Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2021-N-0336]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
 DATES: Submit written comments (including recommendations) on the collection of information by April 27, 2022.
 ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to 
                        *https://www.reginfo.gov/​public/​do/​PRAMain.*
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The title of this information collection is “Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim `Healthy' on Packaged Foods.” Also include the FDA docket number found in brackets in the heading of this document.
 FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White 
                        ( print page 17301)
                        Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
                        *PRAStaff@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim “Healthy” on Packaged Foods OMB Control Number 0910-NEW I. Background Section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 343(r)(1)(A)) permits the use of label and labeling claims that characterize the level of a nutrient in a food when the claims are made in accordance with FDA's regulations. Such claims are referred to as “nutrient content claims.” We have issued regulations under section 403(r)(1)(A) of the FD&C Act describing “implied nutrient content claims” as those that, among other things, suggest that a food, because of its nutrient content, may help consumers maintain healthy dietary practices (21 CFR 101.65(d)(1)(i). The rule finalizing these claims also describes implied claims, in part, as those that imply that a food, because of its nutrient content, may be useful in achieving a total diet that conforms to current dietary recommendations (“Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms,” 58 FR 2302 at 2374, January 6, 1993)). We have determined that a claim that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices is clearly a claim that characterizes the level of nutrients in that food. The claim is essentially saying that the level of nutrients in the food is such that the food will contribute to good health (58 FR 2302 at 2375). In 1994, we issued a definition of “healthy” as an implied nutrient content claim (59 FR 24232, May 10, 1994); the regulation is codified at 21 CFR 101.65(d)(2). FDA seeks to improve dietary patterns in the United States to help reduce the burden of diet-related chronic diseases and advance health equity. We are committed to accomplishing this by, in part, empowering consumers with information to make more informed dietary choices. To help advance these goals, we are exploring the development of a graphic symbol to help companies communicate and consumers identify packaged food products that meet FDA's definition of “healthy.” The symbol would be a graphic representation of the nutrient content claim “healthy” and, like the implied nutrient content claim “healthy” itself, would be voluntary for packaged food companies. Companies could voluntarily use the symbol on food products that meet FDA's definition of “healthy.” In 2019 and 2020, FDA conducted a review of the literature on front-of-package (FOP) nutrition-related symbols and conducted a series of focus groups to test symbol concepts and draft FOP symbols (see Docket No. FDA-2021-N-0336 for the literature review and a table of draft FOP symbols). As part of our efforts to promote public health, we intend to conduct two consecutive quantitative research studies—a survey (Study 1) and an experimental study (Study 2) to explore consumer responses to the draft FOP symbols that companies could voluntarily use on a food product as a graphic representation of the nutrient content claim “healthy.” If research results suggest the need, the symbols will be fine-tuned following the survey and again following the experimental study. Study 1 will use non-probability survey methods, using a web-based panel to draw a sample of 2,000 U.S. adults ages 18 and older who self-identify as primary food shoppers. The sample will be balanced to the demographics of the U.S. population. The survey instrument will focus on clarity, relevance, and appeal of a set of symbols. Study 2 will be a controlled, randomized experiment that will use a 15-minute web-based questionnaire to collect information from 5,000 U.S. adult members of an online consumer panel. Conditions for Study 2 will be: (1) A set of draft FOP symbols, including “no-symbol” controls; (2) three types of mock food products (
                    *i.e.,*
                     a breakfast cereal, a frozen meal, and a canned soup); (3) a “no-information” condition where no explanation of the symbol is provided; and; (4) a Uniform Resource Locator (URL) condition, in which a URL is tested alongside the symbol. Each participant in Study 2 will be randomly assigned to a condition, which will include viewing a label image and responding to various measures of the symbol's effectiveness. Measures of response in the experiment will include product perceptions (
                    *e.g.,*
                     healthfulness and contribution to a healthy diet), label perceptions (
                    *e.g.,*
                     believability, trustworthiness, message effects), and purchase/choice questions. The instrument will also collect information from participants about their history of purchasing or consuming similar products; nutrition knowledge; dietary interests; motivation regarding label use; health status; and demographic characteristics. The studies are part of our continuing effort to enable consumers to make informed dietary choices and construct healthful diets. We intend to use the results to inform our continued exploration of a symbol manufacturers could voluntarily use to represent the nutrient content claim “healthy” on the food label. We will not use the results to develop population estimates. *Description of Respondents:*
                     Respondents to this collection of information include members of the general public. In the 
                    **Federal Register**
                     of May 7, 2021 (86 FR 24629), FDA published a 60-day notice requesting public comment on the proposed collection of information (“60-day notice”). We received 43 comments, 27 of which were PRA-related. The remaining comments were non-responsive to the four PRA topics, and so we will not address them in this document. A. Comments Regarding the Necessity and Practical Utility of the Information Being Collected and FDA Response Several comments addressed the necessity and practical utility of collecting information on a voluntary symbol depicting the nutrient content claim “healthy” on packaged foods. (Comment 1) Some comments supported FDA's proposed collection of information through the three proposed quantitative consumer research studies. Some comments expressly supported FDA's end research goal of enabling consumers to make informed dietary choices and construct healthful diets. Some supported FDA's intention to understand consumer responses to draft FOP symbols and gather data and other information to inform our thinking on a “healthy” symbol. Many comments indicated the importance of conducting this research before taking regulatory action on any symbol. Some comments supported conducting the research in conjunction with development of a proposed rule that would update the definition of “healthy” on food packages. Other comments opposed FDA research on a “healthy” symbol. Some of these comments suggested the research is unnecessary, claiming that a single food is not “healthy” or “unhealthy,” that overall diet matters more than individual foods, or that symbols are industry marketing. A few comments suggested a “healthy” symbol could be particularly misleading to, or misinterpreted by, people who are 
                    ( print page 17302)
                    experiencing eating disorders. Some comments also questioned whether a “healthy” symbol would: (1) Have a positive and meaningful impact on improving health or (2) lead consumers to overconsume foods bearing the symbol. (Response 1) We intend to conduct this research now, in conjunction with further work on updating our definition of the claim “healthy” and before taking regulatory action on any symbol. Our intended research will help us better understand how consumers might respond to and use a graphic symbol to identify packaged food products that meet our definition of “healthy.” This research will help address many points raised in the comments, such as how consumers might react to and understand a “healthy” symbol and misinterpretations they may have. While we agree that there are some symbols that may be used exclusively for industry marketing, companies could use any FDA “healthy” symbol we develop and finalize only when the product displaying the symbol meets FDA's regulatory definition of “healthy.” This could help consumers make more informed dietary choices and construct healthful diets. The comments claiming that a single food is not “healthy” or “unhealthy” and that overall diet matters more than individual foods are commenting on the “healthy” claim itself, which we do not intend to test in this research. Rather, we intend to test consumer reactions to symbols that could be a graphic representation of the claim. Nonetheless, we note that a “healthy” symbol, such as the ones FDA is exploring in our research, could help consumers choose food products, 
                    *as part of their overall diet,*
                     that meet FDA's regulatory definition of “healthy.” The research is not designed to study long-term health effects or consumer consumption patterns. We reiterate that this research is about graphical representations of the nutrient content claim “healthy”—in other words, we intend to study only the symbol, not the claim itself. Depending on the results of this data collection, we may decide to test additional symbols or revise our current symbols. (Comment 2) Many comments expressed a preference for conducting the research after we revise our regulatory definition of “healthy,” as they wondered whether the definition of the claim could influence both the design and consumer understanding of the symbol. Some expressed concern that testing a symbol without clearly communicating what the symbol means could lead to ambiguous results. One comment expressed concern that, by conducting testing only on the symbols in the notice, we would not consider testing any other symbols in the future. A few comments contended that FDA's testing would be invalid if the mock products used in testing do not meet FDA's updated “healthy” definition. (Response 2) FDA has an existing definition for the claim “healthy,” and in the 
                    **Federal Register**
                     of September 28, 2016, we announced our intent to exercise enforcement discretion around some criteria for the claim (see “Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry,” 81 FR 66527). However, as part of this data collection, we have included experimental conditions in which participants will read general information outlining the use of the claim “healthy” only for purposes of this study. This will help us better understand how consumers might respond to the symbols we are proposing to test if participants understand a “healthy” definition, even if not necessarily an updated definition. While the symbol is intended to represent the nutrient content claim “healthy,” our research on the symbol is not dependent on specific criteria for “healthy.” We are researching general consumer perceptions and impressions of the symbols themselves, not the definition that may underly those symbols, and as such, we do not need to wait until we have a final, updated regulatory definition of “healthy” before conducting this research. Moreover, the symbols being tested would not need to be modified with a changing definition of “healthy;” the symbol would remain a simple graphic representation of the “healthy” claim. Regarding the claim that our testing would be invalid if the mock products used in testing do not meet FDA's updated “healthy” definition, our mock products represent broad and basic food categories. They include foods such as vegetables and whole grains with limited nutrients of concern (
                    *e.g.,*
                     sodium or saturated fat) that would meet our current definition of “healthy” and would help consumers build a diet consistent with the 
                    *Dietary Guidelines for Americans, 2020-2025.* B. Comments Regarding the Accuracy of Our Burden Estimates, Including the Validity of the Methodology and Assumptions Used, and FDA Response Many comments discussed the accuracy of FDA's estimate of the burden for this information collection, including the validity of FDA's methodology and the assumptions used. (Comment 3) Several comments alleged that we provided limited details about our proposed research studies and encouraged us to publish additional information on the proposed scope and methodology of our consumer research to allow for more comprehensive input from experts in the field of consumer research. One comment suggested we “pre-register” details of the proposed studies on AsPredicted.org or ClinicalTrials.gov so that stakeholders could better understand the primary outcome of the research, hypotheses, analytic plan, and power analysis used. (Response 3) We described the research in the 60-day notice, providing information on research design, measures, sampling, and sample size. Many comments substantively addressed these issues, and so we believe there was enough information about the studies in the 60-day notice for the public—including consumer researchers—to comment on the research. We specified in the 60-day notice that we intend to use the results to inform our continued exploration of a symbol manufacturers could voluntarily use to represent the nutrient content claim “healthy” on the food label (86 FR 24629 at 24631). The comment did not provide sufficient information regarding additional details that it believed necessary for stakeholders to better understand this primary outcome, hypotheses, analytic plan, and power analysis used, and it did not explain what additional details might be available via pre-registration that would not be available in our 
                    **Federal Register**
                     notices. Therefore, we are unable to provide those details here, and we also decline to pre-register our studies. (Comment 4) One comment questioned the ordering of the quantitative research, asking why the experimental studies come before the surveys. Other comments suggested we use the two surveys to test draft symbols first to narrow down options and test the “final” symbols in the experiment, or to conduct preliminary research to narrow the options for the experiment. (Response 4) We conducted several phases of qualitative research to solicit input from consumers, allowing us to evaluate symbol prototypes and design elements to learn what resonated with consumers. Through that process we narrowed our draft symbol options. After considering public comments, we have reconsidered the order of the research, and plan to conduct one survey with a larger sample size (instead of two surveys with smaller sample sizes each) before the experimental study. In other words, we will reorder 
                    ( print page 17303)
                    the studies and combine the two surveys into one, which will allow us to test all symbols in a single survey. While our proposed information collection is intended to help us better understand how consumers might respond to and use a graphic symbol that indicates packaged food products meet FDA's definition of “healthy,” and all the draft symbols we proposed to test would allow us to do that, we expect conducting a single survey first will help us further revise and narrow down the set of symbols. (Comment 5) One comment suggested we use a more naturalistic study environment, such as an online store setting, instead of using images. (Response 5) Online store settings and other naturalistic study environments have been successfully employed in some studies on food labeling effects. One advantage of employing such naturalistic study environments is that they more closely reflect participants' actual shopping experience. However, there are substantial additional costs associated with using such research settings, and results in these settings generally do not differ appreciably from results garnered through the simple random-assignment-to-condition design that we proposed. Therefore, we decline to change our study environment. (Comment 6) One comment suggested that FDA separate different aspects of the symbols to isolate consumer perceptions of the word “healthy,” the graphic itself, and the graphic accompanied by the word “FDA.” One comment suggested that FDA should test each symbol with and without “FDA.” (Response 6) Separating each aspect of the symbols for our testing would increase the number of conditions exponentially, making the design impractical. We instead elected to use a full factorial design with simple random assignment to condition, to give us results on the performance of the various symbol designs. Using random assignment to condition, we may be able to eliminate some symbols without needing to test particular attributes in any one symbol. We may consider alternate study designs when we have a narrower set of symbols. One finding of our literature review was that institutional endorsement may be related to greater confidence in the symbol. Our focus group research affirmed that participants regarded symbols with “FDA” as more trustworthy than symbols without “FDA.” Therefore, for the intended research, we are testing draft symbols with “FDA.” We may consider additional research on this point depending on the results. (Comment 7) One comment recommended using images of real food products in the experimental studies instead of using mock product images. (Response 7) FDA does not agree with the recommendation to use images of real products in the experimental studies. Mock images remove the potential for brand biases, a source of response error that has been demonstrated to affect the way individuals answer survey questions. Mock food product labels psychologically remove the salience of branded product informational cues present in the retrieval stage of the response process (Refs. 1 and 2). Additionally, the mock product labels we designed are visually similar to labels consumers could expect to see in stores for each given product category. We confirmed this assertion in our qualitative testing by noting that participants perceived the mock product labels as ones with which they were unfamiliar, but which were plausible for the food product depicted. (Comment 8) One comment suggested that we should assess “multi-tier symbols” in addition to the symbols we intend to test. The comment suggested that multi-tier symbols are those that use, for example, an increasing number of stars to indicate to the consumer that a choice is “good,” “better,” or “best.” The comment argued that a multi-tiered approach could encourage consumers to make incremental improvements in their diets, enable manufacturers to reformulate products to meet the initial tier of the system, and increase the number of foods with at least some healthful benefits that could carry a symbol. Another comment suggested that FDA consider a symbol that warns consumers about high levels of unhealthy nutrients. Another comment asserted that we should also test what it suggested were more neutral FOP labels, such as traffic lights, nutrition scoring symbols, and warning symbols, to better assist consumers in making healthy choices and motivate manufacturers to make healthier foods. (Response 8) For the purpose of this study, we are testing only symbols that would be a graphic representation of the nutrient content claim “healthy”—a food that could bear that claim could also bear the symbol. FDA's systematic literature review suggested that a summary indicator—the type we are proposing to test—would have the greatest utility to depict the “healthy” claim to a broad array of consumers, especially those with lower education or lower health literacy. As such, we disagree that we should test other kinds of symbols to depict the nutrient content claim “healthy.” We are testing different draft symbol designs based on our literature review and the feedback we collected through our focus group research. Our current study plans are limited to testing summary symbols depicting the nutrient content claim “healthy” to get reactions to design elements and to reduce the current number of symbols under consideration. Because there are no “healthy” tiers in the nutrient content claim, we decline to test a tiered symbol. (Comment 9) One comment encouraged us to consider testing the “healthy” symbol alongside other current voluntary FOP labels—rather than as the only symbol on a package—to determine the effect of other FOP labels on the efficacy of the “healthy” symbol. (Response 9) Our studies are designed to test general consumer responses to the symbols presented. Testing additional variables, such as the effect of other packaging elements on the symbols, is outside the scope of this research. We may decide to test “healthy” symbols alongside other FOP symbols in later research depending on the results from this data collection. (Comment 10) One comment recommended randomizing participants to see subgroups of symbols, claiming it would be an efficient use of resources. (Response 10) FDA agrees with the recommendation that participants be randomly assigned; however, we disagree with the recommendation to have participants view subgroups of symbols. We plan to randomly assign participants to see a single symbol condition, including product type, information on the definition of healthy, URL/no-URL, and set of symbols. Viewing a single symbol condition precludes the effects of biases that may result from having viewed and responded to questions about one symbol affecting responses about another symbol (Ref. 1). Therefore, even if we might use fewer resources by assigning participants to see subgroups of symbols, the practice would introduce biases and confounds that could make interpreting the results very difficult. (Comment 11) One comment recommended incorporating time limits for a choice task to better mimic real-life scenarios where consumers have only limited time to shop. (Response 11) The current experimental study design is random assignment to condition with no “choice task.” While time-constraint 
                    ( print page 17304)
                    studies can be useful to test certain variables, our research goal is for the participants to provide thoughtful responses, unaffected by the stress that a time limit could impose. (Comment 12) A few comments recommended that the studies be adequately powered to enable FDA to do appropriate statistical analysis. (Response 12) Our studies are designed to have the appropriate statistical power to conduct all necessary statistical analysis. We will test hypotheses related to between-label differences. We will impose no a priori direction of differences, if any (
                    *i.e.,*
                     we assume all tests are two-tailed). The target sample size (5,000 for the experimental study and 2,000 for the survey) will yield enough observations to provide adequate power to identify 4-way interactions of a medium size (Ref. 3). (Comment 13) One comment recommended that we test the draft “healthy” symbols in the context of restaurants. (Response 13) Our research plans include testing symbols solely on packaged foods. Testing “healthy” on a packaged food label versus in a restaurant minimizes the many confounding factors inherent in studying claims in a restaurant environment, such as the enormous variance in size and content of materials used to sell restaurant food. Keeping the studies limited to packaged food labels allows FDA to better isolate various effects of the symbols to strictly test consumer perceptions about the symbols. Additionally, as we noted in response to another comment, we have no reason to believe that adding additional test product categories would change the study outcomes given our goal of testing consumer responses to the symbols. (Comment 14) Some comments recommended that FDA include more than three mock product types in the experimental studies because of the potential that consumer perceptions of a “healthy” symbol might be different on different products. One comment suggested including a variety of food categories in the studies, while a few other comments recommended including specific product categories, including beverages and fresh produce, so FDA could assess consumer reactions to, or preferences for placement of, a symbol on those products. (Response 14) FDA disagrees with the recommendation to add more product types to the studies. We are proposing to test “healthy” symbols on a set of mock products that belong to large food categories, with many product types within each category. The broad product categories for those mock products are likely to contain multiple products that currently meet FDA's regulatory definition of “healthy.” For our research, we chose three packaged foods that are commonly consumed and that are clearly distinct food types. The selected products will give us sufficient information on general consumer responses to the symbols to continue development of a proposed “healthy” symbol. We also note that adding any products would increase the scope and cost of the studies while providing limited new information and that the comments provided no evidence that additional test products from other food categories would impact our study outcome. We decline to include a beverage as one of the mock products. While beverages that meet FDA's definition of “healthy” could bear any “healthy” symbol we finalize, the same is true of any packaged food, and as we explained above, we have no reason to believe that adding additional test product categories would change the study outcomes. We decline to add fresh produce to the studies for the same reasons. (Comment 15) A few comments recommend comparing foods with a “healthy” symbol and foods that may have healthful attributes but do not meet the regulatory definition of “healthy,” to evaluate whether use of the symbol might result in discouraging purchase of foods that have important nutrients but that do not meet the definition of “healthy.” Another comment suggested testing a variety of products (“healthier” and “less healthy”) for each food product category included in the studies. (Response 15) The studies are not designed to test purchasing behavior, and so we decline to add mock products for that purpose. Rather, this research is designed to test general consumer responses to the symbols themselves. Additionally, a product could only bear the symbol if it qualified to bear the “healthy” claim itself—the symbol is a graphic representation of the claim—and we are not testing the claim definition or its effects here. One of the study assumptions is that, like the nutrient content claim “healthy,” any food bearing a “healthy” symbol on its label must meet the regulatory definition of “healthy.” Therefore, to test consumer responses to the symbols, we do not need to test the ancillary effects of a “healthy” symbol on foods that do not bear the claim. Moreover, FDA intends to test “healthy” symbols on a set of mock products whose product categories are likely to contain multiple products that currently meet FDA's regulatory definition of “healthy”—we are making no claims about the relative healthfulness of any product. Using these mock products in our research will provide us with sufficient information to understand how consumers might respond to a “healthy” symbol on food packaging, and that information is our goal with these studies. Testing the selected products will give us sufficient information to continue development of a proposed “healthy” symbol. The comment did not provide an explanation for its recommendation to test “healthier” and “less healthy” products for each food product category. We are not testing “healthier” and “less healthy” versions of a given product in this research effort, as the goal of the research is to gauge participants' reactions to a symbol. Additionally, we are working on updating our definition of “healthy” and will describe our proposed updated definition in any related rulemaking. It would be inappropriate to assign relative “healthfulness” to comparator products. Products bearing the “healthy” symbol, which would be a graphic version of the nutrient content claim “healthy,” would have to meet the criteria for using the claim. (Comment 16) One comment noted a symbol with the term “FDA” may cause confusion if that symbol is used on any products regulated by the U.S. Department of Agriculture (USDA) and urged us to consider the potential for such confusion in our research. Another suggested that we engage with the Food Safety and Inspection Service during our proposed consumer research on the “healthy” symbol to develop a symbol that could apply to all products that meet the “healthy” claim criteria. (Response 16) We cannot comment on whether or how USDA might allow an FDA “healthy” symbol on the products it regulates that meet FDA's definition of “healthy.” However, we intend to coordinate with our federal partners, including USDA, as appropriate, as we continue our work on a “healthy” symbol. (Comment 17) A few comments asserted it was important to consider the symbols' placement on packaging and noted that food packaging size, type, and appearance vary, suggesting that FDA should study how consumers may respond to a “healthy” symbol on a wider variety of packaging formats than are currently proposed for the studies. One comment suggested testing the symbol on different locations on the package and with varying prominence. 
                    ( print page 17305)
                    Another encouraged flexibility in specified requirements (
                    *e.g.,*
                     placement, type size, color format, scannable images) surrounding the FOP symbol. (Response 17) We anticipate that any “healthy” symbol we propose would be standardized in certain ways. However, the purpose of this research is to gauge consumer responses to the symbols we are testing, not to decide on a single symbol, its potential placement on packaging, or what aspects we would require, should a company choose to use the symbol. (Comment 18) A few comments suggested we include questions or conduct additional research to assess the potential for consumer misunderstanding of the symbols. Some comments suggested that we investigate whether consumer perceptions of some symbols might imply messages other than “healthy” (such as “organic,” “natural,” “plant-based,” and “minimally processed”) or whether the symbols we are testing may appear similar to other existing or abandoned symbols (such as the USDA Organic Seal, Smart Choices, or any of USDA's bioengineered food symbols). One comment claimed that a lack of legibility of the text in the symbol could cause consumer confusion. Another comment recommended that FDA avoid leaf or nature imagery in the symbol because it could imply that the product is plant-based, “natural,” or unprocessed. One comment encouraged us to examine how appealing the symbols are to consumers, and another comment described the proposed symbols as too simplistic. (Response 18) We have selected study designs and draft symbols that we expect, when used together, will reveal how consumers will react when they see such symbols on a food label. We included questions in our studies on what the symbols lead participants to believe about the products bearing them. We also expect to hear from participants whether the symbols we are testing are perceived as too complex, too simplistic, or invoke concepts other than “healthy.” We agree that any symbol we propose should be legible and minimize imagery that our research indicates could widely lead consumers to think the symbol means something unintended. As such, we will add an open-ended question to the experimental study asking what the symbol brings to mind to help determine if any symbols should be removed from consideration or revised on this basis. Moreover, we agree that the FDA symbol design for “healthy” should not be easily confused with other existing symbols and should be viewed as professional and credible by consumers. We expect to get some data on these points through this round of testing and may undertake further research before we make any formal regulatory decision on a symbol. (Comment 19) One comment suggested that FDA test other terms besides “healthy,” such as “nourishing” or “nutrient-dense.” (Response 19) We are not testing the nutrient content claim “healthy;” rather, we are testing consumer responses to graphic representations of the claim. We similarly do not intend to test other terms. (Comment 20) Several comments supported conducting research on the use of an accompanying URL with the “healthy” symbol; however, others stated the purpose for including a URL was unclear, and one comment expressed concern that a URL would not work as well in a brick-and-mortar retail setting. Another comment stated that future labeling could include the use of other technologies, such as a quick response (QR) code or digital watermark, to provide consumers access to all the labeling information included on the package and suggested that we incorporate digital disclosure flexibility into our labeling regulations because technology continues to evolve. Other comments suggested that consumers may not have internet access in stores or may not know how to use QR codes, while another comment suggested that researchers could develop unique QR codes for each condition and track participant use. (Response 20) Our research efforts on the “healthy” symbol are intended to collect sufficient data for the development and finalization of a “healthy” symbol. We are studying several dimensions of a proposed symbol, including the inclusion of a URL as part of the symbol. This research will help us better understand study participants' reactions to and understanding of those different elements. Our preliminary research indicated that participants are interested in learning more about the symbols, and a URL can serve as a representation to participants that more information is available. The current study design proposes to test a URL alongside some of the symbols to gauge the ability of the URL to indicate that information about the symbol is available and to assess the degree to which a URL improves confidence and trust in the symbol. We are not studying participants' actual ability to access the URL in stores or elsewhere. We are also not considering inclusion of other technologies, such as a QR code or digital watermark, in this information collection because a URL will help us gauge whether participants want a way to access additional information about the symbol. Further, a QR code or digital watermark would not indicate government involvement in the way a URL ending “.gov” may, and we are interested in how participants will respond to a “.gov” URL. While we agree that technology changes over time, we are only studying consumer responses to the symbols in this research. It would be premature to comment on any requirements surrounding any symbol we might propose. However, we could consider other digital elements, such as QR codes or digital watermarks, in future research depending on our future research goals. (Comment 21) Some comments raised concerns that the use of FDA's name as part of the “healthy” symbol. The comments said that the use of FDA's name could create the appearance of an FDA endorsement of a given food. (Response 21) We are testing draft symbols with “FDA.” We note that we are studying several dimensions of a proposed symbol to help us better understand study participants' reactions to and understanding of those different elements, including any impression of an FDA endorsement. (Comment 22) A few comments expressed uncertainty as to whether FDA research participants would come from a nationally representative sample and recommended paying particular attention to or using quota samples similar to the demographic breakdown of the U.S. population regarding sex, age, race/ethnicity, income, and education. Some comments also stated that FDA should consider oversampling from certain groups at highest risk for dietary-related disparities, asserting that it is important to ensure that any proposed healthy symbol works well among all populations. One comment noted this is especially important for lower-education groups who, the comment asserted, may be less likely to use or understand the package's nutrition label. Some comments also requested that FDA screen participants to ensure a sample large enough to collect responses from food-allergic individuals, caregivers to food-allergic individuals, and parents. (Response 22) We designed our studies to test consumer responses to draft symbols in a randomized controlled setting, with participants drawn from a general population. Our research collection is not intended to produce population estimates. However, we intend to select the samples in each study to be reflective of the general U.S. 
                    ( print page 17306)
                    population (
                    *e.g.,*
                     sex, race/ethnicity). We believe our approach is reasonable because any “healthy” symbol we finalize will be available to the general U.S. population. (Comment 23) One comment suggested that we test a Spanish language version of the symbol and consider whether including “FDA” as part of the symbol would resonate with consumers of products sold in other countries. (Response 23) Our regulations, at 21 CFR 101.15(c), generally require that the labeling of all food offered for sale in the United States be in English, and outline requirements for manufacturers that also choose to label their products in additional languages. Because we generally require only English labeling, and manufacturers may choose whether to use or include foreign-language labeling, we are testing only an English-language version of the symbol in this set of studies. As for products sold in other countries, the nutrient content claim “healthy,” and any related symbol we finalize, are specifically for products marketed and sold in the United States. We decline to comment on marketing and sales in, or the food labeling requirements of, other countries. (Comment 24) One comment argued that we should not generalize the results from this study to all FOP label systems. (Response 24) We agree that findings from this research should not be generalized to all FOP label systems. C. Comments Regarding Ways To Enhance the Quality, Utility, and Clarity of the Information To Be Collected, and FDA Response Several comments suggested ways to enhance the quality, utility, and clarity of the information about “healthy” symbols to be collected. (Comment 25) Some comments stated FDA should conduct thorough research regarding the development and finalization of a symbol for “healthy,” and should collect comprehensive data so that FDA's final decision promotes health. (Response 25) FDA agrees with the comments. Our research goal is to explore consumer responses to draft symbols that could represent the nutrient content claim “healthy.” The goal of the symbol is to help consumers make more informed dietary choices. (Comment 26) Several comments recommended we change certain aspects of the questions we include in the experimental study. Some comments suggested that we select specific outcome measures, such as purchase intent, sales data, ability of the symbols to attract consumer attention, long-term behavior change, consumer perceptions of the taste and cost of products bearing the “healthy” symbol, the healthfulness of the products consumers purchased, the number of “healthier” products purchased in a shopping setting, and any unintended consequences of the symbol. One comment recommended adding covariates, such as health status, particularly for conditions that are related to nutrition, such as diabetes, weight status, and hypertension, to help us understand responses. Regarding the interpretation of measurements, one comment suggested we avoid “believability” or “trustworthiness” as indicators of which symbol can help people make more informed dietary choices, claiming that these are not strong predictors of behavior. The comment cited a study on cigarette pack warning messages that found that measures on the effects of the warning message resulted more in intended behavior change than did measures on attitude perceptions (Ref. 4). Another comment recommended FDA provide an option for open-ended responses to gauge consumers' perceptions of “healthy.” (Response 26) The intended studies cover the key measurements and covariates that will help us understand consumer perceptions of the symbols. The comments did not provide, and we are not aware of, evidence that adding covariates or measurements would enhance the quality, utility, or clarity of the information we intend to collect. We will evaluate our draft symbols based on our analysis of all—not just a subset—of these measurements. We acknowledge that there are measurements we are not including in this research effort (
                    *e.g.,*
                     long-term behavior changes). These studies are designed to explore consumer responses to the draft symbols, and inclusion of variables such as long-term behavior changes would be premature. We plan to use a variety of measures to help understand the potential impact of a voluntary FOP symbol for “healthy,” and intend to use “believability” and “trustworthiness” as outcome measures because well-established scientific literature has shown that consumers' attitudes and perceptions affect their behavior (Refs. 5 to 7). Additionally, we note that the cigarette-pack study one comment cited qualified its findings as unsure if the same would be found in other message or product scenarios (Ref. 4). Because the published literature does not indicate that “effects perception measures” have been tested in the food label domain, we will add some questions to the experimental study to evaluate their use as outcome measures compared to “message effects measures.” We disagree with the suggestion to query consumers on their perception of “healthy.” Our research is designed to test consumer responses to the draft symbols, not determine consumer perceptions of “healthy.” D. Comment Regarding Ways To Minimize the Burden of the Collection of Information on Respondents, Including Through the Use of Automated Collection Techniques, When Appropriate, and Other Forms of Information Technology, and FDA Response One comment discussed minimizing the information collection burden on respondents to our proposed “healthy” symbol research. (Comment 27) One comment supported the proposed research and noted that the use of online surveys will help alleviate participant and administrative burden while ensuring that the research reaches sufficient participants. (Response 27) We agree with the comment for the purposes of this research. E. Nonresponsive Comments to the PRA Some comments addressed aspects of “healthy” symbols that are outside the scope of this information collection or addressed issues other than the “healthy” symbol research. These discussed, for example, the definition of “healthy,” potential impacts of the “healthy” nutrient content claim generally, whether the symbols should be voluntary or mandatory, and whether we should develop an accompanying consumer education campaign. These are outside the scope of this information collection, and we will not address them here. Interested parties will have an opportunity to comment on any “healthy” symbol we propose and any proposed updated definition of the nutrient content claim “healthy” in response to their respective 
                    **Federal Register**
                     notices. FDA estimates the burden of this collection of information as follows:
                    ( print page 17307) Table 1—Estimated Annual Reporting Burden 1
Activity
Number of
                             respondents
Number of
                             responses per respondent
Total annual responses
Average burden per response
Total hoursStudy 1 (Survey) Cognitive interview screener
75
1
75
0.083 (5 minutes)
6Study 2 (Experiment) Cognitive interview screener 2
75
1
75
0.083 (5 minutes)
6Study 1 (Survey) Cognitive interview
5
1
5
1
5Study 2 (Experiment) Cognitive interview
9
1
9
1
9Study 1 (Survey) Pretest
60
1
60
0.17 (10 minutes)
10Study 2 (Experiment) Pretest
180
1
180
0.25 (15 minutes)
45Study 1 (Survey)
2,000
1
2,000
0.17 (10 minutes)
340Study 2 (Experiment)
5,000
1
5,000
0.25 (15 minutes)
1,250Total




1,6711
                         There are no capital costs or operating and maintenance costs associated with this collection of information.2
                         Since Study 3 is identical to Study 2, only one set of cognitive interviews and pre-tests are needed.
 II. References The following references are on display with the Dockets Management Staff (see 
                    **ADDRESSES**
                    ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these are not available electronically at 
                    *https://www.regulations.gov*
                     as these references are copyright protected. Some may be available at the website address, if listed. FDA has verified the website addresses, as of the date this document publishes in the 
                    **Federal Register**
                    *,*
                     but websites are subject to change over time. 1. Odsakoff, P.M., S.B. MacKenzie, N.P. Podsakoff, 2012. “Sources of Method Biases in Social Science Research and Recommendations on How to Control It.” 
                        *Annual Review of Psychology,*
                         63, pp. 539-569. 2. Sheff, J.N., 2011. “Biasing Brands.” 
                        *Cardozo Law Review,*
                         32(4), pp. 1245-1314. 3. Cohen, J., 1992. “A Power Primer.” 
                        *Psychology Bulletin,*
                         112(1), pp. 155-159. 4. Baig, S.A., S.M. Noar, N.C. Gottfredson, et al., 2021. “Incremental Criterion Validity of Message Perceptions and Effects Perceptions in the Context of Anti-smoking Messages.” 
                        *Journal of Behavioral Medicine,*
                         44, pp. 74-83. 5. Azjen, I., 2011. “The Theory of Planned Behaviour: Reactions and Reflections.” 
                        *Psychology and Health,*
                         26(9), pp. 1113-1127. 6. Azjen, I., 2014. “The Theory of Planned Behaviour is Alive and Well, and Not Ready to Retire: A Commentary on Sniehotta, Presseau, and Araujo-Soares.” 
                        *Healthy Psychology Review,*
                         9(2), pp. 131-137. 7. Ajzen, I., 2016. “Consumer Attitudes and Behavior: The Theory of Planned Behavior Applied to Food Consumption Decisions.” 
                        *Italian Review of Agricultural Economics,*
                         70(2), pp. 121-138. Dated: March 21, 2022. Andi Lipstein Fristedt, Deputy Commissioner for Policy, Legislation, and International Affairs, U.S. Food and Drug Administration.


[FR Doc. 2022-06419 Filed 3-25-22; 8:45 am] BILLING CODE 4164-01-P