Supplier Requirements for U.S. Food Market Entry
| CORE REQUIREMENTS | |
|---|---|
| FDA Facility Registration | 21 CFR Part 1, Subpart H – Registration of Food Facilities |
| U.S. Agent Requirement |
21 CFR § 1.232(a)(2) — U.S. Agent Information Requirement; Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 415(a)(2) |
| Prior Notice Submission to FDA | 21 CFR Part 1, Subpart I — Prior Notice of Imported Food |
| FSMA Compliance | Public Law 111-353 (FDA Food Safety Modernization Act) |
| Traceability and Recordkeeping |
Recordkeeping (21 CFR Part 117 - Preventive Controls for Human Food); Traceability for High-Risk Foods (21 CFR Part 1 - Food Safety Modernization Act); Foreign Supplier Verification Program (FSVP) (21 CFR Part 1, Subpart L) |
| KEY DOCUMENT REQUIREMENTS | |
| Allergen Declaration and/or Compliance Statement |
Food Allergen Labeling and Consumer Protection Act of 2004; 21 CFR 117 Subpart B (cGMPs), 21 CFR 117.135 (Preventive Controls for Allergens), FSMA Final Rule |
| Statement of Authenticity | 21 CFR 101 (Food Labeling), FSMA |
| Bill of Lading (Sample) | 19 CFR 18 (Customs Regulations) |
| Country of Origin Certificate and/or Statement | 19 CFR Part 134 - Country of Origin Marking |
| FDA Bioterrorism Registration Affidavit/FDA Food Facility Registration Statement | Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 U.S.C. 350d) |
| Food Safety Modernization Act (FSMA) Compliance Statement | 21 CFR 117 (Preventive Controls Rule) |
| HACCP/PC/Food Safety Compliance Statement | 21 CFR 117.126 - Food safety plan |
| Hold Harmless Agreement, Guaranty-Warranty of Product Statement | Section 303 of the Federal Food, Drug, and Cosmetic Act |
| Product Specification Sheets | 21 CFR 117.475(c)(6) |
| Proof of Laboratory Testing and Results (Certificate of Analysis) | 21 CFR 117.475(c)(8) |
| Safety Data Sheets/MSDS | 29 CFR 1910.1200 (OSHA Hazard Communication Standard) |
| Transportation Agreement and/or Letter | 21 CFR 117.410(d)(1)(iv) |
| GRAS Statement | 21 CFR 170.30 (Generally Recognized as Safe - GRAS) |
| PRODUCT-SPECIFIC REQUIREMENTS | |
| Meat and Poultry | |
| USDA Meat & Poultry Inspection Certificate | USDA Regulations (9 CFR Chapter III) |
| USDA Label Approval | USDA Regulations (9 CFR Chapter III) |
| Acidified Foods | |
| Approved Scheduled Process Document | 21 CFR 108, 21 CFR 114 |
| Acidified Foods Compliance Statement | 21 CFR 108, 21 CFR 114 |
| pH Monitoring Records | 21 CFR 108, 21 CFR 114 |
| Dairy Products | |
| Grade A Pasteurized Milk Ordinance (PMO) Compliance Documentation | Grade "A" Pasteurized Milk Ordinance |
| Pasteurization Records | Grade "A" Pasteurized Milk Ordinance |
| Seafood | |
| Raw Seafood Certification | 21 CFR Part 123 - Fish and Fishery Products |
| Ready-to-eat Foods | |
| Environmental Monitoring Program | 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) |
| Shelf-Life Validation Study | 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food) |
| RETAILER REQUIREMENTS | |
| Mock Recall Compliance Statement | 21 CFR Part 7, Subpart C |
| Coding, Traceability & Recall Systems Details/Reference | FSMA Section 204 |
| Most recent 3rd party audit certificate, audit report, and audit corrective actions | FSMA |
| Pallet Requirements | FSMA 21 CFR 1 Subpart O (Sanitary Transportation) |
| Product Safety Events Compliance Letter | 21 CFR 7.1-7.59 (Product Recalls) |
| Halal Certificate (if applicable) | FDA Food Labeling Guidance |
| Kosher Certificate (if applicable) | FDA Food Labeling Guidance |
| Non-GMO Statement (if applicable) | FDA Food Labeling Guidance |
| Organic Certificate (if applicable) | FDA Food Labeling Guidance |
| Third-Party Food Safety Certification (GFSI-recognized) | GFSI (Global Food Safety Initiative), SQF, BRC, FSSC 22000, or other recognized standards. |
| Social Compliance Audit Report (if requested) | Retailer-specific requirements |
| Product Liability Insurance Certificate | Retailer-specific requirements |
| Packaging Compliance Statements (if applicable) | U.S. Packaging Laws |
| Vendor Questionnaire or Supplier Self-Assessment Form (if applicable) | Retailer-specific requirements |
| LABELING REQUIREMENTS | |
| Product Identity Statement | 21 CFR 101.3 |
| Ingredient List | 21 CFR 101.4 |
| Allergen Information | 21 CFR 101.9 |
| Net Quantity of Contents | 21 CFR 101.105 |
| Nutritional Information | 21 CFR 101.9 |
| Country of Origin | 21 CFR 101.13 |
| Manufacturer/Distributor Information | 21 CFR 101.5 |
| Expiration or Use-by Date | 21 CFR 101.22 |
| Supplemental Statements (if applicable) | 21 CFR 101.13 |