In accordance with the Food Safety Modernization Act regulations, the Food and Drug Administration requires domestic and foreign facilities that manufacture, pack, or hold food for human or animal consumption in the United States to register or renew their registration on a biennial basis.
Registration renewals take place on even-numbered years, from October 1st – December 31st. It should be noted that food facilities must renew within this timeframe regardless of when they initially registered. For example, if a facility registered September 30, it is still required to renew the registration between October and December.
How to Renew
The registration renewal process is easy and may be submitted directly to the FDA online here. Facilities may also authorize a third-party individual, such as a Regulatory Specialist, to complete its renewal.
U.S. Agents: Foreign facilities are required to designate a U.S. Agent for FDA communications in section 7 of their renewal. The FDA will e-mail the listed U.S. Agent and will not activate the foreign facility’s registration until the U.S. Agent agrees.
Should you require a U.S. Agent, we recommend the services of Registrar Corp, a leading provider of FDA compliance assistance since 2003.
Why It Matters
The registration renewal process is important because it ensures that the FDA has current information about facilities that handle food for consumption in the U.S.
Information about a facility’s food product categories is a key element to allow for rapid communications between the agency and facilities directly impacted by actual or potential food-related emergencies or food safety incidents.
The FDA will cancel registrations that are not renewed by the December 31 deadline.
Without a valid registration, distributing food or beverages in the U.S. is a prohibited act and may result in possible civil and/or criminal prosecution under provisions of the Food, Drug, and Cosmetic Act (21 U.S.C. 332).
For food exported to the United States, the FDA will hold the food at the port of entry and will not release it until such time as the facility is registered properly.
Don’t Wait for December 31st, Renew Your Registration Now
Avoid compliance issues, supply chain disruptions, or clearance delays at the border by renewing your registration as quickly as possible.
Need More Information?
- Food Facility Registration User Guide: Update Registration Step-by-Step Instructions
- Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
Should you have any questions about this or other FDA-related issues, don’t hesitate to contact one of our helpful trade experts today.