It’s a food and beverage executive's fear: Finding out an FDA registration number has expired, and all the goods the company produced from the registration deadline to the present cannot be legally sold in the U.S. Yet, it’s all too common for food facilities to not renew their FDA registration by the appropriate deadline.
Not complying with FDA registration can be costly for domestic and foreign food and beverage manufacturers, processors, packagers, and distributors. Though regulations for FDA registrations have been around for several years, the fluctuation of registration numbers year to year proves that not all manufacturers know, understand, and/or abide by those regulations.
To make the food supply safer and the FDA’s oversight more accurate, manufacturers can learn everything they need to know about FDA registrations and what they should do to comply — especially if they are among those who haven’t registered or renewed registration on time.
What to do when a deadline passes
For better or worse, the FDA currently charges no penalty for late food facility registrations, and registration is a free and simple process that can be completed online or via paper forms. If a manufacturer realizes it hasn’t registered with the FDA by the most recent biennial deadline, it can simply contact the FDA or register online and resume production.
The FDA does not require an inspection for registration. But the registrant, whether foreign or domestic, must agree to consent to FDA inspections when requested. Sometimes the fear of an inspection keeps manufacturers from registering or renewing their registration, David Lennarz, vice president of FDA consulting firm Registrar Corp, told Food Dive.
"If there’s no immediate penalty for not being registered, there’s certainly a percentage of companies out there that might say, 'Well what’s the rush?'" Lennarz said. "'What’s the hurry in getting this done?'"
Food facilities that continue operations with or without an expired FDA registration number are technically in violation of FDA regulations, which is subject to civil or criminal penalties, according to Lennarz.
That’s why it’s critical for all manufacturers, large and small, to check that their FDA registration numbers are valid and current. Often that registration has lapsed due to simple ignorance of the rules, not remembering to renew, or not realizing the renewal date has already passed.
That compliance is also critical for the FDA itself and consumers in general.
"The registration requirement allows the FDA to have more accurate data, which better allows them to target inspections, and in turn allows them to focus on higher risk facilities or food types," said Lennarz. "And that is ultimately good for the U.S. food supply."
FDA registration 101
It's important to know where these registration requirements came from to ensure total compliance.
Per the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (aka the Bioterrorism Act), the FDA is tasked with "(protecting) the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies," according to FDA guidance. In accordance with the act, the FDA established two regulations, effective Dec. 12, 2003:
- Food facilities must register with FDA.
- FDA must receive advanced notice on imported food shipments.
For manufacturers based in or shipping to the U.S., this is old news. A facility would register with the FDA, which costs nothing, and then it was registered for life. The FDA’s database grew to about 440,000 food facility registrations by 2012.
However, many of these facilities were registered more than once, as they may have requested a new registration number after forgetting their original, and the FDA never updated the file. Or facilities went out of business or stopped exporting to the U.S. Either way, in the FDA’s case, more data became bad data.
To combat this issue, the FDA released updated guidance per the Food Safety Modernization Act (FSMA). FSMA was enacted on Jan. 4, 2011 and amended section 415 of the Federal Food, Drug, and Cosmetic Act.
The updated guidance required that food facilities register with the FDA but also renew that registration every other year, on Dec. 31 of even-numbered years. The most recent registration requirement date was Dec. 31, 2014.
If a food facility does not update its registration before the final day of an even-numbered year, that registration number is no longer valid. That means domestic manufacturers that continue producing with an invalid registration number cannot legally distribute the goods produced between the time the registration is expired and when it is later renewed again.
Foreign food facilities with an expired registration number will have their shipment stopped by customs and prevented from entering the U.S. until that registration is renewed.
Despite these regulations being several years old, many manufacturers are unaware of them, forget them, or choose to ignore them. And with those expired registrations, a pattern has emerged.
Registering a pattern
Since these guidelines took effect more than four years ago, the number of FDA registered facilities has fluctuated from year to year. Given the fast growth of new food and beverage companies and the frequent failure of many of these businesses, fluctuation isn’t a surprise — to a degree.
But upon looking more closely at the numbers, a pattern appears in these fluctuations, as pointed out by Registrar Corp:
- From even to odd-numbered years, the number of registrations decreases: down 14% from 2014 to 2015, and another significant drop reported from 2012 to 2013.
- From odd to even-numbered years (2015-2016), the number of registrations increases: up 24% from 2015 to 2016 to a total of 207,655 registered facilities.
In both cases of registration decreases, the drop has been attributed to facilities’ failure to renew their registration during the biennial renewal period. The increase the following year happens as facilities realize their registration numbers are no longer valid and then renew at that time, past deadline
"During peak times of the year when companies are really gearing up for shipments for the holiday season, they realize their registrations are not valid and need to find out why," said Lennarz. "And ultimately, what most of them discover is that FDA purged them from the database."
This year’s biennial FDA registration period begins Oct. 1 and ends Dec. 31.