List of food, supplement facilities registered with FDA misses firms that avoid filing, expert says

By Hank Schultz contact

- Last updated on GMT

List of food, supplement facilities registered with FDA misses firms that avoid filing, expert says

Related tags: Food and drug administration, Dietary supplement

More than half of food facilities currently registered with the Food and Drug Administration are located outside the US. But that figure might disguise a number of unregistered domestic facilities, according to a recent analysis.

Registrar Corp recently submitted a Freedom of Information Act request to FDA to obtain the registry data. David Lennarz, vice president of Registrar, shared with NutraIngredients-USA some of what the company found by parsing the data. Registrar Corp is an FDA consulting firm headquartered in Hampton, VA with 19 regional offices around the world.

Lennarz said Registrar found that 207,655 food facilities registered with FDA as of January 1, 2016.  Of those registered food facilities, 120,822 were located outside of the US. All food facilities that manufacture, process, pack, or store food, beverages, or dietary supplements for consumption in the United States are required to register with FDA.

The ten countries with the largest number of FDA registered food facilities remain the same in 2016 as those reported in 2015:

 1 United States (86,773)

 2 Japan (13,941)

 3 France (10,450)

 4 Italy (10,125)

 5 China (9,667)

 6 Mexico (9,575)

 7 Canada (6,690)

 8 Spain (4,688)

 9 Republic of Korea (3,921)

 10 India (3,455)

Double counting

The 207,655 registered facilities reported in the FOIA request is significantly lower than the 300,539 registered food facilities FDA reported on the agency's Food Facility Registration Statistics​ page on February 4, 2016. According to FDA, this is because facilities that engage in more than one activity (manufacturing, labeling, etc.) are recorded multiple times on FDA's website, thus leading to inflated registration numbers. 

Registrar Corp's 2016 FOIA request shows a 24% increase in registrations since 2015. From 2014 to 2015, however, the firm's data showed a 14% decrease ​in registrations. According to FDA, there was also a large drop in the number of registered facilities from 2012 to 2013 due to facilities failing to renew their registration during FDA's biennial renewal period.

Lennarz said that pattern is likely to continue with an increase in registrations from odd to even years, and a significant decrease from even to odd years. This is because many facilities are unaware of or forget about FDA's biennial registration renewal requirement, a requirement established under the Food Safety Modernization Act (FSMA) in 2011. Under FSMA, food facilities must renew their FDA registrations each even-numbered year between October 1 and December 31. The first registration renewal period occurred in 2012. The next registration renewal period will begin on October 1, 2016.

While the potential double counting of companies might inflate the number of firms eligible to file, another factor might lead to undercounting, Lennarz said. He said his company has come across numerous companies lacking registrations, including a dietary supplement finished goods manufacturer that had requested that Registrar conduct a mock FDA inspection of its manufacturing facility. Lennarz said it was unclear in that case as in some others whether this was a question of willful ignorance.

“Sometimes companies are unaware of the need to keep a registration up to date. When we ask them for one, they say, here it is, and it was good in 2008 . . .” ​Lennarz said. “The US guys don’t renew because there is no mechanism to remind them.”

Lennarz said that it seems as if some companies ‘neglect’ to file because they are actively trying to stay off of FDA’s radar. 

“The consequence is that of course FDA will have never inspected that company because they don’t even know they exist. We’ve had companies tell us they’re not ready to file because they don’t think they’re ready for an inspection,” ​Lennarz said.

Foreign supplier compliance

By contrast, foreign companies are much better at this aspect of compliance, Lennarz said, because there is a hard control at the border.

“Their shipment is not going to get into the US if they don’t have a valid registration number they can submit at the time of entry,”​ Lennarz said.

The consequences for a domestic company that doesn not have a current registration could theoretically include civil and criminal penalties. Lennarz said he has not seen FDA shut down a company solely for this reason, and has usually seen merely a stern remonstrance to get this taken care of.  But he said dealing with a company that lacks a registration could certainly raise the risk, and might be an attractive fact for a class action lawyer to add to a suit.

“It can certainly jeopardize a company’s relationship with its customers,” ​Lennarz said.

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