FDA Rules for Foreign Food Importers in the United States

What is the Foreign Supplier Verification Program (FSVP)?

The Foreign Supplier Verification Program (FSVP) is a regulation under the Food Safety Modernization Act (FSMA) that requires U.S. importers to perform risk-based activities to verify that food imported into the United States has been produced in a manner that meets U.S. safety standards. This program shifts the burden of food safety from the federal government to the importers, ensuring that foreign suppliers utilize the same preventive controls and hazard analyses required of domestic producers.

To comply with FSVP, a U.S. importer must develop, maintain, and follow a written plan for each food category and each foreign supplier. This process must be overseen by a "Qualified Individual" who possesses the education, training, or experience necessary to evaluate food safety risks.

Core FSVP Requirements

• Hazard Analysis: Importers must identify known or reasonably foreseeable biological, chemical, and physical hazards for each food.
• Supplier Evaluation: You must evaluate the foreign supplier's performance and the risk posed by the food, including the supplier's compliance history with the FDA.
• Verification Activities: These may include annual on-site audits of the supplier, sampling and testing of the food, or a review of the supplier's relevant food safety records.
• Corrective Actions: Importers must take appropriate steps if they determine a foreign supplier has not produced the food in compliance with U.S. standards.
• Recordkeeping: All FSVP activities must be documented and records must be kept for at least two years.

How Do I Register a Foreign Food Facility with the FDA?

Foreign food facility registration is the process of notifying the FDA that a facility is involved in the production of food for consumption in the United States. Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, any facility that manufactures, processes, packs, or holds food for U.S. distribution must register via the FDA Industry Systems (FURLS).

Registration is a mandatory prerequisite for entry into the U.S. market. If a facility is not registered, its food products will be held at the port of entry, and the owner may face significant storage fees or the destruction of the goods.

Step-by-Step Registration Process

1. Obtain a DUNS Number: The FDA requires a Data Universal Numbering System (DUNS) number for the facility location. This is used to verify the facility's physical address.
2. Appoint a U.S. Agent: Every foreign facility must designate a U.S. Agent who lives or maintains a place of business in the U.S. and acts as a point of contact for the FDA.
3. Create an FDA Industry Systems Account: Register for an account through the FDA's online portal to manage your facility's information.
4. Complete the Registration Form: Provide the facility's name, address, emergency contact info, and the general categories of food handled.
5. Biennial Renewal: You must renew your registration between October 1 and December 31 of every even-numbered year. Failure to renew results in an "expired" status, which will block your shipments at the border.

What are the U.S. Food Labeling and Ingredient Requirements?

FDA labeling requirements ensure that consumers receive accurate information about the nutritional content and ingredients of the food they buy. All food labels in the United States must be written in English (though bilingual labels are permitted) and must strictly adhere to the Fair Packaging and Labeling Act and the Nutrition Labeling and Education Act (NLEA).

Imported foods must also comply with the Food Allergen Labeling and Consumer Protection Act (FALCPA). If an ingredient is not "Generally Recognized as Safe" (GRAS) or is an unapproved color additive, the product will be considered adulterated and refused entry.

Essential Labeling Elements

• Statement of Identity: The common or usual name of the food must appear on the front panel.
• Net Quantity of Contents: Expressed in both U.S. customary (ounces/pounds) and metric (grams/kilograms) units.
• Nutrition Facts Panel: Must follow the updated 2016 format, including "Added Sugars" and updated serving size requirements.
• Ingredient List: Ingredients must be listed in descending order of predominance by weight.
• Allergen Disclosure: Major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans, and sesame) must be clearly declared.
• Country of Origin: The label must clearly state where the product was manufactured (e.g., "Product of Italy").

How Does the FDA Conduct Overseas Facility Inspections?

The FDA conducts overseas inspections to verify that foreign food facilities are following U.S. Good Manufacturing Practices (GMPs) and preventive controls. Unlike domestic inspections, which are often unannounced, the FDA typically notifies foreign facilities and the host government in advance to coordinate logistics.

An inspection is not just a walkthrough; it is a rigorous audit of the facility's food safety plans, sanitation procedures, and employee training records. If a foreign facility refuses an FDA inspection, the agency will issue an Import Alert, effectively banning all products from that facility from entering the U.S.

Preparing for an Inspection

• Review the Food Safety Plan: Ensure your Hazard Analysis and Risk-Based Preventive Controls (HARPC) documentation is up to date and translated into English.
• Sanitation Records: Maintain meticulous logs of cleaning, pest control, and water quality testing.
• Staff Training: Be prepared to prove that employees are trained in food hygiene and safety according to their roles.
• Mock Inspections: Conduct internal audits to identify potential "FDA Form 483" observations (notices of inspectional observations) before the official investigators arrive.

What are the Consequences of Non-Compliance and Import Alerts?

Failure to comply with FDA regulations can result in severe financial and legal consequences, most notably the issuance of an Import Alert. An Import Alert signals to U.S. Customs and Border Protection (CBP) and FDA field staff that a product or supplier has a history of violations, allowing the FDA to detain shipments "without physical examination" (DWPE).

When a product is on the "Red List" of an Import Alert, the burden of proof shifts to the importer. You must prove that the specific shipment is compliant through private laboratory testing or third-party audits, which is an expensive and time-consuming process.

Types of Enforcement Actions

Common Misconceptions about FDA Food Compliance

"My product is FDA Approved."

The FDA does not "approve" food products, labels, or facilities. The agency registers facilities and regulates the standards they must meet. Claiming "FDA Approval" on food packaging is actually a violation of labeling laws and can lead to enforcement actions.

"The foreign exporter is responsible for FSVP."

While the exporter must provide data, the legal responsibility for the FSVP lies solely with the U.S. Importer of Record. If the FDA finds the FSVP is missing or inadequate, the importer-not the foreign supplier-is the party that faces penalties.

"Small businesses are exempt from all FDA rules."

While some very small businesses have modified requirements or longer compliance timelines, no facility is entirely exempt from basic food safety and registration requirements. Even "low-risk" foods must comply with GMPs and labeling laws.

FAQ

How much does FDA food facility registration cost?

There is no fee charged by the FDA to register a food facility or to renew a registration. However, foreign facilities may incur costs for hiring a U.S. Agent or obtaining a DUNS number.

Is a DUNS number mandatory for all importers?

Yes. As of 2020, the FDA requires a valid DUNS number for the physical location of the food facility as part of the registration process. This is the only "Unique Facility Identifier" (UFI) currently recognized by the FDA.

What happens if my shipment is detained at the border?

If the FDA detains a shipment, you will receive a "Notice of FDA Action." You typically have 10 to 20 business days to provide evidence (test results or documentation) to overcome the appearance of a violation.

Do I need to submit my labels to the FDA for review?

No. The FDA does not pre-approve food labels. It is the responsibility of the manufacturer and importer to ensure the label complies with all federal laws before the product enters the U.S. market.

When to Hire a Lawyer

Navigating FDA regulations is complex, and the stakes for international businesses are high. You should consult a legal professional specializing in FDA law if:

• Your facility has received an FDA Warning Letter or a Form 483 with significant observations.
• Your products have been placed on an Import Alert (Red List) and you need to petition for removal.
• You are importing high-risk foods (such as seafood, juice, or low-acid canned foods) that require specific HACCP plans.
• You are unsure if your product ingredients or additives are permitted under U.S. law.
• You need to draft or review complex FSVP contracts with foreign suppliers to ensure liability protection.

Next Steps

1. Verify Registration: Check that your foreign facility is currently registered and that you have a valid DUNS number.
2. Audit Your Labels: Review your packaging against the latest FDA Labeling Guidance.
3. Designate a Qualified Individual: Ensure you have a person trained to manage your FSVP and conduct hazard analyses.
4. Secure a U.S. Agent: If you are based outside the U.S., confirm your U.S. Agent is reliable and capable of handling urgent FDA communications.
5. Document Everything: Establish a centralized digital filing system for all supplier audits, safety tests, and certificates of analysis.