SUPPLEMENTARY INFORMATION:

I. Electronic Access and Filing

A copy of the notice of proposed rulemaking (87 FR 59168, September 29, 2022), all comments received, the final rule (89 FR 106064, December 27, 2024), and all background material may be viewed online at https://www.regulations.gov using the docket number listed above. A copy of this document will be placed in the docket. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register's website at https://www.federalregister.gov and the Government Publishing Office's website at https://www.gpo.gov.

II. Background

FDA published a final rule, entitled “Food Labeling: Nutrient Content Claims; Definition of Term `Healthy,' ” ( printed page 10593) in the Federal Register on December 27, 2024 (89 FR 106064). The final rule was published with an effective date of February 25, 2025. On January 20, 2025, the President issued a memorandum entitled “Regulatory Freeze Pending Review” (90 FR 8249 (January 28, 2025)). With respect to rules that have been published in the Federal Register , but have not taken effect, the memorandum orders Agencies to consider postponing the rules' effective dates for 60 days ( i.e., until April 28, 2025) for the purpose of reviewing any questions of fact, law, and policy the rules may raise.

In accordance with this direction, FDA is delaying the effective date of the final rule “Food Labeling: Nutrient Content Claims; Definition of Term `Healthy' ” (89 FR 106064), until April 28, 2025. We note that the compliance date remains unchanged at this time. The final rule:

• updates the requirements for when the term “healthy” can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that can serve as the foundation of a nutritious diet that is consistent with current dietary recommendations;
• establishes parameters for use of the term “healthy” or derivative terms “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness” as an implied nutrient content claim on the label or in labeling of a food that suggests that a food, because of its nutrient content, may help consumers maintain healthy dietary practices, where there is also implied or explicit information about the nutrition content of the food on the label or in the labeling;
• establishes a framework based on food groups and nutrients to limit (NTL) for the “healthy” claim;
• establishes that “food group,” for the purposes of the “healthy” claim, refers to the groups of foods recommended in theDietary Guidelines, 2020-2025 (for adults and children 2 years of age and older; available at https://www.dietaryguidelines.gov), which are vegetables, fruits, dairy, grains, protein foods, as well as oils;
• establishes food group equivalents (FGEs) that identify qualifying amounts of foods from each food group based on nutritional content;
• requires that, to bear a claim subject to the rule, 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 for these nutrients;
• provides that individual foods or mixed products that are comprised of one or more of the following foods encouraged by theDietary Guidelines, 2020-2025, 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 ( i.e., without having to meet the FGE and NTL requirements) for the “healthy” claim because of their nutrient profile and positive contribution to an overall healthy diet;
• provides that all water, tea, and coffee with less than 5 calories per reference amount customarily consumed and per labeled serving automatically qualify for the “healthy” claim; and
• requires the establishment and maintenance of certain records for foods bearing the “healthy” claim where the FGE contained in the product is not apparent from the label of the food. The records must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. During an inspection, such records must be provided to FDA upon request for official review and photocopying or other means of reproduction.

To the extent that 5 U.S.C. 553 applies to this action, it is exempt from notice and comment because it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, FDA's implementation of this action without opportunity for public comment, effective immediately, is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Seeking public comment is impracticable, unnecessary, and contrary to the public interest. The temporary delay in the effective date until April 28, 2025, is necessary to give Agency officials the opportunity for further review and consideration of the new regulation, consistent with the memorandum described previously. Seeking public comment is unnecessary because of the limited impact of the delayed effective date; the compliance date, and not the effective date, controls when parties must comply with this rule, and the compliance date in the final rule is not until 2028. FDA also stated in the final rule that parties are free to begin implementing the rule earlier than the compliance date. In addition, given the imminence of the effective date and the brief length of the extension of the effective date, seeking prior public comment on this temporary delay would have been impracticable, as well as contrary to the public interest in the orderly promulgation and implementation of regulations. FDA also recognizes that certain affected entities would benefit from being informed as soon as possible of the extension and its length in order to plan and adjust their implementation process accordingly.

90 FR 10592