FDA “Healthy” Labeling Guidelines
What’s Changing: FDA Redefines “Healthy” for Food Labels
The FDA has finalized its new definition of “healthy” for food labeling, going into effect April 28, 2025.
This update sets stricter criteria for:
- Nutrient Content: Products must meet specific thresholds for ingredients like sodium, saturated fat, and added sugars.
- Ingredient Requirements: Foods must contain meaningful amounts of key food groups like fruits, vegetables, dairy, or whole grains to qualify as “healthy.”
Read the FDA’s Official Announcement
Key Deadlines to Watch
- Effective Date: April 28, 2025
- Compliance Deadline: February 25, 2028
Manufacturers must comply fully by the compliance deadline to avoid regulatory consequences.
Read the Full FDA Final Rule PDF
Specific Nutrient Limits for “Healthy” Claim
To qualify as “healthy,” foods must not exceed the following per Reference Amount Customarily Consumed (RACC):
- Saturated Fat: ≤ 5% of the Daily Value (DV) (about 1g per serving)
- Sodium: ≤ 10% of the DV (about 230mg per serving)
- Added Sugars: ≤ 5% of the DV (about 2.5g per serving)
Limits may vary for mixed products and meals.
Ingredient Requirements
A product must contain a minimum amount of food from at least one of the following groups:
- Vegetables
- Fruits
- Grains
- Dairy
- Protein Foods (lean meats, seafood, eggs, beans, nuts)
Required amounts vary by product type:
- Individual Foods: At least ½ cup equivalent per RACC
- Mixed Products: At least ¾ cup equivalent per RACC
- Meals: At least 1 cup equivalent per RACC
FDA Guidance on Ingredient Requirements
What Happens If You Miss the Deadline?
- Non-compliance fines and potential recalls
- Inaccurate packaging or labeling issues
- Production delays and supply chain disruptions
- Loss of consumer trust and retail market access
How Valdata Helps Manufacturers Stay Compliant
Valdata’s ERP system supports manufacturers in meeting the new FDA “Healthy” labeling requirements and staying audit-ready by:
- Recipe Management: Adjust formulations to meet updated nutrient thresholds.
- Label Printing: Automate label printing based on real-time formulation data.
- Compliance Tracking: Monitor and document standards adherence.
- Audit Preparedness: Maintain accessible records for inspections.
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