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Are You a Food Facility Required to Register?

Today, the U.S. Food and Drug Administration released is the seventh edition of a guidance which answers several questions around the following topics:

1. Who Must Register
2. Who is Exempt
3. Definitions of Food
4. Holding Facilities
5. Trade Names
6. US Agent for FDA Registrations of foreign food facilities
7. When to register and renew your FDA registration
8. Unique Facility Identifier Number (October 2020)
9. Updates and Changes to FDA Registration
10. Is Food Registration information publicly available?

Who must register under the food facility registration requirements?

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U.S. FDA—FSMA Update July 2018

Food Safety Modernization Act

Most of the U.S. FDA rules under the Food Safety Modernization Act (FSMA) are finalized and compliance dates are in effect. FSMA aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The law also provides the FDA with new enforcement authority designed to achieve stronger compliance and allow the FDA to better respond when problems occur. Imported food are now held to the same standards as foods produced in the United States.

Here, we provide a summary of several important deadlines and requirements.

  1. Registration and renewal of food facilities – (FFR)
  2. Preventive controls for human and animal food – (PCHF Rule)
  3. Foreign supplier verification programs – (FSVP Rule)
  4. Prevention of intentional adulteration of the food supply – (IA Rule)

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Small Entity Compliance Guide (SECG)

Small Entity Compliance Guidance for Human and Animal Food facility registrations issued by FDA, May 25, 2018

The U.S. Food and Drug Administration issued a Small Entity Compliance Guide (SECG) to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The SECG explains which types of food facilities are required to register with the FDA, when and how to register. The guide also outlines the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order. Note that it is the food facility that must be registered, not related trading companies. Continue reading

Foreign Supplier Verification Program Rule – May 2018

Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Programs (FSVP) requires a U.S. importer of food to develop, maintain, and follow a Foreign Supplier Verification Program for Importers of Food for Humans and Animals (FSVP) (80 FR 74225) to ensure that each food it imports meets FDA food safety standards.

Who is covered?

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US Agent & Registration Information for Food Facilities

When a food company wants to export food products to the United States, they must first register with the U.S. FDA. All food facilities that engage in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S. If food being imported or offered for import into the U.S. is from a foreign facility for which registration has not been submitted, the food will be held at the port of entry and may not be delivered to the importer, owner, or consignee of the food. Trading companies that do not come into contact with the food do not need to be registered. Continue reading