FDA Proposal for Front-of-Package Nutrition Labels (2025)

Table of Contents

1. What the FDA Proposed
2. What the Nutrition Info Box Would Show
3. How the Box Would Look and Where It Would Go
4. Which Foods Would Carry It, and Which Would Not
5. Changes to “Low Sodium” and “Low Saturated Fat” Claims
6. The Consumer Research the FDA Describes
7. The Background the Documents Give
8. Two Decades of Front-of-Package Discussion
9. Estimated Costs and Expected Effects
10. What the Proposal Does Not Do
11. Dates and Status as of October 11, 2026
12. How It Fits Other FDA Nutrition Actions
13. Primary Documents
14. Key Research Papers
15. Connections

1. What the FDA Proposed

The FDA press release, “FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods,” is dated 14 January 2025. It states that the agency is “proposing to require a front-of-package (FOP) nutrition label for most packaged foods” that would give consumers “readily visible information about a food’s saturated fat, sodium and added sugars content—three nutrients directly linked with chronic diseases when consumed in excess.”

The formal document is a proposed rule — the first published step in federal rulemaking, in which an agency sets out a draft regulation and asks the public to comment before it decides whether to finalize it. It was published on 16 January 2025 in the Federal Register (the federal government’s daily journal of rules and notices) on pages 5426–5463 of volume 90, as FR Doc. 2025-00778, with Regulation Identifier Number (RIN) 0910-AI80. It opened public Docket No. FDA-2024-N-2910, the official file where comments and supporting documents are collected. The proposed rule would add a new section, 21 CFR 101.6, to the federal food-labeling regulations.

The rule’s summary says the box “would provide consumers, including those who have lower nutrition knowledge, with standardized, interpretive nutrition information that can help them quickly and easily identify how foods can be part of a healthy diet.” It also proposes amending the definitions of two existing label claims, “low sodium” and “low saturated fat” (section 5).

The press release quotes the FDA Commissioner at the time, Robert M. Califf, M.D.: “The science on saturated fat, sodium and added sugars is clear … It is time we make it easier for consumers to glance, grab and go. Adding front-of-package nutrition labeling to most packaged foods would do that.”

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2. What the Nutrition Info Box Would Show

Under the proposed text, the box would carry the heading “Nutrition Info” and two column headings, “Per serving” (with the serving size, for example “Per serving (1/2 cup)”) and “% Daily Value.” It would list three nutrients, always in this order:

• Saturated Fat
• Sodium
• Added Sugars

For each one the box would give the percent Daily Value (%DV) — the share of the government’s daily reference amount for that nutrient that one serving supplies, the same figure already printed on the Nutrition Facts label — followed by a one-word rating:

• Low: 5% DV or less;
• Med: 6% to 19% DV;
• High: 20% DV or more.

The rule describes these cut-offs as FDA’s “longstanding general approach for interpreting the percent DV of a nutrient,” often called the 5/20 rule. The %DV values used would be those for people aged 4 and older. A banner along the bottom of the box would read “FDA.gov,” and the proposed text states that “no other information may be included in the Nutrition Info box.”

Why these three nutrients, and no calories. The rule says saturated fat, sodium and added sugars were chosen because nutrition science and the Dietary Guidelines for Americans, 2020–2025 call for limiting them, and because most Americans exceed the recommended limits. It considered adding nutrients people often get too little of, such as fiber and calcium, but reports that focus-group participants were confused when one label mixed “nutrients to limit” with “nutrients to get enough of.” It did not include a calorie rating because there is no Daily Value for calories — calorie needs vary with age, sex, size and activity — so there is nothing to rate calories against. Manufacturers could still state calories voluntarily elsewhere on the front of the package; the FDA invited comment on whether calories belong in the box.

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3. How the Box Would Look and Where It Would Go

The proposed formatting rules are detailed. The box would have to:

• appear in the upper third of the principal display panel — the part of the package most likely to be seen at the point of sale, usually the front;
• use a single, easy-to-read type style, at least 8 point and no smaller than the package’s required net-quantity statement;
• use one color (for example black) for all text and lines, on a white or other neutral contrasting background;
• separate the heading and each nutrient row with thin horizontal rules, with the ratings “Low,” “Med” and “High” in extra-bold type at the right.

The rule explains the single-color design partly through legibility: dark text on a light background with high contrast reads best. Its research section reports that in the focus groups, red-yellow-green coloring confused participants when a label mixed nutrients to limit with nutrients to get enough of.

Special versions are proposed for particular packages: a package holding several different foods would show one box per food; a food with “as packaged” and “as prepared” nutrition columns would show the “as packaged” values with a note saying so; packages with 40 square inches or less of label space could use a smaller box that drops the %DV numbers and abbreviates “Sat. Fat” and “Add. Sugar”; foods sold from bulk bins would display the box on the bin’s labeling; and game meats such as deer or bison would show it at the point of purchase if sold unpackaged.

The proposed text also contains a preemption paragraph: a State or local government “may not establish or continue into effect any law, rule, regulation, or other requirement that is different from the requirements in this section for the Nutrition Info box.” Like the rest of the proposal, this would take effect only if the rule is finalized.

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4. Which Foods Would Carry It, and Which Would Not

The proposal would apply to foods that must already carry a Nutrition Facts label and that are marketed for people aged 4 and older. The rule treats pregnant and breastfeeding people as part of this general population, because their reference values for the three nutrients are the same.

Not covered or proposed as exempt:

• Foods for infants and children under 4. The FDA has no Daily Values for saturated fat, sodium or added sugars for infants up to 12 months, so a Low/Med/High rating could not be calculated; for children 1 to 3 the agency says it is still evaluating its reference values against the newer Dietary Guidelines. It invited comment on future labeling for these ages.
• Most dietary supplements, which use their own Supplement Facts label and are already exempt from Nutrition Facts labeling. The rule notes that some supplements may contain high levels of the three nutrients and invited comment on this exemption.
• Any food already exempt from Nutrition Facts labeling;
• packages with less than 12 square inches of label space;
• gift packages containing an assortment of foods;
• individual units inside a multi-unit retail package, when the outer package carries the box.

Considered for exemption but kept in: foods with insignificant amounts of all three nutrients (they would still carry the box, so shoppers can compare products), and conventional-food electrolyte drinks, glucose products and nutrition shakes, which the rule says are widely used by the general population.

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5. Changes to “Low Sodium” and “Low Saturated Fat” Claims

A nutrient content claim is a regulated phrase on a label, such as “low sodium,” that describes how much of a nutrient a food contains; each one has a legal definition. The proposal would change two:

• Low sodium. The ceiling would drop from 140 mg to 115 mg of sodium per reference amount customarily consumed (RACC — the standard serving amount the regulations set for each type of food), and for meals and main dishes from 140 mg to 115 mg per 100 g. The rule says this matches the sodium Daily Value updated in 2016 and roughly lines up with the box’s “Low” band of 5% DV or less.
• Both claims. A food required to carry the box could make a “low sodium” or “low saturated fat” claim only if its box shows “Low” for that nutrient. The rule says a package carrying a “low” claim next to a “Med” or “High” rating “could result in consumer confusion.”

The rule also states that the information in the box itself would not count as a nutrient content claim, in the same way the Nutrition Facts label does not.

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6. The Consumer Research the FDA Describes

The rule sets out the research behind the design in four steps:

1. A systematic literature review, most recently made public in April 2023. The rule summarizes its themes as: front-of-package labels can help consumers identify and select healthy foods, consumers generally prefer simple labels, and government endorsement may increase confidence in a label.
2. Focus groups in 2022 that tested 41 variations of four label types used in the U.S. and abroad: “Guideline Daily Amount” icons, “Nutrition Tips,” “Nutrition Tips–High In” and “High In” labels.
3. A randomized online experiment. The rule describes a controlled experiment using a 15-minute web questionnaire with 9,200 U.S. adults from an online consumer panel, balanced to Census data and to a range of nutrition literacy; the press release describes the 2023 study as covering “nearly 10,000 U.S. adults.” Eight label versions in three categories were tested. According to the rule, the “Nutrition Info” versions produced the most correct answers about which product was healthier, and in less time; among them, “the versions that were black and white with percent DV performed best in most instances.” “High In” labels, which flag only nutrients that are high, “performed the worst” at identifying a product’s healthfulness, and the numbers-only Guideline Daily Amount icons were well liked but led to fewer correct readings of nutrient levels. The rule says the final study report was peer reviewed by independent experts and placed in the docket.
4. A second set of focus groups in fall 2023, in which almost all participants said they viewed the box the same way on beverages as on other foods.

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7. The Background the Documents Give

Chronic disease. The press release states that chronic diseases, including heart disease, cancer and diabetes, are the leading cause of disability and death in the U.S., that 60% of Americans have at least one chronic disease, and that such diseases are the leading drivers of $4.5 trillion in annual health-care costs. It says “a large body of research indicates that a major contributor to this problem is excess consumption of saturated fat, sodium and added sugars,” and that foods considered ultra-processed “often contain high levels of these nutrients.” The rule adds that about one in 10 Americans has diabetes and that nearly half of American adults have high blood pressure.

How people use today’s labels. The rule cites FDA survey data that 87% of U.S. adults have looked at the Nutrition Facts label and nearly 80% use it sometimes or often, but only 49% report looking at the %DV, and up to 40% of Americans aged 16 and older do not understand what %DV means. It also reports that fewer label readers look at the nutrients to limit, and that regular label use is lower among men and among people with less education or lower income. The FDA’s stated aim is to add a plain-language interpretation on the front of the package to the numbers already on the back.

Other countries. According to the rule, as of 2024 countries in North America, South America, Asia and Africa had implemented or were implementing mandatory front-of-package schemes, and several countries in Africa, Europe, Asia and Oceania had voluntary ones. These include warning-type schemes (for example a triangle or exclamation point for nutrients above a threshold) and summary schemes that give a food a single grade.

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8. Two Decades of Front-of-Package Discussion

The rule records that the FDA has considered front-of-package labeling “since at least 2007”:

• 2007: a public hearing notice on nutrition symbols then in use on food labels (72 FR 39815).
• 2008–2009: a focus-group study (April 2008) and two experimental studies submitted for federal clearance (74 FR 62786).
• 2009–2012: Congress directed a study by the Institute of Medicine (now the National Academies of Sciences, Engineering, and Medicine). Its 2010 Phase I report found such systems had existed internationally since 1989; its 2012 Phase II report concluded that a single, standardized system appearing on all products and understood by most age groups would be the best option.
• 2010: a docket seeking information on front-of-pack and shelf-tag symbols (75 FR 22602).
• 2011: a letter of enforcement discretion allowing two food-industry trade associations to run a voluntary industry front-of-package program showing calories, saturated fat, sodium and total sugar. The same year, an FDA-commissioned literature review found summary systems combining text and color worked better than numbers alone at attracting attention; an update covering 2010–2016 found consumers preferred simple, quick-to-read labels.
• 2022: the White House National Strategy on Hunger, Nutrition, and Health (September 2022) listed a standardized FDA front-of-package system among its goals. On 5 August 2022 three nutrition and public-health organizations filed a citizen petition (Docket No. FDA-2022-P-1832) asking for a mandatory, nutrient-specific, interpretive label that included calories; the rule says the FDA considered it.

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9. Estimated Costs and Expected Effects

The rule’s preliminary economic analysis estimates annualized costs over 10 years (2025–2034, 2023 dollars, 2% discount rate):

• Relabeling: $66 million to $154 million a year, primary estimate $105 million;
• Reformulation: $125 million to $377 million a year, primary estimate $227 million;
• Total: $191 million to $530 million a year, primary estimate $333 million.

The rule states that “reformulation is not a requirement or goal of the proposed rule,” but that some manufacturers may change recipes to keep a nutrient content claim or move a product into a “Low” or “Med” rating; it notes costs may be partly passed on to consumers as higher prices. It did not put a dollar value on the benefits, which it describes as the value consumers receive from the information. The press release quotes the FDA Deputy Commissioner for Human Foods at the time, Jim Jones: “it’s possible we’ll see manufacturers reformulate products to be healthier in response to front-of-package nutrition labeling.”

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10. What the Proposal Does Not Do

• It changes no label today. It is a proposal. Nothing would be required until a final rule is published, takes effect, and a further 3- to 4-year compliance period runs out.
• It uses no traffic-light colors and no warning symbols. The box is a single color on a neutral background, and every covered food would show all three ratings — not only the high ones.
• It does not replace the Nutrition Facts label, which the press release says the box “complements.”
• It does not rate calories or nutrients such as fiber, calcium or potassium.
• It does not cover foods for children under 4 or most dietary supplements.
• It does not require any recipe change; the rule says reformulation is neither a requirement nor a goal.
• It does not stop manufacturers from stating calories or other truthful information elsewhere on the front of the package.

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11. Dates and Status as of October 11, 2026

• 14 January 2025: FDA press release announces the proposal.
• 16 January 2025: proposed rule published, 90 FR 5426. Comment deadline set at 16 May 2025 (a 120-day period).
• 9 May 2025: extension notice published, 90 FR 19664 (signed 5 May 2025 by the FDA Deputy Commissioner for Policy, Legislation, and International Affairs). It says the FDA received requests for more time because the 120 days did not allow a “meaningful response,” and it extended the deadline by 60 days.
• 15 July 2025: comment period closed.
• Proposed timing if finalized: the rule would take effect 60 days after a final rule is published; compliance would be required 3 years after that effective date for businesses with $10 million or more in annual food sales, and 4 years after it for smaller businesses.

Status on 11 October 2026: proposed. The Federal Register record under RIN 0910-AI80 contains only the two 2025 documents above; it shows no final rule and no withdrawal. The documents give no information on when, or whether, a final rule will follow.

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12. How It Fits Other FDA Nutrition Actions

The rule and press release place the proposal in a sequence of FDA nutrition-labeling work:

• 1993 and 2016: the FDA first issued Nutrition Facts label regulations in 1993 and revised them in 2016, when the FDA added a mandatory line for added sugars and updated the Daily Values the box would rely on.
• 2021 and 2024: voluntary sodium-reduction targets for the food industry — short-term targets published in 2021 and draft Phase II targets in August 2024.
• December 2024: a final rule updating the “healthy” claim (89 FR 106064), which sets limits on saturated fat, sodium and added sugars for foods using the word; the press release also mentions work on a “healthy” symbol.

The press release ties these efforts to foods “commonly considered ultra-processed.” In July 2025 the FDA and USDA asked the public for data toward a uniform federal definition of ultra-processed foods (see FDA and USDA Seek a Definition of Ultra-Processed Foods (2025)), and other 2025 food actions dealt with food dyes and chemical oversight; these are listed on the 2025 FDA actions hub.

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13. Primary Documents

1. U.S. Food and Drug Administration (2025). FDA Proposes Requiring At-a-Glance Nutrition Information on the Front of Packaged Foods. FDA News Release, 14 January 2025 — fda.gov press announcement
2. Food and Drug Administration, HHS (2025). Food Labeling: Front-of-Package Nutrition Information; Proposed Rule. Federal Register 90:5426–5463, 16 January 2025. Docket No. FDA-2024-N-2910; RIN 0910-AI80 — FR Doc. 2025-00778 (official PDF, govinfo.gov)
3. Food and Drug Administration, HHS (2025). Food Labeling: Front-of-Package Nutrition Information; Extension of Comment Period. Federal Register 90:19664–19665, 9 May 2025. Docket No. FDA-2024-N-2910 — FR Doc. 2025-08204 (official PDF, govinfo.gov)
4. Public docket FDA-2024-N-2910, “Food Labeling: Front-of-Package Nutrition Information,” at regulations.gov (comments and the FDA’s supporting documents, including the consumer-research report).

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Key Research Papers

1. Campos S, Doxey J, Hammond D (2011). Nutrition labels on pre-packaged foods: a systematic review. Public Health Nutrition 14(8):1496-1506 — PubMed PMID: 21241532
2. Hersey JC, Wohlgenant KC, Arsenault JE, Kosa KM, Muth MK (2013). Effects of front-of-package and shelf nutrition labeling systems on consumers. Nutrition Reviews 71(1):1-14 — PubMed PMID: 23282247
3. Christoph MJ, Larson N, Laska MN, Neumark-Sztainer D (2018). Nutrition Facts Panels: Who Uses Them, What Do They Use, and How Does Use Relate to Dietary Intake? Journal of the Academy of Nutrition and Dietetics 118(2):217-228 — PubMed PMID: 29389508
4. Acton RB, Vanderlee L, Roberto CA, Hammond D (2018). Consumer perceptions of specific design characteristics for front-of-package nutrition labels. Health Education Research 33(2):167-174 — PubMed PMID: 29514225
5. Acton RB, Hammond D (2018). Do manufacturer ‘nutrient claims’ influence the efficacy of mandated front-of-package labels? Public Health Nutrition 21(18):3354-3359 — PubMed PMID: 30345943
6. Roberto CA, Ng SW, Ganderats-Fuentes M, Hammond D, Barquera S, Jauregui A, Taillie LS (2021). The Influence of Front-of-Package Nutrition Labeling on Consumer Behavior and Product Reformulation. Annual Review of Nutrition 41:529-550 — PubMed PMID: 34339293
7. Shrestha A, Cullerton K, White KM, Mays J, Sendall M (2023). Impact of front-of-pack nutrition labelling in consumer understanding and use across socio-economic status: A systematic review. Appetite 187:106587 — PubMed PMID: 37169260

All seven papers appear in the reference list of the proposed rule (section XII).

PubMed Topic Searches

1. PubMed: front-of-package nutrition labeling
2. PubMed: front-of-pack labels and consumer understanding
3. PubMed: front-of-package labels and product reformulation
4. PubMed: Nutrition Facts label use and dietary intake

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Connections

• Major FDA Actions of 2025
• FDA and Regulation
• FDA and USDA Seek a Definition of Ultra-Processed Foods (2025)
• FDA Plan to Phase Out Petroleum-Based Food Dyes (2025)
• FDA Moves on Self-Affirmed GRAS and Chemical Reviews (2025)
• FDA Action Levels for Lead in Baby Food (2025)
• Ultra-Processed Foods
• Added Sugar, Sugary Drinks, and Weight
• Sodium
• American Food and Health Policy Reset (News, 12 April 2026)

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