-8. See also, Speirs K et al, Health Literacy and Nutrition Behaviors among Low-Income Adults. Accessed July 30, 2014.
6 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, § 2, 104 Stat. 2353–57 (codified as amended at 21 U.S.C. § 343).
7 Condrasky M, Frost S, Lee A, Simmons S, Hrabski T. What's cooking? A culinary nutrition research program with dietetic interns. Topics In Clinical Nutrition [serial online]. July 2010;25(3):280-288. Available from: CINAHL Complete, Ipswich, MA. Accessed April 29, 2015.
8 Campos S, Doxey J, Hammond D. Nutrition labels on pre-packaged foods; a systematic review. Public Health Nutr. 2011; 14(8):1496-506.
10 Antonelli R, Viera AJ. Potential effect of physical activity calorie equivalent (PACE) labeling on adult fast food ordering and exercise. PLoS One. 2015 Jul 29;10(7):e0134289.