Food safety is a top concern for consumers, regulators, and food importers worldwide. In the United States, the Food and Drug Administration (FDA) plays a crucial role in ensuring the safety of the food supply. One of FDA’s important programs is the Foreign Supplier Verification Program (FSVP), designed to ensure that imported foods into the United States are safe and meet FDA standards.

In this article, let’s discuss with GOL whether FSVP food importers are required to register with the FDA or not. We will examine the requirements of the FSVP program and explain what food importers need to do to comply.

Who Must Register with the FDA?

The majority of facilities involved in the manufacturing, processing, packaging, receiving, or storing of food are required to register with the FDA every two years. This obligation extends to most foreign manufacturers and certain importers, with a few exemptions from the registration mandate.

If your activities solely involve importing food, beverages (including alcoholic beverages), or dietary supplements, registration with the U.S. FDA is not required. However, if you have ownership, operational control, or act as the designated agent for a facility engaged in manufacturing, processing, packaging, or storing food, obtaining FDA food facility registration is mandatory.

You can find detailed information in: What importers need to know about FSVP?

Do the FSVP requirements include mandatory registration with the FDA?

The confusion regarding whether an importer must register with the FDA often arises from the FDA’s requirement for Foreign Supplier Verification Program (FSVP) importers to obtain a Unique Facility Identifier (UFI).

FSVP is a component of the FDA Food Safety Modernization Act (FSMA), which places the responsibility on most food, beverage, and dietary supplement importers to ensure that their foreign suppliers adhere to U.S. food safety standards. FSVP importers are mandated to utilize supplier compliance data to verify and approve suppliers, monitor their compliance status, and take corrective actions if necessary to meet FSVP requirements.

Additionally, FSVP food importers are subject to routine inspections to assess their compliance with FSVP regulations.

The confusion may stem from the fact that FDA also requires food facilities to provide a UFI during registration. This could imply that importers need to register with the FDA in addition to obtaining a UFI, which is not accurate. The necessity for FDA registration among importers depends on the extent of their involvement in food operations beyond importing.

Which food importers do not need FDA registration?

Exemptions from FSVP requirements are determined by existing regulations, oversight by other jurisdictions regarding product safety, or specific intended uses or destinations. These exemptions include:

• Juice and seafood, which are subject to FDA’s Hazard Analysis Critical Control Points (HACCP) regulations.
• Meat and poultry, which fall under USDA regulations upon import.
• Alcoholic beverages, which remain under the jurisdiction of the Alcohol and Tobacco Tax and Trade Bureau (TTB).
• Foods intended solely for research or evaluation purposes.
• Foods intended for individual consumption.
• Foods imported for processing and subsequent overseas shipment.
• Transshipped foods.

To summarize, importers of food, beverages, and dietary supplements who do not engage in manufacturing, processing, packaging, or holding products are not obligated to register with the FDA. Nonetheless, they are required to adhere to FDA regulations for importing goods destined for distribution in the U.S. market. This encompasses complying with requirements such as the Unique Facility Identifier (UFI) for the Foreign Supplier Verification Program (FSVP) and Prior Notice.

Read more: FDA Import Holds and Detentions

FSVP food importers must obtain a UFI (Unique Facility Identifier)

FSVP food importers are required to obtain a Unique Facility Identifier (UFI) and furnish it during the filing process at a port of entry with the U.S. Customs and Border Protection (CBP). This information must be submitted, along with the importer’s name and email address, to the CBP Automated Commercial Environment (ACE) system for each line entry of food offered for import.

The FDA designates the Data Universal Numbering System (DUNS) numbers as the sole acceptable UFI. DUNS numbers are distinctive 9-digit codes established by the credit bureau Dun & Bradstreet for credit reporting and business identification purposes. Failure to obtain a UFI before the arrival of your products at Customs will result in the detention and withholding of shipments until the DUNS number is provided. Failure to provide a DUNS number will result in the refusal of the shipment.

The FDA mandates unique DUNS numbers for each facility, rather than per company. Importers of alcoholic beverages are exempt from FSVP requirements and are not obligated to obtain a UFI. However, they may still need to register with the FDA if they engage in the manufacturing, processing, packaging, or holding of products.

GOL’s FDA Registration and FSVP Compliance Services

FSVP regulations mandate that food importers under FSVP import from approved suppliers. Importers must designate a Foreign Supplier Verification Program (FSVP) Qualified Individual (QI) to conduct assessments and verify foreign supplier compliance to ensure imported foods meet FDA food safety requirements before importation.

GOL is a leading reputable service company providing support for businesses wishing to export food products to the U.S. market. GOL provides services:

• Consultation: GOL advises businesses on FDA registration requirements, including registration documentation, registration procedures, and related fees. GOL advises businesses on how to develop and implement food safety management systems in accordance with FSVP regulations.
• Documentation Preparation: GOL assists businesses in preparing complete and accurate FDA registration documentation as required by the FDA.
• Submission: GOL submits FDA registration documentation to the FDA and monitors the processing status.
• Post-Registration Consultation: GOL advises businesses on post-FDA registration obligations, including updating registration information and maintaining compliance with FDA regulations.
• Inspection: GOL assists businesses in conducting internal inspections to ensure compliance with FSVP regulations.

Which Food Importers Need to Register with the FDA

According to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, all facilities that manufacture, process, pack, or hold food for consumption by humans or animals in the United States must register with the U.S. Food and Drug Administration (FDA). This includes facilities located outside of the United States.

If you are a food importer and unsure whether you need to register with the FDA, you should contact the FDA for guidance.

Below are some tips to help you determine whether you need to register with the FDA:

• Do you manufacture, process, pack, or hold food for consumption by humans or animals in the United States?
• Do you sell food directly to consumers?
• Do you only handle food for animals that are not human?

If you answer yes to the first question and no to either of the next two questions, you may need to register with the FDA.

After registering with the FDA, Importers must comply with the FSVP duties. If you need help to complete your FSVP compliance or FDA registration, you can contact GOL for further advice and assistance on FSVP and FDA registration to help you meet all compliance requirements.

Read more: Selling Online to the US – An E-commerce superpower

Steps to Registering with the FDA as a Food Importer

Step 1: Prepare Necessary Documents

Before beginning the food facility registration process with the FDA, you need to gather all required information and documents. Below is a list of important documents you need to prepare:

Basic Information:

• Facility name
• Facility address
• Contact phone number
• Emergency contact information
• Unique Facility Identifier (UFI)
• Parent company name (if applicable)
• Parent company address and contact information (if applicable)
• Trade name (if applicable)
• Name and contact information of the U.S. agent (if applicable)
• Date of operation (if seasonal)

General Product List

Information about the Responsible Individual:

• Owner, operator, or designated agent name
• Contact information of the responsible individual

Confirmation and Agreement:

• Confirm that all provided information is accurate and true.
• Confirm that you are authorized to share the provided information.
• Agree to allow FDA to conduct unannounced facility inspections.

In addition to the above documents, you may also need to prepare additional documents depending on the type of activities and products of the facility. To ensure you have a complete registration file, refer to the detailed guidance provided by the FDA or contact the FDA directly for assistance.

Application Submission

Registrants are required to electronically submit their applications through the FDA Industry Systems (FIS) online platform using the FURLS Food Facility Registration Module (FFRM). In certain circumstances, the FDA may grant a waiver, allowing registration applications or renewals to be submitted via mail or fax.

Upon submission of your application, you may receive a “Verification Pending” notification if the provided information is incomplete. If, for instance, an inaccurate UFI is provided, you will have a 30-day window to rectify the application before the FDA removes it from the FIS database.

Receive FDA Registration Number

Once your registration application is confirmed, you will receive an email containing:

• FDA Registration Number: This is a unique identifier confirming your facility’s registration with the FDA.
• PIN Code: Used to access and manage registration information online.
• Expiration Date: Typically falls on the last day of October or December of the following even year.

Use this information to:

• Confirm FDA registration.
• Update facility registration information.
• Renew registration when due.

Note:

• Keep the email containing registration information and PIN code safe for future use.
• FDA registration is valid for two years. Renewal is required before expiration to continue legal operation.

How to maintain FDA registration?

After completing FDA registration, the next step, and arguably the most important one, is maintaining compliance. This ensures the smooth operation of your food facility and mitigates potential issues with the FDA. There are several ways to maintain FDA compliance after you’ve completed your registration, including preparing for FDA inspections and updating your information with FDA.

FDA conducts several types of inspections on both domestic and international food facilities, including routine and targeted surveillance inspections for food safety and compliance follow-up inspections for previous violations. Non-U.S. food facilities typically take place at manufacturers, re-packers, warehouses, and distribution hubs, though they also occur on non-U.S. farms.

One of the best ways to prepare for FDA inspections is by conducting Mock Inspections either internally or with a regulatory specialist.

Another way to stay prepared and compliant is by keeping your registration and DUNS number information up to date. If you file an updated FDA registration, FDA will also check that the business information attached to your DUNS number matches it. Failure to update both before you renew can result in a suspended or canceled registration.

Introducing our FDA registration services for food, medical devices, and cosmetics:

At our agency, we specialize in facilitating FDA registration for a variety of products, including food, medical devices, and cosmetics. Our experienced team is dedicated to ensuring a smooth and efficient registration process for our clients, helping them navigate the regulatory requirements with ease.

For food products, we offer comprehensive assistance with FDA registration, guiding our clients through the necessary steps to ensure compliance with food safety regulations. From ingredient analysis to labeling requirements, we provide thorough support to streamline the registration process.

When it comes to medical devices, we understand the complexity of FDA regulations and work closely with our clients to navigate the registration process effectively. Whether it’s class I, II, or III devices, our knowledgeable team is equipped to handle the registration requirements and expedite approval.

Additionally, we offer FDA registration services for cosmetics, helping companies bring their products to market while adhering to FDA guidelines. From ingredient labeling to product testing, we assist our clients in meeting the necessary regulatory standards for cosmetic products.

With our expertise and personalized approach, we aim to provide exceptional FDA registration services tailored to the unique needs of each client. Trust us to be your partner in achieving compliance and bringing your products to market with confidence.

References: 

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Importing Food Products into the United States

According to Registrar Corp – Do FSVP Food Importers Have To Register with FDA?