On December 27, 2024, the Food and Drug Administration (FDA) published its final rule updating the definition for the implied nutrient content claim “healthy.” Specifically, this rule is updating the requirements a human food product must meet to be eligible to use the labeling claim “healthy” on its packaging. This final rule follows a proposed rule that was published on September 28, 2022. To learn about the proposed rule, click here to read NALC article “Focus on Food: the Proposed ‘Healthy’ Rule and the White House Conference.”

Background on labeling claims

In the United States, the food supply is primarily regulated by two federal agencies – the United States Department of Agriculture (USDA) and the FDA. The USDA is responsible for all meat, poultry, catfish, and unshelled eggs products, while the FDA regulates the other 80% of foods. While the USDA and FDA try to work together to provide a food label that presents consistent and understandable to consumers, the labeling rules created by one agency do not immediately impact the regulation of the other. For example, this updated “healthy” rule will impact all food regulated by the FDA but will not apply to foods under the jurisdiction of the USDA. In fact, the USDA has its own rules for use of the labeling claim “healthy.” To learn more about USDA’s regulation of “healthy,” click here for the regulations and here for a guidance.

Under the FDA, a labeling claim is a term that a manufacturer may use but is not required to include. The FDA recognizes three types of labeling claims – health claims, nutrient content claims, and structure/function claims. Specifically, the term “healthy” is a nutrient content claim, or a claim that characterizes the level of a nutrient in the food. A nutrient content claim can either be expressed or implied; however, in the case of the term “healthy,” the claim is implied. This is because the presence of the term healthy implies to a consumer that the nutrient contents of the particular food may be useful in maintaining healthy dietary practices.

Background on the Healthy rule

The labeling claim “healthy” was first regulated by the FDA in 1994 – which is also the last year that its definition was updated. The FDA sought to update the requirements for using the term “healthy” in recognition that nutrition science and federal dietary guidance have changed since 1994. Simply put, what is considered “healthy” by nutrition scientists in 2024 is different than what was considered “healthy” 30 years ago in 1994. Under the old rule, a “healthy” food was one useful in creating a diet that is consistent with dietary recommendations, if the food meets certain nutrient conditions. Specifically, a food had to contain less than a certain amount of total fat, saturated fat, cholesterol and sodium, and a minimum amount of at least one “nutrient to encourage.” The “nutrient to encourage” requirement meant that the food must contain a minimum amount of at least one of the following nutrients for which consumption is encouraged – vitamin A, vitamin C, calcium, iron, protein, or dietary fiber.

Final Rule

The updated rule modifies the requirements a food must meet to use the labeling claim “healthy.” Significantly, the rule changes the limits placed on total fat, saturated fat, cholesterol and sodium by instead placing limits on the amount of saturated fat, sodium, and added sugars in a food. The FDA states that these changes reflect the current nutrition science and guidance from the Dietary Guidelines for Americans. Additionally, the FDA is moving away from requiring food to contain specific individual nutrients and is instead focusing on food groups. This reflects current diary guidance that focusing on food groups better reflects the overall nutrient content of a food than focusing on an individual nutrient. In the final rule, the FDA identifies the following food groups – vegetables, fruits, grains, dairy, and protein foods as the food groups recommended in the Dietary Guidelines. Under the updated rule, FDA establishes “food group equivalents” to identify qualifying amounts of food from each food group that must be present for the food to use the claim “healthy.”  For example, a ½ cup of cooked green beans would be a food group equivalent for the vegetable food group, and 1 large egg would be a food group equivalent for the protein food group.

Additionally, the updated rule includes criteria specific categories of food must meet in order to use the term “healthy” or its derivative terms as an implied nutrient content claim.

• An individual food or mixed product may use the term healthy if it is comprised of one or more of the following foods with no other added ingredients except for water – vegetable, fruit, whole grains, fat-free or low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts, or seeds. For example, a package of sliced apples with no other ingredients may use the term healthy.
• An individual food with a reference amount customarily consumed (RACC) greater than 50 g or greater than 3 tablespoons that meets the food group equivalent requirements and does not exceed certain limits for added sugar, sodium and saturated fats may use the term “healthy.” For example, an individual vegetable product must contain at least a ½ cup equivalent vegetable and may not have an added sugar content greater than 2% of daily value (DV), a sodium content greater than 10% DV, and a saturated content greater than 5% DV to use the claim “healthy.”
• An individual food with a RACC of 50 g or less or 3 tablespoons or less must meet both the food group equivalent requirements, and may not exceed certain limits for added sugar, sodium, and saturated fats. For example, a grain product must meet the ¾ oz equivalent whole grain, and contain less than 10% DV of added sugars, 10% of sodium, and 5% DV of saturated fats to use the “healthy” claim.
• A mixed product using the labeling claim “healthy” must contain one total food group equivalent with no less than ¼ food group equivalent from at least two of the specified food groups in the rule and must contain no greater than 10% DV of added sugars, 15% DV of sodium, and 10% DV of saturated fat. This provision specifies that the saturated fat inherent in seafood, nuts, seeds, and soybean in soy products is excluded from counting as the 10% DV of saturated fat. For example, a mixed product would be able to use the “healthy” claim if it has one total food group equivalent comprised of a ¼ cup of vegetable equivalent and a ½ cup of dairy equivalent, and contains 8% DV of added sugars, 10% DV of sodium, and 10% DV of saturated fats.
• A main dish using the labeling claim “healthy” must contain two total food group equivalents with no less than ½ food group equivalent from at least two of the food groups specified in this rule and a content not greater than 15% DV for added sugars, 20% DV for sodium, and 15% DV for saturated fat. This provision also specifies that the saturated fat inherent in seafood, nuts, seeds, and soybean in soy products is excluded from counting as the 10% DV of saturated fat. For example, a main dish would be able to use the “healthy” claim if it has two total food group equivalents comprised of a ¼ cup of vegetable equivalent, a ½ cup of dairy equivalent, a ½ oz of whole grain equivalent and contains 10% DV of added sugars, 15% DV of sodium, and 10% DV of saturated fats.
• A meal product using the labeling claim “healthy” must contain three total food group equivalents with no less than ½ food group equivalent from at least three of the food groups specified in this rule, and a content no greater than 20% DV of added sugar, 30% DV of sodium, and 20% DV of saturated fats. This provision also specifies that the saturated fat inherent in seafood, nuts, seeds, and soybean in soy products is excluded from counting as the 10% DV of saturated fat. For example, a meal product would be able to use the “healthy” claim if it has three total food group equivalents comprised of a ¼ cup of vegetable equivalent, a ½ cup of dairy equivalent, a ¾ oz of whole grain equivalent and contains 10% DV of added sugars, 30% DV of sodium, and 15% DV of saturated fats.
• All water, tea, and coffee with less than 5 calories per RACC and per labeled serving can use the labeling claim “healthy.”

Finally, the updated rule includes record keeping requirements. Manufacturers of foods with the healthy claim must make and keep written records that verify that the food meets the food group equivalent requirements. The records must be kept for a period of at least 2 years after the introduction of food into interstate commerce. If the food is one where the standard information required on the food label provides sufficient information to verify the food meets the food group equivalent requirements then the manufacturer will not be required to keep records. For example, if a package of green beans with the labeling claim “healthy” only includes green beans in the ingredient list, then the manufacturer will not be required to make or keep records on the food item.

Next Steps

The future of the finalized “healthy” rule is unclear. With the upcoming presidential administration transition, the leadership of the FDA will be changing, and it is unclear what steps the new administration will take regarding the rule. There are few options the new leadership might pursue.

1. It could enforce the rule as it set up now. If this is the case, then the final rule will go into effect on February 25, 2025 with an anticipated compliance deadline for food manufacturers three years later.
2. The new administration might decide to leave the rule in place but fail to actually enforce it. For example, if the FDA is made aware of a food manufacturer using the voluntary “healthy” claim without meeting the standards set forth in the rule, it might choose to allow the manufacturer to continue using the claim despite the noncompliance.
3. The administration could go through the formal amending or repealing process. To amend or repeal a finalized rule, the agency will have to follow the rulemaking procedures set forth by the Administrative Procedure Act and other statutory and executive order requirements. This is a very long and involved process that will require a public comment period.
4. With the assistance of Congress, the new administration could use the Congressional Review Act (CRA) to overturn it through the “lookback” mechanism. This is a feature of the CRA that allows Congress to review a rule in its following session if the rule was submitted with fewer than 60 legislative days left in either the House of Representative or Senate before the prior session ends. Under the CRA, a final rule must be submitted to both houses of Congress before it can take effect. Following its submission, members of Congress will have 60 days to introduce a joint resolution of disapproval. If the joint resolution is passed by both houses of Congress, it will be presented to the president for signature or veto, and if the president signs the resolution, the rule will not take effect. Here, the final healthy rule was finalized after Congress had adjured. This means that the new Congress will have the ability to review the rule and could choose to pass a joint resolution of disapproval that President-elect Trump could sign. To learn more about rulemaking and the presidential transition, click here to read Congressional Research Service Report “Presidential Transitions: Midnight Rulemaking.”

Additionally, in the future, there might be a judicial challenge to the “healthy” rule. Following the Supreme Court’s 2024 decision in Loper Bright Enters. v. Raimondo, courts are now required to exercise independent judgment in determining whether an administrative agency has acted within its statutory authority. Loper Bright overturned the long-standing doctrine of deference established in Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984). Under the two-step deference process established in Chevron, federal courts were to defer to an agency’s interpretation of ambiguous statutory language if the agency’s interpretation was deemed “reasonable.” Now, courts will no longer be required to defer to an agency’s interpretation of a statute. If the “healthy” rule is challenged in the future, courts will be required to exercise independent judgement to determine whether the FDA has acted within its statutory authority in updating this rule. It is uncertain what the outcome of such a legal challenge would be. Further, it will be up to the Trump administration and any future presidential administrations whether to defend the prior administration’s agency rule in a legal action. To learn more about Loper Bright, click here to read NALC article “Supreme Court Overturns Long-Standing ‘Chevron’ Doctrine.”