FDA Food Contact Testing — U.S. Food Contact Material Compliance
FDA Food Contact Testing refers to compliance assessment for materials and articles intended to come into contact with food under the regulations of the U.S. Food and Drug Administration (FDA).
Food contact materials (FCMs) must be safe for their intended use and comply with applicable FDA requirements before being used in food processing, packaging, or consumer products sold in the United States.
Regulatory Background
FDA food contact regulations are primarily governed under Title 21 of the Code of Federal Regulations (21 CFR). These regulations establish permitted substances, usage conditions, and safety requirements for materials that may directly or indirectly contact food.
FDA compliance is a critical requirement for manufacturers, importers, and brand owners supplying food contact products to the U.S. market.
Products Subject to FDA Food Contact Requirements
FDA food contact testing typically applies to:
Food packaging materials and containers
Kitchenware and tableware
Food processing equipment components
Plastic, rubber, silicone, and coated materials
Metal, ceramic, glass, and composite food contact articles
Baby feeding and drinkware products
Both finished products and raw materials may be evaluated.
FDA Compliance Pathways for Food Contact Materials
FDA compliance may be demonstrated through one or more regulatory pathways, including:
Compliance with applicable 21 CFR sections
Food Contact Notifications (FCN), where applicable
Prior-sanctioned substances or effective food contact notifications
Threshold of Regulation (TOR) exemptions (in specific cases)
The appropriate pathway depends on material type, chemical composition, and conditions of use.
Typical FDA Food Contact Testing Scope
Depending on the product and material, testing may include:
Overall migration and extractables testing
Specific migration or substance-specific analysis
Heavy metals and elemental impurities
Volatile and semi-volatile organic compounds
Sensory or organoleptic assessment (where applicable)
Test conditions are selected based on FDA-defined food simulants, contact time, and temperature.
FDA Food Contact Testing Workflow
1) Product and Material Assessment
Technical review to identify applicable FDA regulations, permitted substances, and intended conditions of use.
2) Test Plan Development
Definition of testing scope, simulants, extraction conditions, and analytical methods aligned with FDA expectations.
3) Laboratory Testing Execution
Testing is conducted under controlled laboratory conditions using validated analytical methods.
4) Data Evaluation and Compliance Determination
Results are assessed against FDA limits, thresholds, and permitted use conditions.
5) Reporting and Compliance Documentation
A professional test report is issued to support FDA compliance and customer or regulatory review.
Deliverables
Typical FDA food contact testing deliverables include:
FDA food contact test report
Analytical data and method descriptions
Compliance summary aligned with applicable 21 CFR sections
Supporting documentation for customer audits or regulatory inquiries
These documents support U.S. market access and supply chain compliance.
Why FDA Food Contact Compliance Matters
Non-compliant food contact products may result in:
Import detention or refusal by U.S. authorities
Product recalls or enforcement actions
Retailer or brand rejection
Legal and reputational risks
FDA food contact testing helps demonstrate product safety and regulatory diligence in the U.S. market.
Start Your FDA Food Contact Testing Project
Provide your product details, material composition, and intended use conditions to receive a tailored FDA food contact testing plan and quotation. Our team supports end-to-end FDA food contact compliance, from regulatory assessment to final report delivery.
