The Food and Drug Administration’s Updated Definition of “Healthy” and Other Changes to Food and Nutrition Regulations

Introduction

In December 2024, the U.S. Food & Drug Administration (FDA) published its long-anticipated final rule (the Final Rule) defining “healthy,” on the heels of the 2025 Dietary Guidelines Advisory Committee (DGAC) issuing its Scientific Report to the Secretaries of the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) recommending their updates to the U.S. Dietary Guidelines for Americans (the Dietary Guidelines). Both actions are expected to greatly influence how food is manufactured in the U.S. and what companies can or have to say about the food provided to consumers.

This Advisory discusses FDA’s new updated definition of “healthy,” while also highlighting aspects of the Scientific Report of the 2025 DGAC (the Scientific Report), the nutrition-related federal agenda that should be on the radar of any company involved in the manufacture, labeling, or sale of food products in the United States.

FDA’s Updated Definition of “Healthy”

Since 1994, FDA has regulated whether food manufacturers could claim that their food products are “healthy.” On December 27, 2024, FDA published the Final Rule, which establishes revised standards for when companies may use “healthy” or similar terms to describe food products. FDA first issued the proposed rule on September 29, 2022. The Final Rule marks FDA’s first update to the standard for “healthy” claims since 1994.

The Final Rule will be effective 60 days after the final date of publication (February 25, 2025, given a publication date of December 27, 2024) and the compliance date for the Final Rule will be February 25, 2028.

The Final Rule updates the definition of the implied nutrient content claim “healthy” to be consistent with current nutrition sciences and federal dietary guidelines, particularly the Dietary Guidelines. The goal of the Final Rule is to help consumers identify which foods are particularly useful as a foundation of a nutritious diet. The Final Rule limits the amount of added sugar, saturated fat, and sodium in foods that carry the “healthy” claim, while at the same time updating the definition to include foods that are higher in healthy fats. In the preamble, FDA also stresses that foods that do not meet the updated definition of “healthy” are not unhealthy, but that other food products “can still be incorporated as part of a healthy dietary pattern.”

For a food to be defined as “healthy” or other specified variations of that word (such as healthful, healthier, healthfulness), it must fit into one of the six food groups that FDA has specified. These food groups are derived from the Dietary Guidelines, along with the addition of oils. A food group equivalent (FGE) is one that has a qualifying amount of food from each food group based on the nutritional content. The qualifying food amounts that must be in an FGE are taken from the Dietary Guidelines, 2020-2025 and will depend on the type of food group:

• Vegetables: half cup equivalent
• Fruit: half cup equivalent
• Grains: three-quarters of an ounce equivalent to whole grain
• Dairy: two-thirds cup equivalent
• Protein:
  • Game meat: one and a half ounces equivalent
  • Seafood: one ounce equivalent
  • Egg: one ounce equivalent
  • Beans, peas, or lentils: one ounce equivalent
  • Nuts and seeds, or soy products: one ounce equivalent

Food products can contain multiple types of FGEs depending on the product. A mixed product must contain the amounts for one total FGE and no less than one quarter FGE from at least two food groups. A main product dish must contain two total FGEs with no less than a half FGE from at least two food groups. A meal product¹ must contain three total FGEs with no less than a half FGE from at least three food groups.

There are also specific limits to the amount of added sugars, saturated fats, and sodium present in an FGE. These limits depend on the type of FGE and are based on a percentage of the Daily Value for these nutrients. There will be enforcement discretion for some of these limits. For example, FDA noted in the Final Rule that it would exercise enforcement discretion for the added sugar limits for cranberry and tart cherry products because these products are often nutritious and would not be palatable without added sugar because of the lack of sugar found in the fruits.

FDA stated that it does not consider high intensity (low and no calorie) sweeteners to be added sugars. The addition of these artificial sweeteners thus does not factor into determining whether a product will meet the definition of “healthy.”

For foods where it is unclear from the label what FGEs are in the product, manufacturers must establish and maintain certain records if they wish to label their food “healthy.” Manufacturers must keep records for a period of at least two years after introduction or delivery for introduction into interstate commerce. The records must be provided to FDA upon request during an inspection.

In publishing the Final Rule, FDA stated that the definition of “healthy” is consistent with the current nutrition science and the federal dietary guidelines. FDA stated that 75% of Americans have low vegetable, fruit, and dairy intake, 63% exceed the limit for added sugars, 77% exceed the limit for saturated fat, and 90% exceed the Chronic Disease Risk Reduction limits for sodium. On its website, FDA stated that the updated “healthy” claim will now allow for a “healthy” claim to be used with respect to foods such as water; avocados; nuts and seeds; higher fat fish such as salmon; olive oil; and fresh, frozen, or canned fruits and vegetables. Based on the standards in the Final Rule, food products that can no longer be labeled as “healthy” include fortified white bread, highly sweetened yogurt, and highly sweetened cereal.

While the Final Rule did not contain any standardized symbol for use on food labels to convey the “healthy” claim, FDA is continuing to research the development of a standardized symbol.

Scientific Report of the 2025 Dietary Guidelines Advisory Committee

The Final Rule extensively uses scientific data published in the former Dietary Guidelines and the upcoming 2025 Dietary Guidelines. The Scientific Report was submitted to the secretaries of HHS and USDA on December 10, 2024, and is currently open for public comment. The Scientific Report will inform USDA and HHS as they develop the Dietary Guidelines, 2025-2030, which are scheduled to be published later in 2025. However, the Dietary Guidelines are also subject to input from the Secretaries of HHS and USDA, and President-elect Trump’s nominee to head HHS, Robert F. Kennedy Jr., has demonstrated skepticism towards the Dietary Guidelines and could seek to influence their content.

In the Scientific Report, the DGAC recognized the role that poor nutrition plays in chronic health conditions. The DGAC stated that there is significant data showing the disparities in nutrition-related chronic health conditions between sociodemographic groups. The Scientific Report noted that almost all Americans could benefit from shifting to a healthier diet. The DGAC also looked at the dietary intakes across different stages of life to determine whether current dietary intakes are fostering a healthy lifestyle.

The DGAC stated that a healthier dietary pattern included foods that are higher in vegetables, fruits, legumes, nuts, whole grains, fish/seafood, and vegetable oils, and lower in foods such as red and processed meats, sugar-sweetened foods and beverages, refined grains, and saturated fats. The DGAC also noted that there are cardiovascular health benefits to switching from butter, processed and unprocessed red meat, and dairy towards the consumption of plant-based food sources.

Although the DGAC also noted that sugar-sweetened beverages are associated with unfavorable health outcomes, they have not changed the current recommendations for primary consumption of unsweetened fat-free and low-fat milk. The DGAC also noted that there was no relationship between 100% juice consumption and any adverse or beneficial health effects. They did, however, emphasize that water should be the primary beverage for all individuals and that sugar-sweetened beverage consumption should be limited.

The DGAC did not propose the addition of a new dietary pattern, but instead found additional evidence to support potential modification from the 2020 Healthy U.S. Style Dietary Patterns. This included modifications such as an increase in beans, peas, and lentils, and a decrease in starchy vegetables and a reduction in total protein foods.

Food Related Items on the FDA Unified Agenda

Reinforcing the national focus on nutrition policy, FDA has included several action items on its 2025 agenda that could affect stakeholders in the food industry, including the following:

• In January of 2025, FDA will issue a proposed rule regarding amendments to exempted provisions in the standards for the growing, harvesting, packing, and holding of produce for human consumption.
• In February of 2025, FDA will issue a proposed rule on the permanent listing of lake (non-water soluble) color additives.
• In April of 2025, FDA will issue a final rule regarding color additive certification and an increase in fees for certification services.
• In April of 2025, FDA will issue a final rule on fish and shellfish, canned tuna standard of identity, and standard fill containers.
• In April of 2025, FDA will issue a final rule on food labeling regarding health claims for soy protein and coronary heart disease.
• In April of 2025, FDA will issue a proposed rule regarding general principles and food standards modernization.
• In April of 2025, FDA will issue a proposed rule regarding the standard of identity for maple syrup.
• In April of 2025, FDA will issue a final rule on the use of salt substitutes to reduce the sodium content in standardized foods.
• In May of 2025, FDA is looking at a petition regarding an amendment to the procedures for color and food additives.

Of course, it is not yet clear whether HHS nominee Kennedy and FDA nominee Marty Makary will retain this agenda. However, to the extent FDA proceeds with these actions, there will be opportunities for public comment, and these developments will be closely monitored by the Arnold & Porter FDA and Consumer Products team.

Conclusion

The new year brings a heightened focus on nutrition policy in the United States that can have a significant impact on the regulatory scheme governing the manufacture, labeling, and sale of food products in the United States for years to come for any company in the food or retail sector. Arnold & Porter will continue to monitor these developments. If you have any questions about the content discussed in this Advisory or would like more information, please reach out to one of the authors or your existing Arnold & Porter contact.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.