FDA drastically affected by US government shutdown. What does this mean for GRAS notices and food additive petitions?

FDA drastically affected by US government shutdown. What does this mean for GRAS notices and food additive petitions?

Posted 9 January, 2019

The partial US federal government shutdown that began on Saturday 22 December 2018 is having a noticeable impact on the activities of the Food and Drug Administration (FDA). The lapse in funding due to the absence of either an FY 2019 appropriation or Continuing Resolution has resulted in as many as 40% of the agency’s staff placed on furlough, and Donald Trump stated that he could continue the shutdown for “months or even years” if there is no agreement on the $5,000 million that US President wants to include in the budget to finance the US-Mexico border wall.

Although the majority of FDA workers remain in their workplace during the shutdown, they are exclusively dedicated to activities funded by user fees and work that is critical to public health and safety. The agency released a statement clarifying that they will continue to do all the work that they are legally allowed to do during the lapse in funding, including, among others:

Responding to outbreaks related to foodborne illness and the flu
Supporting high-risk food and medical product recalls when products endanger consumers and patients
Pursuing civil and criminal investigations when they pose an imminent threat to public health
Screening food and medical products imported into the U.S.

On the other hand, the US Department of Health and Human Services (HHS) published a contingency staffing plan announcing that routine regulatory and compliance activities including some medical product, animal drug, and most food-related activities will come to a halt, as they are less likely to have an immediate impact on the health and safety of consumers. Establishment inspections, cosmetics and nutrition work, and many ongoing research activities will also be paused for as long as the lapse in funding continues.

This has impacted FDA branches like the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), whose work is not supported by user fees. Therefore, they will be unable to process any requests until they are fully staffed, meaning that it is highly likely that GRAS Notices and Food Additive Petitions (FAP) will not be evaluated. Indeed, the federal register stopped publishing on 3 January 2019.

Feel free to contact us if you have any questions or concerns about how this will impact your business.