FSMA Updates 2026: What Food Importers Need to Know

FSMA 204 Traceability Rule

The FSMA Section 204 Food Traceability Rule (also called the Food Traceability Final Rule) requires additional traceability recordkeeping for foods on the Food Traceability List (FTL). This rule went into effect in January 2026, and FDA is now actively enforcing it.

The rule requires companies that manufacture, process, pack, or hold foods on the FTL to maintain specific Key Data Elements (KDEs) at Critical Tracking Events (CTEs) throughout the supply chain. This means importers must be able to trace food products from their foreign suppliers through US distribution within hours, not days.

Foods on the Traceability List

The FTL includes high-risk foods that have been associated with outbreaks or recalls:

• Fresh-cut fruits and vegetables
• Shell eggs
• Nut butters
• Fresh herbs
• Certain cheeses (soft, semi-soft, and fresh)
• Certain fresh seafood (finfish, crustaceans, mollusks)
• Ready-to-eat deli salads
• Fresh-cut leafy greens
• Tropical tree fruits

FSVP Enforcement Trends

The Foreign Supplier Verification Program continues to be a top enforcement priority for FDA. In 2025, FDA issued more FSVP-related warning letters than any previous year, and that trend is continuing into 2026. The most common violations cited include:

For a comprehensive overview of FSVP requirements, see our FSVP compliance guide.

Intentional Adulteration Rule

The FSMA Intentional Adulteration (IA) rule requires covered facilities to develop and implement Food Defense Plans to protect against intentional adulteration from acts intended to cause wide-scale harm. While primarily targeting domestic facilities, importers must verify that their foreign suppliers have adequate food defense measures in place.

In 2026, FDA is placing increased emphasis on IA compliance during routine inspections. Importers should ensure their FSVP procedures include verification that foreign suppliers have food defense plans when required.

Foreign Supplier Verification Changes

Several developments in 2026 affect how importers should approach foreign supplier verification:

Increased Focus on Supplier Audits

FDA is increasingly expecting importers to conduct or commission on-site audits of foreign suppliers, particularly for high-risk foods. While the FSVP regulation does not always require audits, FDA has indicated that relying solely on testing or supplier certifications may be insufficient for certain risk profiles.

Digital Recordkeeping Expectations

FDA is encouraging electronic recordkeeping systems that can produce records quickly during inspections. Importers still using paper-based systems face practical disadvantages during FDA inspections, as inspectors increasingly expect rapid access to records.

Mutual Recognition Agreements

FDA continues to expand mutual recognition agreements with foreign regulatory authorities. These agreements can reduce the verification burden for importers sourcing from countries with recognized food safety systems. Check whether your suppliers' home countries have active agreements with FDA.

What Importers Should Do Now

Based on current enforcement trends and regulatory developments, food importers should prioritize these actions in 2026:

1. Audit your traceability records: If you import foods on the FTL, verify that your recordkeeping systems capture all required KDEs at each CTE. Run a mock traceability exercise to test your ability to trace products within 24 hours.
2. Update your FSVP documentation: Review and update hazard analyses for each food-supplier combination. Ensure verification activities are current and documented.
3. Schedule supplier audits: Plan on-site or virtual audits of your highest-risk foreign suppliers. Document all audit findings and corrective actions.
4. Train your team: Ensure that all employees involved in importing understand FSVP and traceability requirements. FDA inspectors may interview staff during inspections.
5. Review your registration: Confirm that your food facility registration is current and your US Agent information is up to date.

Resources and Next Steps

Staying on top of FSMA compliance requires ongoing attention. Here are resources to help:

• FSVP Compliance Guide - Detailed walkthrough of FSVP requirements
• Food Facility Registration Guide - Complete registration instructions
• Prior Notice Filing Guide - Filing requirements for imported food
• Import Alert Checker - Check if your products or suppliers are on FDA import alerts
• Deadline Calculator - Calculate your regulatory deadlines