The FDA issued a final rule to update the definition of the voluntary nutrient content claim “healthy” on Dec. 19. It was the first change in the rule in 30 years. The compliance date for the final rule is Feb. 25, 2028; however, manufacturers who choose to use the claim can use the new criteria sooner.

The final rule, published in the Federal Register on Dec. 27 (89 Fed. Reg. 106064), revised the requirements for when the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that are particularly useful as the foundation of a nutritious diet that is consistent with dietary recommendations.

In addition, in a press briefing on the new rule, FDA’s Deputy Commissioner for Human Foods Jim Jones said the agency is “working really hard” to release its proposal for front-of-package (FOP) labeling before “the end of the administration.”

The FDA also is working to develop a “healthy” symbol that manufacturers could use to indicate their food meets the criteria of “healthy.” “It’s a priority,” Claudine Kavanaugh, director of FDA’s Office of Nutrition and Food Labeling told the press briefing. “The symbol would be another way, in addition to using the term ‘healthy,’ to convey to consumers that a food meets the ‘healthy’ criteria. Symbols may be particularly helpful to those who are less familiar with nutrition information to identify the foods that can be the foundation of a healthy eating pattern,” Kavanaugh said.

“Food labeling can be a powerful tool for change. Food labeling, like ‘healthy,’ may help foster a healthier food supply if manufacturers choose to reformulate their products to meet the new definition,” Jones said. “There’s an opportunity here for industry and others to join us in making ‘healthy’ a ubiquitous, quick signal to help people more easily build nutritious diets.”

To qualify as “healthy” under the updated definition, food products must contain a certain amount of a food from at least one of the food groups or subgroups outlined by the Dietary Guidelines for Americans including fruits, vegetables, protein foods, dairy and grains. Foods that qualify for the “healthy” claim also must meet certain limits on saturated fat, sodium and added sugars.

As an example, to include the “healthy” claim on the package, a cereal needs to contain a certain amount of whole grains and adhere to limits for saturated fat, sodium and added sugars. Nuts and seeds, higher fat fish, such as salmon, certain oils, such as olive, and water are examples of foods that did not qualify for the “healthy” claim before but are foundational to a healthy eating pattern and recommended by the Dietary Guidelines. These foods now qualify to bear the “healthy” claim. “Many foods that fit into a range of budgets such as some peanut butters and canned fruits and vegetables also qualify,” the FDA said.
“Our review of the products available in the current marketplace demonstrates that the updated ‘healthy’ criteria allow affordable, accessible, and culturally preferred nutrient-dense foods within different food groups and subgroups to bear the ‘healthy’ claim, including frozen, canned, dried, and other shelf-stable products,” the FDA said.

The rule establishes that “food group,” for the purposes of the “healthy” claim, refers to the groups of foods recommended in the Dietary Guidelines, 2020-2025 (for adults and children 2 years of age and older), which are vegetables, fruits, dairy, grains, protein foods, as well as oils.

The rule noted that the guidelines do not categorize oils as a “food group,” but emphasized that “oils are one of the six core elements of a healthy dietary pattern, along with vegetables, fruits, grains, dairy, and protein foods, and recommended daily intake objectives for oils, similar to the food groups. Therefore, we include oils as a food group for purposes of this rule,” the FDA said.

The rule also established food group equivalents (FGEs) that identify qualifying amounts of foods from each food group based on nutritional content. An FGE contains the following:

• Vegetable – 1/2 cup equivalent;
• Fruit – 1/2 cup equivalent;
• Grains – 3/4 oz. equivalent whole grain;
• Dairy – 2/3 cup equivalent;
• Game meat – 1 1/2 oz. equivalent;
• Seafood – 1 oz. equivalent;
• Egg – 1 oz. equivalent;
• Beans, peas or lentils – 1 oz. equivalent;
• Nuts and seeds, or soy products – 1 oz. equivalent.

The rule requires that to bear a “healthy” claim individual food products, mixed products, main dishes and meals must meet FGEs and specific limits for added sugars, saturated fat and sodium based on a percentage of the Daily Value (DV) for those nutrients. “To bear a claim that is subject to this rule an individual food that has a reference amount customarily consumed (RACC, used to determine serving size), greater than 50 grams or greater than 3 tablespoons and meets the following conditions per RACC; or an individual food that has a RACC of 50 grams or less or 3 Tbsp. or less and meets the following conditions per 50 grams of food: (§ 101.65(d)(3)(ii)(A) and (B))”:

A mixed product that meets the following conditions per RACC (§ 101.65(d)(3)(iii)):

A main dish product as defined in § 101.13(m) (21 CFR 101.13(m)) that meets the following conditions per labeled serving: (§ 101.65(d)(3)(iv)):

A meal product as defined in § 101.13(l) that meets the following conditions per labeled serving: (§ 101.65(d)(3)(v)):

In addition, the final rule provides that individual foods or mixed products that are comprised of one or more of the following foods encouraged by the Dietary Guidelines, with no other added ingredients except for water: vegetable; fruit; whole grains; fat-free and low-fat dairy; lean meat, seafood, eggs, beans, peas, lentils, nuts and seeds, automatically qualify, without having to meet the FGE and nutrients to limit requirements for the “healthy” claim because of their nutrient profile and positive contribution to an overall healthy diet.

The final rule also provides that all water, tea and coffee with less than 5 calories per RACC and per labeled serving automatically qualify for the “healthy” claim.

The rule also requires the establishment and maintenance of records for foods bearing the “healthy” claim where the FGE contained in the product is not apparent from the label of the food. These records, such as analyses of databases, recipes, formulations, information from recipes or formulations, or batch records, will verify that the food meets the food group equivalent requirements. These records must be kept for at least two years after introduction or delivery for introduction of the food into interstate commerce. During an inspection, the records must be provided to the FDA upon request for official review and photocopying or other means of reproduction.