One-Time Product Label Review Service
Food/Supplement Labeling 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 verifies whether the food label/s 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 (One-time Review)
FDA Food or Supplement Product Label Content
- • 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
- • Verify formatting and visibility of allergen statements
Marketing and Environmental Claims
- • Review of claims in line with Federal Trade Commission (FTC) guidelines, including:
- ∘ Health-related Claims
- ∘ Environmental Claims
- ∘ Claims Substantiation
- ∘ Use of Certification Seals or Logos and Accreditation Claims
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 compliant)
- • Issued only if elements are verified compliant following the one-time review
- • Confirms the label complies with FDA and federal labeling regulations at the time of assessment
Service Fees and Timeline
| Package | Description | Timeline | Fee |
|---|---|---|---|
| One-Time Product Label Review | Comprehensive one-time review of one product/SKU label, with recommendations | Up to 10 business days | $500.00 USD |
Ideal For:
- • New or reformulated products entering U.S. retail
- • Foreign exporters seeking quick labeling compliance verification 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 verifying compliance of your food/supplement labels?
- Reach out to us today to begin your regulatory review.
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 one-time review performed is limited to label compliance and does not cover product formulation safety, manufacturing practices, nutrition formulation, or other regulatory requirements outside the stated scope.