FDA Final Rule Updates the “Healthy” Nutrient Content Claim

By Brigid DeCoursey Bondoc, Claudia Vetesi, Lauren N. Margolies, Elena Catherine Klonoski, and Brandy Guarda

Overview

In a Final Rule published in December 2024, the U.S. Food and Drug Administration (FDA) updated the “healthy” implied nutrient content claim requirements to be consistent with modern nutrition science and current federal dietary guidance, particularly the Dietary Guidelines for Americans (“Dietary Guidelines”).[i] The Final Rule aims to reduce diet-related chronic diseases and advance health equity by helping consumers easily identify nutritious foods and maintain healthy dietary practices. Born out of the 2022 White House National Strategy on Hunger, Nutrition, and Health, FDA’s update to the definition of “healthy”—its first since the 1990s—partially fulfills the goal of ensuring that foods labeled as “healthy” align with current nutrition science and the Dietary Guidelines.[ii]

Beginning on February 25, 2028, manufacturers that wish to use the term “healthy” on their covered food product labels must: (1) meet the applicable nutrient limitations on sugar, sodium, and saturated fat and (2) contain the applicable minimum amount of food from at least one of several specified food groups or subgroups, which reflect the recommendations in the Dietary Guidelines. Manufacturers may choose to use the new “healthy” claim standards, starting on April 28, 2025, before the compliance deadline.[iii]

Under the new requirements and beginning on April 28, 2025, several foods that were previously unable to bear the “healthy” claim will be able to qualify, including nuts, seeds, higher fat fish (e.g., salmon), certain oils, and water. Starting on February 25, 2028, other products that previously qualified to bear the claim no longer will, such as fortified white bread, highly sweetened cereal, fortified fruit punch (not 100% juice), and fruit snacks that are high in added sugar.

FDA made several changes from the proposed rule, issued in 2022, to the Final Rule, including allowing more foods consumed in small amounts to qualify, not expanding the claims considered to be a “healthy” nutrient content claim, and expanding product exemptions.

 

Background

Under the Nutrition Labeling and Education Act of 1990, a food label may only make a claim that characterizes the level of a nutrient in the food if (1) FDA has authorized the claim, and (2) the claim is made in accordance with FDA regulations.[iv] Authorized claims include “free,” “high,” and “low,” when describing the level of a nutrient in the food, as well as comparison terms, such as “more,” “reduced,” and “light.” In 1994, FDA added “healthy,” and derivatives of the term “health,” as an implied nutrient content claim because the terms imply that a food’s nutrient content helps consumers maintain healthy eating habits. Currently, manufacturers that make such claims on their labels must meet all requirements listed in 21 C.F.R. § 101.65, including nutrient minimums and limitations.

 

Changes Under the Final Rule

Change in Nutrient Limitations

The Final Rule updates the current requirements for “healthy” nutrient content claims by removing the limitations for total fat and cholesterol and by adding a limitation for added sugar. This change reflects advances in nutrition science, as well as a change in the Dietary Guidelines. When FDA began regulating “healthy” nutrient content claims, the Dietary Guidelines recommended diets low in total fat. Currently, the Dietary Guidelines instead emphasize decreasing intakes of saturated fat, which affects blood cholesterol, and added sugar.

Additionally, the Final Rule excludes from the saturated fat limitation requirement the saturated fat that is inherent in nuts, seeds, soy products, and seafood.

Because of the limitation on added sugar, many food products that previously qualified to bear the term “healthy” will no longer qualify beginning on February 25, 2028, such as highly sweetened yogurt and snack bars that are high in added sugar. Conversely, because the Final Rule has removed the total fat limitation and excluded certain foods from the saturated fat definition, as detailed above, several foods that were previously unable to bear the “healthy” claim will be able to qualify.

Minimum Food Group Requirements Replace Minimum Nutrient Levels

Currently, under 21 C.F.R. § 101.65(d)(2), most foods labeled as “healthy” must meet certain minimum nutrient requirements for vitamin A, vitamin C, calcium, iron, protein, and fiber. The Final Rule eliminates these requirements and replaces them with minimum food group equivalents (FGEs). Because of these changes, manufacturers that add nutrients to foods will no longer be able to claim that fortified foods, such as fortified fruit punch (not 100% juice) and fortified white bread, are “healthy” beginning on February 25, 2028.

Beginning in 2028, covered food products labeled as “healthy” must contain a certain amount of food from at least one[v] of the following food groups: vegetables, fruits, dairy, protein foods, whole grains, and oil. The Dietary Guidelines categorize these as food groups, except for oil, which the Guidelines emphasize as one of six core elements of a healthy diet.

The Final Rule establishes FGEs that specify the minimum amount of each food group or subgroup, generally per Reference Amounts Customarily Consumed (RACC).[vi] For example, the FGE for vegetables is 1/2 cup equivalent.[vii] However, due to differences in food density and the amount of air and water a food contains, this FGE does not necessarily translate into 1/2 cup of the specific vegetable in a food product.[viii]

The Final Rule aims to better reflect current nutritional science and the Dietary Guidelines, which emphasize targeting nutrient-dense foods as core elements of a healthy dietary pattern, rather than focusing on isolated nutrients.

Defined Claim Scope

The Final Rule also specifies a complete list of “healthy” derivative terms (“health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”)[ix] and clarifies that other terms are not subject to the healthy nutrient content claim regulatory requirements.[x]

 

Covered Manufacturers Under the Final Rule

The Final Rule applies to manufacturers that produce food products (including beverages), unless an exemption applies.

Covered Products

Mixed food products,[xi] individual food products,[xii] main dish products,[xiii] and meal products[xiv] are all covered under the Final Rule.

Exemptions

All manufacturers that choose to display the term “healthy,” or derivative terms, on such food products (“covered manufacturers”) must comply with Final Rule by the compliance date, unless the products fall into one of the following exemptions:

1. Individual foods or mixed products made up of at least one of the following food categories, with no other added ingredients except water: (1) vegetables, (2) fruits, (3) whole grains, (4) fat-free or low-fat dairy, and (5) lean meats, seafood, eggs, beans, peas, lentils, nuts, and seeds.[xv] For example, sliced fruits and vegetables, frozen seafood, frozen edamame, unsalted roasted soybeans, dried lentils, frozen avocado pieces, 100% whole grain flours, and nut butters that only contain nuts are all exempt as a result of their composition as single-ingredient foods, recommended by the Dietary Guidelines. Examples of exempt mixed products include a frozen mix comprised of a vegetable and whole grain, and a juice blend that is comprised of 80% fruit juice and 20% vegetable juice.
2. Carbonated or noncarbonated water, coffees, and teas that contain less than 5 calories per RACC and per labeled serving, even if they contain low-calorie sweeteners, flavors, vitamins, or minerals.[xvi]

 

Notable Changes Between the Proposed Rule and the Final Rule

More Foods Consumed in Small Amounts Qualify

Under the proposed rule, the FGE requirements for all food had been on a per RACC basis, which unintentionally excluded certain foods consumed in small amounts, such as hummus, from using the “healthy” label. In allowing foods with an RACC of 50 grams or less (or 3 tablespoons or less) to meet the FGE requirements per 50 grams of food, the Final Rule gives more food products the ability to use the “healthy” label.[xvii]

Expanded Product Exemptions

The Final Rule greatly expanded the proposed rule’s exemption for raw whole fruits and vegetables to many other individual (e.g., frozen edamame) and mixed food products (e.g., frozen vegetable and whole grain mix). The Final Rule also expanded the exemption for plain and carbonated water to include tea and coffee,[xviii] but FDA declined to include diet soft drinks or sodas in this exemption.[xix]

FGE Criteria Changes

The Final Rule updated several proposed FGE criteria, including allowing vegetable and fruit powders to be considered in calculating vegetable and fruit FGEs. The Final Rule provided additional flexibility in FGE-required proportions for mixed products, main dishes, and meals, so that more food products, including plant-based patties, can meet FGE requirements. For example, instead of requiring main dish products to have exactly one FGE for each food group, the Final Rule requires such products to have at least 1/2 FGE per food group component, which, in combination with the other food group component(s), comprises a total of at least two FGE per labeled serving.

Changes to Nutrient Requirements

The Final Rule also provides greater flexibility for certain food categories, such as increasing sodium limits in mixed products, increasing added sugar limits in whole grain products, and excluding inherent saturated fat in seafood from the saturated fat limit. Additionally, the Final Rule streamlines the nutrient criteria for combination foods[xx] by replacing the proposed limits, which varied based on food groups, with single limits for saturated fat, sodium, and added sugars.

No Expansion of “Healthy” Definition

In both 2016 and the 2022 proposed rule, FDA sought comments on whether other words or terms should be included in the “healthy” nutrient content claim definition, including terms that communicate the overall healthfulness of a food product.[xxi] Ultimately, FDA limited the qualifications in the Final Rule to uses of the term “healthy” or the following derivative terms: “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness.” However, FDA reiterated that while terms such as “nutritious,” “wholesome,” and “good for you,” will not be considered to make a “healthy” implied nutrient content claim, they can be implied nutrient content claims when placed in a nutritional context on a label. Additionally, the Final Rule noted that labels with such terms may be subject to regulation under the Federal Food, Drug, and Cosmetic Act’s misbranding provision.

 

Potential Challenges for the Final Rule

Court Challenges Expected

We expect to see court challenges to the Final Rule before the 2028 required compliance date, given last year’s Loper Bright Supreme Court decision that overturned Chevron deference, a doctrine which had previously instructed courts to defer to federal agencies’ reasonable interpretations of ambiguous statutes.[xxii] In a public comment, the Consumer Brands Association criticized the 2022 proposed rule as “overly restrictive,” particularly regarding the limitations on added sugar, and argued that it would fail the Central Hudson test[xxiii] and therefore violate the First Amendment. Following the Final Rule’s publication, the Consumer Brands Association expressed continuing concerns that the rule “is not based on clear and unambiguous scientific evidence or an in-depth economic analysis that considers all the potential impacts to consumers and the market . . . .”[xxiv]

Limits on Consumer Suits

The 2024 Consolidated Appropriations Act specified that for “healthy” implied nutrient content claims, both the current and the Final Rule requirements during the regulatory compliance period (i.e., before February 25, 2028) preempt state law requirements.[xxv] This preemption hampers consumers’ ability to sue companies via state consumer protection laws for not complying with the updated “healthy” nutrient content claim requirements before the February 25, 2028 mandatory compliance date.

Regulatory Freeze Memorandum + MAHA

On February 24, 2025, the U.S. Department of Health and Human Services delayed the original effective date for the Final Rule from February 25, 2025 until April 28, 2025.[xxvi] This notice, signed by Robert F. Kennedy Jr., followed President Trump’s “Regulatory Freeze Pending Review” memorandum issued on January 20, 2025, which orders federal agencies to consider postponing the effective date of rules that have been issued, but not yet taken effect, for 60 days.[xxvii]

The Final Rule’s compliance date, February 25, 2028, remains unchanged. However, according to the memorandum, FDA may open a comment period for the Final Rule and, as necessary, further delay the effective date. If FDA opens a comment period and, upon review, finds that the Final Rule “raise[s] substantial questions of fact, law, or policy,” FDA would likely need to consult with the OMB Director and “take further appropriate action.”[xxviii]

 

Conclusion

The Final Rule, if codified, would bring the “healthy” implied nutrient content claim into the 21st century by updating the requirements to better reflect modern nutrition science. In doing so, the Final Rule would allow more nutritious foods recommended by the Dietary Guidelines to bear the claim “healthy,” including nuts, seeds, and salmon. Additionally, many food products that previously qualified to bear the claim, such as highly sweetened yogurt and cereal, beginning on February 25, 2028, will no longer qualify. The changes in the Final Rule remind consumers and companies that “healthy” is an evolving concept that may become a moving target.

As the new administration advances President Trump’s policy agenda, and as Robert F. Kennedy Jr. shapes FDA’s approach to regulating food, food manufacturers that are or would be impacted by the Final Rule should closely monitor for new developments.

 

[i] U.S. Dep’t of Agric. and U.S. Dep’t of Health & Hum. Servs., Dietary Guidelines for Americans, 2020‑2025 (2020).

[ii] The White House, Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health 22 (2022).

[iii] 89 Fed. Reg. 106064, 106140 (Dec. 27, 2024); see infra “Regulatory Freeze Memorandum.”

[iv] Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, § 3, 104 Stat. 2353, 2357-2362.

[v] Combination products require FGEs from multiple food groups. See Table 4, Table 5, and Table 6 on 89 Fed. Reg. 106064, 106164-106165 (Dec. 27, 2024) (to be codified at 21 C.F.R. § 101.65(d)(3)).

[vi] The RACC is the basis for determining a food product’s serving size. Use of the Term Healthy on Food Labeling, U.S. Food & Drug Admin. (last updated Dec. 20, 2024), https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/use-term-healthy-food-labeling#Products. While most FGEs are calculated on a per RACC basis, certain foods consumed in small quantities are calculated on a per 50 gram basis. See discussion infra “More Foods Consumed in Small Amounts Qualify.”

[vii] 89 Fed. Reg. 106064, 106163 (Dec. 27, 2024) (to be codified at 21 C.F.R. § 101.65(d)).

[viii] Id.

[ix] 89 Fed. Reg. 106064, 106163 (Dec. 27, 2024) (to be codified at 21 C.F.R. § 101.65(d)(3)).

[x] Id.

[xi] Mixed food products contain one of the total Food Group Equivalents (FGEs) with no less than 1/4 FGE from at least two food groups. Sugar content cannot be more than 10% of the daily value. Sodium cannot be more than 15% of the daily value. Saturated fat content cannot be more than 10% of the daily value.

[xii] Individual food products contain one or multiple food components from a single food group (e.g., product that contains both seafood and nuts because seafood and nuts are subgroups of the “protein foods” food group).

[xiii] Main dish products contain two total FGEs with no less than 1/2 FGE from at least two food groups. Sugar content cannot be more than 15% of the daily value. Sodium cannot be more than 20% of the daily value. Saturated fat content cannot be more than 10% of the daily value.

[xiv] Meal products contain three total FGEs with no less than 1/2 FGE from at least three food groups. Sugar content cannot be more than 20% of the daily value. Sodium cannot be more than 30% of the daily value. Saturated fat content cannot be more than 20% of the daily value.

[xv] 89 Fed. Reg. 106064, 106078, 106163 (Dec. 27, 2024) (to be codified at 21 C.F.R. § 101.65(d)(3)(i)).

[xvi] 89 Fed. Reg. 106064, 106130-106131, 106165 (Dec. 27, 2024) (to be codified at 21 C.F.R. § 101.65(d)(3)(vi)).

[xvii] 89 Fed. Reg. 106064, 106077, 106163 (Dec. 27, 2024) (to be codified at 21 C.F.R. § 101.65(d)(3)(ii)(B)).

[xviii] See supra “Covered Manufacturers.”

[xix] 89 Fed. Reg. 106064, 106131 (Dec. 27, 2024).

[xx] The Final Rule refers to mixed food products, main dish products, and meal products collectively as “combination products.” 89 Fed. Reg. 106064, 106105 (Dec. 27, 2024).

[xxi] 81 Fed. Reg. 66562, 66564 (Sept. 28, 2016); 87 Fed. Reg. 59168, 59183 (Sept. 29, 2022).

[xxii] Loper Bright Enters. v. Raimondo, 603 U.S. 369 (2024).

[xxiii] A test to determine whether government regulation of commercial speech is constitutional, established by the Supreme Court in Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557, 566 (1980).

[xxiv] Ryan Daily, FDA issues final rule on ‘healthy’ claim, updates requirements, FoodNavigator USA (Dec. 19, 2024, 21:02 GMT), https://www.foodnavigator-usa.com/Article/2024/12/19/fda-updates-healthy-definition/.

[xxv] Pub. L. No. 118-42, § 745, 138 Stat. 25, 112 (2024).

[xxvi] Memorandum on Regulatory Freeze Pending Review, 2025 Daily Comp. Pres. Doc. (Jan. 28, 2025).

[xxvii] 89 Fed. Reg. 106064, 106140 (Dec. 27, 2024).

[xxviii] Id.