Import Alert: Foreign Food Facilities Should Check Their Registration

Update February 22, 2017:  Many foreign manufactures of foods and dietary supplements are finding that their FDA Food Facility Registrations have been invalidated.  These are companies that updated their registration between October and December 2016 as required but whose US Agent failed to confirm the registration.  FDA’s Ombudsman for the Office of Regulatory Affairs, Jessica Zeller, described the issue as “a systemic matter”.

The problem was caused by a change in the process that came as a surprise to US Agents.  Since inception of the registration requirement US Agents were informed that they were listed as agent on a facility registration by email that required no action if the information about them in the registration was correct.  This year the email from the registration system looked very much like those sent in previous years but there was a new requirement to confirm the registration.  Ombudsman Zeller stated that, “there was obviously some confusion this year and communication could have been better.”

Most companies have learned of the invalidation of their registration only when they tried to notify FDA of a new import.  The problem is easily and almost immediately rectified by re-registering the facility and ensuring that the US Agent confirms the registration.  All foreign food and dietary supplement facilities should log into the facility registration system to ensure they remain registered prior to shipping product to the US.

Original Post October 20, 2016:

It’s Time to Renew Food Facility Registrations

All facilities that manufacture, process, package or warehouse food or dietary supplements for sale in the US must renew their facility registration between October 1st and December 31st of even-numbered years.  2016 is of course an even-numbered year and the renewal period is open. This requirement applies to domestic as well as foreign facilities and also includes facilities handling medical foods and animal foods.

The Food Safety Modernization Act has affected this process by requiring that the registration include the facility’s “activity type”.  The form lists 39 types of activities for human food facilities and 28 for animal food facilities.  Also new with this year’s registration is the requirement that the facility agree to FDA inspection by checking a box next to this statement:

“FDA will be permitted to inspect the facility at the time and in the manner permitted by the Federal Food, Drug, and Cosmetic Act”.

Failure to check the box will result in rejection of the registration.  If the company later refuses inspection, FDA can revoke the registration and prohibit distribution of the registrant’s products in the US.

Electronic registration is required using FDA’s online system, which can be accessed here.  If you do not already have an account you can create one there as well.

Step by step instructions for registering food facilities are available and you may preview registration form as a PDF. If you have trouble downloading the form, let me know and I will email it to you.  If you have questions about the form, let me know.

Another note for food and dietary supplement companies is to begin asking your suppliers to provide data on the levels of vitamin D, potassium and added sugars in the ingredients you use so you can get ready to comply with the new nutrition facts regulations.  These regulations became effective July 26, 2016.  While the new regulations will not be enforced until 2018 it may take time for your supplier to understand that they need to provide this data and then test their products to get the values.  Based on my experience when trans fat labeling was first required, it can take many months for suppliers to provide the data.

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