Who must register?

 If you are a facility that manufactures, processes, packs, or holds food intended for human or animal consumption in the United States  you must register with FDA by December 12, 2003, unless you qualify for an exemption. 

“Facility” means “any establishment, structure, or structures under one management at one general location, or in the case of a mobile facility, traveling to multiple locations, that manufactures/processes, packs, or holds food for consumption in the United States.”

“Food” is defined broadly to include all foods regulated by FDA, including raw agricultural commodities, pet food, alcoholic beverages, food ingredients, dietary supplements and dietary ingredients, and substances that migrate to food from immediate food packaging and other articles that contact food.

Do foreign facilities have to register?

Foreign facilities must register unless exempt.  A foreign facility is any facility not located in one of the 50 States of the United States, Washington, DC, Puerto Rico, or a U.S. Territory.

Do foreign facilities have to have a U.S. Agent?

If you are a foreign facility that is required to register with FDA, you must designate a U.S. Agent.  A “U.S. Agent” is defined as “a person residing or maintaining a place of business in the United States whom a foreign facility designates as its agent.”  The purpose of the U.S. Agent is to serve as a communications link between you and FDA A U.S. Agent may be a parent company, business partner, broker, or U.S. lawyer.  A U.S. Agent may not be a mailbox, answering machine, or answering service. 

Is my facility exempt from registration?

Certain types of facilities are exempt from registration.  You may be exempt if you operate a:

What if information in my registration changes?

If any registration information changes, you must submit an update to FDA within 30 calendar days after the change.

What happens if I don’t register?

If you are a foreign facility, you may not be able to import your food into the United States.  Food from a foreign facility that is required to register but fails to do so will be refused admission and held at port of entry.

Failure to register is also a prohibited act, and FDA may bring a civil action to enjoin (i.e., to compel registration) or a criminal prosecution against the offender.

Is USA Food Agents, LLC part of the U.S. government?

No. USA Food Agents, LLC is a joint venture between The Food Institute and the Washington, D.C. law firm of Olsson, Frank and Weeda, P.C. USA Food Agents, LLC is not part of the FDA or any other government entity. USA Food Agents, LLC is offering a full range of services for companies needing assistance with the registration process. FDA has stated that no company offering these registration and agency services is part of the U.S. government. To read FDA's statement, click here.

Why choose USA Food Agents, LLC?

USA Food Agents, LLC is a joint venture between The Food Institute and the law firm of Olsson, Frank and Weeda, P.C.  The Food Institute is a non-profit organization that has been serving the educational and information needs of the food industry since 1928.  The Washington, D.C. law firm of Olsson, Frank and Weeda, P.C. has been advising clients on food law and FDA regulatory requirements since 1979, and includes several attorneys who used to work at FDA.  Together, we combine an intimate understanding of the food industry with detailed knowledge of FDA regulatory requirements.

USA Food Agents, LLC can:

By choosing USA Food Agents, LLC, you are not selecting an unknown entity.  Both The Food Institute and Olsson, Frank and Weeda, P.C. have long track records of service to the food industry.  Please visit their websites (www.foodinstitute.com and www.ofwlaw.com) for more information about The Food Institute and Olsson, Frank and Weeda, P.C.  We invite you to compare us to other companies offering registration and U.S. Agent services.  We think you’ll find that our experience and expertise are unmatched.

How will registration work?

You will be able to register electronically at FDA’s website.  If you do so, you will receive an instantaneous confirmation and facility registration number.  You will also be able to register by mail, but receipt of confirmation and a registration may take weeks or months.  If you hire USA Food Agents, LLC, we will submit registration to FDA on your behalf and obtain a confirmation and registration number for each of your facilities. To find how easy it is to use USA Food Agent's service, please click here.