Home > USFDA Registration Process for Food Facility

INTRODUCTION

The Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 (Bio-terrorism Act) added section 415 to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA.

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended the food facility registration requirements in section 415 of the FD&C Act.

ABOUT REGISTRATION

Food Facility Registration Requirement

Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined in 21 CFR 1.227, for human or animal consumption in the United States must register with FDA.

Why Facility Registration Is Required?

Food facility registration will help FDA to:
• Determine the location and source of a potential bio-terrorism incident or an outbreak of food- borne illness; and
• Quickly notify facilities that may be affected

What It Costs?

There is no fee for registration, registration renewal or updates to a registration.

HOW REGISTRATION AFFECTS YOU

Which Facilities Must Register?

If your facility is in one of the following food industry sectors, you must register your facility with FDA.

• Domestic and foreign manufacturers or processors
• Domestic and foreign packers
• Domestic and foreign storage operations

Food Included in the Regulation

Registration pertains only to facilities that manufacture/process, pack, or hold food, as defined in 21 CFR 1.227, for consumption by humans or animals in the United States.

The following foods that are included in or excluded from the facility registration regulation. If your facility handles any of the included foods, it must be registered.

INCLUDED Foods

• Dietary supplements and dietary ingredients
• Infant formula
• Beverages (including alcoholic beverages and bottled water)
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs
• Raw agricultural commodities for use as food or components of food
• Canned and frozen foods
• Bakery goods, snack food, and candy (including chewing gum)
• Live food animals
• Food for animals (e.g., pet food, pet treats and chews, animal feed)

EXCLUDED Foods

• Food contact substances
• Pesticides

When, how and who can register a facility?

Your facility must register before you begin manufacturing/processing, packing, or holding food for consumption in the United States.

A food facility is required to submit an initial registration to FDA only once. Requires your facility to renew its registration with FDA every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

The owner, operator, or agent in charge of a facility, or an individual authorized by one of them, may register that facility.

Foreign facilities must designate a U.S. agent, who lives or maintains a place of business in the United States and is physically present in the United States, for purposes of communication
between the facility and FDA. The U.S. agent also may be authorized to register the facility.

SUSPENSION OF REGISTRATION

FDA can suspend a food facility’s registration when FDA determines that:

1. Food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals (SAHCODHA); and
2. A facility:
   • Created, caused or was otherwise responsible for that reasonable probability of SAHCODHA; or
   • Knew of, or had reason to know of, the reasonable probability of SAHCODHA, and packed, received, or held such food (section 415(b) of the FD&C Act).

Note: 

• If the registration of a food facility is suspended, no person can import or export, or offer to import or export, food from the facility into the United States, or otherwise introduce food from the facility into interstate or intrastate commerce in the United States while the suspension order for the facility is in effect.
• The introduction or delivery for introduction into interstate commerce of an article of food in violation of section 415 is a prohibited act under section 301(d) of the FD&C Act.
• If a domestic facility that is subject to a registration suspension order introduces food from such facility into intrastate or interstate commerce, FDA may pursue enforcement action, such as
  administrative detention, seizure, injunction, mandatory recall, prosecution, or a combination of such actions, as appropriate, provided that the applicable legal requirements are satisfied.
• If FDA determines that a food offered for entry into the United States is from a foreign food facility with a suspended registration, such article shall be held at the port of entry according to
  section 801(l) of the FD&C Act.

REGISTERING YOUR FACILITY

How to Register Your Facility?

Registrants must use Form FDA 3537 to register, renew, or update a registration. This form is available online and in paper form.

FDA will process paper submissions in the order received.

Note: FDA does not allow registration in person.

Online Registration

You can save time by registering online. FDA offers online help and operates 24 hours a day, seven days a week. You can register online wherever the Internet is available — including libraries, copy centers, schools, and Internet cafes.

A Registration Help Desk is available on business days, from 7:00 AM until 11:00 PM U.S. Eastern Standard Time to help you.

Offline Registration

If your facility does not have reasonable access to the Internet, you can request a copy of Form FDA 3537 from FDA by mail or phone. The form can be mailed or faxed to you. Fill out the form completely and legibly and email it.

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