FDA Food Import Requirements: Prior Notice, FSVP, and Facility Registration

The US Food and Drug Administration regulates imported food and dietary supplements to maintain public safety standards. Failing to meet these requirements leads to immediate shipment detention at the US port of entry and subsequent supply chain delays. This article outlines the compliance categories foreign exporters and US importers must manage.

Scope

The FDA governs all food and dietary supplements entering US commerce, regardless of origin. This covers conventional foods, beverages, and ingredients.

NOTE: Dietary supplements are classified as food under FDA regulations, not as drugs. As of writing time, there is no pre-market approval process for supplements.

However, meat, poultry, and egg products fall under USDA’s Food Safety and Inspection Service instead. FDA does not certify, license, or approve individual shipments. The importer carries the compliance responsibility from the first shipment onward.

FDA Facility Registration

Before the fall 2001 anthrax exposures, only facilities transferring select agents had to register with the CDC. Rapid legislative response ensued, leading to the Bioterrorism Act of 2002. Since then, any facility that manufactures, processes, packs, or holds food for US distribution must register with FDA. Foreign facilities must name a US Agent, a person based in the United States who serves as the contact point for FDA communications. To register or renew, facilities must provide an acceptable Unique Facility Identifier.

NOTE: The FDA currently only recognizes the Data Universal Numbering System (DUNS) number for this requirement.

Registrations require biennial renewal in even-numbered years between October 1 and December 31. A registration that has lapsed or is missing can lead to refusal at the port.

FDA Prior Notice

The Prior Notice serves as a mandatory step for all food imported into the United States. This includes animal feed and dietary supplements. No minimum shipment size applies, and no exemptions exist for first-time importers.

NOTE: The confirmed Prior Notice number shows only that FDA received the submission. It does not equal clearance.

Filing

The Prior Notice can be submitted by the US importer, a licensed customs broker, the overseas exporter, or any designated third party. There are two filing routes: through CBP’s Automated Commercial Environment (ACE), which is the more common path when working with a customs broker, or directly through the FDA’s Prior Notice System Interface (PNSI). The submission must include:

• FDA Product Code
• Food Description
• Manufacturer’s Name & Address
• Shipper’s Name & Address
• Country of Origin
• Country from which the goods were shipped
• Anticipated US port of arrival
• Anticipated date of arrival
• Importer’s contact information

A shipment that arrives without a confirmed Prior Notice will be refused entry at the port. Repeated failures to file can expose the importer to injunctions and, in serious cases, criminal penalties.

Deadlines

The deadline for submission depends on the mode of transport used:

The submission window opens up to 30 days before arrival when filed through ACE/CBP, or 15 days through FDA’s PNSI system.

Upcoming Changes

Effective October 1, 2026, Prior Notice for food arriving via international mail must include the mail service name and tracking number. This rule aims to increase the traceability of small shipments, which are no longer exempt from scrutiny, regardless of value.

Foreign Supplier Verification Programs (FSVP)

The Foreign Supplier Verification Program, or FSVP, took effect under FSMA in 2017. It places food safety responsibility directly with the US importer. The per-supplier, per-product structure is where FSVP tends to catch importers off guard. A separate FSVP is required for each combination of food and supplier. For example, sourcing five products from three suppliers in Southeast Asia means fifteen FSVPs are required.

The core obligations under a standard FSVP are:

• Hazard analysis for each food type
• Formal Supplier Approval
• Ongoing verification activities
  • Annual onsite audits
  • Sampling and testing of product
  • Review of supplier’s food safety record
• Re-evaluation at least every three years, or sooner if new risk details appear.

All FSVP activities must be developed and supervised by a Preventive Controls Qualified Individual (PCQI).

Dietary Supplements

FSVP requirements for finished dietary supplements differ from those that apply to conventional food. Importers of finished dietary supplements are not required to conduct a hazard analysis. Instead, the modified requirement focuses on verifying that the supplier’s facility complies with the FDA’s current Good Manufacturing Practice regulations for dietary supplements.

Importers who also manufacture the products and follow supply-chain program rules under preventive controls may satisfy many FSVP duties through that compliance.

Enforcement

FDA holds power to stop all of an importer’s shipments upon finding an incomplete FSVP, even when the food itself meets safety standards.

A real-world example: the FDA issued a warning letter to New India Bazar Inc. after investigators, following up on a product recall, found the company had no FSVP on file at all. The recall centered around Maggi Noodles that were found to contain peanuts without declaring them on the product label.

Food Labeling and Allergen Compliance

Product label formatting undergoes heavy scrutiny during FDA entry. This review falls within the scope of FSVP verification to confirm the food is safe and branded correctly. All mandatory information, such as ingredients and Nutrition Facts, must appear in English. Facilities must explicitly declare major food allergens according to US labeling laws.

Conclusion

Maintaining an active Facility Registration and executing timely Prior Notices are mandatory steps for entering the US market. Foreign suppliers must also actively support FSVP evaluations. If you are shipping food or supplement products from Southeast Asia to the United States, contact us to discuss how we can support your logistics process.

For nearly two decades, Express Freight Management has been the trusted partner for businesses shipping between the United States and Southeast Asia. We handle the technological complexity for you, managing everything from carrier selection and customs clearance to warehousing. Discover a streamlined approach to logistics with Express Freight Management for your shipping needs between the United States and Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam today!