FDA Compliance for Foreign Food Importers in 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 primary responsibility for food safety from the federal government to the importers themselves.

To comply with FSVP, an importer must develop, maintain, and follow a written plan for each food and each supplier. This process involves several critical steps:

• Hazard Analysis: You must identify and evaluate known or reasonably foreseeable hazards for each type of food, including biological, chemical, and physical hazards.
• Evaluation of Supplier Performance: You must assess the foreign supplier's food safety history, including their compliance with FDA regulations and any history of food safety issues.
• Verification Activities: Based on the risk assessment, you must conduct activities such as annual on-site audits, sampling and testing of food products, or a review of the supplier's relevant food safety records.
• Corrective Actions: If you determine that a supplier is not producing food in compliance with U.S. standards, you must take appropriate corrective actions and document them.

How do foreign food facilities register with the FDA?

Foreign food facilities must register with the FDA before their products can be imported into the United States. This registration provides the FDA with necessary information regarding the origin of food products and helps the agency respond quickly to potential food safety incidents.

The registration process is completed through the FDA Industry Systems (FIS) portal and involves the following steps:

1. Obtain a DUNS Number: The FDA requires a unique facility identifier (UFI) for registration. Currently, the Data Universal Numbering System (DUNS) number is the only recognized UFI.
2. Designate a U.S. Agent: Every foreign facility must have a U.S. Agent. This person or entity must reside or have a place of business in the United States and be available to answer the phone during 24-hour business days.
3. Submit Electronic Registration: Access the FDA Food Facility Registration system to enter facility details, including the types of food handled and emergency contact information.
4. Biennial Renewal: Facility registrations must be renewed every even-numbered year between October 1 and December 31. Failure to renew results in an expired registration, and products will be refused entry at the border.

What are the FDA labeling and ingredient safety standards?

FDA labeling requirements ensure that consumers receive accurate information about the food they purchase and that ingredients used are safe for consumption. All food products imported into the United States must have labels printed in English, though bilingual labels are permitted if they contain all required information in both languages.

The mandatory elements of a U.S. food label include:

Beyond labeling, importers must ensure that all food additives and color additives are approved for use in the United States. Many substances permitted in other countries are strictly prohibited or restricted by the FDA.

How should overseas facilities prepare for FDA inspections?

The FDA has the legal authority to inspect foreign food facilities to ensure they are complying with the Food Safety Modernization Act (FSMA) and Current Good Manufacturing Practices (CGMPs). These inspections are often high-stakes; if a facility refuses an inspection, the FDA will issue an Import Alert, effectively banning all products from that facility from entering the U.S. market.

To prepare for an inspection, foreign facilities should maintain a "readiness" mindset:

• Document Everything: Ensure all Standard Operating Procedures (SOPs), cleaning logs, and employee training records are up to date and translated into English if necessary.
• Hazard Analysis and Risk-Based Preventive Controls (HARPC): Have a written food safety plan ready for review, detailing how the facility identifies and prevents hazards.
• Facility Maintenance: Conduct internal audits to ensure the physical facility meets CGMP standards, focusing on sanitation, pest control, and cross-contamination prevention.
• Mock Inspections: Regularly perform internal "mock" FDA inspections to identify gaps in compliance before an official inspector arrives.

What are the consequences of non-compliance and Import Alerts?

Failure to follow FDA regulations can lead to severe financial and legal repercussions for both the foreign supplier and the U.S. importer. The most common enforcement tool used by the FDA is the "Import Alert," which places a company on a "red list" for specific violations.

Common consequences include:

• Detention Without Physical Examination (DWPE): If a product is on an Import Alert list, Customs and Border Protection (CBP) will automatically detain the shipment at the port. The importer must then prove the product is safe at their own expense, often through third-party laboratory testing.
• Seizure and Destruction: If a shipment is found to be adulterated or misbranded and the importer cannot bring it into compliance, the FDA may order the product to be destroyed or re-exported.
• Administrative Fines: The FDA can levy significant monetary penalties for repeated violations of FSVP or registration requirements.
• Criminal Prosecution: In cases of intentional fraud or gross negligence resulting in illness or death, the Department of Justice may pursue criminal charges against company executives.

Common Misconceptions About FDA Food Imports

Myth 1: The FDA "approves" food labels before they can be used. The FDA does not provide a pre-approval service for food labels. It is the sole responsibility of the importer and manufacturer to ensure that the label complies with all federal regulations. The FDA only reviews labels during inspections or when a product is detained at the border.

Myth 2: Small foreign producers are exempt from FSVP requirements. While there are "modified requirements" for very small importers (those with less than $1 million in annual sales) or food from certain small suppliers, no importer is entirely exempt. Even small businesses must verify their suppliers and keep basic records to prove they are importing safe food.

Myth 3: If a product is legal in Europe or Canada, it is legal in the U.S. This is a frequent mistake. The U.S. has different standards for food additives, colorings, and labeling formats. For example, certain food dyes permitted in the EU require specific cautionary labeling or are outright banned in the United States.

FAQ

What is a U.S. Agent and do I really need one?

Yes, a U.S. Agent is mandatory for every foreign facility. They act as the liaison between the FDA and the foreign facility for both routine and emergency communications. The agent must be physically located in the United States.

How much does it cost to register a food facility with the FDA?

There is no government fee to register a food facility with the FDA. However, most foreign facilities incur costs related to hiring a U.S. Agent and obtaining a DUNS number if they do not already have one.

How long does the FSVP process take?

Developing a compliant FSVP plan can take several weeks to several months, depending on the complexity of the food product and the cooperation of the foreign supplier in providing safety documentation.

Can I import food samples without a registration?

There are limited exemptions for food samples intended for trade shows or laboratory testing, provided they are not for retail sale or public consumption. However, these shipments must still be clearly marked as "Samples-Not for Resale."

When to Hire a Lawyer

Navigating the Food Safety Modernization Act (FSMA) is a complex legal undertaking that involves significant liability. You should consult a specialized FDA attorney if:

• You are setting up a new import business and need to draft your initial FSVP protocols.
• Your products have been detained at the border or placed on an Import Alert.
• The FDA has issued a Warning Letter or Form 483 following an inspection.
• You are importing high-risk foods, such as seafood, juice, or infant formula, which have additional specialized regulations.
• You need to dispute an FDA finding regarding labeling or ingredient safety.

Next Steps

1. Verify Registration: Ensure your foreign facility is registered and your U.S. Agent is correctly designated in the FDA system.
2. Audit Your Labels: Review your current packaging against the FDA Labeling Guide to ensure total compliance.
3. Draft Your FSVP: If you are an importer, begin the hazard analysis for every product you bring into the country.
4. Organize Records: Centralize all food safety records and translations so they are ready for immediate review during an audit or inspection.