FDA Final Rule Redefining “Healthy” on Food Labels (2024)

Table of Contents

1. What the FDA Did
2. What a “Healthy” Claim Is
3. The New Test: Food Groups Plus Three Limits
4. The Limits Food Group by Food Group
5. Mixed Products, Main Dishes and Meals
6. Foods That Qualify Automatically
7. What Changed From the 1994 Definition
8. Records Manufacturers Must Keep
9. What the Rule Does Not Do
10. The FDA’s Cost and Benefit Estimates
11. Dates and Status as of 11 October 2026
12. How the Rule Fits Earlier and Later FDA Actions
13. Primary Documents
14. Key Research Papers
15. Connections

1. What the FDA Did

The FDA’s program page “Use of the ‘Healthy’ Claim on Food Labeling” states that the agency “announced on December 19, 2024, a final rule to update the ‘healthy’ claim that manufacturers can voluntarily use on food packages.” The formal rule appeared in the Federal Register eight days later, on Friday 27 December 2024, filling pages 106064–106165 of volume 89. A Federal Register docket is the public file that holds a rulemaking’s documents and the comments people send in; this rule’s docket is FDA-2016-D-2335, opened in 2016, and its regulation identifier number is RIN 0910-AI13.

The rule amends Part 101 of Title 21 of the Code of Federal Regulations, chiefly the “healthy” paragraph at 21 CFR 101.65(d). The document’s summary says the FDA is “updating the definition for the implied nutrient content claim ‘healthy’ to be consistent with current nutrition science and Federal dietary guidance, especially the Dietary Guidelines for Americans.” It was signed on 12 December 2024 by Robert M. Califf, Commissioner of Food and Drugs.

The FDA states that it received approximately 400 comments on the 2022 proposal, from industry, trade organizations, academia, public health and advocacy groups, consumers, members of Congress, State and local governments and others, and that several of its changes from the proposal “will result in more foods qualifying to bear the ‘healthy’ claim.”

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2. What a “Healthy” Claim Is

A nutrient content claim is a word or phrase on a food label that describes the level of a nutrient in the food. An implied nutrient content claim says it indirectly. The rule explains that “since 1994, we have recognized that when a manufacturer uses labeling that describes a product as ‘healthy’ in the nutritional context, it is making an implicit claim about the level of nutrients in the product.”

The rule covers the word “healthy” and its derivative terms — “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily” and “healthiness” — when they suggest that a food, because of its nutrient content, may help consumers maintain healthy dietary practices, and when the label also carries implied or explicit information about the food’s nutrition content.

Using the claim is voluntary. A manufacturer chooses whether to print it; the rule sets the conditions a food must meet if it does. In its response to comments the FDA notes that the label has other tools as well: other nutrient content claims such as “low saturated fat,” health claims (which link a food or food component to reduced risk of a disease), structure/function claims and dietary guidance statements, each with its own criteria.

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3. The New Test: Food Groups Plus Three Limits

The FDA program page summarizes the updated test in two parts. To carry the claim, a food product needs to:

1. “contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans,” and
2. “meet specific limits for added sugars, saturated fat and sodium.”

Three terms carry the rule:

• Food group equivalent (FGE). The minimum amount of a food group a product must contain — for example half a cup equivalent of vegetables or fruit, or three-quarters of an ounce equivalent of whole grain. For the purposes of the rule, “food group” means the groups in the Dietary Guidelines for Americans, 2020–2025 for adults and children 2 years and older: vegetables, fruits, dairy, grains and protein foods, plus oils. The rule notes that those Guidelines do not call oils a food group but treat them as one of six core elements of a healthy dietary pattern, so the FDA included oils for this rule.
• Nutrients to limit. Added sugars, saturated fat and sodium, each capped as a percentage of its Daily Value (DV).
• Reference Amount Customarily Consumed (RACC). The standard amount on which serving sizes are based. The limits are set per RACC. For individual foods whose RACC is 50 grams or less (or 3 tablespoons or less), the final rule applies the criteria per 50 grams instead, a change from the proposal that the FDA says lets foods eaten in small amounts qualify.

The FDA page states that the amounts required and the limits “vary for individual food products, mixed products (which contain certain amounts of more than one food group), main dishes and meals.”

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4. The Limits Food Group by Food Group

The FDA’s table “Updated Criteria for Certain Food Groups and Sample Foods” lists, per RACC, the minimum food group amount and the upper limits for added sugars, sodium and saturated fat. The figures below are copied from that table.

• Grains product: 3/4 oz whole-grain equivalent; added sugars no more than 10% DV (5 g); sodium 10% DV (230 mg); saturated fat 5% DV (1 g).
• Dairy product: 2/3 cup equivalent; added sugars 5% DV (2.5 g); sodium 10% DV (230 mg); saturated fat 10% DV (2 g).
• Vegetable product: 1/2 cup equivalent; added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat 5% DV (1 g).
• Fruit product: 1/2 cup equivalent; added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat 5% DV (1 g).
• Game meat: 1½ oz equivalent; added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat 10% DV (2 g).
• Seafood: 1 oz equivalent; added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat 5% DV (1 g), not counting the saturated fat naturally present in seafood.
• Egg: 1 egg; added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat 10% DV (2 g).
• Beans, peas and lentils: 1 oz equivalent; added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat 5% DV (1 g).
• Nuts, seeds and soy products (the rule’s grouping): 1 oz equivalent; added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat 5% DV (1 g), not counting the saturated fat naturally present in nuts, seeds and soy products.
• 100% oil: no food group minimum; added sugars 0% DV; sodium 0% DV; saturated fat no more than 20% of total fat.
• Oil-based spreads: added sugars 0% DV; sodium 10% DV (230 mg); saturated fat no more than 20% of total fat.
• Oil-based dressings (at least 30% oil): added sugars 2% DV (1 g); sodium 10% DV (230 mg); saturated fat no more than 20% of total fat.

The dairy group in the rule is worded “fat-free and low-fat dairy.” These are the rule’s categories as the FDA wrote them; this page reports them as regulatory wording, not as a view on which foods make up a good diet.

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5. Mixed Products, Main Dishes and Meals

Foods built from more than one food group have their own thresholds. The FDA’s sample-food table gives these upper limits and food group amounts:

• Individual food: 1 food group equivalent (the example given is 2/3 cup yogurt); no more than 2 g saturated fat, 230 mg sodium and 2.5 g added sugars.
• Mixed product: 1 total food group equivalent, with at least 1/4 equivalent from each of 2 or more food groups (the example is 1/8 cup dried fruit and 1/4 oz nuts); no more than 2 g saturated fat, 345 mg sodium and 5 g added sugars.
• Meal: 3 total food group equivalents, with at least 1/2 equivalent from each of 3 or more food groups (the example is 1 oz salmon, 1/2 cup green beans and 3/4 oz brown rice); no more than 4 g saturated fat, 690 mg sodium and 10 g added sugars.

For main dishes, the rule requires 2 total food group equivalents with no less than 1/2 equivalent from each component group; for meals, 3 total equivalents with no less than 1/2 from each. The FDA describes these proportions as more flexible than the 2022 proposal, which would have required exactly one equivalent from each of two or three groups, and gives plant-based patties as an example of products that can now meet the requirement. The rule also states that vegetable and fruit powders made by drying and grinding whole vegetables and fruits may count toward the vegetable and fruit equivalents. As in the single-food table, saturated fat naturally present in nuts, seeds, soy products and seafood does not count toward the limit.

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6. Foods That Qualify Automatically

Some foods carry the claim without meeting the food group and nutrient-limit tests. The rule provides that individual foods or mixed products made only of one or more of the following foods encouraged by the Dietary Guidelines, “with no other added ingredients except for water,” automatically qualify: vegetables; fruits; whole grains; fat-free and low-fat dairy; and lean meat, seafood, eggs, beans, peas, lentils, nuts and seeds. (The FDA consumer page words the meat item as “lean game meat.”) The FDA gives the reason as these foods’ “nutrient profile and positive contribution to an overall healthy diet.”

A second automatic category covers drinks: all water, tea and coffee with fewer than 5 calories per RACC and per labeled serving. The rule states that this includes carbonated or noncarbonated water, coffee and tea containing non-caloric ingredients such as flavors, no- or low-calorie sweeteners, vitamins and minerals.

The FDA program page adds that qualifying foods include “many varieties of these foods that fit into a range of budgets, for example, fruits, vegetables, and fish that are either fresh, frozen, or canned.”

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7. What Changed From the 1994 Definition

The FDA first defined “healthy” in a final rule published 10 May 1994 (59 FR 24232). According to the 2024 rule and the FDA program page, that definition set limits on total fat, saturated fat, cholesterol and sodium, and required a food to provide at least 10% of the Daily Value of one or more of vitamin A, vitamin C, calcium, iron, protein or fiber.

The 2024 rule says nutrition science and federal dietary guidance have changed since then, focusing on healthy dietary patterns, the type of fat rather than total fat, and the amounts of sodium and added sugars. It gives two consequences of the old test: a number of nutrient-dense foods could not carry the claim (it names salmon, “due to fat amounts”), while some foods high in added sugars could.

The FDA program page lists both sides of the change:

• Foods that now qualify: “foods such as water, avocados, nuts and seeds, higher fat fish, such as salmon, and olive oil will now qualify to use the ‘healthy’ claim.”
• Foods that no longer qualify: “Examples of products that qualified for ‘healthy’ under the original claim that do not under the updated claim include fortified white bread, highly sweetened yogurt, and highly sweetened cereal.”

The site’s pages on olive oil, avocado and salmon describe the research on those foods themselves.

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8. Records Manufacturers Must Keep

When the amount of a food group in a product bearing the claim is not apparent from its label, the rule requires the manufacturer to make and keep written records showing that the product meets the food group requirement (21 CFR 101.65(d)(4)). The records must be kept for at least 2 years after the food is introduced, or delivered for introduction, into interstate commerce, and must be provided to the FDA on request during an inspection for review and copying. The rule states that failing to make, keep and provide these records would cause a food bearing the claim to be misbranded.

In the rule’s Paperwork Reduction Act section, this requirement is a revision of the information collection “Food Labeling Regulations,” OMB Control Number 0910-0381.

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9. What the Rule Does Not Do

• It does not require any food to carry the word. The claim is voluntary; the rule sets the conditions for using it.
• It does not call other foods unhealthy. The rule states that foods that do not qualify “are not deemed to be ‘unhealthy’ or unable to provide any nutritional benefits to consumers,” and that the definition does not “represent a determination by FDA that consumers should only choose foods that qualify” or “completely avoid choosing foods that do not qualify.”
• It does not cover foods for infants and children under 2. The FDA states that “at this time” it is “not extending use of the ‘healthy’ claim to foods marketed for consumption by infants and children younger than 2 years of age,” citing the specific nutrient needs of that age group and the need for more time.
• It does not exempt dietary supplements. The FDA declined a request to exempt them; a supplement may bear the claim if it meets the criteria, and the rule says that under some circumstances a supplement may use the word as part of a structure/function claim without being subject to these requirements.
• It does not issue a “healthy” symbol. The FDA program page describes a symbol manufacturers could use to show a product meets the definition as “a separate but related track” and states that “the FDA continues to work on development of the symbol.”
• It does not rewrite the Nutrition Facts label. Its amendments are to 21 CFR 101.13 and 101.65 only; the rule describes the Nutrition Facts label update as a separate 2016 final rule (81 FR 33742), and the 2025 front-of-package proposal is a separate rulemaking (see section 12).

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10. The FDA’s Cost and Benefit Estimates

The rule’s executive summary states that “about 5 percent of all packaged foods are labeled as ‘healthy’” in the current marketplace. Its economic analysis, discounted at 3 percent over 20 years, gives these estimates:

• Benefits: a mean present value of $686 million ($46 million a year annualized), estimated as a reduction in all-cause mortality among consumers who rely on the claim and choose more healthful foods. The FDA calculated this through the inverse association between a Healthy Eating Index score and all-cause mortality reported in a 2014 study (Reedy and colleagues, listed under Key Research Papers).
• Costs: a mean present value of $403 million ($27 million a year) to manufacturers for reformulating, relabeling and recordkeeping. The FDA says possible costs of rebranding certain foods are discussed only qualitatively.
• Net benefits: $283 million ($19 million a year).

These are the agency’s modeled projections, not measured outcomes.

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11. Dates and Status as of 11 October 2026

Legal status: final rule, in effect. The dates, as the documents give them:

• 27 December 2024 — final rule published. As published, it was to take effect on 25 February 2025, with a compliance date of 25 February 2028. The effective date is when a rule becomes law; the compliance date is when products must follow it.
• 25 February 2025 — the FDA published a delay of the effective date (90 FR 10592, FR Doc. 2025-03118), signed by Robert F. Kennedy, Jr., Secretary of Health and Human Services. Citing the 20 January 2025 presidential memorandum “Regulatory Freeze Pending Review,” which directed agencies to consider postponing not-yet-effective rules for 60 days to review questions of fact, law and policy, it moved the effective date to 28 April 2025. The notice states: “We note that the compliance date remains unchanged at this time.”
• 3 July 2025 — an FDA notice filed under this docket among others (90 FR 29567, FR Doc. 2025-12408) lists Office of Management and Budget approval of the “Food Labeling Regulations” information collection (0910-0381) through 30 April 2028. It does not change the rule.

A query of the Federal Register for this docket and regulation number found no further delay, withdrawal or amendment of the rule through 11 October 2026. The compliance date of 25 February 2028 is the date stated in the 2024 rule; no later document re-confirms or changes it.

Until the compliance date, the rule’s response to comments states that the FDA “does not intend to enforce against products that are in compliance with the original definition of ‘healthy’ before the compliance date.” It also cites section 745(a) of the Consolidated Appropriations Act, 2024 (Pub. L. 118-42, signed 9 March 2024), which, as the rule describes it, lets manufacturers continue to comply with the original definition until the compliance date, and section 745(b), which addresses State requirements for foods labeled “healthy” before that date.

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12. How the Rule Fits Earlier and Later FDA Actions

The documents in docket FDA-2016-D-2335 trace the rulemaking:

• 28 September 2016 — the FDA announced a guidance for industry on the term “healthy” (81 FR 66527). The 2024 rule says the guidance stated the agency’s intent to exercise enforcement discretion for foods not low in total fat whose fat is predominantly mono- and polyunsaturated. Enforcement discretion means the agency states it will not act against products meeting stated conditions, without changing the regulation itself. The same day it opened a request for information and comments on the term (81 FR 66562).
• 9 March 2017 — a public meeting on use of the term (announced at 82 FR 10868).
• 29 September 2022 — the proposed rule (87 FR 59168).
• 27 December 2024 — the final rule described on this page.

The rule’s executive summary states that updating the claim is one action listed in the White House National Strategy on Hunger, Nutrition, and Health. The FDA program page describes the separate “healthy” symbol work, for which the agency issued two procedural notices on consumer research in May 2021 and March 2022.

Other FDA food-labeling actions on this site:

• Earlier in 2024 the FDA allowed a qualified health claim on yogurt and type 2 diabetes — a different kind of claim, about disease risk: FDA Allows a Qualified Yogurt and Type 2 Diabetes Claim (2024).
• In January 2025 the FDA proposed a front-of-package nutrition label, a separate rulemaking: FDA Proposal for Front-of-Package Nutrition Labels (2025).
• In 2025 the FDA and USDA asked for public input on a definition of ultra-processed foods: FDA and USDA Seek a Definition of Ultra-Processed Foods (2025).

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13. Primary Documents

1. Food and Drug Administration, HHS (2024). Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”. Final rule. Federal Register 89:106064–106165, 27 December 2024. Docket No. FDA-2016-D-2335; RIN 0910-AI13 — FR Doc. 2024-29957
2. U.S. Food and Drug Administration. Use of the “Healthy” Claim on Food Labeling (program page, content current as of 16 January 2025) — fda.gov: Use of the “Healthy” Claim on Food Labeling
3. Food and Drug Administration, HHS (2025). Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”. Final rule; delay of effective date. Federal Register 90:10592–10593, 25 February 2025. Docket No. FDA-2016-D-2335 — FR Doc. 2025-03118
4. Food and Drug Administration, HHS (2022). Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”. Proposed rule. Federal Register 87:59168, 29 September 2022. Docket No. FDA-2016-D-2335 — FR Doc. 2022-20975
5. Food and Drug Administration, HHS (2016). Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry; Availability. Federal Register 81:66527, 28 September 2016. Docket No. FDA-2016-D-2335 — FR Doc. 2016-23367
6. Food and Drug Administration, HHS (2016). Use of the Term “Healthy” in the Labeling of Human Food Products; Request for Information and Comments. Federal Register 81:66562, 28 September 2016. Docket No. FDA-2016-D-2335 — FR Doc. 2016-23365
7. Food and Drug Administration, HHS (2017). Use of the Term “Healthy” in the Labeling of Human Food Products; Public Meeting; Request for Comments. Federal Register 82:10868, 16 February 2017. Docket No. FDA-2016-D-2335 — FR Doc. 2017-03117
8. Food and Drug Administration, HHS (2025). Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals. Federal Register 90:29567–29568, 3 July 2025. Docket Nos. FDA-2016-D-2335 and others — FR Doc. 2025-12408
9. Public docket FDA-2016-D-2335 — regulations.gov docket FDA-2016-D-2335

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Key Research Papers

1. Reedy J, Krebs-Smith SM, Miller PE, Liese AD, Kahle LL, Park Y, Subar AF (2014). Higher diet quality is associated with decreased risk of all-cause, cardiovascular disease, and cancer mortality among older adults. Journal of Nutrition 144(6):881-889 — PubMed PMID: 24572039
2. Shangguan S, Afshin A, Shulkin M, Ma W, Marsden D, Smith J, Saheb-Kashaf M, Shi P, Micha R, Imamura F, Mozaffarian D (2019). A meta-analysis of food labeling effects on consumer diet behaviors and industry practices. American Journal of Preventive Medicine 56(2):300-314 — PubMed PMID: 30573335
3. Antman EM, Appel LJ, Balentine D, Johnson RK, Steffen LM, Miller EA, Pappas A, Stitzel KF, Vafiadis DK, Whitsel L (2014). Stakeholder discussion to reduce population-wide sodium intake and decrease sodium in the food supply: a conference report from the American Heart Association Sodium Conference 2013 Planning Group. Circulation 129(25):e660-e679 — PubMed PMID: 24799511
4. Murphy MM, Scrafford CG, Barraj LM, Bi X, Higgins KA, Jaykus LA, Tran NL (2021). Potassium chloride-based replacers: modeling effects on sodium and potassium intakes of the US population with cross-sectional data from NHANES 2015-2016 and 2009-2010. American Journal of Clinical Nutrition 114(1):220-230 — PubMed PMID: 33755042
5. Johnson RK, Lichtenstein AH, Anderson CAM, Carson JA, Després JP, Hu FB, Kris-Etherton PM, Otten JJ, Towfighi A, Wylie-Rosett J (2018). Low-calorie sweetened beverages and cardiometabolic health: a science advisory from the American Heart Association. Circulation 138(9):e126-e140 — PubMed PMID: 30354445
6. Baker-Smith CM, de Ferranti SD, Cochran WJ (2019). The use of nonnutritive sweeteners in children. Pediatrics 144(5) — PubMed PMID: 31659005

All six papers appear in the reference list of the final rule (section XI, references 16, 17, 31, 32, 44 and 45).

PubMed Topic Searches

1. PubMed: “healthy” nutrient content claims and food labeling
2. PubMed: nutrient profiling of added sugars, sodium and saturated fat
3. PubMed: Healthy Eating Index and mortality

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Connections

• FDA Actions in 2024
• FDA and Regulation
• FDA Proposal for Front-of-Package Nutrition Labels (2025)
• FDA and USDA Seek a Definition of Ultra-Processed Foods (2025)
• FDA Allows a Qualified Yogurt and Type 2 Diabetes Claim (2024)
• FDA Revokes Brominated Vegetable Oil (BVO) in Food (2024)
• Ultra-Processed Foods
• Olive Oil
• Avocado
• Salmon
• Sodium

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