Product Label Regulatory Review Compliance Assessment
Initial Label Compliance Based on 21 CFR 101, Food Allergen Labeling Act, 19 CFR 134, and FTC Environmental Marketing Guidelines
This one-time regulatory review provides a comprehensive label compliance evaluation to support food manufacturers, brand owners, and importers entering the U.S. market. The review ensures that food labels meet FDA, FTC, and CBP requirements, covering critical regulatory elements such as identity labeling, ingredient declarations, allergen disclosures, origin marking, and claim substantiation.
Scope of Work
Label Content Compliance
Review of food label based on 21 CFR Part 101:
• §101.1 – Principal Display Panel
• §101.2 – Information Panel
• §101.3 – Identity Labeling
• §101.4 – Ingredient Declaration
• §101.5 – Business Name and Address
• §101.7 – Net Quantity of Contents
Food Allergen Labeling
• Confirm declarations under the Food Allergen Labeling and Consumer Protection Act of 2004
• Ensure correct formatting and visibility of allergen statements
Marketing & Environmental Claims Review
Review of claims based on FTC 16 CFR Part 260 – Green Guides for:
• Reusable, Circular, Upcycled, Compostable, Biodegradable, Planet Conscious
• Non-Toxic, Insulating, “3X” Performance Claims
• Verify claims are substantiated, truthful, and not misleading
Additional Label Requirements
• UPC Barcode – Correct placement, size, and scannability
• Lot Number – Visibility for traceability and recall purposes
• Best Before/Expiration Date – Regulatory formatting and placement
• Country of Origin – Verified under 19 CFR §134.11, including proper terminology and position on label
Deliverables
Regulatory Compliance Assessment Report
• Summary of findings identifying areas of compliance and non-compliance
• Guidance on necessary changes with references to applicable regulations
• Visual annotations (if needed) on proposed label for clarity
Certificate of Product Label Compliance
• Issued upon completion of corrective updates
• Confirms compliance with U.S. federal labeling regulations at time of review
Fees and Subscriptions
Optional:
Annual Product Label Reassessment Program
Annual Service Fee:
$450.00 per Label | $350.00 for Each Additional Label (Reassessment Only)
To maintain compliance as regulations evolve or changes are made to the label, we offer an annual reassessment service that includes:
• Full re-evaluation of the label based on current regulations
• Review of any changes to claims, ingredients, packaging, or regulatory rules
• Renewed Certificate of Product Label Compliance (if compliant)
• Compliance advisory based on regulatory updates (e.g., new allergens, updated FTC guidelines)
Pricing Summary
| Service | Fee |
|---|---|
| First Label – One-Time Review | $750.00 |
| Additional Labels – One-Time Review | $650.00 each |
| First Label – Annual Reassessment | $450.00/year |
| Additional Labels – Annual Reassessment | $350.00 each/year |
Customized Packages Available:
For projects involving multiple SKUs or seasonal/rebranded label portfolios (5 or more labels), we offer tailored packages with bundled pricing, streamlined review workflows, and coordinated label compliance planning. Contact us to create a custom solution for your brand.
Ideal For:
• New or reformulated products entering U.S. retail
• Foreign exporters needing FDA-compliant label review for customs and FSVP
• Marketing teams launching new packaging with performance, sustainability, or health claims
• Importers or co-packers managing multiple product SKUs across brands