Mandatory biennial FDA food facility registration period is now open until December 31

Companies that own or operate a food facility must renew their biennial registration by December 31, 2022 in accordance with the Food Safety Modernization Act (FSMA). Applicable food facilities include both domestic and foreign facilities where persons engage in manufacturing/processing, packing, or holding food for human or animal consumption in the US.

Owners, operators, or agents must complete this registration process online through their FDA Industry Systems account, unless FDA has granted a waiver to submit a paper submission. There is no fee for registering or renewing the food facility registration. Regardless of the mode of submission, each registration must include certain information including:

• Name and contact information for the facility and its parent company (if applicable)
• Name and contact information for the owner, operator, or agent in charge
• Unique facility identifier (UFI)
• All trade names the facility uses
• Applicable food product categories of any food manufactured/processed, packed, or held at the facility
• Type(s) of activities performed at the facility for each product category
• Statement certifying that the information submitted is true and accurate and that the person submitting the registration is authorized by the facility to register on its behalf; and
• Emergency contact information (required for all foreign facilities and for domestic facilities, only if emergency contact is different from the facility contact person)

As noted in FDA’s FSMA Final Rule and codified in 21 CFR 1.241, FDA will cancel a registration if the facility’s registration has expired because the facility failed to timely renew its registration. Operating a food facility without a valid FDA registration is a prohibited act under section 301(dd) of the Food, Drug, and Cosmetic Act (21 U.S.C. 331(dd)). As explained in FDA guidance, persons found guilty of performing a prohibited act may be subject to civil or criminal action or other enforcement actions.

DLA Piper is experienced in counseling clients on food and beverage matters. To learn more about these food facility registration requirements and how they might apply to your business, please contact any of the authors or your usual DLA Piper relationship attorney.