FDA issues updated final rule for "healthy" labeling

The US Food and Drug Administration (FDA) released the final rule providing new criteria for when foods may be labeled with the nutrient content claim “healthy.” This rule, released on December 19, 2024, has been a priority for the Biden Administration, as part of a larger effort to address chronic disease through its White House Conference on Hunger, Nutrition, and Health. The final rule updates the criteria of the preexisting rule[1] and the proposed rule[2] to better align with current nutrition science; the Dietary Guidelines for Americans, 2020-2025 (Dietary Guidelines); and the updated Nutrition Facts label.

The final rule made notable changes to the proposal in response to stakeholder comments. These changes include increasing the list of foods that automatically qualify for the claim, providing additional flexibility in the criteria to expand the use of the claim for foods that can contribute to a healthy diet (including foods consumed in small quantities), decreasing the cup equivalency for dairy, and changing the levels of nutrients to limit for several food categories.

Background

FDA issued a proposed rule in September 2023 to revise an earlier 1994 rule that resulted from the Nutrition Labeling and Education Act (NLEA). FDA’s proposal transitioned away from the 1994 focus on minimum nutrient content thresholds, and instead adopted a food group-based approach. The proposed rule would have allowed a food product to voluntarily bear the “healthy” claim if it were to: (1) contain a certain amount of food (FGE) from at least one of the food groups or subgroups recommended by the Dietary Guidelines (eg, fruits, vegetables, and fat-free and low-fat dairy), and (2) adhere to specified limits for the following nutrients: saturated fat, sodium, and added sugars. While the final rule keeps this basic framework, the agency made changes in response to comments.

Overview of comments on the proposed rule

FDA received approximately 400 comments on the proposed rule. These comments came primarily from industry, trade organizations, consulting firms, law firms, academia, public health organizations, public advocacy groups, consumers, consumer groups, Congress, and state and local governments. In summary, the comments:

• Demonstrated support for the proposed rule on the premise that it would help consumers make healthier choices and improve the average consumer’s nutritional knowledge
  
  
• Demonstrated support for the proposed rule on the premise that it could help combat the high rate of obesity and diet-related chronic diseases and illnesses in the US
  
  
• Requested changes to provide more flexibility and called for increasing the allowable nutrient levels in existing food criteria and also the number of foods that could qualify for the “healthy” claim
  
  
• Requested that FDA simplify and streamline the criteria for combination foods to allow more flexibility in formulations and recipes for combination foods recommended by the Dietary Guidelines
  
  
• Suggested entirely different, alternative frameworks for the definition of “healthy”
  
  
• Recommended changes to either raise or lower the nutrient limits for added sugars, saturated fat, and sodium
  
  
• Discussed possible exemptions from the FGE criteria and/or nutrient limits for certain foods, such as seafood, certain plant-based proteins and beverages, tart fruits, and beverages other than plain water, such as coffee, tea, and flavored bottled water.

In particular, industry expressed concern that nutrient-dense foods such as canned fruits, cereals, yogurts, whole grain breads, canned vegetables, and salad kits would not be able to qualify for a “healthy” claim under the proposed criteria. Accordingly, industry requested that FDA revise the nutrient thresholds by increasing levels for added sugars and sodium; including nutrients that encourage thresholds for dietary fiber, protein, vitamin D, calcium, potassium, or iron as an alternative to meeting food group requirements in order to qualify a food as healthy; and requiring all food categories outside of the small Reference Amounts Customarily Consumed (RACC) individual and mixed foods category to factor composite contributions of food groups.

Significant changes in the final rule

While FDA maintained the same basic framework as in the proposal, the agency made significant changes in the final rule in response to stakeholder comments. For example, the agency:

• Expanded the list of foods that automatically qualify for the “healthy” claim without having to meet the FGE and NTL requirements. This list now includes vegetables, fruits, whole grains, fat-free and low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds, as well as all water, tea, and coffee with less than 5 calories per RACC and labeled serving
  
  
• Provided increased flexibility for foods consumed in small quantities (ie, foods with a RACC of 50 grams or less or 3 tablespoons or less) to use the claim
  
  
• Provided increased flexibility for mixed food, main dish and meal products to use the claim
  
  
• Adjusted the baseline limits of saturated fat, sodium, and added sugars for certain categories of food including foods that are core elements of healthy dietary patterns associated with reducing chronic disease risk. For example, FDA’s final rule adjusts the baseline limit of saturated fat for dairy products (10 percent of the daily value limit), game meats, and eggs (10 percent of the daily value limit), seafood (5 percent of the daily value limit, excluding saturated fat inherent in seafood), and total fat for oils and oil-based spreads and dressings (total of 20 percent of the daily value limit).

FDA noted that the updates to this “healthy” criteria will allow affordable, accessible, and culturally preferred nutrient-dense foods within different groups and subgroups to contain the “healthy” claim, including frozen, canned, dried, and other shelf-stable products.

Summary of requirements

The rule groups foods into categories based on their nutrient content and how they are ordinarily consumed, with separate criteria based on the type of food product consumed. The FDA has finalized criteria in each of the following food categories:

Type of food (proposed rule)	Criteria (proposed rule)	Type of food (final rule)	Criteria (final rule)
Raw, whole fruits and vegetables	Automatically qualifies for “healthy” claim	An individual or mixed product consisting of vegetables, fruits, whole grains, fat-free and low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds (with no added ingredients except for water)	Automatically qualifies for “healthy” claim
Plain water and plain carbonated water without flavoring or additional ingredients	Automatically qualifies for “healthy” claim	All water, tea, and coffee with less than 5 calories per RACC and per labeled serving	Automatically qualifies for “healthy” claim
Individual food products	Must contain at least 1 FGE of one of the identified food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugars	Individual food products	Permits the use of “healthy” for foods with smaller RACCs, if the food would meet the criteria for a RACC greater than 50 grams or greater than 3 tablespoons Must contain at least 1 FGE of one of the identified food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugars
Mixed food products	Must contain at least ½ of a FGE from at least 2 different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar	Mixed food products	Must contain at least ¼ of a FGE from at least 2 different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar
Main dish products	Must contain at least 1 FGE from 2 or more different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar	Main dish products	Must contain at least 2 FGEs with no less than ½ FGE from 2 or more different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar
Meal products	Must contain at least 1 FGE from at least 3 different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar	Meal products	Must contain at least 3 total FGEs with no less than ½ FGE from at least 3 different food groups AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar
Oil products	Must be one of the following: 100 percent oil An oil-based spread whose fats come solely from oil or An oil-based dressing that contains at least 30 percent oil provided the oil meets the requirements of 100 percent oil AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar	Oil products	Must be one of the following: 100 percent oil An oil-based spread whose fats come solely from oil or An oil-based dressing that contains at least 30 percent oil provided the oil meets the requirements of 100 percent oil AND Must not exceed the threshold limits for saturated fat, sodium, and added sugar

 

Food group equivalents

The rule further explains the concept of FGEs needed for each food group to bear the ‘healthy’ claim.” The cup-equivalent and ounce-equivalent amounts in the rule are based on amounts discussed in the Dietary Guidelines, 2020-2025.

The following chart summarizes these FGEs and the amount of a given food product they equate to:

Food group	Food group equivalent (proposed rule)	Food group equivalent (final rule)
Vegetables	½ cup equivalent	½ cup equivalent
Fruits	½ cup equivalent	½ cup equivalent
Grains	¾ ounce equivalent whole grain	¾ ounce equivalent whole grain
Dairy	¾ cup equivalent	⅔ cup equivalent
Protein	1½ ounce equivalent of game meats	1½ ounce equivalent of game meats
	1 ounce equivalent of seafood, eggs, beans, peas, soy, nuts, and seeds	1 ounce equivalent of seafood, eggs, beans, peas, lentils, nuts, seeds, and soy   [Note that FDA added lentils to the beans and peas food group and moved soy to the nuts and seeds food group.]

 

Limited nutrients

The final rule provided additional flexibility for the nutrients to limit in several food product categories. For example, for individual foods with a RACC greater than 50 grams or greater than 3 tablespoons, the baseline limit of saturated fat, sodium, and added sugars changes as follows:

Nutrient type (proposed rule)	Baseline limit (proposed rule)	Baseline limit (final rule)
Saturated fat	≤5 percent daily value (DV) per RACC in vegetables, fruits, whole grain, beans, peas, soy, nuts and seeds   ≤10 percent DV per RACC in dairy, game meats, seafood, and eggs   ≤20 percent DV per RACC in oils, oil-based spreads, and oil-based dressings	≤5 percent DV in in vegetables, fruits, whole grain, seafood (excluding saturated fat inherent in seafood), beans, peas, lentils, nuts, seeds, and soy (excluding the saturated fat inherent in nuts, seeds, and soybeans)   ≤10 percent DV per RACC in dairy, game meats, and eggs   ≤20 percent DV per RACC in oils, oil-based spreads, and oil-based dressings that meet specified requirements
Sodium	≤10 percent DV per RACC in everything but oils, oil-based spreads, and oil-based dressings   0 percent DV per RACC in oils   5 percent DV per RACC in oil-based spreads and oil-based dressings	≤10 percent DV per RACC in everything but oils   0 percent DV per RACC in oils   ≤10 percent DV per RACC in oil-based spreads and oil-based dressings that meet specified requirements
Added sugars	0 percent DV per RACC in vegetables, fruits, protein, oils, and oil-based spreads   ≤5 percent DV per RACC in whole grain and dairy   ≤2 percent DV per RACC in oil-based dressing	≤2 percent DV per RACC in vegetables, fruits, protein, and oil-based dressings that meet specified requirements   ≤5 percent DV per RACC in dairy   ≤10 percent DV per RACC whole grain   0 percent DV in oil and oil-based spreads that meet specified requirements

 

Scope of the final rule

FDA’s final rule updates the circumstances when use of the term “healthy” is considered an implied nutrient content claim subject to the regulation’s criteria, with the aim to help consumers identify foods that can serve as the foundation of a nutritious diet that is consistent with current dietary recommendations.

FDA’s rule explains that the new criteria for “healthy” claims would apply not only to the term “healthy” but also to “derivative terms” such as “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” when used in a nutritional context.

FDA limited the rule’s applicability to these expressly defined terms. In response to comments regarding the use of terms such as “nutritious,” “wholesome,” and “good for you,” FDA stated that it did not have sufficient information to include those terms within the regulatory definition of “healthy.” Therefore, industry can use those types of terms in labeling as long as they are not false or misleading under Section 403(a) of the US Food, Drug, and Cosmetic Act. Notably, FDA does state that “terms such as ‘nutritious,’ ‘wholesome,’ and ‘good for you’ can be implied nutrient content claims when they appear in a nutritional context on a label or in labeling.”

As with the 1994 rule and proposed rule, FDA also limited the use of “healthy” nutrient content claims in the final rule to foods directed to adults and children two years of age and older.

Additionally, FDA is continuing to develop a standardized symbol that manufacturers could use on food labels to demonstrate that the product meets the criteria for a “healthy” claim.

Recordkeeping requirements

The final rule requires that manufacturers of foods bearing a “healthy” claim maintain certain records where compliance cannot be verified through the product label. These requirements did not change from the proposed rule. Records must verify that a given product making a “healthy claim” meets the FGE requirements and that the use of the claim is truthful and not misleading.

FDA, in a response to comments, noted that some of the foods requiring additional recordkeeping (because compliance cannot be verified through the product label) include mixed products, main dish products, and meal products. Manufacturers have discretion to determine the type of records they maintain and would not be required to produce any specific form or document. Records used to verify that a given food product meets the requirements for “healthy” could include, for example, batch records providing data on the weight of certain ingredient contributions to the total batch or certificates of analysis from ingredient suppliers. These records would need to be provided to FDA upon request during an inspection.

Effective and compliance date

While this rule is effective 60 days after it is published in the Federal Register, the date for compliance is February 25, 2028. Although industry has nearly three years to comply, subject entities and related products making “healthy” claims are free to relabel in accordance with the new requirements sooner.

Commentary

The new rule helps provide further clarity on use of the term “healthy,” and provides key insight into FDA’s perspective of specific scenarios that have been previously subject to scrutiny from both a regulatory compliance and false advertising perspective.

Many of the changes made in the final rule provide needed flexibility for industry, allowing additional foods that contribute to a healthy diet to bear the “healthy” claim. Nevertheless, there were requested changes that were not made, leaving open the possibility that there might be challenges to this rule. These challenges could come either from stakeholders or from the incoming Trump Administration. We note that the current nominees for US Department of Health and Human Services Secretary and FDA Commissioner are focused on the dietary impact of chronic disease, not only from a nutritional perspective, but also from a chemical perspective (eg, “ultra-processed foods”). There is also an opportunity for Congress to disapprove of a final rule under the Congressional Review Act, although this has only been used a total of 20 times since the Act’s enactment in 1996.

^{[1] See 21 C.F.R. 101.65(d)(1).}

^{[2] Food Labeling: Nutrient Content Claims; Definition of Term “Healthy,” 87 Fed. Reg. 188 (proposed Sept. 28), Federal Register: Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.”}