FDA Proposes a New Definition of “Healthy” on Food Labels (2022)

Table of Contents

1. What the FDA Did on September 28–29, 2022
2. What a “Healthy” Claim Is
3. The 1994 Definition the Proposal Would Replace
4. What the Proposal Would Change
5. Foods the FDA Said Would Newly Qualify
6. The Reasons the FDA Gave
7. A Separate Track: A “Healthy” Symbol
8. How the Proposal Came About: 2016–2017
9. Public Comments and the Extension
10. What the Proposal Did Not Do
11. Dates and Legal Status as of October 18, 2026
12. How It Fits Earlier and Later FDA Labeling Actions
13. Primary Documents
14. Key Research Papers
15. Connections
16. Featured Videos

1. What the FDA Did on September 28–29, 2022

The FDA’s constituent update of September 28, 2022 begins: “The U.S. Food and Drug Administration today issued a proposed rule to update the definition of the nutrient content claim ‘healthy.’” The proposed rule appeared in the Federal Register the next day:

• Title: “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy’”
• Document type: proposed rule
• Citation: 87 FR 59168–59202 (35 pages), published September 29, 2022
• Docket: FDA-2016-D-2335; Regulation Identifier Number (RIN) 0910-AI13
• Regulations affected: 21 CFR part 101, the FDA’s food labeling regulations

A proposed rule is a draft regulation published for public comment; it changes nothing until the agency publishes a final rule. The Federal Register is the U.S. government’s daily publication of rules and official notices, and a docket is the public file for an action, where the documents and public comments are kept on regulations.gov. The “healthy” docket number dates from 2016, when the FDA first opened it to collect comments on the term (section 8).

The Federal Register summary states the aim in the agency’s words: the FDA “is proposing to update 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.”

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2. What a “Healthy” Claim Is

“Healthy” is one of the words the FDA regulates when it appears on a food label. The Federal Register summary calls it an implied nutrient content claim: a word that is used, in the summary’s words, “to indicate that a food’s level of nutrients may help consumers maintain healthy dietary practices by helping them achieve a total diet that conforms to dietary recommendations.” A food may carry the word in this sense only if it meets the criteria the FDA sets.

The FDA’s program page on the claim says that “Foods must meet specific criteria to use the ‘healthy’ nutrient content claim,” and the 2022 constituent update describes the claim as something that “can act as a quick signal on food package labels to help empower consumers, including those with lower nutrition knowledge, with information to identify foods that will help them build healthy eating patterns.”

Using the claim is a choice the manufacturer makes. The FDA’s program page describes “healthy” as a claim “that manufacturers can voluntarily use on food packages.” No food is required to carry it, and the rule sets the conditions only for foods that do.

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3. The 1994 Definition the Proposal Would Replace

The FDA’s program page states that the nutrient content claim “healthy” “was set in 1994.” It describes that definition this way: “The previous definition had limits for total fat, saturated fat, cholesterol and sodium and to qualify, foods also had to provide at least 10% of the Daily Value (DV) for one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, and fiber.”

The “% DV” is the percent Daily Value printed for each nutrient on the Nutrition Facts label. Under the 1994 approach, a food therefore qualified by staying under limits for four nutrients and providing enough of at least one of six listed nutrients. A later FDA consumer update describes the old definition as “solely focused on individual nutrients.”

A 2016 FDA guidance had already loosened two parts of that definition while the agency worked on a new one. According to the Federal Register notice announcing it, the guidance stated the FDA’s intent to exercise enforcement discretion (that is, not to take enforcement action) for the claim “healthy” on foods that have “a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of ‘low fat’,” or that contain at least 10 percent of the Daily Value of potassium or vitamin D per serving reference amount.

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4. What the Proposal Would Change

The 2022 constituent update says the proposed changes “are aligned with current nutrition science, the Dietary Guidelines for Americans, 2020-2025 and the updated Nutrition Facts label.” It describes the FDA’s approach as one that “focuses on ensuring that nutrient-dense foods that help consumers to build a diet consistent with current dietary recommendations can qualify to bear the claim.”

In practice, the proposal would move the test from single nutrients to two conditions:

• A food-group requirement. The food would need to contain a certain amount of food from at least one of the food groups or subgroups the Dietary Guidelines recommend, such as fruit, vegetables, grains, dairy or protein foods.
• Limits on three nutrients. The food would have to stay within limits for added sugars, saturated fat and sodium.

The FDA gave one worked example in its announcement: “to include the ‘healthy’ claim on the package, a cereal would need to contain a certain amount of whole grains and adhere to limits for saturated fat, sodium, and added sugars.” Grains such as oats and brown rice are described on the site’s Grains and Staples pages.

The Federal Register summary adds that the action, “if finalized, will revise the requirements for when the term ‘healthy’ can be used as an implied claim in the labeling of human food products.”

The proposal’s exact numbers are not given here. The full text of the 2022 proposed rule, which sets out the amounts of each food group and the nutrient limits food category by food category, could not be read for this page, and the FDA’s program page now shows the table from the 2024 final rule, which the FDA changed after public comment. The final rule’s figures are reported on the 2024 final rule page and are not the figures the FDA proposed in 2022.

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5. Foods the FDA Said Would Newly Qualify

The September 2022 constituent update named foods that the 1994 definition kept from using the claim but that would qualify under the proposal: “Nuts and seeds, higher fat fish, such as salmon, certain oils, and water are examples of foods that cannot currently be labeled as ‘healthy’ but are part of a healthy dietary pattern and recommended by the Dietary Guidelines and would qualify to bear the ‘healthy’ claim under the proposed definition announced today.”

These foods have their own pages on the site: Nuts and Seeds and Salmon. The FDA program page lists total fat among the 1994 limits, and notes that current U.S. dietary guidelines include a focus on “the type of fat in the diet rather than the total amount of fat consumed.”

The constituent update also expressed the hope that the change could affect what manufacturers make: labeling “may help foster a healthier food supply for all if some manufacturers include more fruits, vegetables, dairy and whole grains and limit saturated fat, sodium, and added sugars in their products, to qualify to use the updated claim.”

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6. The Reasons the FDA Gave

The FDA’s documents set the proposal in the context of diet-related disease. The constituent update states: “Diet-related chronic diseases in the U.S. are the leading causes of death and disability.” It continues: “Healthy eating patterns, which include fruits, vegetables, lower-fat dairy and whole grains, are associated with improved health, such as reduced risk of cardiovascular disease, type 2 diabetes, certain types of cancers, and being overweight or obese.” These are the FDA’s statements. The conditions themselves are described on the site’s Type 2 Diabetes, Obesity and Cardiology pages.

The agency called the proposal “just one part of the agency’s ongoing commitment to reduce diet-related chronic diseases and advance health equity.” On the same day, the update says, the FDA joined the White House Conference on Hunger, Nutrition, and Health, “highlighting the agency’s support of the national strategy to improve nutrition and health.”

The FDA’s program page states the wider goal of its nutrition work: “Improving nutrition is one of the best public health interventions for reducing these and other chronic illnesses and premature death,” and the agency promotes nutritious eating patterns “in part, by providing information so that consumers can make healthier food choices.”

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7. A Separate Track: A “Healthy” Symbol

The 2022 constituent update also described a related project: “On a separate but related track, the FDA is also researching a symbol that manufacturers could use on the front of the pack to show that their product meets the definition of the ‘healthy’ claim.” The FDA said a standardized graphic would further support its goal of helping consumers “more easily identify packaged food products that help them build healthy eating patterns.”

The symbol was not part of the proposed rule. The FDA program page records two procedural notices, required under the Paperwork Reduction Act before a federal agency collects information from the public, for the symbol’s “preliminary quantitative consumer research”:

• May 7, 2021: a proposed collection of information on “Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim ‘Healthy’ on Packaged Foods” (86 FR 24629; Docket FDA-2021-N-0336).
• March 28, 2022: the submission of that collection to the Office of Management and Budget for review (87 FR 17300; same docket).

The program page states that “the FDA’s research was approved” and that the agency “continues to work on development of the symbol.” No symbol had been issued as of that page’s January 16, 2025 update.

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8. How the Proposal Came About: 2016–2017

The Federal Register records three earlier steps in the same docket:

• September 28, 2016 — a request for information. The FDA opened docket FDA-2016-D-2335 “to receive information and comments on the use of the term ‘healthy’ in the labeling of human food products” (81 FR 66562). The notice says the FDA had received a citizen petition asking it to update its nutrient content claim rules to match federal dietary guidance and, in particular, to amend the “healthy” definition “with respect to total fat intake” and “to emphasize whole foods and dietary patterns rather than specific nutrients.” Comments were first due January 26, 2017; the FDA later extended that period (81 FR 96404, December 30, 2016).
• September 28, 2016 — the enforcement-discretion guidance described in section 3 (81 FR 66527).
• March 9, 2017 — a public meeting “to give interested persons an opportunity to discuss the use of the term ‘healthy’ in the labeling of human food” (82 FR 10868). The FDA program page states that the 2022 proposed rule “was informed in part by” that meeting.

A guidance document describes how the FDA reads and applies its rules; it does not itself create new legal requirements, which is why the change to the definition needed a rule.

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9. Public Comments and the Extension

The proposed rule set two deadlines. Comments on the rule itself were due December 28, 2022, 90 days after publication. Written comments on the rule’s information-collection provisions, under the Paperwork Reduction Act, were due October 31, 2022. The constituent update asked that comments be submitted to regulations.gov under docket number FDA-2016-D-2335.

On November 28, 2022, the FDA announced that it was extending the comment period by 50 days, to February 16, 2023. The notice was published the next day (87 FR 73267, November 29, 2022). In the Federal Register’s words, the extension was made “in response to a request from stakeholders to extend the comment period to allow interested persons additional time to submit comments.”

The comments received, and the changes the FDA made in response, are described in the 2024 final rule; they are reported on the 2024 final rule page.

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10. What the Proposal Did Not Do

• It did not change the definition in 2022. It was a proposal. The 1994 definition stayed in force until the final rule took effect in 2025 (section 11).
• It did not require any food to carry the claim. “Healthy” is a claim manufacturers may choose to use; the proposal set conditions only for foods that use it.
• It did not create a “healthy” symbol. The symbol was a separate research project (section 7).
• It did not ban or restrict any food. A food that does not qualify for the claim can still be sold; it simply cannot use the word “healthy” as a nutrient content claim.
• It is not the same as the final rule. The FDA changed the criteria between 2022 and 2024. The limits shown on the FDA’s current program page are the final rule’s, not the proposal’s.

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11. Dates and Legal Status as of October 18, 2026

• September 28, 2016: request for information, enforcement-discretion guidance and opening of docket FDA-2016-D-2335.
• March 9, 2017: public meeting on the term “healthy.”
• March 28, 2022: second procedural notice for the “healthy” symbol research.
• September 28, 2022: the FDA announces the proposed rule.
• September 29, 2022: the proposed rule is published (87 FR 59168).
• October 31, 2022: deadline for comments on the information-collection provisions.
• November 29, 2022: the comment period is extended (87 FR 73267).
• February 16, 2023: the extended comment period closes.
• December 27, 2024: the final rule is published (89 FR 106064). The FDA program page says the agency announced it on December 19, 2024. Effective date February 25, 2025; compliance date February 25, 2028.
• February 25, 2025: the effective date is delayed to April 28, 2025 (90 FR 10592), under the President’s memorandum of January 20, 2025, “Regulatory Freeze Pending Review.”
• April 28, 2025: the final rule takes effect. An FDA consumer update states that manufacturers who choose to use the claim “can use the new criteria starting on April 28, 2025.”

Status as of October 18, 2026: the 2022 proposal has been made final. The final rule is in effect, with a compliance date of February 25, 2028. A check of the Federal Register through October 18, 2026, of both the docket (FDA-2016-D-2335) and the regulation number (RIN 0910-AI13), found no document that withdraws, stays or further delays the final rule; the only later document listed in the docket is a July 3, 2025 notice listing information collections approved by the Office of Management and Budget (90 FR 29567).

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12. How It Fits Earlier and Later FDA Labeling Actions

The proposal is the middle step of a rulemaking that ran from 2016 to 2024: the 2016 request for information and guidance, the 2017 public meeting, the 2022 proposal and the 2024 final rule, all in one docket. The constituent update also tied the 2022 proposal to the updated Nutrition Facts label, with which it says the proposed changes are aligned.

Later FDA labeling actions are reported on their own pages:

• The 2024 “healthy” final rule, which sets the definition now in effect and describes how it differs from this proposal.
• The 2025 front-of-package nutrition label proposal, a separate rulemaking on a nutrition box for the front of packages.
• The 2025 request for information on defining ultra-processed foods; the foods themselves are described on the site’s Ultra-Processed Foods page.
• The 2023 plant-based milk labeling draft guidance and the 2023 sesame allergen labeling change, two other actions on what a food label tells the reader.

Among the FDA’s 2022 food actions, others concerned what is in food rather than what the label says: the fluoride limit for bottled water, the draft action levels for lead in juice, the revocation of phthalate authorizations for food-contact use and the food traceability final rule.

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13. Primary Documents

1. Food and Drug Administration, HHS (2022). Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.” Proposed rule. Federal Register 87 FR 59168–59202, September 29, 2022. Docket No. FDA-2016-D-2335; RIN 0910-AI13; 21 CFR part 101. Comments due December 28, 2022 — FR Doc. 2022-20975
2. Food and Drug Administration, HHS (2022). Food Labeling: Nutrient Content Claims; Definition of Term “Healthy;” Extension of Comment Period. Federal Register 87 FR 73267, November 29, 2022. Docket No. FDA-2016-D-2335. Comments due February 16, 2023 — FR Doc. 2022-26002
3. U.S. Food and Drug Administration. FDA Proposes to Update Definition for “Healthy” Claim on Food Labels. Constituent update, September 28, 2022 (updated November 28, 2022) — fda.gov constituent update
4. U.S. Food and Drug Administration. Use of the “Healthy” Claim on Food Labeling. Program page, content current as of January 16, 2025 — fda.gov “healthy” claim page
5. U.S. Food and Drug Administration. A Fresh Take on What “Healthy” Means on Food Packages. Consumer update, content current as of February 24, 2025 — fda.gov consumer update
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 FR 66562, September 28, 2016. Docket No. FDA-2016-D-2335 — FR Doc. 2016-23365
7. 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 FR 66527, September 28, 2016. Docket No. FDA-2016-D-2335 — FR Doc. 2016-23367
8. 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 FR 10868, February 16, 2017. Docket No. FDA-2016-D-2335 — FR Doc. 2017-03117
9. Food and Drug Administration, HHS (2022). Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on a Voluntary Symbol Depicting the Nutrient Content Claim “Healthy” on Packaged Foods. Federal Register 87 FR 17300, March 28, 2022. Docket No. FDA-2021-N-0336 — FR Doc. 2022-06419
10. Food and Drug Administration, HHS (2024). Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.” Final rule. Federal Register 89 FR 106064, December 27, 2024. Docket No. FDA-2016-D-2335; RIN 0910-AI13. Effective February 25, 2025; compliance date February 25, 2028 — FR Doc. 2024-29957
11. Food and Drug Administration, HHS (2025). Food Labeling: Nutrient Content Claims; Definition of Term “Healthy.” Final rule; delay of effective date to April 28, 2025. Federal Register 90 FR 10592, February 25, 2025. Docket No. FDA-2016-D-2335 — FR Doc. 2025-03118
12. Regulatory agenda entry, RIN 0910-AI13, Nutrient Content Claims, Definition of Term: Healthy — federalregister.gov RIN 0910-AI13
13. Public docket FDA-2016-D-2335 — regulations.gov FDA-2016-D-2335

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Key Research Papers

1. Siu K, Drewnowski A (2023). Toward a New Definition of “Healthy” Food: Issues and Challenges. Current Developments in Nutrition 7(5):100080 — PubMed PMID: 37197022
2. Hyink J, McFadden BR, Ellison B (2024). Potential consumer response to the healthy symbol proposed by the U.S. food and Drug Administration. Heliyon 10(10):e30863 — PubMed PMID: 38778947
3. Belarmino EH, Carfagno M, Kam L, Ifeagwu KC, Nelson ME, Seguin-Fowler RA (2024). Consideration of nutrition and sustainability in public definitions of ‘healthy’ food: an analysis of submissions to the US FDA. Public Health Nutrition 27(1):e119 — PubMed PMID: 38569921
4. Kelly B, Ng SH, Carrad A, Pettigrew S (2024). The Potential Effectiveness of Nutrient Declarations and Nutrition and Health Claims for Improving Population Diets. Annual Review of Nutrition 44(1):441-470 — PubMed PMID: 38857539
5. Hooker K, Sanjeevi N, Monsivais P (2025). An Updated Definition of “Healthy” Foods in the United States: How Do They Measure in Nutrient Density, Cost, and Frequency of Consumption? Current Developments in Nutrition 9(10):107545 — PubMed PMID: 41158961
6. Tucker AC, Martínez-Steele E, Caulfield LE, Rebholz CM, Wolfson JA (2026). What is “healthy” food? A cross-sectional evaluation of foods and beverages consumed by United States adults that satisfy the United States Food and Drug Administration’s updated “healthy” claim criteria. The American Journal of Clinical Nutrition 123(2):101121 — PubMed PMID: 41309038

The first two papers study the 2022 proposal directly. Siu and Drewnowski applied the proposed criteria to a U.S. food composition database and report that they were met by 58% of fruits, 35% of vegetables, 8% of milk and dairy products and 4% of grain products. Hyink and colleagues tested, in an online experiment with 1,018 U.S. adults, how a front-of-pack “healthy” symbol might change whether people identify a food as healthy. Belarmino and colleagues analysed the 1,125 public comments sent to the FDA in 2016–2017 in the same docket. Kelly and colleagues review the evidence on nutrient declarations and nutrition and health claims in general. The last two apply the criteria of the 2024 final rule, not the 2022 proposal, to U.S. foods; both report that about 14–15% of the foods and beverages they examined qualified.

PubMed Topic Searches

1. PubMed: FDA “healthy” claim definition
2. PubMed: nutrient content claims and consumer perception
3. PubMed: nutrient profiling and food labels

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Connections

• FDA Actions of 2022
• FDA and Regulation
• “Healthy” Claim Final Rule (2024)
• Front-of-Package Nutrition Label Proposal (2025)
• Ultra-Processed Foods Definition Request (2025)
• Plant-Based Milk Labeling Draft (2023)
• Sesame Becomes the Ninth Major Allergen (2023)
• Bottled Water Fluoride Limit (2022)
• Lead in Juice Draft Action Levels (2022)
• Phthalates Food-Contact Revocation (2022)
• Food Traceability Final Rule (2022)
• Ultra-Processed Foods
• Food
• Nuts and Seeds
• Salmon
• Grains and Staples
• Type 2 Diabetes
• Obesity
• Cardiology

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