What is FDA’s new “healthy” claim rule, and who qualifies?
“Healthy” is a nutrient content claim with a specific legal definition. Under FDA’s updated final rule, a food can only be labeled “healthy” if it contains a meaningful amount of a recommended food group — such as fruit, vegetables, or dairy — and stays within new limits on added sugars, sodium, and saturated fat.
The rule became effective April 28, 2025, with a compliance date of February 25, 2028. Brands can use the new standard now, ahead of the compliance deadline.
What is a nutrient content claim?
It’s a labeling term — like “healthy,” “low fat,” or “high fiber” — that has a specific legal definition under FDA regulations, not just a marketing meaning. “Healthy” is one of these regulated terms.
What does a food need to qualify as “healthy” now?
Two things. First, it needs to contain a meaningful amount of food from at least one recommended food group — fruit, vegetables, dairy, whole grains, protein foods, and similar categories.
Second, it needs to stay within the rule’s limits on added sugars, sodium, and saturated fat. Both conditions have to be met; meeting one is not enough.
Why did FDA change the definition?
The prior “healthy” definition dated to 1994 and focused mainly on total fat, saturated fat, cholesterol, and sodium in isolation. That let some highly sweetened cereals and low-fat snack foods qualify as “healthy” while excluding foods like salmon, nuts, and plain water that don’t fit the old criteria.
The updated rule is meant to better match current nutrition science and the Dietary Guidelines for Americans.
What happens if a product uses “healthy” without qualifying?
Using “healthy” on a product that doesn’t meet the current definition is a misbranding violation. That exposes a brand to FDA warning letters and can get a product pulled from a retailer’s shelf — a commercial consequence on top of the regulatory one.
What is the compliance timeline?
The rule became effective April 28, 2025. The compliance date — the point by which every “healthy” claim on the market must meet the new definition — is February 25, 2028. Brands are permitted to adopt the new standard immediately; they are required to by the compliance date.
What should a food brand do now?
First, check each product carrying a “healthy” claim against the new food-group and nutrient-limit criteria.
Second, start updating labels and formulations well before the 2028 deadline — reformulation and packaging changes take longer than the label edit itself.
Third, keep documentation showing how each “healthy” product actually qualifies, in case FDA or a retailer asks.
Frequently Asked Questions
Q: Is the “healthy” claim required?
A: No. It’s voluntary. But if a product carries the claim, it has to meet the current definition or the claim is misleading.
Q: Can I use the new “healthy” definition before the 2028 compliance date?
A: Yes. The rule is already in effect; February 25, 2028 is the deadline for full compliance, not the earliest date brands may use it.
Q: Does meeting the old 1994 definition still count?
A: No. The 1994 definition is being phased out. A product must meet the updated food-group and nutrient criteria by the compliance date regardless of whether it satisfied the old rule.
Q: How is this different from the front-of-package labeling proposal?
A: They’re separate. The “healthy” claim rule is final and governs a specific word on your label. The front-of-package “Nutrition Info” box is still a proposed rule, not yet final, and would be a different on-package disclosure. Both focus on similar nutrients — saturated fat, sodium, and added sugars.
Q: What foods benefit most from the new definition?
A: Foods like salmon, nuts, olive oil, and water — nutrient-dense foods that couldn’t qualify as “healthy” under the old fat-and-sodium-only test — can now qualify if they meet the updated food-group and nutrient-limit criteria.
Video Transcript
Thinking of putting the word healthy on your food package? The FDA’s new rule changes who is actually allowed to. Here is the short version.
Healthy is a nutrient content claim, which is a labeling term with a specific legal definition.
Under the FDA’s updated rule, a food can only be called healthy if it contains a meaningful amount of a recommended food group, like fruit, vegetables, or dairy…
…and stays within limits on added sugars, sodium, and saturated fat.
Why does this matter? The old definition dated back to 1994. It let some sugary cereals qualify as healthy, while shutting out foods like salmon, nuts, and water. The new rule flips that.
And using healthy when your product does not meet the definition is a misbranding violation. It can trigger FDA warning letters and get your product pulled from retailer shelves.
So what should you do? First, check whether your product meets the new food-group and nutrient requirements.
Second, update your labels. The compliance date is February 25, 2028, but you are allowed to use the new standard right now.
Third, document how each healthy product qualifies.
Not sure if your label still makes the cut? Contact us today.
Talk to an FDA Compliance Attorney
Talk to an FDA compliance attorney before a problem becomes a recall, a hold, or a lost contract. Contact Capote Law Firm today.
- Related video: Front-of-Pack Nutrition Labeling: What’s Coming and How to Prepare
- Related video: “Natural,” “Healthy,” and “Clean Label” Claims: Legal Risk Explained
- Service page: Food Labeling and Claims Review
This content is provided for educational purposes only and does not constitute legal advice. For guidance specific to your business, contact us.