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Unlocking the "Healthy" Label: What FDA’s New Rule Means for Food Manufacturers

On December 19, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that redefines the criteria for when foods can be labeled with the nutrient content claim “healthy.” This update marks a significant shift in food labeling regulations, aligning with current nutrition science and the Dietary Guidelines for Americans, 2020-2025.

For food manufacturers, this rule presents both opportunities and challenges. At Taste Symmetry, we specialize in guiding manufacturers through regulatory changes, ensuring compliance while maximizing product appeal. Here's a break down of the key updates and how we can help your brand make the most of this evolving landscape.



Key Changes in the FDA’s Final Rule

Expanded List of Automatically Qualifying Foods

Under the new rule, the following foods automatically qualify for the “healthy” claim without meeting Food Group Equivalents (FGE) or Nutrient to Limit (NTL) requirements:

  • Vegetables, fruits, whole grains, fat-free and low-fat dairy

  • Lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds

  • Water, tea, and coffee with less than 5 calories per Reference Amount Customarily Consumed (RACC) and per labeled serving


Greater Flexibility for Foods Consumed in Small Quantities

Foods with a RACC of 50 grams or less (or 3 tablespoons or less) now have additional flexibility to qualify for the “healthy” claim. This is particularly beneficial for products like nuts, seeds, and spice blends.


Adjusted Nutrient Thresholds

The FDA has revised the baseline limits for saturated fat, sodium, and added sugars across different food categories. Some notable adjustments include:

  • Dairy, game meats, and eggs: Up to 10% of the daily value (DV) for saturated fat

  • Seafood: 5% DV limit for saturated fat (excluding naturally occurring fats)

  • Oils and oil-based spreads: Total fat capped at 20% of the daily value

These adjustments allow more nutrient-dense products to qualify as “healthy.”


Revised Requirements for Combination Foods

The rule provides more flexibility for mixed dishes, main dishes, and meal products, reducing the amount of required food group equivalents (FGE) from multiple food groups. For example:

  • Mixed food products must contain at least ¼ of a FGE from two different food groups (down from ½ FGE)

  • Main dishes must contain at least two FGEs with no less than ½ FGE from two different food groups

  • Meal products must contain at least three FGEs, with no less than ½ FGE from three different food groups


New Recordkeeping Requirements

Manufacturers must maintain records to verify compliance for products that cannot be assessed solely from the label. This applies particularly to mixed foods, main dishes, and meals, ensuring transparency in nutrient calculations and ingredient contributions.


How Taste Symmetry Can Help You Make the “Healthy” Claim

Navigating these new regulations requires a strategic approach. At Taste Symmetry, we help food manufacturers:

  • Evaluate Product Formulations: We analyze your recipes and ingredient profiles to determine whether they meet the new “healthy” criteria.

  • Reformulate for Compliance: We can assist in adjusting nutrient levels, reducing added sugars, sodium, and saturated fat while maintaining product integrity.

  • Develop Labeling & Marketing Strategies: We ensure your packaging, claims, and marketing materials align with FDA guidelines and resonate with health-conscious consumers.

  • Maintain Regulatory Documentation: We assist in recordkeeping and compliance documentation to satisfy FDA requirements during inspections.

  • Navigate Certification & FDA Review: We help you streamline the approval process and avoid compliance pitfalls.


Prepare for the February 2028 Compliance Deadline

While the rule takes effect in early 2025, manufacturers have until February 25, 2028, to fully comply. However, early adoption can position your brand as a leader in the health-conscious market.


If you’re ready to optimize your products for the new "healthy" claim, Taste Symmetry is here to help. Contact us today to develop a compliant, market-ready strategy for your food products.

 
 
 

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