Imported Food Product List Regulatory Review for U.S. Compliance Requirements
Regulatory Compliance Review Based on FDA, USDA, CBP, FTC, and Trade Regulations
To establish and confirm full regulatory compliance for imported food and beverage products prior to entering the U.S. market. This includes classification under FDA or USDA authority, evaluation of customs and labeling obligations, and identification of compliance gaps in accordance with 21 CFR, USDA import regulations, and CBP requirements.
Scope of Work
Product Information Collection & Classification
Gather essential product documentation and details, including:
- • Product formulation and ingredient breakdown
- • Packaging type, dimensions, and labeling artwork
- • Country of origin and production process
- • Review the accuracy and completeness of the submitted information and determine the jurisdictional oversight (FDA, USDA) and appropriate import category under CBP and FSVP.
Product Regulatory Assessment
Perform a detailed regulatory classification based on:
- • Intended use, formulation, and claims
- • FDA or USDA jurisdiction
- • Evaluation of restricted ingredients or substances
- • Nutrition facts, allergen declarations, and other label requirements under 21 CFR 101, 117, and related parts
- • Determine any required pre-market approvals, registrations, or third-party certifications.
Import and Customs Compliance Review
Assess import entry obligations, including:
- • Harmonized Tariff Schedule (HTS) code identification and duty estimation
- • FDA Prior Notice requirements and CBP entry filing roles
- • FSVP applicability and U.S. Agent or Consignee requirements
- • USDA import permits (as applicable)
Trade and Labeling Compliance Review
Evaluate marketing and promotional compliance:
- • Country of origin labeling
- • Certification claims such as “Organic,” “Non-GMO,” “Made in USA,” etc.
- • Verification of compliant language for promotional and packaging claims in accordance with FDA and FTC advertising standards.
Deliverables
Regulatory Overview Report
A comprehensive summary of all applicable federal regulations (FDA, USDA, CBP, FTC), including agency-specific obligations for the reviewed product(s).
Import & Labeling Requirements Summary
Detailed summary of customs-related information:
- • HTS codes, estimated duties, and required import declarations
- • Applicable prior notice and registration obligations
- • Label compliance based on U.S. identity and nutrition labeling laws
Compliance Checklist for U.S. Market Entry
Itemized checklist outlining all steps needed to bring each product into full compliance with U.S. import and labeling standards.
Reviewed Product Information Summary
A report assessing the completeness, accuracy, and classification of submitted product information, including recommended revisions and next steps.
Fees and Subscriptions
| Package Description | Fee | Turnaround Time |
|---|---|---|
| Regulatory review of one product | $650 | 5–10 business days |
Ideal For:
Foreign manufacturers, exporters, brand owners, and regulatory consultants preparing to launch food or beverage products into the U.S. market and requiring a professional regulatory assessment for compliance, classification, importation, and labeling.