According to the Department of Health and Human Services’s (HHS) contingency staffing plan of the 14,800 total FDA employees, 8,180 were expected to keep working and 6,620 were expected to be furloughed.
Commenting on the implications of the shutdown for the industry, the American Herbal Products Association (AHPA) said that it appears that FDA will not be initiating any new cGMP inspections during the shutdown.
“On the other hand, the agency did post its weekly list of Warning Letters this morning, though it is unclear whether this was automated for distribution prior to the shutdown. And the fact that FDA has retained staff that oversee adverse event reporting should remind companies that their obligation to submit any received serious reports within 15 days is not in any way affected by the shutdown.
“On a similar issue, FDA's Reportable Food Registry portal appears to be fully operational, and ingredient and food companies that must comply with this regulation should assume that reporting requirements are unchanged during the shutdown,” stated AHPA.
In addition, AHPA staff were reportedly informed by an FDA inspector the agency does not expect in-transit import shipments to be delayed.
According to the HHS’ contingency plans:
“FDA will be unable to support the majority of its food safety, nutrition, and cosmetics activities. FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision making.”
The plan also states that FDA will continue limited activities including “maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues”.