FDA’s New Healthy Claims: Labeling Rules & Compliance Guide

The U.S. Food and Drug Administration (FDA) has announced a significant update to the “healthy” claim definition for food labeling, which will take effect on April 28, 2025. This new regulation alters how the term can be applied on packaging, making it more aligned with current nutrition science and federal dietary recommendations. For food manufacturers, regulatory experts, and health-minded consumers, this revision presents both challenges and opportunities.

Why Did the FDA Change the Definition of “Healthy”?

For many years, the “healthy” label on food products was determined by outdated guidelines. Many nutrient-rich foods—such as avocados, nuts, and fish—were excluded, while some processed foods with minimal nutritional content qualified. The revised definition seeks to rectify this by aligning “healthy” claims with the existing Dietary Guidelines for Americans, enabling consumers to make better-informed choices.

Updates to FDA Food Labeling Regulations 2025

Certain previously excluded items are now permitted: nuts, seeds, fatty fish, avocados, select oils, plain coffee, and tea are now included under the new criteria.

Some products are no longer eligible: items like sugary cereals, sweetened yogurts, and fortified white bread will no longer be allowed to carry the “healthy” label.

Clarification: Criteria Differ by Product Category

The FDA has outlined that the “healthy” claim will vary by food category—differentiating between single foods, mixed products, and meals/main dishes explicitly.

Requirements for Using the FDA “Healthy” Claim:

A minimum amount of one or more food-group equivalents (fruits, vegetables, whole grains, low-fat dairy, lean proteins, or certain oils) is needed.

Products must adhere to established limits for saturated fat, sodium, and added sugars.

Category-Specific Standards:

Product Type

Food Group Requirement

Nutrient Limits

Individual Food

≥ 1 food-group equivalent (e.g., 2/3 cup of yogurt)

≤ 2 g saturated fat, ≤ 230 mg sodium, ≤ 2.5 g added sugar

Mixed Product

≥ 1 equivalent, with ≥¼ from 2+ groups (e.g., trail mix)

≤ 2 g saturated fat, ≤ 345 mg sodium, ≤ 5 g added sugar

Meal/Main Dish

≥ 3 equivalents, ≥½ of the total from 3+ groups (e.g., salmon + rice + beans)

≤ 4 g saturated fat, ≤ 690 mg sodium, ≤ 10 g added sugar

**The above figures reflect FDA guidance on serving sizes and daily values.

Real-World Example

For instance, a bar labeled “healthy” is required to include at least ¾ ounce of whole grains and a maximum of 5 grams of added sugar per serving.

What This Implies for Food Manufacturers?

Voluntary Participation

Using the “healthy” claim is still voluntary. However, businesses choosing to use it must meet the new standards.

Adjustment Period

Manufacturers have until February 28, 2028, to ensure that their products and labeling comply.

Reformulation Needs

Items high in sodium, added sugars, or saturated fats may require reformulation, which could necessitate changes in ingredients or processes.

Labeling Changes

Packages will need to be updated to conform to the new standards, affecting design, layout, and marketing messages.

Benefits for Consumers

Enhanced Clarity: The “healthy” label will more accurately represent nutritious, balanced choices.

Improved Options: Look for an increase in products made from whole grains, fruits, and vegetables, with less added sugars or sodium.

How Freyr Solutions Can Assist

Adapting to the FDA’s revised rule can be intricate. From reformulating recipes to revamping packaging, achieving compliance demands careful planning and regulatory knowledge.

Regulatory Gap Assessments

Product evaluations to determine adherence to the new “healthy” criteria

Market-specific regulatory alignment for international brands

Labeling & Artwork Management

Creation of FDA-compliant SPL formats for nutrition facts

Support for multilingual labeling, allergen disclosures, and digital graphic lifecycle management

Reformulation Guidance

Strategies for ingredient substitution

Assistance with optimizing taste, texture, and nutritional value

Recordkeeping & Documentation

Automated tracking systems for nutrient details

Audit-ready documentation and validation of compliance

Final Thoughts

The redefinition of “healthy” marks a significant change in FDA Nutrition labeling rules. Manufacturers are urged to adapt promptly to remain competitive. Reformulate, relabel, and reposition your offerings to meet shifting consumer preferences and regulatory demands.

Freyr Solutions is prepared to support you at every point in the transition process. From gap analyses to compliant label launches, we help ensure your brand remains competitive, compliant, and consumer-friendly.

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