Every domestic and foreign food facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA. This requirement, established under the Bioterrorism Act of 2002 and strengthened by FSMA, is one of the most fundamental regulatory obligations for food businesses operating in or exporting to the U.S. market. Failure to register — or to keep your registration current — can result in your food products being held, refused entry, or subject to other regulatory action.
FDA food facility registration applies to a wide range of operations, from large manufacturing plants to smaller specialty food producers. Understanding whether your business requires registration, how to complete the process, and what ongoing obligations you must meet is essential for maintaining compliance and avoiding disruptions to your business.
The FDA requires registration from facilities that manufacture, process, pack, or hold food for consumption in the United States. This includes both domestic facilities located within the U.S. and foreign facilities that export food to the U.S. market.
Domestic facilities include food manufacturers, food processors, food warehouses, and many food distributors. If your facility performs any of these functions — even if food handling is not your primary business activity — you may be required to register. For example, a company that primarily distributes office supplies but also stores food products in a warehouse section would need to register that facility.
Foreign facilities must register if they manufacture, process, pack, or hold food for export to the United States. The foreign facility must also designate a U.S. agent who resides or maintains a place of business in the United States. This agent serves as the primary point of contact between the FDA and the foreign facility for all communications and regulatory matters.
However, several types of operations are exempt from registration requirements. Farms that grow, harvest, and pack their own produce on the farm are generally exempt, though they may be subject to other FSMA rules such as the Produce Safety Rule. Retail food establishments — including restaurants, grocery stores, and food service operations — that sell food directly to consumers are also exempt from facility registration. Private residences where food is prepared or stored are exempt as well.
It is important to note that even exempt operations may have other FDA obligations. A restaurant that also manufactures packaged sauces, dressings, or baked goods for retail sale at other locations may need to register the manufacturing portion of its operation. The line between exempt and non-exempt can be nuanced. The FDA facility registration guidance provides detailed information on exemptions and specific scenarios.
FDA food facility registration is completed through the FDA's electronic registration system, known as the Food Facility Registration Module (FFRM), accessible through the FDA Industry Systems portal online.
To register, you will need to create an FIS account if you do not already have one. The registration form requires comprehensive information about your facility including its legal name, physical address, mailing address if different, the type of activity conducted at the facility, and the food product categories you handle. You will also need to provide emergency contact information and, for foreign facilities, your U.S. agent details including their name, address, phone number, and email.
Registration is free — the FDA does not charge fees for food facility registration or renewal. The process can typically be completed in 30 to 60 minutes if you have all your information prepared in advance. Having your facility's D-U-N-S number ready, while not required, can speed up the process.
Upon successful registration, you will receive a unique registration number for your facility. This number is permanent and must be included in certain FDA communications, prior notice filings for food imports, and may be requested by business partners. Keep this number in a secure, accessible location and ensure key personnel know where to find it.
Paper registration is available for those who cannot register electronically, but the FDA strongly encourages electronic registration due to faster processing and easier management of updates and renewals.
Once registered, your obligations extend well beyond the initial submission. Active maintenance of your registration is a continuous regulatory requirement that demands attention and organization.
You must update your registration within 60 calendar days of any change to the information previously submitted. This includes changes to facility name, physical or mailing address, contact information, product categories handled, type of activity conducted, or U.S. agent information for foreign facilities. Failing to update your registration can result in inconsistencies that create problems during inspections or regulatory interactions.
Biennial renewal is mandatory. Every two years during the renewal window of October 1 through December 31 of even-numbered years, you must log into the FIS portal and confirm or update your facility's information. The FDA sends reminder notices by email, but it is your responsibility to ensure timely renewal regardless of whether you receive a reminder. Set calendar alerts well in advance of the renewal window.
If your facility ceases operations or no longer manufactures, processes, packs, or holds food, you should cancel your registration through the FIS portal. An active registration for a non-operational facility can create confusion during regulatory oversight and may complicate future business transactions.
Record keeping for your registration activities is strongly recommended. Keep copies of your registration confirmation, any updates submitted, renewal confirmations, and correspondence with the FDA regarding your registration. These records demonstrate your ongoing compliance and can be invaluable during inspections or when responding to regulatory inquiries.
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Try it free →The consequences of failing to register your food facility with the FDA are significant and can severely impact your business operations. Under FSMA, the FDA has enhanced enforcement authority that it actively exercises.
Food from an unregistered facility is considered adulterated under the Federal Food, Drug, and Cosmetic Act. This means the food is prohibited from being introduced or delivered for introduction into interstate commerce. For domestic facilities, this effectively shuts down your ability to sell food products across state lines or through interstate distribution channels.
For foreign facilities, the consequences can be even more immediate and disruptive. Food arriving at U.S. ports from unregistered foreign facilities will be refused entry. The FDA can place an import alert on your products, which means future shipments will be automatically detained without physical examination until you demonstrate compliance. Clearing an import alert can take weeks or months.
The FDA can also administratively suspend a facility's registration if the agency determines that food from the facility has a reasonable probability of causing serious adverse health consequences or death. A suspended registration immediately prohibits the facility from distributing any food in the U.S. and blocks all imports from foreign facilities.
Beyond regulatory action, operating without proper registration exposes your business to significant liability risks. Insurance policies may contain exclusions for losses arising from non-compliance with federal regulations. Business partners and retailers increasingly require proof of current FDA registration as a condition of purchase orders and distribution agreements.
Several situations create confusion regarding FDA registration requirements. Understanding these nuances can help you avoid compliance gaps and unnecessary registrations.
Co-packers and contract manufacturers must each have their own registration. If you hire a co-packer to produce your food products, both your facility (if you also handle food) and the co-packer's facility must be independently registered. You cannot rely on your co-packer's registration to cover your operations.
Storage facilities and warehouses that hold food must register, even if they do not process or manufacture food. This includes cold storage facilities, dry warehouses, third-party logistics providers, and distribution centers. The holding of food is itself a registrable activity under the regulation.
Seasonal operations that only manufacture or process food during certain times of the year must still maintain an active registration year-round. Your registration does not expire or become suspended when your production season ends. You must still complete biennial renewal even during off-seasons.
Mixed-use facilities require careful analysis. If a single facility conducts both exempt activities (such as retail food service) and non-exempt activities (such as food manufacturing for wholesale), the non-exempt portion requires registration. Clearly defining and documenting which activities are conducted in which areas of your facility is important.
The FDA Food Safety Modernization Act information page provides additional guidance on how registration requirements interact with other FSMA obligations and can help you determine the full scope of your compliance responsibilities.
Maintaining your FDA food facility registration is not a one-time event but an ongoing regulatory obligation that requires attention to renewal deadlines, update requirements, and changes in regulatory expectations. The biennial renewal requirement means that every food facility must re-register during a specific window every two years, and failure to renew results in the registration being considered expired.
Beyond the formal renewal cycle, food facilities are required to update their registration within 60 calendar days of any change to the information previously submitted. This includes changes in facility name, address, contact information, types of food handled, and the identity of the U.S. agent for foreign facilities. Failing to update registration information promptly can result in having an inaccurate registration, which may be treated as a violation during regulatory inspections.
The FDA has progressively enhanced the registration system to collect more detailed information about food facilities and their operations. Each renewal cycle may include additional data fields or modified requirements that reflect the agency's evolving approach to food safety oversight. Staying informed about these changes through FDA communications, industry associations, and regulatory update services helps ensure that your registration remains accurate and complete.
Restaurants that sell food directly to consumers are generally exempt from FDA food facility registration. However, if a restaurant also manufactures packaged food products for retail sale at other locations or for wholesale distribution, the manufacturing operation may require registration. The exemption applies specifically to retail food establishments as defined by the FDA.
FDA food facility registration is completely free. The FDA does not charge any fee for initial registration, updates, or biennial renewal. Be cautious of third-party services that charge fees to submit your registration on your behalf — you can complete the entire process yourself through the FDA's online portal at no cost.
If you fail to renew your registration during the October 1 to December 31 renewal period of the applicable even-numbered year, your registration will lapse. Food from a facility with an expired registration is prohibited from being distributed in interstate commerce. You should renew as soon as possible after discovering the lapse and contact the FDA for guidance on resolving your specific situation.
FDA food facility registration is a foundational compliance requirement that enables your food business to operate legally in the U.S. market. If you are unsure whether your operation requires registration, review the FDA's guidance materials or contact the agency directly. For businesses already registered, mark your calendar for the biennial renewal period and keep your registration information current.
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