Update 01/13/2019:
Commissioner Scott Gottlieb announced that they have increased surveillance sampling of imported high-risk products. Additionally, the FDA has expanded other activities that they have deemed “excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life.”
Posted 01/11/2019:
“FDA Lapse in Funding” is boldly declared on the Food and Drug Administration (FDA)’s website, but what does this mean in realty?
This lapse severely impacts the Agency but during the current Government shutdown some critical functions continue, including “screening the food and medical products that are imported to the U.S.” However, this line from FDA’s initial
statement gives little detail about how FDA’s import operations are actually functioning. Importers and Customs brokers are experiencing that FDA is not operating as business as usual.
Here’s what we know thus far as it relates to imports
Who’s Working: In our experience and conversations, it appears roughly 50% of the import staff is working. As an outsider, it is hard to predict who is there or not because about half are furloughed, including supervisors. There is one exception: any FDA official who is a Public Health Service Officer is working hard to keep the import process moving.
“Fun Fact”: This is because the Public Health Service is funded through separate
appropriations than the general FDA.
What’s Happening with Imports: FDA is continuing to examine, detain (including automatically detain under an import alert), and release imported shipments. However, the time to complete the import process may take longer, especially if the shipment includes issues that require input from headquarters or an FDA laboratory.
FDA has indicated that they are conducting very few random surveillance samples. However, that does not mean FDA is allowing any import into the United States. FDA continues to conduct for-cause exams and testing, and detain products that appear non-compliant. For example, the Commissioner, Scott Gottlieb, posted a picture of inspectors examining products at Chicago O’Hare Airport’s International Mail facility.
In addition to FDA automatically detaining products under an import alert; we have also seen import detentions for issues with drug or device registrations and listings.
What about Import Alerts: FDA’s import alert system is still fully functional. Not only are shipments being automatically detained; FDA is continuing to add firms to the various import alerts. We have also continued to work with the FDA to have firms removed from import alerts.
You can view the most recent import alert activity here on the FDA site.
Imports are but one part of FDA and there are several resources for discussing FDA’s functions during the shutdown. The Alliance for a Stronger FDA’s FDA Shutdown Toolkit provides an excellent summary. For the most recent updates, Commissioner Scott Gottlieb has been diligent in updating the public through his Twitter account.
FDAImports.com and Benjamin L. England & Associates are here for you during this stressful time. Our dedicated staff can assist in figuring out how this shutdown will affect your shipments. Contact us today with your questions and concerns.
