The FDA recently redefined what it means for a food to be labeled “healthy”—and it’s a big shift. Instead of focusing on specific nutrients, the new guidelines emphasize whole food groups and balance. Good fats are in, and added sugars are getting capped.
If your product includes enough of the right food groups—and stays within limits for sugar, sodium, and fat—you may be able to make a “healthy” claim. But be careful: making the claim without meeting the criteria could land you in hot water. Here’s what you need to know.
Out with the Old—In with the New
The previous definition of “healthy,” in effect since 1994, required the inclusion of a minimum amount of single beneficial nutrients, such as vitamins A and C, calcium, iron, protein, or fiber. It also limited total fat, saturated fat, cholesterol, and sodium. There was no limit on sugar.
The FDA’s new rule requires “healthy” foods to have a certain amount from at least one of the designated healthy food groups, such as fruits, vegetables, grains, fat-free and low-fat dairy, and proteins. It also sets limits on sugar, as well as sodium and saturated fat.
The result of this change is that foods that were considered “healthy” under the original definition, like fortified white bread, highly sweetened yogurt, and highly sweetened cereal, may no longer use that claim. Foods with beneficial fats, however, may now qualify for the new “healthy” claim.
What Foods Qualify as “Healthy”?
Shifting the definition of healthy foods to emphasize food groups allows a variety of food products to qualify as healthy. The requirements for each type of food vary depending on the number and types of ingredients. The categories of foods include individual foods, mixed foods, main dishes, and meals.
Whole Foods
Raw, whole foods automatically qualify for the “healthy” claim. Frozen or canned options of nutrient-dense foods such as fruits, vegetables, seafood, and legumes also qualify, provided they contain no added ingredients except for water. These foods are encouraged by the FDA’s dietary guidelines and considered healthy because they contribute positively to a balanced diet.
Mixed Foods, Main Dishes, and Meals
Foods with multiple ingredients must contain a certain amount of ingredients from at least one of the food group equivalents (FGE) to meet the new requirements for a healthy claim. Plus, they have to stick to specific limits on added sugars, saturated fats, and sodium. The amount you need from a FGE and the nutrient limits vary depending on whether the food is an individual item (e.g., eggs), a mixed product (such as trail mix), a main dish (like lasagna), or a complete meal (like a frozen dinner).
For example, trail mix (a mixed product) would require ¼ FGE from two food groups, like dried fruits and nuts. For more examples of food group criteria, check out this chart from the FDA.
Good Fats
Foods containing beneficial fats like avocados, nuts, seeds, higher-fat fish such as salmon, and olive oil will now be eligible to use the “healthy” label. Since the focus is on consuming the right types of fats rather than reducing fat intake, there is no limit set for total fat or cholesterol.
When Does the New Rule Start?
The new rule took effect in February 2025, so if your product qualifies, you can start using the healthy claim now. Products must comply with this rule by February 2028. Therefore, if you are still making a healthy claim under the old rules and your food product no longer meets the criteria, you should either remove the healthy claim from your label or reformulate your product to comply.
Do You Need to Keep Records?
Yes, the new rule requires verification that a food product meets the requirements of the “healthy” claim. Manufacturers must analyze their product to ensure it meets the claim’s requirements. They must provide written records to verify that the FGE requirements are met.
What Are the Risks of Non-Compliance?
Misusing the FDA’s “healthy” claim can lead to enforcement actions by the FDA, including mandatory product recalls, civil penalties from the FTC, class action lawsuits, or damage to your brand’s reputation. Softly Solutions’ Green Claim Navigator gives you easy access to up-to-date information on federal and state-specific regulations. The Green Claim Navigator enables you to make informed decisions about compliance with current regulations and legislation.
What about Foods that Do Not Meet the FDA’s “Healthy” Definition?
Not having a ‘healthy’ claim does not mean that the food is unhealthy. You can convey other positive nutrient attributes like “good source of fiber” or “fortified” as long as the food complies with the FDA’s definitions of these claims. Schedule a free consultation with Softly to learn more about the claim that fits your product.
What Will a Healthy Claim Label Look Like Going Forward?
Labeling your food product as “healthy” according to FDA standards can boost its market appeal and attract more customers. The FDA is developing a logo to convey this message. According to a CBS News report, the FDA has tested several logo designs for this purpose, and a new logo would likely resemble the USDA’s organic foods seal. Additionally, the FDA is considering the implementation of front-of-package nutrition labels, which would make it easier for consumers to identify the nutritional value of your products at a glance.
FAQs
- Some of my food products carry the “healthy” claim. Will I still be able to use it?
- That depends. All food products using the “healthy” claim must contain a required amount from healthy food groups and limit sugar, sodium, and saturated fats. Make sure your product complies with the new requirements.
- When does the new definition take effect?
- The updated regulations took effect in February 2025, with full compliance required before February 2028.
- What foods are healthy under the new rule?
- Whole, raw foods automatically qualify for the “healthy” claim. Mixed foods and meals that meet specific criteria for ingredients and nutrients also qualify. Additionally, foods that contain beneficial fats, such as avocados and nuts, are now eligible to carry the “healthy” label.
- What can I do if my product doesn’t comply with the “healthy” claim criteria, but it still has healthy attributes?
- You can convey other positive nutrient attributes like “good source of fiber” or “fortified” as long as the food complies with the FDA’s definitions of these claims.
References
- Use of the “Healthy” Claim on Food Labeling | FDA
- Federal Register :: Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
- eCFR :: 21 CFR 101.54 — Nutrient content claims for “good source,” “high,” “more,” and “high potency.”
- FDA to develop new “healthy” logo this year – here’s what consumers could see, and which foods could qualify – CBS News
- FDA’s Fresh Take on Use of “Healthy” in Food Labeling