Food Facility Registration with FDA

Posted by Lisa Capote | May 02, 2011 | 0 Comments

Under the FDA food law known as the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 food facility registration is required to certain food facilities as well as providing FDA advanced notice of shipments carrying imported foods. Under the food laws domestic and food facilities that manufacture, process, pack or hold food for human or animal consumption must provide a FDA registration.

Foreign FDA registration is required in specific instances depending on what process of manufacturing is occurring in the particular facility. There are situations where the “primary” facility must register and there are situations where both the primary and secondary facilities must register.

Foods that are included and result in the requirement of food facility registration include dietary supplements, beverages, infant formulas, fruits and vegetables, dairy products, raw agricultural commodities, bakery goods, and many more. There are also a few exclusions as to what foods require FDA registration.

Foreign facilities must designate a US agent, who maintains a location in the US and is physically present in the US.

The purpose of the facility registration requirement is to provide FDA with the location and source of potential bioterrorism incident or an outbreak of food-borne illness as well as allow FDA to quickly notify any facilities that may be affected.

Failure to register is prohibited under US regulations.  The federal government may bring a civil action, or it may bring a criminal action to prosecute persons who are responsible for the commission of a prohibited act.  Furthermore, a foreign facility that fails to register will not be able to pass US Customs. The food product will be detained by FDA or Customs and Border Protection Services.

The repercussions of failing to register are widespread and can have a direct impact on your company's ability to conduct business.  Be sure your facility is registered before going to market.

About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


There are no comments for this post. Be the first and Add your Comment below.

Leave a Comment


AV Preeminent Rating

10.0Lisa Capote


Lisa Capote
Rated by Super Lawyers

loading ...

Copyright © 2021 Capote Law Firm

This website is intended solely to convey general information about Capote Law Firm and should not be construed as legal advice. Neither your use of this site nor your transmission of electronic mail to Capote Law Firm or any of its lawyers will create an attorney-client relationship. The formation of an attorney-client relationship requires satisfaction of multiple factors such as resolution of possible conflicts of interest, an appropriate fee arrangement, and mutual agreement on the terms of the engagement. This Website should not be interpreted as an offer by Capote Law Firm or any of its attorneys to practice law in any jurisdiction in which Capote Law Firm or the attorneys are not properly authorized to do so. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience or call us to discuss any specific questions.