FDA Import Compliance
Prior Notice · FSVP · Hold Resolution

FDA's Role at the U.S. Border

The U.S. Food and Drug Administration (FDA) has authority over roughly 20% of all U.S. consumer spending — and a significant share of U.S. imports. FDA-regulated products must comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and related regulations before they can legally enter U.S. commerce. FDA exercises this authority at every U.S. port of entry, working in coordination with CBP through the Automated Commercial Environment (ACE) and the FDA's Operational and Administrative System for Import Support (OASIS).

Unlike CBP, which can release cargo upon payment of duties and proper documentation, FDA admissibility is a separate legal determination. A shipment can clear CBP but still be detained by FDA — and that hold can last days or weeks while FDA makes its determination. Understanding FDA's import requirements before cargo arrives is the only way to prevent these delays.

FDA Product Categories: What's Covered

FDA regulates a wide range of imported products. Compliance requirements differ significantly by product category:

FDA Prior Notice: Requirements and Timing

FDA Prior Notice is the electronic notification that an article of food (for humans or animals) is being imported or offered for import into the United States. It is required under Section 801(m) of the FD&C Act, as amended by the Bioterrorism Act of 2002 and updated under FSMA. Prior Notice must be submitted through the ACE portal (or FDA's PN Interface) before the cargo arrives.

Transportation Mode	Prior Notice Deadline
Ocean Freight (vessel)	8 hours before arrival at U.S. port
Air Freight	4 hours before arrival
Truck (land border)	2 hours before arrival at port
Rail	8 hours before arrival
International Mail	At time of mailing if origin country is abroad

What must Prior Notice contain? Each notice must identify the article of food, the manufacturer, the grower (if known), the shipper, the importer, the country of origin, the country from which the article is shipped, the anticipated port of arrival, the anticipated date and time of arrival, and the FDA facility registration number of the manufacturer, packer, or distributor. Missing data fields cause the notice to be refused, which can delay cargo.

FSVP: Foreign Supplier Verification Program

The Foreign Supplier Verification Program (FSVP) is one of the most significant FDA import compliance requirements introduced under the Food Safety Modernization Act (FSMA). It applies to most importers of food for human or animal consumption and requires importers to take positive steps to verify that their foreign suppliers are producing food in a manner that meets U.S. food safety standards.

FSVP Core Requirements

At a minimum, FSVP requires the importer to:

• Identify a qualified individual (QI): A person with appropriate food safety education and experience to develop and oversee the FSVP. This person must be identified at the time of CBP entry.
• Conduct a hazard analysis: Evaluate the food and the foreign supplier to identify potential hazards and the risk they present.
• Verify supplier performance: Using one or more of the following: onsite audits, sampling and testing, review of food safety records, or other appropriate verification activities.
• Maintain records: FSVP records must be kept for at least 2 years and be available for FDA inspection.
• Correct problems: Take corrective action when verification activities reveal that a supplier is not producing food in compliance with applicable U.S. food safety standards.

FDA Import Alerts: Detention Without Physical Examination (DWPE)

An FDA import alert places a foreign product, manufacturer, or importer on a watch list that triggers automatic detention of every shipment without requiring physical examination. Import alerts are publicly listed on FDA's website and can be issued for:

• Prior contamination findings (e.g., Salmonella, Listeria, heavy metals)
• Fraudulent labeling or misrepresentation of ingredients
• Violation of Good Manufacturing Practice (GMP) regulations at the foreign facility
• Unapproved drug or device claims on food or supplement labels
• Failure to register with FDA as required
• FSVP non-compliance

When a shipment is subject to a DWPE import alert, the importer has the right to present admissibility testimony — documentation that overcomes the basis for the alert for this specific shipment. Depending on the alert type, this might include: third-party laboratory testing, a certificate of analysis from a recognized laboratory, evidence of process changes at the supplier facility, or other documentation specific to the alert's grounds.

GLCHB reviews the applicable import alert before preparing admissibility evidence, and coordinates with FDA at the port to schedule examination and expedite the determination wherever possible.

Cosmetics: MoCRA Compliance

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly expanded FDA's authority over cosmetics for the first time in decades. For importers of cosmetics, MoCRA introduces new requirements:

• Facility registration: Every domestic and foreign facility that manufactures or processes cosmetics for U.S. distribution must register with FDA. Facilities must renew registration biennially.
• Product listing: Each cosmetic product marketed in the U.S. must be listed with FDA, including the product name, cosmetic category, ingredients, and responsible person information.
• Serious adverse event reporting: Responsible persons must report serious adverse events associated with their cosmetics to FDA within 15 business days.
• Records access: FDA now has broader authority to inspect cosmetic facilities and access records.

Importers of cosmetics who are also the "responsible person" under MoCRA (typically the case for U.S.-branded products) must ensure their foreign suppliers are registered and their product listings are current before imports arrive. GLCHB verifies facility registration status and product listing compliance as part of cosmetic entry processing.

Medical Devices: Import Requirements

Medical devices imported into the United States face a tiered regulatory framework based on device classification (Class I, II, or III). All device importers must:

• Ensure the device is listed with FDA (unless exempt)
• Register as an initial importer with FDA
• Ensure the device meets applicable FDA performance standards
• For Class III devices and many Class II devices: confirm premarket approval (PMA) or 510(k) clearance is in effect

Medical devices without proper FDA clearance are considered "unapproved" and are subject to mandatory refusal of admission. CBP works with FDA to flag entries with medical device-related HTSUS codes for FDA examination.

How GLCHB Handles FDA-Regulated Imports

FDA compliance is not an afterthought at GLCHB — it is integrated into our pre-arrival process for every FDA-regulated shipment. Our standard process:

1. Identify FDA-regulated status based on HTS code and product description
2. Verify FDA facility registration number for the applicable manufacturer/packer
3. File Prior Notice through ACE at the required timing (well before the minimum deadline)
4. Confirm receipt and acceptance of Prior Notice before cargo arrives
5. For FSVP-covered products: confirm QI information is on file and FSVP records exist
6. Screen the shipper and product against FDA import alerts database before entry filing
7. Prepare entry with accurate FDA product codes and appropriate PGA data elements
8. Monitor CBP/FDA messaging for examination holds or refusals; respond immediately

If FDA places an examination or hold, we act immediately to prepare required documentation and coordinate with the FDA district office at the port of entry.