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 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
Assessment of Other Additional Labeling Elements
• UPC Barcode
• Lot Number
• Expiration or Period After Opening (PAO)
• Country of Origin (19 CFR §134.11)
Deliverables
Regulatory Compliance Assessment Report
• Summary of findings identifying areas of compliance and non-compliance
• Guidance/recommendations on necessary changes with references to applicable regulations
• Visual annotations (if needed) on label review report for clarity
Certificate of Product Label Compliance (if applicable, once fully compliant)
• Issued if, after final review and implementation of corrections, elements are verified compliant
• Confirms compliance with U.S. federal labeling regulations at time of review
Fees and Subscriptions
Pricing Summary
| Package | Description | Fee | |
|---|---|---|---|
| Label Review for First Label | Comprehensive review of one product/SKU label only (includes review of up to 2 label revisions*) | $750.00 USD | Purchase |
| Label Review for Additional Labels | Review of each additional product/SKU label submitted (includes review of up to 2 label revisions*) | $650.00 USD | Purchase |
| First Label – Annual Reassessment | Annual label reassessment to reflect regulation updates or product revisions (one-time review only) | $450.00 USD/year | Subscribe |
| Additional Labels – Annual Reassessment | Ongoing annual reviews for any additional labels (one-time review only) | $350.00 USD/year | Subscribe |
| Tailor-fit Label Compliance Assessment Package | Customized review terms per client preference | Custom Quote | Inquire |
Customized Packages Available:
For start-ups and small-scale enterprises or for brands managing multiple SKUs, seasonal packaging updates, or frequent rebranding, we offer customized packages with bundled pricing, streamlined review processes, and coordinated regulatory planning.
Contact us to build a solution tailored to your product portfolio.
Ideal For:
• New or reformulated products entering U.S. retail
• Foreign exporters seeking compliant labeling for customs and U.S. FDA/USDA labeling requirements
• Brands launching new products and formulations or redesigning packaging with marketing claims
• Importers, co-packers, and private labelers managing multi-brand label portfolios
Need help ensuring your food/supplement labels are compliant?
Reach out to us today to begin your regulatory review.
*Notes:
• Clients must submit label revisions within 10 business days from the date the Compliance Assessment Report is issued.
• Reviews that remain inactive beyond this period will be considered closed.
• To resume a closed review:
- ∘ A 40 percent reopening fee applies if resubmission occurs within 30 calendar days after the revision window.
∘ A new review package purchase is required if resubmission occurs more than 30 calendar days after the revision window.
Disclaimer:
This service is based solely on the documents and information provided by the client and reflects an assessment of label content against applicable regulations at the time of review. It does not constitute guaranteed regulatory approval, pre-market clearance, or assurance of product sales success in the target market. The review is limited to label compliance and does not cover product formulation safety, manufacturing practices, nutrition formulation, or other regulatory requirements outside the stated scope.