# Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2022-20975 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** September 29, 2022 - **Citation:** 87 FR 59168 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 101 [Docket No. FDA-2016-D-2335] RIN 0910-AI13 Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA or we) is proposing to update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans (Dietary Guidelines), regarding how consumers can maintain healthy dietary practices. This action, if finalized, will revise the requirements for when the term “healthy” can be used as an implied claim in the labeling of human food products to indicate that a food's level of nutrients may help consumers maintain healthy dietary practices by helping them achieve a total diet that conforms to dietary recommendations. DATES: Either electronic or written comments on the proposed rule must be submitted by December 28, 2022. Submit written comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 (PRA) by October 31, 2022. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 28, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”) Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” Instructions: All submissions received must include the Docket No. FDA-2016-D-2335 for “Food Labeling: Nutrient Content Claims; Definition of Term `Healthy.' ” Received comments, those filed in a timely manner (see ADDRESSES ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf . Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. Submit comments on information collection under the Paperwork Reduction Act of 1995 to the Office of Management and Budget (OMB) at 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 proposed collection is “Food Labeling Regulations,” OMB control number 0910-0381. FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Vincent de Jesus, Center for Food Safety and Applied Nutrition, HFS-830, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450, vincent.dejesus@fda.hhs.gov; or Denise See, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. With regard to the information collection: Domini Bean, FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Table of Contents I. Executive Summary A. Purpose of the Proposed Rule B. Summary of the Major Provisions of the Proposed Rule C. Legal Authority D. Costs and Benefits II. Introduction III. Table of Abbreviations/Commonly Used Acronyms in This Document IV. Background A. Regulatory History B. Need To Update “Healthy” C. Actions Taken To Update “Healthy” D. Table of Past Publications Referenced in This Proposed Rule V. Legal Authority VI. Proposed Action A. Overview of Approach B. Description of Proposed Regulation VII. Proposed Effective and Compliance Dates VIII. Preliminary Economic Analysis of Impacts A. Introduction B. Summary of Costs and Benefits IX. Analysis of Environmental Impact X. Paperwork Reduction Act of 1995 XI. Federalism XII. Consultation and Coordination With Indian Tribal Governments XIII. References I. Executive Summary A. Purpose of the Proposed Rule Consumers rely on food labels when navigating the marketplace to make informed choices about the foods that are the foundation of a nutritious diet for both themselves and members of their families. FDA plays an important role in ensuring labels of food for human consumption are accurate, truthful, and not misleading, including claims that appear in product labeling to market a food. One such claim that FDA has regulated is the term “healthy” on product labels. Since 1994, we have recognized that when a manufacturer uses labeling that describes a product as “healthy” in the nutritional context, it is making an implicit claim of the level of nutrients of the product. In particular, such a label implies that the nutrient content of the food may help consumers maintain healthy dietary practices. Given that nutrition science has evolved since the 1990s when FDA first established a definition for the implied nutrient content claim “healthy,” the proposed rule would update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and Federal dietary guidance. The proposed rule would revise the requirements for when the claim “healthy” can be used as an implied nutrient content claim in the labeling of human food products. In particular, because the claim indicates that a food, because of its nutrient content, may help consumers maintain healthy dietary practices, we seek to limit the use of the claim to circumstances in which the food may help consumers achieve a healthy dietary pattern that conforms to current nutrition science and Federal dietary guidance. B. Summary of the Major Provisions of the Proposed Rule The proposed regulation would update the definition for the implied nutrient content claim “healthy,” which specifies the requirements for when the claim can be used on human food products. The claim “healthy,” when used in the nutritional context in food labeling, is an implied claim that the levels of the nutrients in the food are such that the food may help consumers maintain healthy dietary practices. Under the existing regulation, there are specific criteria for individual nutrients that must be met in the food for it to bear the claim, including limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts of nutrients whose consumption is encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber. Since the time the claim was first defined in 1994, nutrition science and Federal dietary guidance have changed, making the current “healthy” definition outdated. Our current definition permits manufacturers to use the claim “healthy” on some foods that, based on the most up-to-date nutrition science and Federal dietary guidance, contain levels of nutrients that would not help consumers maintain healthy dietary practices. Further, a number of foods emphasized in current nutrition science and Federal dietary guidance as key elements of a healthy dietary pattern are not able to bear the “healthy” claim under the current regulation ( e.g., salmon due to fat levels). As a result, we believe that the definition needs to be updated so that the use of the claim will again accurately represent that the levels of the nutrients in the food may help consumers maintain healthy dietary practices, consistent with current nutrition science and Federal dietary guidance, as reflected in the Dietary Guidelines for Americans, 2020-2025 ( Dietary Guidelines, 2020-2025 ) (Ref. 1). The proposed framework for the updated definition of “healthy” uses a food group-based approach in addition to nutrients to limit (based on the understanding that each food group contributes an array of important nutrients to the diet). The proposed, updated “healthy” criteria would emphasize healthy dietary patterns by requiring that food products contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines, 2020-2025 in order to be labeled “healthy.” The proposed regulation would also require a food product to be limited in certain nutrients, including saturated fat, sodium, and added sugars. The proposed rule would also add certain recordkeeping requirements for foods bearing the claim where compliance cannot be verified through information on the product label. C. Legal Authority We are issuing this proposed rule to update the definition of the implied nutrient content claim “healthy” consistent with our authority in sections 201(n), 403(a), 403(r), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(n), 343(a), 343(r), and 371(a)). We are also relying on our authority under sections 403(r), 403(a), 201(n) and 701(a) of the FD&C Act to propose certain records requirements. D. Costs and Benefits In the current marketplace, about 5 percent of all packaged foods are labeled as “healthy.” Because nutrition science has evolved over time, updating the definition of the implied nutrient content claim “healthy” to closely align with nutrition science underpinning the Dietary Guidelines, 2020-2025 will better inform consumers who are selecting those products to choose a more healthful diet, which may result in lower incidence of diet-related chronic diseases, including cardiovascular disease and type 2 diabetes. Quantifiable benefits of the proposed rule are the estimated reduction over time in all-cause morbidity stemming from consumers that rely upon the “healthy” implied nutrient content claim selecting and consuming more healthful foods. This is calculated through the negative association between a Healthy Eating Index score and all-cause mortality. Quantifiable costs to manufacturers associated with updating the “healthy” claim are reformulating, labeling, and recordkeeping. Discounted at 3 percent over 20 years, the mean present value of costs is estimated at $276 million, or $19 million annualized. Potential costs of rebranding certain foods are discussed qualitatively. Discounted at three percent over 20 years, the mean present value of benefits is estimated at $455 million, or $31 million annualized. Net benefits are estimated at $180 million, or $12 million annualized. II. Introduction In 1994, FDA issued a regulation defining “healthy” as an implied nutrient content claim pursuant to the Nutrition Labeling and Education Act (NLEA) of 1990. Implied nutrient content claims were defined in our regulations, in part, as claims that imply that a food, because of its nutrient content, may help consumers maintain healthy dietary practices. At that time, nutrition science and Federal dietary guidance focused more on the individual nutrients contained in food. As a result, the criteria for “healthy” in the current regulation are solely based on individual nutrients. Nutrition science and Federal dietary guidance have evolved since the existing “healthy” regulation was issued in 1994. As the Dietary Guidelines, 2020-2025 explains, current nutrition science focuses “on consuming a healthy dietary pattern” (Ref. 1). Although nearly all foods can be incorporated into a healthy dietary pattern to a greater or lesser extent, current nutrition science emphasizes nutrient-dense foods, such as fruits, vegetables, and whole grains, as key elements of a healthy dietary pattern. “Nutrient dense” foods and beverages are defined as foods and beverages that provide vitamins, minerals, and other health-promoting components and have little added sugars, saturated fat, and sodium (Ref. 1). These foods, which contain a variety of important nutrients, work synergistically as part of a dietary pattern to help improve health (Ref. 1). A number of these nutrient-dense foods are not able to bear the “healthy” claim under the current regulation ( e.g., salmon due to fat levels). Further, the current definition permits manufacturers to use the claim “healthy” on some foods that, based on the most up-to-date nutrition science and Federal dietary guidance, contain levels of nutrients that would not help consumers maintain healthy dietary practices ( e.g., certain ready-to-eat cereals that may be high in added sugars). Thus, we believe that the “healthy” claim definition needs to be updated in order to ensure that products bearing the claim are the products that may help consumers maintain healthy dietary practices, consistent with current nutrition science and Federal dietary guidance. FDA seeks to improve dietary patterns in the United States to help reduce the burden of nutrition-related chronic diseases and advance health equity as nutrition-related chronic diseases are experienced disproportionately by certain racial and ethnic minority groups and those with lower socioeconomic status. We are committed to accomplishing this, in part, by empowering consumers with more informative and accessible labeling to choose healthier diets. By making nutrition information more available to consumers in a direct, accessible, and consistent manner, consumers will be able to make informed and healthful dietary choices. A key element in achieving these goals is updating our policies for nutrition-related labeling claims to reflect current nutrition science and Federal dietary guidance, which includes aligning with the updated Nutrition Facts Label and the Dietary Guidelines, 2020-2025 (Ref. 1), and provide information in a way that is accessible to consumers. Claims like “healthy” provide information to consumers that allow them to quickly identify foods that can be the foundation of a healthy dietary pattern. Thus, the goal of this rulemaking is to update the definition of “healthy” as an implied nutrient content claim in the labeling of human food to help ensure that consumers have access to more complete, accurate, and up-to-date information about those foods. To provide context regarding the scope of the problem Americans face from diet-related chronic disease, chronic diseases, such as heart disease, cancer, and stroke, are among the leading causes of death and disability in the United States, and half of all American adults have one or more preventable, diet-related chronic diseases, including cardiovascular disease and type 2 diabetes (Ref. 2). Each year, more than 630,000 Americans die from heart disease and close to 600,000 die from cancer (Ref. 3). An estimated 37 percent of Americans suffer from cardiovascular disease (CVD) (Ref. 4). As of 2017, 12.2 percent of the population 18 years and older had diabetes, 33.9 percent of adults had prediabetes (Ref. 5), and 38.4 percent of the population was predicted to be diagnosed with cancer during their lifetime (Ref. 6). As noted, many of these chronic diseases are experienced at higher rates by certain racial and ethnic minority groups and those with lower socioeconomic status. For example, in 2017-2018, more than 4 in 10 American adults had high blood pressure, and that number increases to about 6 in 10 for non-Hispanic Black adults (Ref. 27). Additionally, from 2017 to 2018, the prevalence of diagnosed diabetes was highest among American Indian and Alaska Native adults compared to other race-ethnicity groups (Ref. 28). While chronic diseases result from a mix of factors, unhealthy dietary patterns throughout the lifespan increase the risk of developing chronic diseases, along with genetic, biological, behavioral, socioeconomic, and environmental factors (Ref. 1). Further, overweight and obesity, which are associated with poor eating and physical activity behaviors, are major contributors to chronic disease in the United States (Ref. 10). Obesity raises the risk for morbidity from chronic diseases such as type 2 diabetes, coronary heart disease, and some cancers, and is also associated with increased risk of all-cause and CVD mortality (Ref. 10). More than two-thirds of U.S. adults and nearly one-third of children and youth are overweight or obese (Ref. 11). These high rates of overweight and obesity and chronic disease have persisted for more than two decades and come not only with increased health risks, but also at high economic cost. According to the Government Accountability Office, in 2018, $383.6 billion was spent to treat CVD, cancer, and diabetes, making up 25 percent of the approximately $1.5 trillion in total health care spending on conditions among U.S. adults. In particular, government payers, including Medicare and Medicaid, account for more than 50 percent of spending for treatment of CVD, cancer, and diabetes (Ref. 29). Improved nutrition represents an opportunity to help reduce the rates of these diet-related chronic diseases. As part of our nutrition work, we are taking actions to help consumers maintain healthy dietary patterns and make food choices that contribute to such patterns. A key source that has considered the current nutrition science and established recommendations on what healthy dietary patterns look like is the Dietary Guidelines document. The Dietary Guidelines are developed jointly by the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) and provide recommendations on healthy eating and the consumption of foods from various food groups, as well as the intake of specific macronutrients, such as saturated fats and added sugars, and micronutrients such as vitamins and minerals. The Dietary Guidelines are designed for policymakers and nutrition and health professionals to help all individuals and their families consume a healthy, nutritionally adequate diet (Ref. 1). The Dietary Guidelines are the foundation of Federal dietary guidance and are intended to inform policymakers when they implement Federal policies and programs related to food, nutrition, and health. The Dietary Guidelines, in addition to other consensus reports and scientific information, help FDA to shape regulations on nutrition-related claims and other information that is permitted on a food label. The Dietary Guidelines, 2020-2025 explains that a healthy lifestyle—including following a healthy dietary pattern—can help people achieve and maintain good health and reduce the risk of chronic disease throughout all stages of the lifespan. The Dietary Guidelines, 2020-2025 identifies vegetables, fruits, dairy, grains, protein foods, and oils as essential components of a healthy dietary pattern (Ref. 1). However, more than 80 percent of Americans have dietary patterns that are low in vegetables, fruits, and dairy (Ref. 1). Additionally, more than half of the population is meeting or exceeding the total grain and total protein foods recommendations but is not meeting the recommendations for the subgroups within each of these food groups (Ref. 1). In 2019, 42 percent of adolescents and 39 percent of adults said they ate fruit less than once a day, while 41 percent of adolescents and 21 percent of adults said they ate vegetables less than once a day (Ref. 13). At the same time, most Americans exceed the recommended intake limits for added sugars, saturated fats, and sodium, nutrients that should be limited in a healthy dietary pattern according to the Dietary Guidelines, 2020-2025 (Ref. 1). Evidence shows that excess intake of these nutrients is associated with chronic disease risk; for example, diets lower in saturated fat may reduce the risk of CVD (Ref. 7), and high intakes of sodium are directly associated with elevated blood pressure, an important risk factor for CVD (Refs. 9, 10, and 17). As consumers make their food purchases and daily food choices, food labeling provides them with valuable information about food groups, nutrients, and how a food from a particular food group fits into their daily diet. Claims on food packages such as “healthy” can provide quick signals to consumers about the healthfulness of a food or beverage, making it easier for busy consumers to select foods that can help build more healthful diets. To be accurate and effective, however, a claim of “healthy” must be based on current nutrition science and Federal dietary guidance to ensure that the foods bearing the claim in fact are useful to help consumers maintain healthy dietary practices. We are thus proposing to update the implied nutrient content claim “healthy,” to make it consistent with current nutrition science and Federal dietary guidance. This update would modernize the criteria for the “healthy” claim to go beyond just individual nutrients to also incorporate the variety of nutrients present in a food, through the new food group requirements. This change would better reflect the overall nutrient content of the food, including nutrient density, to represent how nutrients work together and make up the food groups and subgroups that are part of a healthy dietary pattern. Aligning the concept of what it means to qualify for the “healthy” claim with current nutrition science and Federal dietary guidance, and its focus on nutrient density, will help ensure that the “healthy” claim is accurate and empowers consumers with information to make healthier decisions. Because we understand that there may be some reluctance by some food manufacturers to use the claim with the current regulatory definition, as it is not consistent with current nutrition science and Federal dietary guidance, we also expect that our proposed updated criteria for the “healthy” nutrient content claim may expand the availability of food labeled with the “healthy” claim for consumers in the marketplace due to manufacturers being more willing to use the updated claim. III—Table of Abbreviations/Commonly Used Acronyms in This Document Abbreviation/acronym What it means CVD Cardiovascular Disease. Dietary Guidelines Dietary Guidelines for Americans. DV Daily Value. DRV Daily Reference Value. c-eq Cup Equivalent. DRI Daily Reference Intake. DGAC Dietary Guidelines Advisory Committee. FDA Food and Drug Administration. FD&C Act Federal Food, Drug, and Cosmetic Act. FGE Food Group Equivalent. HHS U.S. Department of Health and Human Services. G Gram. IOM Institute of Medicine. OMB Office of Management and Budget. National Academies National Academies of Sciences, Engineering, and Medicine. NFL Final Rule Food Labeling: Revision of the Nutrition and Supplement Facts Labels, Final Rule. NLEA Nutrition Labeling and Education Act. oz-eq Ounce Equivalent. Mg Milligram. Oz Ounce. PRA Paperwork Reduction Act. RDI Reference Daily Intake. RACC Reference Amount Customarily Consumed. RFI Request for Information. PHO Partially Hydrogenated Oil. USDA U.S. Department of Agriculture. Dietary Guidelines, 2020-2025 Dietary Guidelines for Americans, 2020-2025 . 2020 DGAC Report Scientific Report of the 2020 Dietary Guidelines Advisory Committee. IV. Background A. Regulatory History In the Federal Register of May 10, 1994, we published a final rule entitled “Food Labeling: Nutrient Content Claims, Definition of Term: Healthy” amending § 101.65(d) to define the term “healthy” as an implied nutrient content claim under section 403(r) of the FD&C Act (59 FR 24232). The definition in § 101.65(d) establishes parameters for use of the implied nutrient content claim “healthy” or related terms (such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) on the label or in the labeling of a food that is useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions. Under the existing regulation, these conditions include specific criteria for nutrients that must be met in the food for it to bear such claims. These criteria include limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts (10 percent of Daily Value (DV)) of nutrients whose consumption is encouraged, such as vitamin A, vitamin C, calcium, iron, protein, and dietary fiber. Under the regulation, foods must meet all limits and contain the minimum amount of at least one nutrient to encourage to bear the “healthy” claim. The required nutrient criteria vary for certain food groups ( e.g., there are different criteria for seafood, game meat, and raw fruits and vegetables) (§ 101.65(d)(2)). The current claim is also linked to use with an explicit or implicit claim or statement about a nutrient ( e.g., “healthy, contains 3 grams of fat”). B. Need To Update “Healthy” The existing definition in § 101.65(d) is linked to certain requirements in the Nutrition Facts label at 21 CFR 101.9 and serving size regulations at 21 CFR 101.12 that were in effect in 1994 when the final rule to define the nutrient content claim “healthy” was published. For example, the existing “healthy” regulation requires that a product provide a specified percentage of the RDI or Daily Reference Value (DRV) for nutrients that were of “sufficient public health significance to warrant their inclusion on the nutrition label” (59 FR 24232). Since that time, FDA has issued final rules updating the Nutrition Facts label and serving size information for packaged foods to reflect new scientific information. This includes the final rules “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (81 FR 33742, “NFL Final Rule”) and “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments” (81 FR 34000, “Serving Size Final Rule”), which were published on May 27, 2016. These rules included changes to the nutrients that must be declared on the Nutrition Facts label. For example, the Nutrition Facts label must now include a declaration of the amount of added sugars in a serving of a product, based on our conclusion that evidence on dietary patterns and health outcomes supports a mandatory declaration of added sugars (81 FR 33742 at 33799). The updates also included changes to the DV of certain individual nutrients to reflect changes in recommended intake levels based on current nutrition science. The Nutrition Facts label declaration requirements and DVs for individual nutrients significantly inform the regulations for nutrient content claims such as “healthy,” including the updated criteria outlined in this proposed rule. The NFL Final Rule and the Serving Size Final Rule reflect the nutrition science in the 2015-2020 Dietary Guidelines, other consensus reports, national survey intake data, and research regarding consumer use and understanding of the label. The Dietary Guidelines are published every five years to reflect current nutrition science. Although some of its specific recommendations have evolved as scientific knowledge has grown, many of its foundational recommendations have remained consistent over time ( e.g., recommending increased consumption of fruits, vegetables, and whole grains, and diets low in saturated fat and sodium). Advancements in nutrition science have provided a greater understanding of, and focus on, the importance of healthy dietary patterns, and how dietary components act synergistically to affect health. The Dietary Guidelines, 2020-2025 has a particular focus on the importance of dietary patterns as a whole, with recommendations to help Americans make choices from across and within all food groups within calorie needs to add up to an overall healthy dietary pattern (Ref. 1). The Dietary Guidelines, 2020-2025 also emphasizes “shifts,” or replacement of less healthy food choices with nutrient-dense foods, as a method for consumers to achieve a healthy dietary pattern. The body of scientific evidence discussed in the Dietary Guidelines, 2020-2025, and the recommendations based on that nutrition science, inform this proposed rule. As stated above, a key element in helping to reduce the burden of nutrition-related chronic diseases and advance health equity is updating FDA's policies for nutrition-related labeling claims to ensure that they reflect current nutrition science and Federal dietary guidance, and provide information in ways that are useful and easier to understand for consumers. Because the implied nutrient content claim “healthy,” as codified at § 101.65(d)(2), is linked to the nutrition labeling regulations and dietary guidance that were in effect at the time of its issuance in 1994, we propose to update the criteria for “healthy” to ensure they are harmonized with current regulations, nutrition science, and Federal dietary guidance. The framework underlying the existing “healthy” claim is, in some respects, inconsistent with current nutrition science and Federal dietary guidance. For example, the Dietary Guidelines, 2020-2025, which reflects current nutrition science, is centered on the importance of dietary patterns; their recommendations focus on the combination of nutrient-dense foods and beverages that people should consume to meet nutritional needs within calorie limits (Ref. 1), rather than focusing on individual nutrients. Nutrient density is important, among other reasons, because consumption of nutrient-dense foods provides beneficial nutrients, with little added sugars, saturated fat, or sodium. In contrast, the existing criteria for “healthy” only include requirements for individual nutrients. Under the solely individual nutrient-based framework, foods that are encouraged by the Dietary Guidelines, 2020-2025 for inclusion in a healthy dietary pattern are sometimes not able to meet the nutrient criteria under § 101.65(d) for use of the claim “healthy.” For example, although consumption of certain oils, such as olive and canola oil, in place of sources of saturated fat, is supported by current nutrition science and emphasized by Federal dietary guidance (such as the Dietary Guidelines, 2020-2025 ) as part of a healthy dietary pattern, these oils are currently ineligible to bear the “healthy” claim, in part, because they do not contain 10 percent of the DV for vitamin A, vitamin C, protein, dietary fiber, calcium, or iron as specified by the existing rule. Thus, the existing “healthy” claim has become inconsistent with the longstanding purpose of this type of implied claim to indicate that the nutrient levels in a food may help consumers maintain healthy dietary practices. To the extent that current nutrition science and Federal dietary guidance (such as the Dietary Guidelines, 2020-2025 ) do still focus on individual nutrients ( e.g., recommending limits on saturated fat, sodium, and added sugars; identifying certain underconsumed nutrients), there have been some developments in scientific understanding related to intake of such nutrients. For example, Federal dietary guidance has shifted from recommending diets low in total fat (Ref. 12) to emphasizing increased intakes of monounsaturated and polyunsaturated fats and decreased intakes of saturated fat (Ref. 1). Additionally, current nutrition science, as reflected in the Dietary Guidelines, 2020-2025, recommends limiting consumption of foods higher in added sugars, which provide excess calories to the diet without contributing significant amounts of essential nutrients. In contrast, the existing “healthy” criteria include limits on total fat and do not include limits for added sugars, which makes the criteria inconsistent with current nutrition science and Federal dietary guidance. Finally, as noted above, the existing definition for healthy includes a nutrient contribution criterion focused on nutrients that had sufficient public health significance to warrant their inclusion on the nutrition label and that had been highlighted by leading health authorities as being important to the public health (59 FR 24232 at 24243). At the time the existing “healthy” regulation was finalized in 1994, the nutrients included in the nutrient contribution requirement were vitamin A, vitamin C, protein, iron, calcium, and dietary fiber. Nutrient intakes have shifted over time, and vitamins A and C are no longer considered nutrients of public health significance because deficiency of these nutrients in the U.S. population is rare and not currently of substantial public health concern. In our recent updates to the Nutrition Facts label, we required declaration of vitamin D and potassium, but no longer required declaration of vitamins A and C (81 FR 33742 at 33744). These updates are consistent with the Dietary Guidelines, 2020-2025, which includes calcium, potassium, dietary fiber, and vitamin D as nutrients of public health concern, in addition to iron, for certain population groups (Ref. 1). Thus, in addition to a shift in focus from consumption of individual nutrients to healthy dietary patterns as the primary way to achieve nutritional adequacy, there have been some changes in Federal dietary guidance regarding individual nutrients since the original “healthy” rule was issued. Noting the changes to the Nutrition Facts label, current nutrition science, and the Dietary Guidelines, 2020-2025, a variety of stakeholders, including from academia, industry, and consumers, have requested that we update the implied nutrient content claim “healthy.” Some stakeholders have provided specific recommendations on how they believe we should approach such an update. For example, in a citizen petition dated December 1, 2015 (Docket No. FDA-2015-P-4564) (“Kind Citizen Petition”), KIND LLC requested that we make certain changes to existing nutrition claim regulations, including a number of changes specifically related to the nutrient content claim “healthy.” C. Actions Taken To Update “Healthy” Because the framework for many of our nutrition labeling regulations is linked to elements in the Nutrition Facts label and serving size regulations, we have already taken several steps toward harmonizing the “healthy” nutrient content claim with our updated regulations and current nutrition science. In the Federal Register of September 28, 2016 (81 FR 66527), we published a notice of availability of a final guidance entitled “Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry.” The guidance describes our intent to reevaluate the existing criteria for “healthy” in light of the changes to the Nutrition Facts label and serving size regulations, as well as the changes in nutrition science as reflected in the Dietary Guidelines. The guidance also advises manufacturers of our intention to exercise enforcement discretion with respect to some of the existing criteria for the nutrient content claim “healthy” until we amend § 101.65(d)(2). The guidance is available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM521692.pdf. Specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim “healthy” for foods that have a fat profile of predominantly monounsaturated and polyunsaturated fats, but do not meet the regulatory definition of “low fat,” and on foods that contain at least 10 percent of the DV per reference amount customarily consumed (RACC) 1 of potassium or vitamin D. This guidance reflects the changes in science and the Dietary Guidelines as described above related to intake of dietary fat and the changes in the nutrients of public health concern since the “healthy” definition was originally issued. 1 Our regulations at § 101.12(b) establish RACCs for specified product categories that manufacturers can use to determine the required label serving size. In September 2016, we also announced the establishment of a docket (Docket No. FDA-2016-D-2335) to receive information and comments (request for information or RFI) on the use of the term “healthy” in the labeling of human food products (81 FR 66562, September 28, 2016). In the RFI, we invited interested persons to comment on the Kind Citizen Petition; the use of the term “healthy” as a nutrient content claim in the labeling of human food products; and when, if ever, the use of the term “healthy” may be false or misleading. We also sought input on 12 specific questions and asked interested parties to provide supporting data, consumer research, and other information to support their comments and answers to our questions. Along with the RFI, we held a public meeting on March 9, 2017, entitled “Use of the Term `Healthy' in the Labeling of Human Food Products” (Ref. 13). The purpose of the public meeting was to give interested persons an opportunity to discuss the use of the term “healthy” in the labeling of human food. Overall, the comments to the docket (nearly 1,200) and at the public meeting supported updating the criteria for the “healthy” nutrient content claim to reflect current nutrition science and the Dietary Guidelines. Most health organizations, industry representatives, and consumers supported an enforceable, specific definition that would help guide consumers toward healthier options. There was broad support for limiting certain nutrients, especially added sugars, in foods labeled “healthy,” and in allowing whole, nutrient-dense foods and foods high in monounsaturated and polyunsaturated fats to meet the definition. Comments to the docket provided specific recommendations for nutrient criteria, whole food servings, and flexibility for different food categories. While there was some variation in the specific criteria proposed in comments, virtually all of the proposed frameworks included a combination of nutrient criteria and food group requirements. Some comments from consumers, and a few comments from industry and health organizations, expressed hesitation at the notion of a “healthy” nutrient content claim. Their primary concerns were that “healthy” could be too simplistic, could deter consumers from looking further into a product's nutritional content, could lead to excessive consumption of “healthy” products, or could mean different things to different consumers ( e.g., some consumers may not understand “healthy” in a nutritional context, but, rather, as referring to other aspects of the product, such as its production method ( e.g., organic)). FDA notes that the claim is not new and has been used on food product labels for decades, but we welcome additional comments on these issues in the context of this proposed rule. We carefully considered comments received in response to the RFI and are addressing many aspects of the concerns noted within those comments in this proposed rule. We view the “healthy” claim as an opportunity to signal and provide information to consumers on which food products, because of their nutrient content, can be most helpful in maintaining healthy dietary practices, based on current nutrition science and Federal dietary guidance. The availability of a revised, updated “healthy” claim may also result in some members of the food industry developing and/or reformulating food products to better match current nutrition science recommendations and use the claim. Given the widespread support for updating “healthy” along with the need to align the claim with current nutrition science, we are proposing updated criteria for the claim. D. Table of Past Publications Referenced in This Proposed Rule Title Publication date Citation Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms Final Rule January 6, 1993 58 FR 2302 Food Labeling: Nutrient Content Claims, Definition of Term: Healthy Final Rule May 10, 1994 59 FR 24232 Food Labeling: Revision of the Nutrition and Supplement Facts Labels Final Rule May 27, 2016 81 FR 33742 Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments Final Rule May 27, 2016 81 FR 34000 Notice of Availability for a Final Guidance “Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry” September 28, 2016 81 FR 66527 Request for Information on the Use of the Term “Healthy” in the Labeling of Human Food Products September 28, 2016 81 FR 66562 V. Legal Authority We are issuing this proposed rule to update the definition of the implied nutrient content claim “healthy” consistent with our authority in sections 201(n), 403(a), 403(r), and 701(a) of the FD&C Act. These sections authorize FDA to adopt regulations that prohibit labeling that is: (1) false and misleading in that it fails to reveal facts that are material in light of the representations that are made with respect to consequences that may result from consuming the food or (2) uses terms to characterize the level of any nutrient in a food that has not been defined by regulation by FDA. Congress passed the Nutrition Labeling and Education Act (NLEA) of 1990 (Pub. L. 101-535), with three basic objectives: (1) to make available nutrition information that can assist consumers in selecting foods that can lead to healthier diets, (2) to eliminate consumer confusion by establishing definitions for nutrient content claims that are consistent with the terms defined by the Secretary of HHS, and (3) to encourage product innovation through the development and marketing of nutritionally improved foods (58 FR 2302, January 6, 1993). The NLEA created section 403(r)(1)(A) of the FD&C Act, which provides specifications for a claim made in the label or labeling of the food which expressly or by implication characterizes the level of any nutrient which is of the type required by section 403(q)(1) or (q)(2) to be in the label or labeling of the food. The statute permits the use of these label and labeling claims that expressly or by implication characterize the level of any nutrient in a food, but only if the claims are made in accordance with FDA's authorizing regulations (section 403(r)(1)(A) & (r)(2)(A) of the FD&C Act). Such claims are referred to as “nutrient content claims.” Nutrient content claims can either be claims that expressly characterize the level of a nutrient (express claims, such as “low fat”) or claims that by implication characterize the level of any nutrient (implied claims, like the “healthy” claim). Nutrient content claims are typically based per RACC. This allows nutrient content claims on foods to be considered consistently across products and product sizes. In rulemaking to implement section 403(r)(1)(A) and 403(r)(2) of the FD&C Act shortly after the enactment of the NLEA, we determined that a claim that states that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices is a claim that characterizes the levels of nutrients in a food (“Food Labeling: Nutrient Content Claims, General Principles, Petitions, Definition of Terms,” 58 FR 2302 at 2374-75, January 6, 1993). That rulemaking resulted in regulations defining “implied nutrient content claims,” in part, as claims that imply that a food, because of its nutrient content, may help consumers maintain healthy dietary practices. As the preamble explained, “[t]he claims are essentially saying that the levels of nutrients in the food are such that the food will contribute to good health” (58 FR 2302 at 2375). FDA issued another implementing regulation in 1994, in which we defined “healthy” when the term is used as an implied nutrient content claim (59 FR 24232, May 10, 1994). We explained in the preamble to the 1994 final rule that the statute requires that FDA define terms by regulation before they are used as nutritional claims in food labeling; more specifically, under the terms of section 403(r)(1)(A) and 403(r)(2) of the FD&C Act, a nutrient content claim would misbrand a food unless it is made in accordance with a definition of the Secretary (and, by delegation, FDA) or with one of the other provisions in section 403(r)(2) of the FD&C Act (59 FR 24232 at 24234). The preamble explained that FDA had already determined that, when used in the nutritional labeling context, the term “healthy” is making an implied claim about the levels of the nutrients in the food; that is, that these levels are such that the food would be useful in achieving a total diet that conforms to current dietary recommendations (56 FR 60421 at 60423, November 27, 1991). Accordingly, FDA was establishing a definition for “healthy” when it is used in a nutritional context. In this rulemaking, we are proposing to update the definition of “healthy” when used as an implied nutrient content claim based on developments in current nutrition science and Federal dietary guidance, as we did with the rulemaking updating the Nutrition Facts label. Our proposed, updated criteria for “healthy” incorporate both food group and nutrient-to-limit requirements. These changes are intended to ensure that foods bearing the implied nutrient content claim “healthy” are foods that may help consumers maintain healthy dietary practices, based on current nutrition science and Federal dietary guidance. The fundamental purpose of this rulemaking furthers the congressional objectives underlying the NLEA of providing nutrition information to consumers to help in selecting foods that can lead to healthier diets and reducing consumer confusion potentially caused by the use of inconsistent definitions for nutrient content claims. The proposed revised definition of “healthy” is consistent with the statutory language, particularly in light of the way current nutrition science and Federal dietary guidance, such as the Dietary Guidelines, have evolved and built upon previous editions. The Dietary Guidelines reflect the consensus scientific understanding that nutrients are not consumed in isolation and focus their recommendations on consuming a variety of nutrient-dense foods, across all food groups, as part of a healthy dietary pattern. The statutory language describes nutrient content claims as claims in the label or labeling of a food that “expressly or by implication” “characterize the level of any nutrient in a food” (section 403(r)(1)(A) of the FD&C Act). The claim “healthy” on its face is an implied claim because it suggests that the food, because of its nutrient content, may help consumers maintain healthy dietary practices. In the 1994 definition of the claim, levels for nine different individual nutrients were discussed: fat, saturated fat, cholesterol, vitamin A, vitamin C, calcium, iron, protein, and fiber (21 CFR 101.65(d)(2)(i)). As discussed elsewhere in this document, in recent years the Dietary Guidelines have shifted to recommending healthy dietary patterns and the consumption of food groups in certain quantities to achieve adequate nutrient intake, based on the understanding that each food group contributes an array of important nutrients to the diet ( Dietary Guidelines, 2020-2025 ). Specifically, the Dietary Guidelines, 2020-2025 states that because foods provide an array of nutrients and other components that have health benefits, nutritional needs should be met primarily through a variety of nutrient-dense foods. Additionally, the Dietary Guidelines, 2020-2025 recommends increasing intakes of food groups to move intakes of underconsumed dietary components closer to recommendations. Accordingly, the new proposed definition includes food groups that provide a number of different nutrients and is thus characterizing the overall nutrient content of the food, rather than focusing on one individual nutrient in isolation, as with an express nutrient content claim. Each food group that is included in the food group requirement for the proposed updated definition of the “healthy” claim represents the inclusion of multiple important nutrients. Therefore, the use of food groups better accounts for how all these nutrients contribute to, and may work synergistically to create, a healthy dietary pattern and improve health outcomes. By requiring products to contain a certain amount of a food group, the proposed rule will help ensure foods bearing the “healthy” claim contain a variety of important beneficial nutrients and, therefore, help Americans meet recommended nutrient intakes and maintain healthy dietary patterns. Consistent with Congress's objectives to provide appropriate nutritional information to consumers, and based on current nutrition science and Federal dietary guidance, the statutory phrase “characterize the level of any nutrient in a food” encompasses both limits on certain individual nutrients and food group criteria that more broadly incorporate a variety of nutrients from nutrient dense foods which may also have a synergistic effect. In addition to section 403(r)(2) of the FD&C Act, we are issuing this proposed rule under section 701(a) of the FD&C Act, which states that we may issue regulations for the efficient enforcement of the FD&C Act and has been interpreted to apply in order to “effectuate a congressional objective expressed elsewhere in the Act” ( Association of American Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980)). We are also relying on our authority under sections 403(r), 403(a), 201(n) and 701(a) of the FD&C Act, to propose records requirements designed to ensure that the use of the “healthy” claim is accurate, truthful and not misleading, based on information known only to the manufacturer, and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records requirements has been upheld under other provisions of the FD&C Act where FDA has found such records to be necessary ( National Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir. 1978)). The recordkeeping we propose to require applies only to foods voluntarily bearing the “healthy” claim for which an adequate analytical method to determine food group equivalents is not available or the amount cannot be discerned from the label alone. The records would allow us to verify that the product meets the requirements to bear the claim and that use of the nutrient content claim “healthy” is truthful and not misleading. Thus, the proposed records requirements would help in the efficient enforcement of the FD&C Act (see discussion in section VI.B.4 “Records Requirements” for more information). The authority granted to FDA under sections 701(a), 403(r), 403(a)(1) and 201(n) of the FD&C Act not only includes authority to establish records requirements, but also includes access to such records. Without access to such records, FDA would not know whether the food meets the proposed requirements to bear the “healthy” claim consistent with section 403(r) of the FD&C Act, and whether the use of the claim is truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine whether a food that is voluntarily bearing a “healthy” nutrient content claim is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer's records that we are requiring be kept under proposed § 101.65(d)(4) (21 CFR 101.65(d)(4)). Failure to make and keep records and provide the records to FDA, as described in proposed §  101.65(d)(4), would result in the food bearing the “healthy” claim being misbranded under sections 403(r) and 403(a)(1) of the FD&C Act. VI. Proposed Action We propose to update the “healthy” nutrient content claim to align its criteria with our updates to the Nutrition Facts label and with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines, 2020-2025. We also took several additional factors into consideration while developing the proposed, updated criteria for “healthy.” We intend for the updated “healthy” criteria to help identify and encourage consumption of nutrient-dense foods to meet current nutrition science and Federal dietary guidance, especially the intake recommendations of the individual food groups as discussed in the Dietary Guidelines, 2020-2025. We also intend for the “healthy” criteria to be appropriately flexible to allow for industry innovation, thereby increasing the availability of foods in the marketplace that will help consumers meet dietary recommendations. Finally, we based the proposed criteria on well-established and longstanding foundations of dietary guidance, including food group recommendations and nutrients to limit. A. Overview of Approach The Dietary Guidelines, 2020-2025 recommends following a healthy dietary pattern at every life stage with a focus on meeting food group needs with nutrient-dense foods and beverages, and staying within calorie limits. Specifically, the Dietary Guidelines, 2020-2025 states that because foods provide an array of nutrients and other components that have health benefits, nutritional needs should be met primarily through a variety of nutrient dense foods. Additionally, the Dietary Guidelines, 2020-2025 recommends increasing intakes of food groups to move intakes of underconsumed dietary components closer to recommendations. Consistent with current nutrition science and Federal dietary guidance, our proposed, updated criteria for “healthy” use an approach based on both food groups and nutrients to limit, rather than focusing solely on individual nutrients. The updated “healthy” criteria emphasize the food groups and subgroups identified in the Dietary Guidelines, 2020-2025 as part of a healthy dietary pattern: vegetables, fruits, grains, dairy, and protein foods, as well as oils. Under the proposed, updated criteria, food products would need to contain a certain amount of food (a “food group equivalent”) from at least one of these recommended food groups or subgroups ( e.g., 1/2 cup of fruit or 3/4 cup of dairy) to be labeled “healthy.” The proposed incorporation of food group criteria is consistent with the current nutrition science articulated in the Dietary Guidelines, 2020-2025 and its focus on dietary patterns as a whole and is appropriate for this implied nutrient content claim because claims that imply a food product contains a certain amount of a food group would characterize the level of a variety of nutrients important to help consumers maintain healthy dietary practices. In addition to the food group criteria, we are proposing that foods must continue to adhere to certain criteria regarding nutrients to limit to be labeled “healthy.” Specifically, we propose maintaining sodium and saturated fat as nutrients to limit (which are already included in the current criteria), along with adding a limit on added sugars, consistent with the rationale for the new Nutrition Facts label requirement for added sugars declaration. These criteria are also consistent with the Dietary Guidelines, 2020-2025 recommendations to limit intake of sodium, saturated fat, and added sugars, and, based on current nutrition science, would strengthen the public health benefits of foods bearing the “healthy” claim. The specific food group criteria and the nutrients to limit are discussed in further detail in sections VI.A.1 and VI.A.2 (“Food Groups” and “Nutrients to Limit”). Because of the proposed food group approach, we propose that the “healthy” criteria no longer include minimum amounts of nutrients to encourage ( i.e., nutrients that are underconsumed and whose low intake in the general population or in individual subpopulations raise public health concern). The Dietary Guidelines, 2020-2025 recommendations to consume various food groups and subgroups in certain quantities are intended to ensure overall nutritional adequacy and consumption in a manner to help consumers maintain healthy dietary practices. FDA is concerned that including criteria for nutrients to encourage could spur fortification to allow foods that are low in saturated fat, sodium, and added sugars to qualify for the “healthy” claim, despite these foods not contributing to a meaningful amount of a food group ( e.g., white bread fortified with calcium). FDA does not support indiscriminate fortification of foods but, rather, encourages the rational addition of nutrients to foods, as discussed further in our fortification policy guidance (Ref. 30). We request comment on whether nutrients to encourage should be included in addition to the food group criteria. As described below, there are some foods that we propose to include in the updated criteria for “healthy” including raw, whole fruits and vegetables, and water, that under the proposed updated criteria, will not need to meet requirements for food group equivalents and nutrients to limit. These foods are included in categories of food that can automatically use the “healthy” claim because of their nutrient content and positive contribution to an overall healthy diet. This is not the case for these foods under the current rule; rather the individual fruit or vegetable must meet the criteria for the nutrients to limit (total fat, saturated fat, sodium, cholesterol) in order to bear the “healthy” claim. These exceptions will be discussed in further detail in section VI.B.3 (“Covered Products”). 1. Food Groups Current nutrition science and Federal dietary guidance specifically emphasize the importance of following a healthy dietary pattern across the lifespan (Ref. 1). As described earlier, the Dietary Guidelines, 2020-2025 notes that foods and beverages are not consumed in isolation, but rather in various combinations over time—a “dietary pattern.” Components of a dietary pattern may have interactive, synergistic, and potentially cumulative relationships, such that the dietary pattern may be more predictive of overall health status and disease risk than individual foods or nutrients (Ref. 1). The principal message of the Dietary Guidelines, 2020-2025 is to follow a healthy dietary pattern that focuses on meeting food group needs with nutrient-dense foods and beverages and stays within calorie limits. The recommendations include an emphasis on meeting nutritional needs “primarily from foods and beverages—specifically, nutrient-dense foods and beverages” (Ref. 1), as opposed to dietary supplements. While FDA's definition includes dietary supplements as foods, they may not always be included in what the nutrition science literature refers to as “foods.” This recommendation also reflects the view that good nutrition does not come from intake of individual nutrients (as dietary supplements often provide) but rather from foods with their mix of various nutrients working together in combination. The Dietary Guidelines, 2020-2025 goes on to describe that “[e]ating an appropriate mix of foods from the food groups and subgroups—within an appropriate calorie level—is important to promote health at each life stage. Each of the food groups and their subgroups provides an array of nutrients, and the amounts recommended reflect eating patterns that have been associated with positive health outcomes” (Ref. 1, page 31). This focus on food groups is consistent with longstanding Federal nutrition education and messaging structured around food groups, such as those associated with MyPlate and the former MyPyramid Food Guidance System and Food Guide Pyramid (Ref. 14). The Dietary Guidelines, 2020-2025 further explains that a healthy dietary pattern includes: • Vegetables of all types—dark green; red and orange; beans, peas, and lentils; starchy; and other vegetables; • Fruits, especially whole fruit; • Grains, at least half of which are whole grain; • Dairy, including fat-free or low-fat milk, yogurt, and cheese, and/or lactose-free versions and fortified soy beverages and soy yogurt alternatives; • Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products; • Oils, including vegetable oils and oils in food, such as seafood and nuts. In the Dietary Guidelines, 2020-2025 and previous iterations, foods fit into groups based on how they are consumed, and their nutrient content, even if this is different from their botanical classification. For example, a bell pepper is considered a vegetable in the Dietary Guidelines, 2020-2025 even though it is botanically a fruit. Additionally, foods from the same source may be categorized differently depending on how they are consumed. For example, soybean oil is classified as an oil, but tofu made from soybeans is classified as a protein food in the Dietary Guidelines, 2020-2025. In considering which foods contribute to meeting the individual food group requirements, we are adopting the categorizations used in the Dietary Guidelines, 2020-2025 to determine the appropriate food group for the food. For example, in the previously mentioned bell pepper example, the presence of bell pepper ingredients would contribute to satisfying the vegetable food group requirements, rather than the requirements for fruit ingredients. Evidence relied on in the Dietary Guidelines, 2020-2025 shows that a healthy dietary pattern, as outlined above, is associated with beneficial outcomes for all-cause mortality, cardiovascular disease, overweight and obesity, type 2 diabetes, bone health, and certain types of cancer) (Ref. 1). Specifically, evidence shows that common characteristics of dietary patterns associated with positive health outcomes include relatively higher intake of vegetables, fruits, legumes, whole grains, low- or non-fat dairy, lean meats and poultry, seafood, nuts, and unsaturated vegetable oils, and relatively lower consumption of red and processed meats, sugar-sweetened foods and beverages, and refined grains (Ref. 1). The existing criteria for “healthy” at § 101.65(d)(2) include minimum content thresholds for a limited number of nutrients for which consumption is encouraged. These nutrient criteria were originally included to identify foods that are particularly helpful to consumers in maintaining healthy dietary practices and achieving dietary recommendations. Instead of including a limited set of nutrients for which consumption is encouraged in the definition as surrogates for recommended food groups and subgroups, we propose to directly incorporate food groups as criteria in the definition of the claim “healthy.” We tentatively conclude that using food groups to encourage as the criteria for “healthy,” rather than a limited set of nutrients, would better identify foods with the nutrient content that may help consumers maintain healthy dietary practices, consistent with current nutrition science and Federal dietary guidance. This approach is consistent with the Dietary Guidelines, 2020-2025 focus on overall dietary patterns to ensure that a range of nutrients are consumed at appropriate levels, rather than on nutrients in isolation. We solicit comment on this tentative conclusion. Our proposed criteria for updating “healthy” emphasize healthy dietary patterns by requiring that food products contain a certain amount of food from a recommended food group to bear the claim “healthy.” In this rule, the phrase “food group” refers to the groups of foods recommended in the Dietary Guidelines, 2020-2025, which include vegetables, fruits, dairy, grains, protein foods, as well as oils (Ref. 1). The Dietary Guidelines, 2020-2025 does not categorize oils as a “food group,” but they emphasize that oils are one of the six core elements of a healthy dietary pattern, along with vegetables, fruits, grains, dairy, and protein foods, and recommend daily intake objectives for oils, similar to the food groups. Therefore, we will include oils as a food group for purposes of this rule. However, because of their specific role in healthy dietary patterns, the proposed criteria for oils differ from the criteria for other food groups, as discussed in further detail in section VI.B.3 (“Covered Products”). In this rule, the phrase “food group equivalent” refers to the amount of a food group that must be contained in a food product for it to bear the “healthy” claim. In this rule, the phrase “food group equivalent” refers to the amount of a food group that must be contained in a food product for it to bear the “healthy” claim. We used the “Healthy U.S.-Style Dietary Pattern,” as described in table A3-2 in the Dietary Guidelines, 2020-2025 (Ref. 1), using the 2000-calorie level pattern as the reference, to determine the food group equivalent amounts. We are basing our food group equivalent recommendations on amounts recommended at the 2,000 calorie level because 2,000 calories is often used for general nutrition advice and this reference amount is already used for other purposes in nutrition labeling. The 2000-calorie level pattern establishes specific daily food group and subgroup amounts in cup-equivalents (c-eq), ounce-equivalents (oz-eq), or grams (g), depending on the type of food. Cup- and ounce-equivalents identify the amounts of foods from each food group with similar nutritional content. For example, while the structural forms of whole wheat bread and brown rice are very different, the Dietary Guidelines, 2020-2025 considers one medium (1 oz) slice of whole wheat bread to be nutritionally similar to one half cup of cooked brown rice, and both represent an oz-eq of whole grains. The 2000-calorie level dietary pattern establishes daily amounts for each food group as follows: • 2 1/2 c-eq of vegetables (comprising recommendations for vegetable subgroups); • 2 c-eq of fruits; • 6 oz-eq of grains, of which at least 3 oz-eq should be whole grains; • 3 c-eq of dairy; • 5 1/2 oz-eq of protein foods (comprising recommendations for protein food subgroups, such as seafood); and • 27 g of oils. In past rulemakings, we have assumed that the typical American dietary pattern is three meals and one snack per day, i.e., four eating occasions, not including beverage-only eating occasions (see final rules on general requirements for health claims and nutrient content claims in food labeling, 58 FR 2478 at 2495 and 58 FR 2302 at 2379 to 2380). In other words, we assume that individuals generally have four opportunities in a day to meet the recommended daily food group amounts in the Healthy U.S.-Style Dietary Pattern, and thereby satisfy their nutritional needs. Consistent with this assumption, and with our approach in past rulemakings, our proposed food group equivalents are based on four eating occasions per day. To determine the amount of a food group required for an individual food to bear the “healthy” claim, we divided the recommended daily food group amounts by four eating occasions. For example, because the recommended daily amount of fruit in the 2000-calorie level pattern is 2 c-eq, we determined that the food group equivalent for fruit would be 1/2 c-eq ( i.e., 2 c-eq divided by four). This would mean that a “fruit product” would need to contain 1/2 c-eq of fruit per RACC (in addition to other requirements) to meet the proposed criteria for “healthy.” While this calculation provided a baseline amount for the food group equivalent requirements, we adjusted the baseline amount for certain food groups and subgroups, as warranted, based on considerations as described in section VI.B.3 (“Covered Products”). This calculation also informs the food group criteria for combination foods (foods that contain a meaningful amount of more than one food group) as will be discussed in section VI.B.3 (“Covered Products”). We seek comment on this proposed calculation—based on four eating occasions per day—for the food group equivalent requirement. 2. Nutrients to Limit While our proposed updates to the “healthy” regulation reflect the importance of the overall nutrient content of foods that build dietary patterns rather than individual nutrients in isolation, we do propose keeping certain nutrients to limit as criteria for bearing the claim “healthy.” This is because current nutrition science and Federal dietary guidance continue to recommend limiting certain nutrients as a key component in emphasizing healthy overall dietary patterns. In the NFL Final Rule, we found that nutrition science supports limiting intake of saturated fat, sodium, and added sugars. Similarly, the Dietary Guidelines, 2020-2025 includes recommendations to choose nutrient-dense foods across and within food groups while limiting foods and beverages higher in added sugars, saturated fat, and sodium (Ref. 1). Moreover, under the Dietary Guidelines, 2020-2025, “nutrient dense” food and beverages are defined as foods and beverages that provide vitamins, minerals, and other health-promoting components and have little added sugars, saturated fat, and sodium. Vegetables, fruits, whole grains, seafood, eggs, beans, peas, and lentils, unsalted nuts and seeds, fat-free and low-fat dairy products-, and lean meats and poultry—when prepared with no or little added sugars, saturated fat, and sodium—are identified as nutrient-dense foods (Ref. 1). Thus, in addition to the food group criteria for “healthy,” we are proposing updates to criteria for nutrients to limit for saturated fat, sodium, and are proposing to add criteria for added sugars. The proposed nutrients to limit criteria help ensure that foods bearing the “healthy” claim do not contain excess saturated fat, sodium, or added sugars, which can increase calories and/or the risk of chronic disease and therefore diminish the potential beneficial public health impact of the “healthy” claim. In setting the criteria for nutrients to limit, we are proposing baseline values for each nutrient and have adjusted the values, as warranted. Different food groups and subgroups each contain foods that provide a variety of nutrients, including important nutrients that are underconsumed and some naturally contain higher amounts of nutrients that should be limited. For example, dairy foods provide vitamin D and calcium; however, they also may contain saturated fat. In contrast, fruits and vegetables contain minimal or no saturated fat. Using the same saturated fat criteria across all food groups could exclude foods that provide important nutrients and that are recommended by the Dietary Guidelines, such as low-fat milk and low-fat cheese. However, increasing the saturated fat limit across all food groups could encourage the unnecessary addition of saturated fat for foods in food groups such as vegetables, which are generally not sources of saturated fat. Therefore, based on current nutrition science and Federal dietary guidance, adjustments to the baseline amount for different food groups allow a variety of foods across recommended food groups to meet the proposed, updated definition without encouraging unnecessary addition of saturated fat, sodium, and added sugars. The adjustments made to the baseline amount for different food groups and subgroups are further described in section VI.B.3.b (“Individual foods”). The baseline values are percentages of the DV for each nutrient to help ensure flexibility and longevity of the “healthy” criteria if the DVs shift in the future. DVs are reference amounts of nutrients to consume or not to exceed each day. Historically, the DVs established in regulation by FDA have been based on the nutritional needs of adults and children 4 years of age and older. However, the recent revisions to the regulations for the Nutrition Facts label have established DVs specific to infants up to 12 months of age and to children 1 to 3 years of age (§ 101.9(c)(9)). As discussed earlier, we are proposing that use of the nutrient content claim “healthy” remains limited to adults and children 2 years of age and older. Therefore, the claim “healthy” could appear on foods directed to children 2 to 3 years of age and on foods directed to adults and children 4 years of age and older. When determining eligibility for use of the claim “healthy,” specifically whether a food meets the “percent DV” criteria for saturated fat, sodium, and added sugars, the “percent DV” criteria will be based on the set of DVs appropriate for that food. For the majority of foods, the DVs established for adults and children 4 years of age and older will be the basis of the nutrient criteria for the claim that are discussed in the following sections. However, for the subset of foods specifically directed to children 2 to 3 years of age ( e.g., fruit pouches, toddler snack puffs), the basis of the “percent DV” nutrient criteria are the specific set of DVs established for that age range in § 101.9(c)(9). a. Saturated Fat The current “healthy” nutrient content claim regulation includes limits on saturated fat for all food categories (§ 101.65(d)(2)(i)(A)-(F)). Dietary recommendations have long recognized the well-established relationship between consumption of saturated fat and its effect on blood cholesterol levels (Refs. 16 and 17). Evidence shows that replacement of saturated fats with unsaturated fats, especially polyunsaturated fats, reduces blood total cholesterol and low-density lipoprotein cholesterol (LDL-cholesterol) concentrations and, therefore, the risk of CVD (Ref. 16). Evidence shows that replacing saturated fats with polyunsaturated fats is associated with a reduced risk of CVD mortality and/or coronary heart disease (CHD) (Ref. 16). Saturated fat is required to be declared on food labels by section 403(q)(1)(D) of the FD&C Act, and we reaffirmed in the NFL Final Rule that saturated fat declaration is necessary to assist consumers in maintaining healthy dietary practices (81 FR 33742 at 33786). The DVs for nutrients are established either as RDIs or as DRVs. The DRV for saturated fat is 20 grams (for children 1 to 3 years old, the DRV is 10 grams), which is approximately 10 percent of calories based on a 2,000-calorie reference intake level (§ 101.9(c)(9)). In the preamble to the proposed NFL rule (79 FR 11879 at 11895, March 3, 2014, Docket No. FDA-2012-N-1210), we discussed how consensus reports ( e.g., Institute of Medicine (IOM) Dietary Reference Intakes (DRI) and 2002 report from the National Cholesterol Education Program of the National Institutes of Health's National Heart, Lung, and Blood Institute) continue to recommend saturated fat intakes of no more than 10 percent of calories, based on risk of CVD. We reaffirmed in the NFL Final Rule that the 20-gram DRV is consistent with scientific evidence (81 FR 33742 at 33786). Additionally, the Dietary Guidelines have consistently recommended limiting calories from saturated fats. The Dietary Guidelines, 2020-2025 states that intake of saturated fat should be limited to less than 10 percent of calories per day by replacing them with unsaturated fats, particularly polyunsaturated fats. Accordingly, we propose limiting saturated fat in foods bearing the implied nutrient content claim “healthy,” to ensure that such foods do not contribute to a dietary pattern that contains excess saturated fat. Many of the comments on the RFI supported including a limit on saturated fat in foods bearing the “healthy” claim. For saturated fat, we are proposing a baseline limit of 5 percent of the DV per RACC (≤1 g for adults and children 4 years of age and older). This level is consistent with the low saturated fat nutrient content claim (21 CFR 101.62(c)(2)), and with the saturated fat criteria for most of the individual foods in the current definition for “healthy.” We are also proposing to adjust the baseline limit for saturated fat, as warranted, based on specific nutrient considerations associated with the different food groups and subgroups and the Dietary Guideline consumption recommendations for different food groups. As discussed in section V.B.3.b (“Individual foods”), we are proposing the baseline limit for saturated fat (5 percent of the DV per RACC) for fruit products; vegetable products; grain products; bean, pea, and soy products; and nut and seed products (excluding saturated fat derived from nuts and seeds, as discussed in section VI.B.3.b (“Individual foods”). We are proposing the following adjustments to the baseline limit for saturated fat, as described further in the discussion of individual foods below, for certain categories of foods that are core elements of healthful dietary patterns associated with reducing chronic disease risk ( e.g., low-fat dairy products): 10 percent of the DV for dairy products; 10 percent of the DV for game meats, seafood, and eggs; and 20 percent of total fat for oils and oil-based spreads and dressings. We are also considering alternatives to the proposed limits on saturated fat. We are considering an approach using a ratio of saturated fat to total fat, such as a ratio based on current DVs for saturated fat and total fat, which are based on 10 percent and 35 percent of daily calorie intake, respectively. The intent of this approach would be to apply a single ratio across all food groups, thereby reducing the variation in the currently proposed limits, while still allowing some flexibility for foods that provide monounsaturated and polyunsaturated fats. We seek comment on the use of a limit for saturated fat based on the ratio of saturated fat to total fat, including any data supporting this approach. b. Sodium The current “healthy” nutrient content regulation includes limits on sodium content for all food categories (§ 101.65(d)(2)(ii)). Dietary recommendations have long emphasized reductions in sodium intake because average population-level intake continually exceeds recommended levels. As we stated in the NFL Final Rule, evidence continues to support the association between increased sodium consumption and blood pressure (81 FR 33742 at 33875). For example, the National Academy of Medicine (formerly IOM), of the National Academies of Sciences, Engineering, and Medicine (National Academies), 2005 DRI Electrolytes Report noted a direct relationship between sodium intake and increased blood pressure (Ref. 9) and the 2013 National Academies report entitled “Sodium Intake in Populations: Assessment of the Evidence” (Ref. 8) concluded that a strong body of evidence has been documented in adults that blood pressure decreases as sodium intake decreases. The Scientific Report of the 2020 Dietary Guidelines Advisory Committee Report (2020 DGAC Report) states that sodium intake is directly related to blood pressure across the lifespan and that elevated blood pressure contributes to the risk of CVD and stroke, which are both leading causes of morbidity and mortality in the United States (Ref. 15). Reducing sodium intake has also been a consistent recommendation in the Dietary Guidelines; the Dietary Guidelines, 2020-2025 carries forward the National Academies' recommendation to limit sodium to less than 2,300 milligrams (mg) per day—and even less for children younger than age 14 (Refs. 1 and 17). According to the Dietary Guidelines, 2020-2025, healthy dietary patterns limit sodium to the Chronic Disease Risk Reduction (CDRR) levels defined by the National Academies—1,200 mg/day for ages 1 through 3; 1,500 mg/day for ages 4 through 8; 1,800 mg/day for ages 9 through 13; and 2,300 mg/day for all other age groups. However, average intakes of sodium are high across the U.S. population compared to the CDRR levels. Average intakes for those ages 1 and older is 3,393 mg/day, with a range of about 2,000 to 5,000 mg/day (Ref. 1). In 2019, the National Academies set the CDRR levels for sodium based on evidence of the beneficial effect of reducing sodium intake on blood pressure and risk of CVD and hypertension (Ref. 17). This most recent evaluation of the evidence reaffirms the 2,300 mg/day recommended daily limit for those 14 years and older. To reduce sodium intake to the recommended limits, the Dietary Guidelines, 2020-2025 recommends implementing multiple strategies, including making food choices in all food groups with less sodium (Ref. 1). We propose to include a limit on the amount of sodium in foods bearing the nutrient content claim “healthy” to help individuals identify foods that are consistent with dietary recommendations for sodium. Many comments on the RFI supported a sodium limit on foods bearing the claim “healthy.” The DRV for sodium is 2,300 mg (for children 1 to 3 years old, the DRV is 1,500 mg). We are proposing a baseline sodium limit of ≤10 percent of the DV (currently, 230 mg for adults and children 4 years of age and older) per RACC for individual foods. This proposed, updated sodium limit is lower than the limit in the existing criteria for “healthy” (480 mg, or about 20 percent of current DV) (§ 101.65(d)(2)(ii)). We expect that it is feasible to lower the sodium level requirement for “healthy” due to reductions in sodium in certain foods and food categories in response to consumer support for policies to limit sodium content in manufactured foods (Refs. 18 and 19) and to technological progress since the existing definition of “healthy” was issued in 1994. Additionally, in October 2021, FDA published short-term (2.5 year) voluntary sodium reduction targets for the food industry (Ref. 31). These targets are anticipated to support gradual sodium reduction in the food supply and increase available options that are lower in sodium. When selecting the proposed, updated limit for the “healthy” claim, we considered the many functions of sodium in food, including taste, texture, microbial safety, and stability. For example, while a baseline limit for sodium of ≤5 percent of the DV would be consistent with the proposed saturated fat and added sugar baseline limits and the low sodium nutrient content claim, we are concerned that a limit of ≤5 percent of the DV for sodium is not practical at this time. We are proposing to adjust the baseline values for sodium as warranted, based on specific considerations of the different food groups and subgroups, as described below. We seek comment on this approach. c. Added Sugars In the NFL Final Rule, we required the declaration of the amount of added sugars in a serving of a product after we concluded that evidence on dietary patterns and health outcomes supports a mandatory declaration of added sugars (81 FR 33742 at 33799). We determined that declaration of the amount and percent DV of added sugars in a serving of a product is necessary to assist consumers to maintain healthy dietary practices and determine how a serving of a product fits into the context of their total daily diet (81 FR 33742 at 33804). This conclusion was based on scientific evidence showing that healthy dietary patterns characterized, in part, by lower intakes of sugar-sweetened foods and beverages are associated with a decreased risk of CVD (Ref. 7). This is consistent with a key recommendation of the Dietary Guidelines, 2020-2025 to limit foods and beverages higher in added sugars (Ref. 1). To achieve this recommendation, the Dietary Guidelines, 2020-2025 recommends that individuals 2 years of age and older consume less than 10 percent of calories per day from added sugars. Current consumption data indicate that most Americans are consuming more than 10 percent of calories from added sugars (Ref. 16). According to the 2020 DGAC Report, current intake of added sugars remains high at 267 calories, or 12.7 percent of total calories per day among the total population ages 1 year old and older (Ref. 16). Evidence shows that consumption of excess calories from added sugars can lead to a less nutrient-dense diet. When sugars are added to foods and beverages, the sugars add calories without contributing essential nutrients. Foods with added sugars displace other nutrient-dense foods in the diet, and as the amount of added sugars increase in the diet, it becomes more difficult to also eat foods with sufficient dietary fiber and essential vitamins and minerals and stay within calorie limits. Thus, a diet low in added sugars helps individuals achieve a healthy dietary pattern through nutrient-dense choices within calorie limits (Ref. 1). Many of the comments on the RFI and public meeting support limiting the amount of added sugars permitted in foods bearing the claim “healthy.” Consistent with our rationale in the NFL Final Rule and with the Dietary Guidelines, 2020-2025, we find that it is critical that foods bearing the implied nutrient content claim “healthy” do not contribute to a dietary pattern that contains added sugars over the recommended levels. We therefore propose including a limit on the amount of added sugars in foods bearing the nutrient content claim “healthy” to help consumers choose foods that will contribute to a healthy dietary pattern that is lower in added sugars, consistent with current nutrition science and Federal dietary guidance. The DRV for added sugars is 50 g (for children 1 to 3 years old, the DRV is 13 g). For individual foods, we are proposing a baseline value for added sugars of ≤5 percent of the DV per RACC (≤2 1/2 g for adults and children 4 years of age and older). While there is no low added sugars nutrient content claim, the proposed ≤5 percent DV level is consistent with our approach of using a low in saturated fat claim, which the Dietary Guidelines, 2020-2025 also recommends limiting to less than 10 percent of calories per day starting at age 2. We are also proposing to adjust the baseline values for added sugars as warranted, based on specific considerations of the different food groups and subgroups, as described in the discussion of individual food groups below. We seek comment on this approach. We note that high-intensity (low- and no-calorie) sweeteners are not considered added sugars by FDA. Additionally, the Dietary Guidelines, 2020-2025 does not consider high-intensity sweeteners to be added sugars and do not make any recommendations for those 2 years of age and older on the intake of high-intensity sweeteners. Therefore, high-intensity sweeteners are not a factor in this proposed rule. The Dietary Guidelines, 2020-2025 did note that “replacing added sugars with low- and no-calorie sweeteners may reduce calorie intake in the short-term and aid in weight management, yet questions remain about their effectiveness as a long-term weight management strategy.” FDA reviews high-intensity sweeteners for use in foods based on available scientific evidence. There is reasonable certainty of no harm under the intended conditions of use of high-intensity sweeteners because the estimated daily intake is not expected to exceed the acceptable daily intake for each sweetener. d. Nutrients Not Included (1) Total Fat In contrast to the existing criteria at § 101.65(d), we propose removing the limit for total fat in the updated criteria for “healthy.” Federal dietary guidance, based on current nutrition science, has shifted away from recommending diets low in total fat—which includes saturated fat, trans fat, and unsaturated fat—to focus instead on the types of fat in the diet due to their different effects on health outcomes. The Dietary Guidelines, 2020-2025, for example, includes no key recommendation for intake of total fat, and emphasize replacing intake of saturated fats with unsaturated fats, particularly polyunsaturated fats (Ref. 1). The shift away from emphasizing total fat is also reflected in the NFL Final Rule (81 FR 33742). For example, the declaration of “Calories from fat” is no longer required on the Nutrition Facts label because current nutrition science supports a view that the type of fat is more relevant than overall total fat intake in risk of chronic diseases. Reflecting this shift in science, our guidance for industry on the use of the term “healthy,” published in 2016, advises food manufacturers of our intent to exercise enforcement discretion for products labeled “healthy” that are not low in total fat, but have a fat profile makeup of predominantly monounsaturated and polyunsaturated fat (Ref. 19). Therefore, while we propose maintaining a limit on saturated fat, we are not proposing to include total fat as part of the criteria for the “healthy” nutrient content claim. (2) Trans Fat In 2015, we released a final determination that partially hydrogenated oils (PHOs) which are the primary dietary source of industrially produced trans fat, are no longer generally recognized as safe for use in food (80 FR 34650, June 17, 2015) to eliminate the majority of uses of PHOs. The compliance date for this determination was June 18, 2018, for most foods, with extended compliance dates in 2020 and 2021 for certain uses of PHOs (83 FR 23358, May 21, 2018). As a result of this determination, what was previously the primary dietary source of trans fat has been largely removed from the food supply. We recognize that there are other sources of trans fat in the food supply, including refined edible oils and naturally occurring sources in products from ruminant animals ( e.g., meat and dairy). The Dietary Guidelines, 2020-2025 does not make any recommendations regarding intake of trans fat but notes that the National Academies recommends that trans fat consumption be as low as possible without compromising the nutritional adequacy of the diet. However, because foods that contain declarable levels of trans fat from sources other than PHOs typically contain saturated fat as well, we expect that the proposed saturated fat limits will disqualify most foods containing declarable levels of naturally occurring trans fat from meeting the “healthy” criteria (Ref. 20). Therefore, we are not proposing to include a limit for trans fat in the updated “healthy” criteria because we do not think such a limit is necessary due to the limits we are proposing for saturated fat in this rule and due to our other regulatory actions to remove PHOs from the marketplace. We seek comment on our proposed approach to trans fat, including any data demonstrating that the saturated fat limit will not adequately disqualify foods containing trans fat from meeting the proposed “healthy” definition. (3) Dietary Cholesterol The Dietary Guidelines, 2020-2025 does not make any recommendations regarding intake of dietary cholesterol but discuss dietary cholesterol in conjunction with trans fat and note that the National Academies recommends that dietary cholesterol consumption be as low as possible without compromising the nutritional adequacy of the diet. The Dietary Guidelines, 2020-2025 also notes that the USDA Dietary Patterns are limited in dietary cholesterol (Ref. 1). Additionally, the 2020 DGAC Report states that “[b]ecause dietary cholesterol is found only in animal-source foods that are typically also sources of saturated fat, the independent effects on blood lipids and CVD are difficult to assess. Although, we recognize the importance of limiting dietary cholesterol, we tentatively conclude that it is unnecessary to include a limit for dietary cholesterol for the “healthy” claim because, as with trans fat, dietary cholesterol is already sufficiently limited by the proposed limits for saturated fat. Dietary cholesterol and saturated fats are found in similar foods, i.e., foods that are higher in dietary cholesterol, such as fatty meats and full-fat cheese, which are generally also higher in saturated fats (Ref. 16). As a result, a dietary pattern low in saturated fat is typically also low in dietary cholesterol. We therefore expect that the proposed saturated fat value of 5 percent DV per RACC (or the adjusted baseline limit for certain foods) will disqualify most foods that contain more than 60 mg of dietary cholesterol, the current limit under § 101.65, from meeting the proposed “healthy” criteria. There are a few exceptions, including foods such as eggs and some shellfish, that contain ≤5 percent DV of saturated fat per RACC and are not low in dietary cholesterol (Ref. 20). However, eggs and seafood (which includes fish and shellfish) are specifically highlighted in the Dietary Guidelines, 2020-2025 as being nutrient-dense foods, supplying nutrients such as choline, vitamin D, and essential fatty acids (Refs. 1 and 17). The Dietary Guidelines, 2020-2025 also found that almost 90 percent of Americans do not meet the recommendations for consumption of seafood, and specifically recommend shifts within the protein foods group to increase seafood intake. Because eggs and seafood are nutrient-dense foods, provide important nutrients, and are specifically recommended by the Dietary Guidelines, 2020-2025 for inclusion in a healthy dietary pattern, we consider that it is appropriate for these foods to meet the updated “healthy” criteria. For these reasons, we are not proposing to include a limit on dietary cholesterol as part of the updated criteria for “healthy.” We seek comments on our proposed approach to dietary cholesterol, including any data showing that the proposed saturated fat limit does not adequately limit dietary cholesterol, or any data indicating that foods containing lower saturated fat levels and higher cholesterol levels ( i.e., seafood and eggs) should not bear the “healthy” nutrient content claim. 3. Infants and Children Under Two Years of Age In developing updates to the criteria for “healthy,” we have also considered whether the proposed definition should be extended to cover foods targeted to those age groups. Defined nutrient content claims currently apply to foods intended for adults and children 2 years of age and older. With the exception of claims on the percent of the Reference Daily Intake (RDI) for vitamins and minerals, nutrient content claims currently cannot be made on foods intended specifically for use by infants and children less than 2 years of age ( e.g., jarred baby foods, fruit pouches, toddler snack puffs) unless the claim is explicitly provided for in the regulations for each individual claim (21 CFR 101.13(b)(3)). Thus, as with most other nutrient content claims, the current definition for the nutrient content claim “healthy” does not include provisions for foods intended specifically for use by infants and children less than 2 years of age. Our tentative conclusion is to continue to limit the use of the claim to foods directed to adults and children 2 years of age and older. As described in section IV.C. (“Need to Update `Healthy' ”), we relied primarily on the science articulated in the Dietary Guidelines, 2020-2025 in developing the specific criteria on which to base the definition of “healthy.” Historically, the Dietary Guidelines have been directed to adults and children 2 years of age and older. The Dietary Guidelines, 2020-2025 highlights the importance of encouraging healthy dietary patterns at every life stage, and have included new recommendations for healthy dietary patterns for infants and children younger than 2 years of age in this lifespan approach. Infants and children younger than 2 years of age have specific nutritional needs that apply to their particular life stages and their dietary recommendations are different from the recommendations for other age groups. In our last update to the Nutrition Facts label (81 FR 33742), we established Daily Values (DVs) specifically for infants 7 through 12 months and children 1 through 3 years of age. The science underlying the recommended intake levels of individual nutrients demonstrates the specific nutritional needs of infants and children in this life stage. Evaluating the specific nutritional needs of this population can help us in determining whether it is appropriate to extend use of the claim “healthy” to foods directed at infants and children younger than 2 years of age. We intend to consider the scientific information discussed in the Dietary Guidelines, 2020-2025, as well as information from other sources, as we evaluate whether specific criteria can be developed for foods targeted to infants and children in those age groups for use in the definition of “healthy.” Because we are continuing to evaluate the information on the nutritional needs of this life stage, at this time, we are not proposing that the updated definition of “healthy” apply to foods targeted to infants and children under 2 years of age. B. Description of the Proposed Regulation 1. Terms Subject to Definition “Healthy” is a broad term that can have connotations beyond the nutritional properties of a food. This proposed rule would define “healthy” as a nutrient content claim only when it is used in a nutritional context; in other words, the proposed criteria would only apply when “healthy” is used on a label or in labeling and other information, such as other claims, images, or vignettes, about the nutrition content of the food is also present somewhere on the labeling. For example, if the word “healthy” is used above a picture of vegetables or alongside another nutrient claim such as “0g of fat,” that would clearly place it in the nutritional context. If, however, the word “healthy” was used on a label to say “our manufacturing processes support a healthy planet” with an adjacent picture of the earth, that would not be in the nutritional context. Under proposed § 101.65(d)(1), this regulation would cover labeling claims that are implied nutrient content claims because they suggest that a food may help consumers maintain healthy dietary practices because of its nutrient content, where there is also implied or explicit information about the nutrition content of the food (other than required disclosures, such as the Nutrition Facts Label) elsewhere on the label or in labeling. We determined in the 1994 rule that the term “healthy” constitutes an implied nutrient content claim only when it appears on the label or labeling of a food in a nutritional context (59 FR 24232 at 24234 to 24235). We first determined that the term “healthy” does not inherently imply the absence or presence of a nutrient in a particular amount, or that the nutrient content of the food would be helpful to consumers in structuring a diet that conforms to the Dietary Guidelines. Rather, such inferences are likely to be drawn only if the term “healthy” is accompanied by additional language or graphic material or is otherwise presented in a context that explicitly or implicitly suggests that the food has a particular nutrient content. Based on this reasoning, we concluded that the nutritional context is a critical factor as to whether “healthy” is used as an implied nutrient content claim. We reaffirm our position in the 1994 rule that “healthy” is only an implied nutrient content claim when used in a nutritional context, as described above. However, we propose some minor revisions to § 101.65(d)(1)(ii) defining implied nutrient content claims. Under the existing regulation, labeling claims are implied nutrient content claims when they are made in connection with an explicit or implicit claim or statement about a nutrient (such as “healthy, contains 3 grams of fat”). While we want to ensure that the regulation only reaches claims that are made in a nutritional context, based on our years of experience with the current claim, we think the existing language may be too narrow and not reach all information about nutritional context. Further, because this proposed rule would expand the criteria for “healthy” to incorporate food group requirements in addition to individual nutrients to limit, we want to ensure that the regulation encompasses the full range of nutrition information covered by the rule. Based on these considerations, we propose revising the existing text to broaden the description of what a nutritional context entails. We seek comment on the definition of nutritional context provided here. Specifically, we propose revising § 101.65(d)(1)(i) and (ii) to appear as § 101.65(d)(1). Proposed § 101.65(d)(1), as revised, would no longer require that an implied nutrient content claim be used “in connection with an explicit or implicit claim or statement about a nutrient.” Instead, we propose in § 101.65(d)(1) that “healthy” constitutes a nutrient content claim where the term “healthy” is used to characterize the food itself and “where there is also implied or explicit information about the nutrition content of the food.” This clarifies that the information on the label that places use of the claim “healthy” into a nutritional context would not necessarily be immediately adjacent to the implied nutrient content claim, as in the “healthy, contains 3 grams of fat” example. Instead, we propose to make clear that any information on the label or labeling that puts the term “healthy” into a nutritional context would make “healthy” an implied nutrient content claim when it is used to characterize the food. For example, where “healthy” appears on the front of a cereal product that is described elsewhere on the label or labeling as high in dietary fiber ( e.g., on the back of the package, or on a website), the “healthy” claim would constitute a nutrient content claim under § 101.65(d). There may also be instances where the use of a graphic on the label of a food bearing “healthy” would place the term in a nutritional context; for example, if the label on a can of beans labeled “healthy” also used the MyPlate symbol (which graphically puts the food groups together in the context of an overall dietary pattern, as a translation of the Dietary Guidelines ) or other front of pack labeling (such as the “Facts Up Front” labeling program) to imply that the product meets nutritional needs (Ref. 32). In addition, some brands include “healthy” or related words in their brand name, which could be considered an implied nutrient content claim if any other information on the label or labeling puts the term “healthy” into a nutritional context—for example, if a food product included “healthy” within the brand name also used the “low sodium” nutrient content claim. FDA considers food labels and labeling as a whole and will consider the context of statements made in labels and labeling to determine whether a product bears a “healthy” implied nutrient content claim. We also propose revising the codified text in § 101.65(d)(1) to no longer require that the accompanying material be a “claim or statement about a nutrient.” It would instead require that it be “information about the nutrition content of the food.” This text is still intended to ensure that the regulation only applies where a “healthy” claim is used in a nutritional context. However, it would not limit the accompanying material on the labeling to phrases declaring presence/level of a specific nutrient (as in the “healthy, contains 3 grams of fat” example), but include any material stating or implying that the nutrient content of the food would be helpful to consumers in structuring a diet that is supported by current dietary recommendations. For example, if a cereal package bore the claim “healthy” as a descriptor of the cereal, and its labeling elsewhere stated, “Provides all of your child's essential vitamins and minerals,” this would constitute an implied nutrient content claim, because in that context, the “healthy” claim suggests that the nutrient content of the food would be helpful in structuring a diet that conforms to current dietary recommendations. Information about the nutrition content of the food need not make explicit references to nutrients but can refer to nutrients by implication. For example, if the label on a food product characterizes food using the term “healthy” and elsewhere stated that the product is “made with whole grain ingredients,” or “made with real fruits and vegetables,” or “contains a variety of nuts,” this would put “healthy” in a nutritional context because the labeling implies that the food should contain nutrients commonly associated with and contributed by those food components. We therefore propose that the updated § 101.65(d)(1) state that it covers labeling claims that are implied nutrient content claims because they suggest that a food may help consumers maintain healthy dietary practices due to its nutrient content, where there is also implied or explicit information about the nutrition content of the food. Additionally, because the language in § 101.13(b)(2)(ii) parallels the definition of “healthy” in § 101.65, we are also proposing to update the language in § 101.13(b)(2)(ii) to provide that an implied nutrient content claim suggests that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices, where there is also implied or explicit information about the nutrition content of the food ( e.g., healthy). Under the proposed regulation, “healthy,” when used outside of a nutritional context, would not be an implied nutrient content claim. However, even outside of the nutritional context, we have the authority under the misbranding provisions at section 403(a) of the FD&C Act, to ensure that “healthy” is not used in a misleading manner. The proposed regulation also does not address use of the term “healthy” when used as part of an implied health claim ( e.g., “heart healthy”) instead of a nutrient content claim. See 21 CFR 101.14 for information on the use of express and implied health claims. 2. Food Group Equivalents As explained in section VI.A (“Overview of Approach”), a food group equivalent is the amount of a food from a particular food group that must be contained in a food product for it to bear the “healthy” claim. Proposed § 101.65(d)(2) would define a “food group equivalent” as equal to the following: • A food group equivalent of a vegetable would be equal to one 1/2 c-eq vegetables. • A food group equivalent of a fruit would be equal to one 1/2 c-eq fruit. • A food group equivalent of grain would be 3/4 oz-eq whole grain. • A food group equivalent of dairy would be equal to 3/4 c-eq dairy. • A food group equivalent of protein would: ○ For game meats, such as deer, rabbit, quail, and wild geese, be 1 1/2 oz-eq; and ○ For seafood; eggs; beans, peas, and soy products; and nuts and seeds, be 1 oz-eq. We have divided the protein foods group into these subgroups, which are distinct from the Dietary Guidelines, 2020-2025 subgroups, as explained further in section V.B.3.b (“Individual foods”). We are not proposing a food group equivalent for oils, because, as explained in section V.B.3.b (“Individual foods”), we are only proposing that certain oil-based foods meet the criteria for healthy, and oil used in other foods does not contribute to eligibility for bearing the “healthy” claim. These food group equivalents are indicated in table 1. Table 1—Food Group Equivalents Food group and/or subgroup Food group equivalent Vegetables 1/2 cup equivalent vegetable. Fruits 1/2 cup equivalent fruit. Grains 3/4 ounce (oz) equivalent whole grain. Dairy 3/4 cup equivalent dairy. Protein Foods Game meats. 1 1/2 oz equivalent. Seafood. 1 oz equivalent. Egg. 1 oz equivalent. Beans, peas, and soy products. 1 oz equivalent. Nuts and seeds. 1 oz equivalent. As noted in section VI.A (“Overview of Approach”), the c-eq and oz-eq amounts are based on the amounts discussed in the Dietary Guidelines, 2020-2025. For vegetables and fruits, a 1 c-eq is: 1 cup raw or cooked vegetable or fruit, 1 cup 100 percent vegetable or fruit juice, 2 cups leafy salad greens, or 1/2 cup dried fruit or vegetable. For grains, a 1 oz-eq is: 1/2 cup cooked whole grain rice, whole grain pasta, or cereal; 1 oz dry whole grain pasta or rice; 1 medium (1 oz) slice whole grain bread, tortilla, or flatbread; 1 oz of ready-to-eat whole grain cereal. For dairy, a 1 c-eq is: 1 cup fat-free or low-fat milk, yogurt or lactose-free versions, or fortified soy beverage or yogurt alternatives; 1 1/2 oz natural cheese or 1 oz processed cheese. For protein foods, a 1 oz-eq is: 1 oz game meat or seafood; 1 egg; 1/4 cup cooked beans or tofu; 1 tbsp nut or seed butter; 1/2 oz nuts or seeds (Refs. 1 and 22). This means, for example, that a 1/2 cup portion of fresh or frozen green beans and a 1 cup portion of raw spinach would both constitute 1/2 c-eq vegetables. A 1/2 cup portion of fresh or frozen fruit, 1/2 cup portion of 100 percent orange juice, and a 1/4 cup portion of raisins (a dried fruit) would all be equal to a 1/2 c-eq of fruit. A slice of whole wheat bread and a 1/2 cup portion of cooked brown rice would both be equal to a 1 oz-eq whole grains. A 6-ounce portion of yogurt would be equivalent to 3/4 c-eq dairy. An ounce portion of walnuts and 2 tablespoons of peanut butter would be equal to 2 oz-eq of protein foods. A 1/2 cup portion of black beans would be equal to 2 oz-eq of protein foods (Refs. 1 and 22). Examples of foods and their amounts that meet the food group equivalent requirements are included in a table in the proposed codified language for § 101.65(d)(2). 3. Covered Products Under proposed § 101.65(3), you may use the term “healthy” or related terms ( e.g., “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”) as an implied nutrient content claim if the food meets the requirements laid out in proposed § 101.65(d)(3)(i)-(vi). These terms are unchanged from the existing regulation at § 101.65(d); see the 1994 “healthy” final rule for a more detailed discussion of how these terms were selected (59 FR 24232 at 24235). However, we seek comments on whether there are any other terms synonymous with “healthy” that we should consider as we finalize this rulemaking. Foods that may bear the nutrient content claim “healthy” under the proposed updated criteria are broken out into several categories: (1) raw, whole fruits and vegetables; (2) individual food products; (3) combination foods, which encompasses mixed products, main dish products, and meal products; and (4) plain water. The specific requirements for these foods are described in more detail in the following sections. Table 2—Eligible Products for “Healthy” Nutrient Content Claim Eligible products for “healthy” nutrient content claim Product Criteria for bearing “healthy” claim Raw, whole fruits and vegetables No additional criteria; all raw, whole fruits and vegetables may bear the claim. Individual food products At least 1 food group equivalent per RACC from 1 food group, and Nutrients to limit. Mixed products At least 1/2 food group equivalent each from at least 2 different food groups, and Nutrients to limit. Main dish as defined at 21 CFR 101.13(m) At least 1 food group equivalent each from at least 2 different food groups, and Nutrients to limit. Meal as defined at 21 CFR 101.13(l) At least 1 food group equivalent each from at least 3 different food groups, and Nutrients to limit. Water Plain water and plain, carbonated water may bear the claim. a. Raw, Whole Fruits and Vegetables A key objective of the updated criteria is to ensure conformity with current nutrition science and Federal dietary guidance by, among other things, ensuring that the nutrient dense foods recommended by the Dietary Guidelines, 2020-2025 are eligible to bear the “healthy” claim. Precluding such foods from bearing the “healthy” claim could undermine an important element of the claim, as the purpose of the healthy claim is to identify foods that, because of their nutrient content, may help consumers maintain healthy dietary practices, consistent with current nutrition science and Federal dietary guidance. Healthy dietary patterns described by the Dietary Guidelines, 2020-2025 include vegetables from all vegetable subgroups (dark green, red and orange, beans, peas, and lentils, starchy, and other) and fruits, especially whole fruits. Vegetables contribute many nutrients to the diet including dietary fiber, potassium, vitamin A, vitamin C, vitamin K, copper, magnesium, vitamin E, vitamin B6, folate, iron, manganese, thiamin, niacin, and choline, while fruits are important contributors of dietary fiber, potassium, and vitamin C. The Dietary Guidelines have consistently emphasized consumption of fruits and vegetables (Ref. 15), and diets high in fruits and vegetables have been associated with specific health benefits, including lower occurrence of coronary heart disease and some cancers (Ref. 16 and 59 FR 24232 at 24244). Despite their importance to a healthy dietary pattern, average intake of vegetables and fruits is below recommended levels among nearly all age-sex groups (Ref. 1). While we are proposing food group equivalent and nutrient-to-limit requirements for most foods, we are not proposing to subject raw, whole fruits and vegetables to the criteria. For the purpose of this rule, “raw, whole” means whole fruits and vegetables that have not been processed, such as whole apples, bananas, or carrots. Raw, whole fruits and vegetables automatically qualify for use of the claim, regardless if they meet the criteria required of other foods. As discussed in the Dietary Guidelines 2020-2025, most of the U.S. population (around 80 percent) does not meet the dietary intake recommendation for fruits and an even larger percentage (around 90%) do not meet the intake recommendation for vegetables. Excluding some raw, whole fruits and vegetables from qualifying for the proposed, updated “healthy” definition is not supported by scientific evidence or current dietary guidance. Therefore, we tentatively conclude that raw, whole fruits and vegetables do not need to contain a certain amount of fruit or vegetable to contribute to a healthy dietary pattern—for example, a strawberry should be able to bear the “healthy” claim even though one strawberry does not constitute a 1/2 c-eq of fruit. Moreover, raw, whole fruits and vegetables are often sold without packaging or labels. While these products typically do not carry label claims, they may appear on other materials in the stores and elsewhere that may constitute labeling. We therefore tentatively conclude that raw, whole vegetables and fruits should be able to meet the “healthy” criteria without meeting a food group equivalent threshold. We seek comment on our tentative conclusions. We also tentatively conclude that it would be inappropriate to apply nutrient-to-limit criteria to raw, whole vegetables and fruits. For example, sodium and added sugars are not a concern for raw, whole fruits and vegetables because they contain no added ingredients. Furthermore, including a limit for saturated fat would actually disqualify certain vegetables, such as whole avocados, which are vegetables containing beneficial nutrients and are sources of unsaturated fat, from meeting the updated “healthy” criteria. For these reasons, we are proposing a narrow exception to the requirements for food group equivalents and nutrients to limit for raw, whole fruits and vegetables. We propose allowing all raw, whole fruits and vegetables to bear the implied nutrient content claim “healthy,” without any additional requirements for food group equivalents or nutrients to limit. We do not propose to include processed fruits and vegetables, such as canned, frozen, dried, or pureed fruits and vegetables, within this exemption, though many may still meet the criteria to bear “healthy.” For purposes of this claim, fruits and vegetables that have been cut and packaged for sale, such as cantaloupe pieces cut and packaged for sale in a supermarket are considered processed. We note that fruits and vegetables that have been solely cut and packaged for sale would generally qualify for use of the claim under the criteria for individual foods, as raw fruits and vegetables do not exceed the nutrient criteria and would meet the food group equivalent requirement. For example, plain frozen fruit or vegetables would not exceed the nutrient-to-limit criteria and would meet the food group equivalent requirement. It is possible, though, that there are a few forms of fruit and vegetable products that may have RACCs that are smaller than the size of the required food group equivalent requirement. For example, frozen avocado pieces, specifically, may have a RACC that does not meet the FGE amount criteria of 1/2 c fruit. We request comment on whether there are any other fruit or vegetable products for which the RACC size may have an impact in terms of qualifying for the claim [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2022-20975. Public record. Not legal advice.