FDA Labeling Compliance Date: What Changes in 2028
The FDA labeling compliance date in 2028 means two dates: January 1 for qualifying labeling rules and February 25 for the updated healthy claim.
The FDA labeling compliance date in 2028 means two different dates: 25 February 2028 for the updated "healthy" nutrient content claim, and 1 January 2028 as FDA's uniform compliance date for certain food labeling regulations. Both are final, but they work in very different ways.
The 25 February date applies only if you choose to put a particular claim on your product. The 1 January date is a mechanism that gathers qualifying labeling changes onto one day so producers can make a single artwork revision instead of several.
Treating them as one deadline is the most common planning error on this subject. This guide separates the two dates, explains what belongs on each, identifies changes that do not have a 2028 deadline despite being widely reported as though they do, and works backwards from both dates to a practical schedule.
FDA labeling compliance date 2028: two dates, two mechanisms
Here is the full picture, including the status that belongs to each item. The third row is included because it is the change most often reported as though it already had a 2028 deadline.
| Date | What it is | Status | Who it applies to |
|---|---|---|---|
| 25 February 2028 | Compliance date for the updated "healthy" claim, 21 CFR 101.65(d) | FINAL rule, VOLUNTARY claim | Only products whose labeling uses "healthy" or a derivative term |
| 1 January 2028 | Uniform compliance date for labeling rules published 1 January 2025 through 31 December 2026 that set no date of their own | FINAL | Any product covered by such a rule |
| No date exists | Front-of-package "Nutrition Info" box, proposed at 90 FR 5426 on 16 January 2025 | PROPOSED | Nobody yet. No final rule as of 2 September 2026 |
Read the status column before the dates.
A final rule with a compliance date is something you schedule. A proposed rule is something you monitor. Confusion about the FDA 2028 compliance date usually starts when both are placed in the same spreadsheet column labeled "deadlines."
25 February 2028: the FDA 2028 compliance date for the "healthy" claim
The final rule "Food Labeling: Nutrient Content Claims; Definition of Term 'Healthy'" was published at 89 FR 106064 on 27 December 2024 and amends 21 CFR 101.65(d).
Its effective date as published was 25 February 2025. A Federal Register notice of 25 February 2025 delayed that date to 28 April 2025 under the regulatory freeze memo of 20 January 2025.
The compliance date did not move with the effective date. It remains 25 February 2028, three years from the original effective date.
The important question is whether this date applies to your product at all.
A nutrient content claim is something you choose to make. Nothing requires a food to be called healthy. The 25 February 2028 date simply establishes when any product that does bear the term must meet the new definition. It is not a deadline for every food label to change.
The covered terms are listed in 21 CFR 101.65(d)(3): "healthy" and the derivatives "health", "healthful", "healthfully", "healthfulness", "healthier", "healthiest", "healthily" and "healthiness" when used as an implied nutrient content claim, meaning in a nutritional context on the label.
If none of those terms appears in that context, this compliance date is not a task on your plan. If one does, your product has three possible outcomes:
- It already qualifies. The food meets the food group equivalent minimum and the added sugars, sodium and saturated fat limits for its category. Nothing needs to change on the label, but you still need the records described below.
- It can qualify with reformulation. This usually means reducing added sugars or sodium. It has the longest lead time on this page because reformulation needs bench work, shelf life confirmation and fresh analysis.
- It cannot qualify. The word comes off the label. This is the cheapest artwork change and often the most awkward commercial conversation, so make that decision first rather than last.
The category a product belongs to and its applicable limits are set out in the tables at 101.65(d)(3), explained product type by product type in the updated healthy claim requirements.
Two details matter when you build your schedule.
First, manufacturers may voluntarily use the new criteria now. There is no reason to wait until 2028 to convert a product that already passes.
Second, 101.65(d)(4) requires written records, such as recipes, formulations, database analyses or batch records, verifying that the food meets the food group equivalent requirements. Those records must be kept for at least 2 years after the food enters interstate commerce and produced to FDA on request during an inspection.
Building that record set has its own lead time. It belongs beside the artwork work, not after it.
1 January 2028: how the uniform compliance date works
The uniform compliance date is a different kind of deadline, and much of the confusion comes from treating it as though FDA ordered one specific label change for that day.
FDA does not give every labeling regulation its own compliance clock. Periodically, it publishes a Federal Register notice establishing one uniform compliance date for a group of labeling regulations issued during a two-year window.
The current notice, published 31 December 2024, sets 1 January 2028 as the uniform compliance date for food labeling regulations published between 1 January 2025 and 31 December 2026 that do not specify a compliance date of their own.
The reason is practical. Every artwork revision carries fixed costs that do not shrink with the size of the change, including prepress, proofing, plates, press setup and the write-off of leftover stock.
If four small rules each arrived with a separate deadline, a producer could pay those costs four times for changes that could have traveled together. A uniform date allows one revision and one print run.
Two consequences follow.
First, the uniform compliance date applies to a class of rules, not a fixed list of label elements.
The useful question is therefore not "what changes on 1 January 2028?" There is no single answer. Instead ask: was a final food labeling regulation published between 1 January 2025 and 31 December 2026 that affects my category and does not specify its own compliance date?
For many producers, nothing published in that window will affect their panel, and 1 January 2028 will pass without requiring an artwork revision.
Second, a rule that sets its own compliance date sits outside this mechanism.
The updated "healthy" claim is the clearest example. It has its own 25 February 2028 compliance date, and it was published on 27 December 2024, before the uniform compliance window even begins.
The proposed front-of-package box is outside for a different reason. It is a proposal, not a published final rule, so nothing about it can fall onto the uniform date.
What does not have an FDA 2028 compliance date
Several developments are repeatedly described as 2028 label changes even though they do not have an FDA food labeling compliance date in 2028.
The front-of-package "Nutrition Info" box has no compliance date at all. It is PROPOSED, published at 90 FR 5426 on 16 January 2025. Comments closed 15 July 2025, and no final rule existed in the Federal Register as of 2 September 2026.
If finalized as proposed, it would require compliance 3 years after the final rule's effective date for businesses with $10 million or more in annual food sales and 4 years for businesses below that. No clock has started.
Projections placing those dates in early 2030 and early 2031 are arithmetic based on a hypothetical late-2026 final rule, not FDA statements.
The Nutrition Facts panel is not changing in 2028. The format commonly described as "the new label" comes from the 2016 rule, which is FINAL and has long been in force. Compliance was 1 January 2020 for manufacturers with $10 million or more in annual food sales and 1 January 2021 for smaller manufacturers.
If your panel still needs that work, it is overdue rather than upcoming. The 2016 Nutrition Facts changes explains what was added.
FDA sodium reduction targets are VOLUNTARY guidance, so they have no compliance date. Phase I was finalized in October 2021, and Phase II was still draft as of September 2026. Guidance carries no deadline because it binds no one.
The ultra-processed foods work is not a labeling rule. A joint HHS and USDA proposed definition went to OMB on 3 August 2026 and was announced on 10 August 2026. It was described as a definition or research tool rather than a proposed rule. There is nothing to put on a label and nothing to schedule.
The Daily Values did not change. The 2025-2030 Dietary Guidelines for Americans, released 7 January 2026, are a guidance document. The Daily Values in 21 CFR 101.9 remain unchanged, and FDA has said only that it will assess whether the "healthy" criteria need aligning with them.
FD&C Red No. 3 has a 2027 date for food. Foods and dietary supplements must stop using it by 15 January 2027 under the order of 15 January 2025. The 18 January 2028 date that circulates alongside it applies to ingested drugs, not food.
State dates are not FDA dates. Texas SB 25 warning labeling has a 1 January 2027 trigger and is subject to a federal preliminary injunction (American Beverage Association v. Paxton, No. 6:25-cv-00566) against enforcement as to the plaintiff trade associations and their members. A New York date-labeling law would take effect 1 July 2028 if enacted, which was unconfirmed as of this writing. Louisiana SB 57 additive disclosure sits at 31 December 2028. None is an FDA compliance date.
Working backwards from the FDA labeling compliance date
A compliance date is the date by which compliant product exists, not the date on which you begin the work.
The useful schedule therefore starts at the applicable deadline and works backwards. The lead times below are ordinary commercial ranges rather than regulatory requirements. Substitute your printer's and laboratory's numbers because the structure of the plan matters more than the exact figures.
| Stage, working backwards | What has to be finished | Typical lead time |
|---|---|---|
| The date itself | 25 February 2028, or 1 January 2028 if a uniform-date rule applies to you | Fixed |
| Inventory turn | Old label stock and finished goods have run out | One to two full stock turns |
| Print and delivery | New labels printed, delivered and released to the line | Weeks, longer for multi-plant rollouts |
| Prepress and proofing | Final files, colour proofs, plates, barcode verification | Weeks per revision round |
| Artwork revision and sign-off | Panel rebuilt, claim text set or removed, approvals recorded | Allow at least two review rounds |
| Analysis and records | Nutrient values confirmed; for a "healthy" claim, the 101.65(d)(4) records assembled | Lab turnaround plus documentation time |
| Reformulation, if needed | New formula locked, shelf life and sensory confirmed | Months, the longest item on the plan |
| Decision gate, do this first | Per product: keep the claim, reformulate to keep it, or drop the word | Start roughly a year out |
Inventory turn is the stage most often left out of the schedule.
The requirement is that by 25 February 2028 any product bearing the term must meet the new definition, and no sell-through allowance for stock already in trade channels is stated.
Plan as though there is none. Size your final order of old label stock so it runs out before the compliance date rather than assuming a grace period you cannot point to in writing.
The decision gate matters for the same reason. Reformulation is the only stage measured in months rather than weeks, so deciding whether to reformulate has to come first.
Leaving that decision until late turns a manageable artwork project into an emergency. The same principle applies to every label change, covered in our wider guide to nutrition label compliance.
Why the uniform compliance date is an argument for batching
FDA grouped qualifying rules onto a uniform compliance date precisely so producers could make one artwork change. Making three separate revisions removes the practical benefit of that mechanism.
Batching means opening the artwork once and fixing everything known at that point:
- Anything on the 1 January 2028 uniform date that applies to your category.
- The "healthy" decision for every product carrying the word.
- Any color additive reformulation you are doing anyway, such as replacing FD&C Red No. 3 before 15 January 2027.
- Every defect found during an audit of the existing label.
That last category is often where much of the value sits. Ingredient statement order, allergen wording and net quantity errors cost nothing extra to correct inside a revision you are already paying for.
Run the audit before opening the artwork, and audit the entire label. Our FDA label checklist walks through the panel element by element so your list of fixes is complete before a designer touches the file.
When both 2028 dates apply to the same product, the sequencing is simple. They are less than two months apart and the uniform date comes first, so build to 1 January 2028 and one revision satisfies both.
When the Nutrition Facts panel itself needs rebuilding as part of that revision, the nutrition label generator produces the compliant Nutrition Facts artwork from your recipe, leaving the claim as the remaining decision.
Frequently asked questions about the FDA labeling compliance date
Is 25 February 2028 a deadline to change my food label?
Only if your label uses "healthy" or one of the derivative terms in 21 CFR 101.65(d)(3) as an implied nutrient content claim. The claim is voluntary. The date establishes when a product bearing the term must comply with the updated definition, rather than requiring every food label to be revised.
The effective date of the "healthy" rule was delayed. Did the compliance date move too?
No. The rule was published at 89 FR 106064 on 27 December 2024 with an effective date of 25 February 2025. A Federal Register notice of 25 February 2025 delayed that to 28 April 2025 under the 20 January 2025 regulatory freeze memo. The compliance date remained 25 February 2028.
Can I use the new "healthy" criteria before 2028?
Yes. The rule is final, and manufacturers may voluntarily use the new criteria now. If your product already meets the food group equivalent minimum and nutrient limits for its category, there is no reason to wait for 2028. Converting early can also spread artwork work across more than one budget year.
Is there a 2028 compliance date for the front-of-package box?
No. The front-of-package "Nutrition Info" box is PROPOSED. It was published at 90 FR 5426 on 16 January 2025, and no final rule had been published as of 2 September 2026. The proposed three-year and four-year compliance periods cannot begin until a final rule takes effect, so no compliance clock is currently running.
What falls on the 1 January 2028 uniform compliance date?
Food labeling regulations published between 1 January 2025 and 31 December 2026 that do not establish their own compliance date. It is a class of regulations rather than a fixed list of label elements. You therefore need to determine whether a final rule published within that window applies to your particular food category.
Do I have to keep records if I use the "healthy" claim?
Yes, under 21 CFR 101.65(d)(4). You must keep written records, such as recipes, formulations, database analyses or batch records, verifying food group equivalent requirements for at least 2 years after the food enters interstate commerce. This does not apply where the content is evident from the label or the food is an automatic qualifier under 101.65(d)(3)(i).
Is the Nutrition Facts panel format changing in 2028?
No. The current Nutrition Facts format comes from the 2016 final rule. It became mandatory on 1 January 2020 for manufacturers with $10 million or more in annual food sales and 1 January 2021 for smaller manufacturers. Nothing in 21 CFR 101.9 changes on either of the 2028 dates discussed here.
Need a nutrition label for your own product? Make it with our free nutrition facts label generator
Sources
- Food Labeling: Nutrient Content Claims; Definition of Term Healthy (89 FR 106064) (Federal Register)
- Uniform Compliance Date for Food Labeling Regulations (31 Dec 2024) (Federal Register (govinfo))
- 21 CFR 101.65 Implied nutrient content claims (eCFR) (eCFR)
- Food Labeling: Front-of-Package Nutrition Information, proposed rule (90 FR 5426) (Federal Register)
- Front-of-Package Nutrition Information; Extension of Comment Period (Federal Register)
- Changes to the Nutrition Facts Label (FDA)
- Order on Plaintiffs' Motion for Preliminary Injunction (11 Feb 2026), American Beverage Ass'n v. Paxton, No. 6:25-cv-00566 (W.D. Tex.), ECF No. 28 (U.S. District Court, W.D. Tex. (via CourtListener RECAP))
