What The New FDA “Healthy” Claim Rule Means For Food Labels In 2025

The U.S. Food and Drug Administration (FDA) has announced a major revision to the criteria for using the “healthy” claim on packaged foods, effective April 28, 2025. This update reflects current nutrition science and the Dietary Guidelines for Americans, reshaping how brands communicate nutritional value.

For food manufacturers, regulatory affairs teams, labelling specialists, and compliance officers, the updated rule brings both compliance challenges and opportunities for brand differentiation.

Why Was the Definition of “Healthy” Updated?

Under previous regulations, certain nutrient-dense foods (like nuts, avocados, salmon, and olive oil) could not carry the “healthy” term due to natural fat levels. Meanwhile, highly processed foods with added sugars or sodium could.

The FDA’s new definition aims to:

• Promote whole-food nutrition
• Discourage highly processed and sugar-heavy formulations
• Support consumer transparency and informed choices

This shift aligns product labelling more closely with real-world dietary health needs.

Key Changes in the 2025 FDA Food Labelling Regulations

Foods Newly Eligible for “Healthy”:

• Nuts and seeds
• Higher-fat fish (e.g., salmon, tuna)
• Avocados and plant-based oils
• Whole grains
• Plain coffee, tea, and water

Foods No Longer Eligible:

• Fortified refined bread
• High-sugar granola and cereals
• Sweetened yogurt products

Updated Category-Based Standards for Using “Healthy”

Example: A snack bar marketed as “healthy” must contain ≥ ¾ oz whole grains and ≤ 5 g added sugar per serving.

What This Means for Food Manufacturers

1. Use of the Claim Remains Voluntary

However, if used, the product must fully meet FDA requirements.

2. Transition Timeline

Compliance phase ends February 28, 2028
 Early preparation reduces relabelling risks and market disruption.

3. Reformulation May Be Necessary

Products with high sodium, sugars, or saturated fats may need:

• Ingredient replacement
• Flavors optimization
• Texture + shelf stability testing

4. Labelling & Packaging Updates

Front-of-pack claims, nutrition facts panels, and digital artwork files must reflect compliant standards.

Consumer Impact & Market Opportunity

• Greater trust in nutrition claims
• Clearer guidance for healthier choices
• Increased demand for:
  • Whole grain snacks
  • Plant-based and minimally processed foods
  • Low-sodium and reduced-sugar alternatives

This rule positions nutrition integrity as a competitive advantage.

How Maven Regulatory Solutions Supports Compliance

Maven Regulatory Solutions partners with food manufacturers to ensure smooth, efficient, and strategic compliance with the new FDA “healthy” claim requirements.

Our Key Service Capabilities Include:

Regulatory Compliance & Gap Assessment

• Product portfolio evaluation
• Nutrient profile compliance mapping
• Category-specific claim eligibility validation

Labelling & Artwork Compliance

• FDA-ready Nutrition Facts Panel formatting
• Claim language approval and proofing
• Packaging artwork lifecycle management

Reformulation & Ingredient Strategy

• Reduced sodium and sugar formulation support
• Fat profile optimization
• Flavors/texture impact balance consulting

Documentation & Recordkeeping

• Compliance tracking workflows
• Audit-ready regulatory reports
• Digital traceability tools for nutrient verification

Final Takeaway

The revised FDA “Healthy” Claim Rule represents a pivotal shift in how nutritional value is communicated on food labels. Manufacturers who adapt early will gain a competitive advantage in a market increasingly driven by health-oriented consumer behaviour.

Maven Regulatory Solutions ensures your transition is compliant, cost-effective, and strategically aligned with evolving regulatory expectations.