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The FDA's New 'Healthy' Label Rule: What Food Businesses Must Budget Before February 25, 2028

7 min readMike ThriftMike Thrift
The FDA's New 'Healthy' Label Rule: What Food Businesses Must Budget Before February 25, 2028

Most food labels change on their own schedule — a new flavor here, a rebrand there. But one word on your packaging is about to come with a federal deadline attached: "healthy."

If your granola bar, yogurt, sauce, or snack currently carries the word "healthy" anywhere on its label, the FDA's updated definition of that term takes full effect on February 25, 2028. That sounds far away. It isn't, once you account for how long reformulation, lab testing, and packaging redesign actually take for a small food business. Waiting until 2027 to start is how companies end up printing "healthy" on a product that no longer legally qualifies.

What Actually Changed

For nearly three decades, the FDA's "healthy" claim was built around limiting fat and cholesterol — a framework from the 1990s low-fat era. The new rule throws that model out and rebuilds it around the nutrition science that actually holds up today: added sugar, sodium, and saturated fat.

Under the finalized definition, a food can only carry a "healthy" claim if it:

  • Contains a meaningful amount of food from at least one food group — vegetables, fruit, dairy, protein foods, whole grains, or oils (roughly a ½-cup equivalent, varying by category)
  • Stays under specific limits for added sugars, sodium, and saturated fat, with thresholds that scale by food category and serving size
  • Excludes naturally occurring saturated fat in foods like nuts, seeds, soy, and higher-fat fish (salmon, for example, is now eligible in a way it wasn't before)

The practical effect is a reshuffling of who's in and who's out. Nuts, seeds, olive oil, avocados, and water now qualify for the claim for the first time. Meanwhile, some products that leaned on "healthy" for years — fortified white bread, sugary cereals, low-fat products propped up with added sugar — no longer meet the bar, regardless of how they were labeled under the old rule.

The Deadline That Matters: February 25, 2028

Here's the timeline in plain terms:

  • April 28, 2025 — The rule became effective, and voluntary early compliance opened.
  • February 25, 2028 — Mandatory compliance date. This is when FDA enforcement begins against products that don't meet the new criteria while still using the "healthy" claim.

Unlike some FDA rulemakings, there's no separate small-business carve-out or extended timeline here — the agency's position is that the compliance window is generous enough (roughly three years from finalization) that a dedicated small-business exemption wasn't necessary. That means a five-person snack company faces the exact same February 2028 deadline as a national manufacturer, without the extra runway smaller operations sometimes get on other labeling rules.

It's also worth being precise about what's mandatory here: using the word "healthy" on a label is entirely voluntary. Nothing requires you to make the claim. But if you currently do — and your product won't meet the new definition — you have three paths: reformulate the product to qualify, drop the claim from your labeling, or accept the compliance risk of an outdated claim after 2028. There isn't a fourth option where the old rules keep applying to your products indefinitely.

Why "Just Update the Label" Undersells the Cost

For a business owner who hasn't been through a labeling change before, it's tempting to think of this as a print-shop problem — swap the artwork, reorder packaging, done. In practice, a "healthy" claim change usually touches three separate cost centers, and they don't happen on the same schedule:

1. Reformulation (if you're keeping the claim). If your product currently clears the old fat/cholesterol test but not the new sugar/sodium test, you're looking at recipe changes — which mean new supplier costs, new shelf-life testing, and often a different flavor profile that needs consumer testing before you commit to a production run. This is the slowest-moving cost and the one most likely to blow through a 2027 timeline if you start late.

2. Nutrient testing and documentation. Even if your existing formulation happens to qualify, you need lab verification of added sugar, sodium, and saturated fat levels against the new thresholds — not just your old Nutrition Facts panel, which may not break out "added sugars" the way the new rule requires. FDA guidance also expects manufacturers to keep records supporting the food-group-equivalent claim (the ½-cup vegetable/fruit/grain/dairy/protein/oil test) for at least two years if that equivalence isn't obvious from the ingredient list alone.

3. Packaging and labeling redesign. The actual print run is usually the cheapest and fastest part of this — but it's also the part most businesses focus on, while underestimating steps 1 and 2. Budget for packaging changes last, not first.

None of this needs to happen in 2028. It needs to start now, because reformulation and testing cycles for a small manufacturer routinely run 6–18 months on their own, before a single new label goes to print.

What Happens If You Miss It

Using "healthy" on a label after February 25, 2028, without meeting the new criteria isn't a gray area — it's a misbranding issue under the Federal Food, Drug, and Cosmetic Act. FDA's typical enforcement path for misbranded claims runs from warning letters to import refusals (for imported ingredients or products) to, in persistent cases, seizure or injunction. For a small business, even a warning letter can mean an expensive emergency relabel, a retailer pulling your product from shelves while you sort it out, and reputational damage with the exact health-conscious customers the "healthy" claim was meant to attract in the first place.

The lower-risk move for products in ambiguous territory: if you're not confident your product will clear the new thresholds by 2028, consider dropping the "healthy" claim proactively rather than defending it after the compliance date. You can always add it back once reformulation is verified.

A Practical Checklist for Small Food Businesses

If you currently use "healthy" anywhere on your packaging, website, or marketing:

  1. Audit every SKU that carries the claim, in every format (front-of-pack, website copy, retailer listings, social media).
  2. Get current nutrient data — added sugar, sodium, and saturated fat, per the new category-specific thresholds — not just your existing Nutrition Facts panel.
  3. Check food-group equivalence for your product category and document how your formulation meets it.
  4. Decide, per SKU, whether to reformulate, drop the claim, or hold — and put a real date on that decision, not "sometime before 2028."
  5. Build the cost into your 2026–2027 budget, not a 2028 line item. Reformulation and testing are the long poles, not printing.
  6. Keep dated records of your nutrient testing and food-group-equivalence determination — FDA's guidance points to a two-year retention expectation.

Budgeting for Compliance the Way You Budget for Everything Else

A labeling deadline like this one is easy to treat as a marketing or regulatory-affairs problem rather than a financial one — until the reformulation and testing invoices start arriving over multiple fiscal quarters, mixed in with your regular COGS and R&D spending. Tracking those costs separately from day one, tagged clearly as compliance spend rather than folded into general product development, makes it far easier to see the real cost of the transition and to know whether you're actually staying ahead of the 2028 deadline or falling behind it.

Beancount.io provides plain-text accounting that gives you complete transparency and control over your financial data — no black boxes, no vendor lock-in — so tracking a multi-year compliance project like this one against your books is straightforward rather than something you reconstruct after the fact. Get started for free and see why developers and finance professionals are switching to plain-text accounting.

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