FDA Food Facility Registration

We can assist manufacturers, processors, packers and holders of food for consumption in the U.S. (“covered parties”) with U.S. Food Facility Registration and U.S. Agent services.

FDA Food Facility Registration Services

If you are a foreign or domestic food facility seeking to market, or marketing, foods in the U.S. for human or animal consumption, you are required to register with the FDA. Food facility registration is a threshold compliance requirement. Garg Law can assist you in registering your food facility, and serving as U.S. Agent (foreign facilities). Our firm can also provide legal and regulatory counsel on navigating food facility registration questions, and other regulatory compliance needs to the successful legal launch of food products in the U.S.

What is U.S. FDA Food Facility Registration?

U.S. regulations require that the owner, operator, or agent in charge of a domestic or foreign facility that manufactures, processes, packs or holds food for human or animal consumption in the United States, to register the facility with the FDA unless there is an applicable exemption.[1] The definition for “food” excludes food contact substances (including packaging materials)[2] and pesticides.[3]

The Food Safety Modernization Act (FSMA) amended the regulations to require food facilities to renew registrations with the FDA biennially. It also provides FDA with the authority to suspend the registration of a food facility under certain circumstances.

Specifically, the regulations require that a food facility renew its registration during the period beginning on October 1 and ending on December 31 of each even-numbered year. Failure to renew a food facility registration is considered a prohibited act and subject to other enforcement actions.

Who does it affect?

The food facility registration requirement applies to domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. This includes:

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

The below chart provides examples of the types of food that are included in or excluded from the definition of “food” in the facility registration regulation:

COVERED Foods	EXEMPT Foods
Dietary supplements and dietary ingredients	Food contact substances
Infant formula	Pesticides
Beverages (including beverage alcohol 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, and animal feed)

Which facilities are exempt from food facility registration?

There are a number of operations and facilities that may be exempt from U.S. FDA facility registration. It is important to have in-house regulatory affairs and/or outside regulatory counsel examine your facility’s operations to determine if your facility is exempt. We also recommend a regulatory rationale be kept on file for support.

Generally, the following types of facilities are not required to register.

• Private residences or individuals
• Transport vehicles that hold food only in the course of their business as carriers
• Primary production farm
• Secondary activities farm
• Restaurants
• Retail food establishments
• Nonprofit food facilities
• Facilities exclusively regulated by the U.S. Department of Agriculture (e.g. facilities processing only meat, poultry or egg products that are inspected by USDA’s Food Safety and Inspection Service)

When Do I need to Register My Facility?

You must register your facility before beginning manufacturing/processing, packing, or holding food for consumption in the U.S.

Why is Facility Registration required?

Food facility registration is aimed to help FDA to determine the location and source of a potential bioterrorism incident or an outbreak of food-borne illness and to quickly notify facilities that may be affected. It provides tracking and tracing of food facilities, both foreign and domestic.

What happens if I do not register with FDA?

The failure to register a food facility is a prohibited act,[4] and may result in enforcement actions, including injunction or prosecution. The regulations provide that if an article of food is being imported or offered for import into the U.S. from a foreign facility that has not registered with the FDA, or from a facility with a suspended registration, the article must be held at the port of entry, and may not be delivered to the importer, owner, or consignee of the article until the foreign facility is registered.

What this means in layman’s terms is that the foreign and/or domestic facility cannot export or import, or offer to export of import, or otherwise introduce the food from that facility into the U.S. until that facility is registered.

Food facility registration is a threshold requirement for U.S. compliance of food products, both human and animal foods.

Costs for Food Facility Registration

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

Garg Law provides a service to register foreign and domestic food facilities at the following services and fees.

How Garg Law Can Help?

Whether you are a foreign or domestic food business, Garg Law can assist you with determining whether your facility needs to register, actually register your foreign or domestic food facility with the U.S. FDA, and serve as U.S. agent. With our specific expertise in FDA food facility registration, Garg Law can assist you with the following:

• Assist foreign and domestic companies in identifying whether and which facility is required to register with the U.S. FDA and whether there are any applicable exemptions. For example, food handled by more than one foreign facility may mean that the first facility is exempt.
• Complete U.S. FDA food facility registration for your company
• Serve as U.S. Agent for your foreign food facility
• Make updates to your food facility registration as needed
• Renew your food facility registration
• Represent and liaise with the appropriate FDA staff to resolve any food facility registration matters

We have streamlined the food facility registration process to more efficiently and quickly respond to business needs. Our step-by-step form and flat fees, which can be found here, allow you to quickly request food facility registration. This allows Garg Law to review and complete the registration process for you timely, enabling you and your business to be on its way and one-step closer to U.S. regulatory compliance.

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[1] See 21 U.S.C. 350d, Section 415 of the Federal Food, Drug & Cosmetic Act (FDCA), 21 CFR 1.226 and 1.227

[2] Defined in 21 U.S.C. 348(h)(6) and Section 409(h)(6) of the FDCA

[3] Defined in 7 U.S.C. 136(u)

[4] 21 U.S.C. 331(dd) and Section 301(dd) of the FDCA