FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations  

The Food and Drug Administration (FDA) is now enforcing the requirement that every Food Facility Registration has a valid DUNS number. The FDA officially began enforcement on January 1, 2023 but gave a 60-day grace period before beginning to verify numbers.

What is a DUNS Number?

DUNS stands for Data Universal Numbering System. It is a proprietary system developed by Dun & Bradstreet (D&B) that assigns a unique number to a business entity that is recognized worldwide. The DUNS system is not unique to the FDA. Other DUNS users include the UN, Apple, and the European Commission.

Why is the FDA Requiring This Now?

The FDA has required food facilities to register with the agency since 2002, but a DUNS number was not required up until now. The DUNS requirement dates back to 2016 when the agency issued a rule implementing new food facility registration requirements. Under the rule, the FDA requires facilities to provide a unique facility identifier (UFI) when registering. Subsequent guidance provided that a DUNS number is an acceptable UFI for registration.

The utilization of DUNS numbers will help the FDA:

Improve accuracy and consistency in the registration database
Identify facilities that pose a risk
Verify the authenticity of registrations
Ensure that facility information is up to date

The FDA has been working with facilities who have had difficulty obtaining a DUNS number and has issued guidance allowing registrants to enter a “PENDING” status if they cannot obtain a number in time.

What Do Food Facilities Need to Do?

Food facilities that are currently registered with the FDA will need to update their registration to include their DUNS number. Food facilities that are not currently registered will need to obtain a DUNS number before registering. A DUNS number can be obtained by contacting D&B.

 What if Your Facility’s DUNS Number is Not Accepted?

While the process of obtaining a DUNS number and adding it to an existing or new registration is relatively straightforward for most businesses, there are instances where the number is not accepted by the FDA. There are four primary reasons a DUNS number may not be accepted:

The number is not associated with the food facility business
The number is invalid
The number is expired
The number is associated with another facility that is registered with the FDA

A simple clerical error can result in your number being rejected – be sure to double check that all digits are entered correctly. If your number is expired or is invalid, D&B can give you a new number. They can also help reassign your number if it is associated with another facility.

If you’ve double checked your information, squared everything with D&B and your number is still rejected, contact the FDA directly. FDA staff can provide assistance on how to resolve the issue. It is also a good idea to speak to a FDA lawyer who has expertise in navigating D&B and FDA processes.

What If Your Registration is Canceled?

If your registration is canceled, you should correct the issue and seek reinstatement. Do not re-register your facility. The reason for your cancelation should be provided to you by the FDA in a cancelation letter.

Contact an Experienced FDA Lawyer For Help With Your Registration

Keeping your food facility registration up to date is critical. A suspended or canceled registration could result in you not being able to legally sell your products in the United States. An experienced FDA attorney can help you secure your DUNS number and complete your registration with the agency.

Diaz Trade Law has a combined six decades of experience and a strong track record of success. We can help with all aspects of the food facility registration process from obtaining a DUNS number to updating your registration to investigating why your registration was canceled. To get in touch with an FDA compliance attorney, call us at 305-456-3830 or fill out our online contact form.

The post FDA Begins Enforcement of DUNS Number Requirement for Food Facility Registrations   appeared first on Customs & International Trade Law Blog.

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