Product Rebranding Compliance Package
Food Product Rebranding with Regulatory Compliance Support
To assist the Client in rebranding their existing dietary supplement or food product for the U.S. market, ensuring full compliance with FDA regulations, including labeling requirements under 21 CFR Part 101, ingredient and formulation review, supplier documentation in accordance with the Foreign Supplier Verification Program (FSVP) under 21 CFR Parts 1.500–1.514, and proper alignment of label claims. This service ensures the product is audit-ready, compliant with U.S. importer and retail standards, and strategically positioned for market reentry or expansion.
Scope of Work
Brand and Regulatory Audit
- • Review of current branding, product claims, and labeling.
- • Assessment of existing supplier documentation and compliance risks.
Regulatory Label Review & Redesign
- • Evaluate product name and branding claims under 21 CFR 101.3 and 101.13.
- • Redesign packaging label layout with proper nutrition/supplement facts, ingredient declaration, allergen statement, and net quantity in compliance with FDA standards.
FSVP Compliance Verification
- • Review supplier’s food safety documentation (HACCP/PCQI, Allergen, Origin, FSMA statements).
- • Identify gaps and assist in organizing FSVP documentation to support rebranded product entry.
- • Provide importer communication support.
Packaging Compliance Checklist
- • Final label compliance checklist to verify alignment with U.S. FDA requirements and Proposition 65 (if applicable).
- • Support with proper label claims (e.g., organic, non-GMO, gluten-free) based on substantiation and documentation.
Launch Support Materials
- • Provide a compliance-ready label file.
- • Regulatory advisory for e-commerce listings, retail onboarding, or importer Q&A support.
Deliverables
| Deliverable | Description | Format |
|---|---|---|
| Regulatory Brand & Label Audit Report | Compliance risks, product claim alignment, labeling gaps | |
| Logo Design | Up to 3 concepts; up to 3 revisions | AI + PDF |
| Final Label Design | Audit-ready label with regulatory layout | AI + PDF |
| Certificate of Label Compliance | Issued product labeling compliance certificate | |
| Supplier Documentation Review Summary | List of accepted and missing compliance records | |
| FSVP Binder Section Update (Optional) | Inclusion of product in existing FSVP files | PDF/Excel |
| Importer Advisory Notes (if requested) | Talking points or clarifications for U.S. partners | Word/PDF |
Estimated Timeline (8–10 Weeks)
| Week | Task |
|---|---|
| Week 1 | Kickoff & Document Review |
| Week 2–3 | Regulatory Audit & Branding Compliance Brief |
| Week 4 | Label Redesign Concepts |
| Week 5–6 | Compliance Verification of Supplier Docs |
| Week 7 | Final Label File + Claim Checklist |
| Week 8 | Rollout Support & Advisory Material |
| Week 9–10 | Revisions and Final Deliverables |
Fees and Subscriptions
Estimated Fees
| Component | Fee (USD) | |
|---|---|---|
| Label Review & Regulatory Audit | $750 | Purchase |
| Logo Design | $800 | Purchase |
| Label Redesign (1 SKU) | $1,500 | Purchase |
| Supplier Compliance Review | $1,000 | Purchase |
| Final Compliance Checklist + Files | $750 | Purchase |
| Launch Advisory Support (Importer/Retail) | $500 | Purchase |
| Full Package | $5,300 | Purchase |
• Add $750 per additional SKU
• Optional add-on: Label Claim Substantiation Letter – $300
• Optional add-on: FSVP Qualified Individual Services – $950/year
• Optional add-on: Label Claim Substantiation Letter – $300
• Optional add-on: FSVP Qualified Individual Services – $950/year
Bundled Package - 4 SKUs
| Component | Fee (USD) | |
|---|---|---|
| Brand-to-Shelf Label Compliance Bundle (4 SKUs) | $8,545 (plus USPTO filing fees) | Purchase |