Food inspections, drug reviews at risk as shutdown slows FDA

FILE - In this Nov. 20, 2018, file photo Lisa Dennis selects a head of green lettuce from the vegetable shelves at the East End Food Co-op Federal Credit Union in Pittsburgh. Health officials on Monday, Nov. 26, said it's OK to eat some romaine lettuce again. The Food and Drug Administration is narrowing last week’s alert warning people not to eat any romaine because of an E. coli outbreak. The agency hasn’t identified a source of contamination. But it says it's OK to eat romaine from parts of California and Arizona that were not harvesting when the illnesses began in October. (Jessie Wardarski/Pittsburgh Post-Gazette via AP, File)
Pittsburgh Post-Gazette via AP/File
A woman shopped for lettuce in Pittsburgh in 2018.

The head of the Food and Drug Administration said that a government shutdown prevents it from doing some routine food safety inspections, and that the agency is weeks away from running out of funds it uses to review new drugs and medical products.

‘‘The functions that can most directly impact consumer safety will continue, to the best of our abilities, subject to the legal and financial limitations of the current circumstances,’’ FDA Commissioner Scott Gottlieb said in a tweet Tuesday.

In a subsequent post Wednesday, Gottlieb said the agency’s limited food safety inspections would be focused on products like seafood, soft cheeses, and unpasteurized juice that are more susceptible to food safety risks, compared to more routine inspections.


Unlike the US Department of Agriculture’s slaughterhouse inspectors, who are still on the job unpaid, the FDA performs spot checks in domestic processing facilities, focusing on those with higher risks; they are not keeping watch around-the-clock.

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‘‘FDA doesn’t tend to do inspections of those unless there’s been a problem,’’ Sarah Taber, a food safety consultant, told Bloomberg. For some foods, most major grocers and distributors require third party, non-government audits.

In a possible sign of the slowed pace of inspections, the FDA hasn’t posted any new warning letters since the beginning of the shutdown, the Center for Science in the Public Interest said in an e-mail.

‘‘That raises concerns that enforcement activities may have effectively stopped,’’ the center said.

Its regulation of new medical products could be affected as well. While the FDA’s drug and medical device approval processes are partly funded with fees from companies, that money will run out since the agency can’t collect new fees during the shutdown.

Scott Gottlieb. MUST CREDIT: Bloomberg photo by Toya Sarno Jordan
Toya Sarno Jordan/Bloomberg
FDA head Scott Gottlieb.


Gottlieb said on Jan. 5 that the agency has enough left over funds to keep reviewing drugs and other medical products for about a month. After that, new drugs won’t get assessed by the agency unless the government reopens.

The agency pays for medical manufacturing and food safety inspections out of its own budget. According to a shutdown contingency plan published by the Department of Health and Human Services, the FDA ‘‘would be unable to support many routine regulatory and compliance activities,’’ including medical product, animal drug, and food inspections. It would also halt some research projects, according to the plan.