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U.S. FDA Compliance

The U.S. FDA ensures the safety and proper labeling of food sold in the United States, both domestically produced and imported. This falls under the jurisdiction of the FD&C Act and the Fair Packaging and Labeling Act.

U.S. FDA Requires only food facility to register that manufacture, process, pack, or hold food for human or animal consumption in the U.S.

The food facility registration process with the US FDA underwent changes with the implementation of the FDA Food Safety Modernization Act (FSMA) in FY 2012. Under FSMA, domestic and foreign food facilities must renew their registration biennially, between October 1 and December 31 of each even-numbered year since 2012. Facilities must update registration information within 60 days of any changes or cancel registration within the same timeframe if operations cease. Previously registered facilities without registration information can contact the US FDA directly for details. Foreign food facilities are required to designate a US FDA Agent for communication and must update agent information during registration changes.


This registration process, along with prior notice requirements, aids the US FDA in tracking the origin and distribution of food products, facilitating rapid responses to potential threats to the US food supply. Statistics from March 2, 2023, indicate a total of 208,034 food facility registrations, comprising 87,729 domestic registrations and 120,305 foreign registrations.


New FDA Food Safety Modernization Act (FSMA)

FDA Registry assists with U.S. FDA food facility registration, compliance with FDA bioterrorism act requirements, and provides U.S. FDA Agent services for foreign food facilities.



U.S. FDA does not issue certificates or recognize third-party certificates. Each facility is assigned a registration number, not indicative of FDA approval.


You're probably

  • Why should I pay to register with the FDA?
    Registering with the FDA is free. FDA Regulatory service providers charge an annual fee to cover account management, customer service; while, representing the food facility to all communication requirements with the FDA. It is crucial to appoint as your U.S. Agent an entity located in the USA that excels in FDA Compliance Regulations; while also understands your priorities and can protect your business efforts in the States.
  • I am anxious to comply with the FDA requirements. What should I do to avoid penalties?
    Relax. Relax. Relax. The U.S. FDA will never inspect your facility unannounced; however, FDA will inspect your shipment at the Points of Entry in the USA. In other words, FDA will inspect your shipments at U.S. Customs during clearance. Be prepared before shipping to the U.S. by following the below: ➡️Register wit the FDA ➡️Comply your products' labels ➡️Appoint an FSVP Importer (applies to every shipment)
  • Appointing your U.S. Buyer as your U.S. Agent to the FDA.
    Selling to the USA requires significant time, investment, and effort. While it may seem convenient to pass FDA responsibilities to your buyer with EXW/FOB terms, this can lead to costly mistakes. It is crucial to recognize that FDA regulations are complicated, and your U.S. Agent must possess expertise to navigate them effectively and shield you from demurrage fees. Moreover, appointing your buyer as your U.S. Agent relinquishes control over your facility's FDA Registration, impacting your ability to expand sales in the USA seamlessly.
  • Who should register with the FDA?
    If you manage a facility involved in making, packaging, or storing food for human or animal consumption in the United States, you must register with the FDA, unless exempt. Domestic facility owners/operators must register regardless of interstate commerce. You can authorize someone else to register your facility. Foreign facilities' U.S. agents may register but aren't obligated to do so. Entities and individuals who do not come into physical contact with food for human or animal consumption, are exempt from registering with the FDA.
  • Can you explain the FDA Registration in simple words?
    Most certainly! When registering with the FDA the below information are required: - Legal name of production facility - Legal representation of production facility - Location of production facility - Contact person in case of emergency - Description of product categories in production (briefly)
  • Do I need a Prior Notice?
    Prior Notice is required at every shipment to the USA. The prior notice submission contains detailed information about the consumable goods and enterprises related to the goods and their shipment. The prior notice submission includes information about the following: Items themselves – what is it that is being sent.
  • What is the FCE/SID number?
    When registering a production facility with the FDA, we provide details about the building and the product categories manufactured within it. Certain packaging materials, such as aluminum cans, tetrapaks, pouches, and glass jars, can potentially harbor bacteria during production due to water activity. Quality Assurance (QA) managers conduct thorough tests to ensure bacteria elimination during the production process. In summary, the production line represents the Facility Canning Establishment (FCE), and all SKUs manufactured on that line are considered Specific Identifiers (SIDs). Therefore, the FCE registration serves as a unique identifier for the production line, which produces specific SKUs intended for export to the USA.
  • I just want to send samples. Can i avoid FDA Compliance requirements?
    Absolutely no! Samples are treated in the same with as regular commercial shipments. Shipper must have the below before shipping to the USA: - Valid FDA Registration - Valid DUNs Number - Compliant labels - Verify if FCE Number is needed (depends on product)

Ready to ship?
FDA Registry can help you
with FDA & U.S. Customs
to avoid penalty fees & delays

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