On December 27, 2024, the U.S. Food and Drug Administration (“FDA” or “Agency”) published a final rule updating the criteria for the implied nutrient content claim “healthy” that appears on food packaging. The “healthy” label serves as a quick, consumer-friendly signal on food packaging to help consumers identify foundational foods that support a balanced, nutritious diet. This update, which goes into effect February 25, 2025, is part of the FDA’s broader initiative to “make food a vehicle for health and wellness, reduce diet-related chronic diseases, and promote health equity.” Manufacturers have the opportunity to voluntarily display the “healthy” claim on their products if they meet the updated criteria. Those who choose to use the claim will have three years to fully comply with the new standards, although they may begin implementing the updated criteria immediately if they wish.
Background
The FDA first proposed changes to the “healthy” nutrient content claim in September 2022, acknowledging that the previous criteria, established in 1994, needed to be updated. Under the previous guidelines, foods were required to meet specific thresholds for total fat, saturated fat, cholesterol and sodium. In addition, to qualify for the “healthy” claim, products had to provide at least 10% of the daily value for at least one of the following nutrients: vitamin A, vitamin C, calcium, iron, protein or fiber.
In 2016, the FDA took steps toward reevaluating the “healthy” claim, issuing a guidance expressing the Agency’s intent to exercise enforcement discretion for products labeled as “healthy” if they met certain nutrient requirements. That same year, the FDA also requested public comments and information on how the term “healthy” should be used in food labeling, laying the groundwork for the more comprehensive rule update.
Updated Criteria for “Healthy” Nutrient Content Claim
The updated definition of “healthy” now reflects the latest nutrition science and looks to align with current federal dietary guidelines. Modern U.S. dietary recommendations emphasize the importance of overall healthy dietary patterns, focusing not only on the types of fats consumed but also on the amounts of sodium and added sugars in the diet. These guidelines underscore the role of nutrient-dense foods from various food groups, such as fruits, vegetables, whole grains, lean proteins and low-fat dairy products, in promoting health and preventing chronic diseases.
To qualify for the “healthy” claim under the new criteria, a food product must meet two conditions:
- It must contain a certain amount of food (food group equivalent) from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy or protein foods) recommended by the Dietary Guidelines for Americans; and
- It must meet specific limits for added sugars, saturated fat and sodium.
The criteria for the required amount of food from a particular food group equivalent, as well as the specific limits for added sugars, saturated fat and sodium, vary depending on the product type and the Reference Amount Customarily Consumed, which determines the serving size. The different product types include individual food products, mixed foods (i.e., products that contain certain amounts of more than one food group) and main dishes and meals.
Under the updated rule, nutrient-dense foods recommended by the Dietary Guidelines—such as vegetables, fruits, whole grains, fat-free and low-fat dairy, lean meats, seafood, eggs, beans, peas, lentils, nuts and seeds—automatically qualify for the “healthy” claim, provided they contain no added ingredients besides water. These products are considered healthy due to their natural nutrient profile and their contribution to a balanced diet. Interestingly, the updated definition now allows for the inclusion of foods previously excluded. For instance, water (including carbonated water), coffee with less than 5 calories, avocados, nuts and seeds, higher-fat fish like salmon and even olive oil now meet the criteria for the “healthy” label. Conversely, some products that qualified under the previous definition, such as fortified white bread, highly sweetened yogurt and sugary cereals, no longer meet the updated standards.
What’s Next?
Looking forward, the FDA is exploring the development of a recognizable symbol that manufacturers can use on food packaging to signify that a product meets the updated “healthy” criteria. Additionally, the Agency is planning to host a stakeholder webinar to provide further insight into the final rule and address any relevant questions. The details of this webinar are planned to be announced by the FDA shortly. So far, the FDA has not announced any food-related webinars for 2025, possibly waiting until the new administration takes over in just a few short days.
Practical Takeaways
- Manufacturers who utilize the “healthy” claim, or plan to, should consider assessing their existing product lines to determine whether they meet the new “healthy” claim criteria.
- With the FDA allowing manufacturers a three-year transition period to fully comply with the updated “healthy” claim criteria, it is important for food manufactures to stay informed on the final rule’s implementation and any new regulatory updates.
- As the updated “healthy” claim becomes more prominent on food labels, manufacturers must ensure that all marketing materials and packaging comply with both the new FDA standards and broader marketing regulations, as misleading or incorrect use of the “healthy” claim can result in regulatory scrutiny, competitor challenges and potential class action litigation as we have seen with “natural” claims over the years.
For more information on the labeling of food and consumer products please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Jemalyn Harvey at (202) 780-2990 or jharvey@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
