On December 19, 2024, the FDA announced a final rule to update the criteria that food must meet to qualify for use of the claim "healthy".
New Requirements
To meet the updated criteria, a food product needs to:
- Contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy and protein foods) recommended by the Dietary Guidelines for Americans, and
- Meet specific limits for added sugars, saturated fat and sodium.
The criteria vary for individual food products.
Under the new rule, nutrient-dense foods that are encouraged by the Dietary Guidelines with no added ingredients automatically qualify for the "healthy" claim. These include:
- Vegetables
- Fruits
- Whole grains
- Fat-free and low-fat dairy
- Lean game meat
- Seafood
- Eggs
- Beans
- Peas
- Lentils
- Nuts
- Seeds
Products that do not qualify for the healthy label under the updated rule include:
- Fortified white bread
- Highly sweetened yogurt
- Highly sweetened cereal
These changes reflect current nutrition science and dietary guidance in the Dietary Guidelines for Americans.
What Food Manufacturers Should Do
The rule is effective February 25, 2025, and the compliance date of the rule is February 25, 2028. In preparation for the compliance date, food manufacturers should review their products to ensure that any product that uses a "healthy" label meets the new criteria. Diaz Trade Law has subject matter FDA expertise and can help you with a proactive compliance plan that meets the new requirements.
Read more:
- Updated "Healthy" Claim Factsheet
- Webinar: Importing Food in Compliance With U.S. FDA and Surviving A FSVP Audit
- FDA Pre-Compliance and Enforcement
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
