Food and Drug Law: Imports and Exports Guide

All FDA-regulated products imported into the United States must meet the same laws and regulations as domestic goods. There is no lower standard for imported products. A food product manufactured in another country and offered for import at a US port of entry is subject to the same adulteration and misbranding standards as one manufactured in New Jersey. A drug or device must be safe and effective. Cosmetics must be safe and properly labeled. Labeling must be in English.

This guide covers the FDA import framework under Section 801 of the FDCA, the enforcement tools available to FDA at the port of entry, the Foreign Supplier Verification Program, prior notice requirements for food, import alerts and what they mean for importers, and the export requirements for FDA-regulated products.

The Legal Authority: FDCA Section 801

Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 381) is the primary statutory basis for FDA’s import enforcement authority. It authorizes FDA to refuse admission to products that appear to be in violation of the FDCA. The key word is “appear” — FDA does not need to prove a violation definitively to refuse entry. The appearance of a violation is sufficient.

Section 801 grounds for import refusal

Ground for refusal

What it covers

Adulteration

Product is contaminated, subpotent, superpotent, manufactured under insanitary conditions, or otherwise does not meet applicable safety or quality standards

Misbranding

Labels contain false or misleading information, required information is missing, labeling is not in English, or product is marketed for unapproved uses

Unapproved new drug or device

Drug or device lacks required FDA approval, clearance, or authorization before marketing in the US

Prohibited from sale

Product is banned, subject to an import alert, or otherwise prohibited from US commerce

Prior notice failure

Food products offered without the required prior notice to FDA before arrival at port

Key point for importers: Refused products must be destroyed or exported from the United States within 90 days of the refusal. The importer bears the cost. There is no mechanism for FDA to hold a product indefinitely; the choice is destruction or re-export. If neither happens within 90 days, FDA may take action against the bond.

The Import Process: How FDA Reviews Shipments

All FDA-regulated products are electronically screened before physical entry. FDA and US Customs and Border Protection (CBP) work together through CBP’s Automated Commercial Environment (ACE) system, through which importers and their brokers submit entry data before arrival.

FDA import process: step by step

Electronic screening via PREDICT: FDA’s risk-based screening system (PREDICT — Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) automatically scores every entry for the likelihood of a violation. High-risk entries are flagged for examination or sampling. Low-risk entries from compliant importers may be released without physical examination.

Examination or sampling: If selected, FDA issues a Notice of FDA Action to the importer of record, consignee, and filer. The importer must make the products available for examination at the designated facility. FDA may collect samples for laboratory analysis.

Detention and hearing: If the product appears to be in violation, FDA issues a Notice of FDA Action indicating the nature of the alleged violation and providing the importer an opportunity to present evidence to overcome the violation within a specified time period.

Refusal or release: If the importer cannot overcome the appearance of violation, FDA issues a refusal. The product must be destroyed or exported within 90 days. If the importer successfully demonstrates compliance, FDA releases the product into US commerce.

Reconditioning option: In some cases, the importer may apply to relabel or recondition the product to bring it into compliance. This requires FDA approval and must be completed under FDA supervision. Not all violations can be corrected by reconditioning.

Import Alerts: Detention Without Physical Examination

An import alert is one of FDA’s most powerful import enforcement tools. Import alerts inform FDA field staff that there is enough evidence to allow for Detention Without Physical Examination (DWPE) of products from a specific firm, country, or product category.

What DWPE means in practice: A product subject to DWPE does not need to be physically examined for FDA to detain and refuse it. The import alert itself creates a presumption of non-compliance. Every shipment from the listed firm is automatically detained upon arrival at a US port. The importer bears the burden of demonstrating that this specific shipment does not have the violation(s) listed on the import alert — a process that can require extensive documentation, laboratory testing, and time.

Import alert consequences for firms and importers

►All shipments from the listed firm are automatically detained at US ports without physical examination

►The importer must provide evidence for each shipment that the product does not have the listed violation — typically private laboratory testing and documentation

►Import alerts remain active until FDA determines the firm has achieved sustained compliance — there is no automatic expiration

►Firms can petition FDA for removal from an import alert by demonstrating sustained compliance through documentation, corrective actions, and often FDA inspections of the foreign facility

Field Observation

In compliance reviews of import operations, the most consistent gap is in the pre-screening of foreign suppliers. Companies that source from multiple foreign facilities often discover an existing import alert on a supplier only when a shipment is detained at the port. Checking the FDA import alert database before contracting with a foreign supplier, and on a regular basis thereafter, is basic supply chain risk management. The FDA publishes import alert updates publicly and searchable by firm, country, and product type.

Prior Notice for Food

Under the Bioterrorism Act of 2002 and implemented through FSMA, importers of food for human and animal consumption must provide prior notice to FDA before the food arrives at the US port of entry. Prior notice must be submitted electronically through FDA’s Prior Notice System Interface (PNSI) or through CBP’s ACE system.

Prior notice requirements for food imports

✓When to submit: Prior notice must be submitted and confirmed by FDA before the food arrives at the US port. The timing depends on how the food arrives — 2 hours for land shipments, 4 hours for air shipments, and 8 hours for ocean shipments.

✓What to include: The article of food, manufacturer and shipper, country of origin, country from which shipped, anticipated port of arrival, date and time of arrival, and FDA registration numbers for the facility.

!Consequence of failure: Food offered for import without required prior notice is subject to refusal of admission and may be held at the port at the owner’s expense. This is a direct, citable violation under FDCA Section 801(m).

The Foreign Supplier Verification Program (FSVP)

FSMA’s Foreign Supplier Verification Program (FSVP), implemented in 21 CFR Part 1 Subpart L, requires US importers of food for human and animal consumption to perform risk-based activities to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as FDA’s domestic requirements.

What FSVP requires

Conduct hazard analysis for each food; evaluate supplier performance and food safety; conduct approved supplier verification activities such as audits, sampling, or review of supplier records; and maintain FSVP records for 2 years.

Common FSVP violations

No written FSVP program; failure to conduct hazard analysis; FSVP records not maintained for 2 years; supplier verification activities not performed on the required schedule; qualified individual not identified for FSVP activities.

Enforcement note: FDA has been actively enforcing FSVP compliance since 2018 and has issued warning letters to US importers for FSVP deficiencies. In 2025, FDA’s enforcement activity under FSVP increased as part of its broader food safety enforcement posture. The importer of record bears FSVP responsibility, not the foreign supplier. A US company that imports food is responsible for ensuring its suppliers meet US safety standards — it cannot delegate this obligation to the supplier.

Facility Registration: Required Before Importing

Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States, including foreign facilities that export food to the US, must be registered with FDA under FDCA Section 415. The registration must be renewed every two years during the October-December registration period. FDA can suspend a facility’s registration if there is a reasonable probability that food from the facility could cause serious adverse health consequences or death.

Registration suspension: FDA’s ability to suspend a foreign facility’s registration effectively blocks all food from that facility from entering US commerce. A suspended registration triggers an automatic DWPE on all shipments from the facility. This tool was expanded under FSMA and has been used against facilities with Listeria monocytogenes contamination and other serious food safety violations. The Totally Cool Inc. consent decree in March 2025 followed an FDA facility registration suspension triggered by Listeria contamination findings.

Export Requirements for FDA-Regulated Products

Export requirements differ from import requirements in one important way: the legal standard that applies to an exported product depends on the destination country, not necessarily on US standards. Section 802 of the FDCA and Section 801(e) set out the conditions under which products that do not meet US requirements can be exported.

Export requirements by product type

Product

Export standard

Documentation

Food and cosmetics

Must meet US standards (adulteration, misbranding) unless exported as non-commercial samples or under specific exemptions. Records kept 3 years.

Export certificate available on request

Approved drugs and devices

Must meet applicable US standards. Export certifications (Certificates to Foreign Governments) available from FDA on request for importing country regulatory purposes.

CFG or export notification

Unapproved drugs (Section 802)

May be exported if the drug complies with the laws of the importing country and has valid marketing authorization from listed countries (Australia, Canada, EU/EEA, Israel, Japan, New Zealand, South Africa, Switzerland).

Export notification letter required

Import for Export (IFE)

A specific and frequently misunderstood entry type is Import for Export (IFE). This allows a product that does not meet US requirements to be imported into the US for further processing or incorporation into another article, and then exported — without the product entering US commerce. IFE entries are exempt from FDA refusal, but they are not exempt from detention.

The IFE exemption applies only to drugs or their components, devices or their components, food additives, dietary supplements, color additives, and biological products. Standard foods and cosmetics cannot be entered as IFE. The importer must declare the IFE affirmation of compliance code at the time of entry — FDA does not accept IFE declarations after the entry has been submitted. If IFE articles are distributed into US commerce rather than exported, this is a prohibited act under FDA law.

Common Import Compliance Failures

Failing to check if a foreign supplier is on an import alert before contracting

Import alert status is publicly available and searchable. Discovering an alert at the port when a shipment is detained is preventable due diligence.

No written FSVP program for food imports

FSVP is mandatory for most importers of human and animal food. “We rely on our supplier’s certifications” is not an adequate FSVP program. The importer must conduct its own hazard analysis and verification activities.

Missing or late prior notice for food imports

Prior notice must be submitted and confirmed before arrival — not on arrival. Late or missing prior notice is a direct refusal basis that delays the entire shipment at the importer’s cost.

Importing unapproved drugs or devices without the Section 802 exemption

Introducing an unapproved drug or device into US commerce is a prohibited act under Section 301, subject to refusal, seizure, and potentially criminal referral.

Submitting inaccurate entry data in ACE

Incorrect information in ACE entry data (wrong product description, wrong manufacturer, wrong country of origin) can result in penalties and increased scrutiny of all future entries from that filer. FDA conducts routine filer evaluations and compares entry documents against electronically submitted data.

Velocity Safe