Who is required to register a food facility with the FDA?

Any domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA, as required under Section 415 of the Federal Food, Drug, and Cosmetic Act and 21 CFR 1.225.

Do brokers, distributors, or importers need to register?

Brokers, distributors, and importers are generally not required to register unless they take physical possession of the food. If you do not manufacture, process, pack, or hold food, FDA registration may not be required.

How much does FDA food facility registration cost?

The FDA does not charge a government fee for food facility registration. Cosmereg's service fee is $350 per year, which includes FDA food facility registration and one year of US Agent representation for foreign facilities.

How often must FDA food facility registration be renewed?

FDA food facility registration must be renewed biennially (every even-numbered year) between October 1 and December 31. Cosmereg's annual service fee includes biennial renewal at no additional cost.

Do foreign food facilities need a US Agent to register?

Yes. All foreign facilities exporting food to the United States must designate a US-based FDA Agent as part of the registration process. Cosmereg's registration fee includes US Agent appointment for one year.

What is a DUNS number and do I need one for FDA registration?

A DUNS number (also called a UFI — Unique Facility Identifier) is issued by Dun & Bradstreet and is required for FDA food facility registration. You can request one at no cost through the D&B website.

FDA Food Facility Registration

Type of Registration

US Domestic Registration
Foreign Facility Registration
Biennial Registration Renewal

Facility Registration Number

If this is a biennial renewal, please enter the registration number. Otherwise, leave this field blank.

If you intend to change your U.S. Agent, please provide the PIN. Otherwise, leave this field blank.

Name of the company / Facility *

DUNS number (UFI)

Need a DUNS number? You can request one at no cost here Get your DUNS number here

Select Company Type

Street Address

Address Line 1

City

State / Province / Region

Postal Code

Country

I confirm that facility is engaged in the manufacturing/processing, packing, or holding of foods. *

Facility Phone Number *

Facility Email *

Describe your products *

Describe the operations you perform *

Do you want to add a Parent Company?

Preferred Mailing Address

Address Line 1

City

State / Province / Region

Postal Code

Country

Do you have different address for Parent company ?

Parent Company Name *

Address Information

Address Line 1

City

State / Province / Region

Postal Code

Country

FDA FOOD FACILITY REGISTRATION FORM

US FDA Regulations

Health Canada Regulations

EU/UK Regulations

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