Food imports into the U.S. are on the rise. The trend now is for agricultural commodity trade deficits, rather than surpluses, with key commodities like beef usually in a deficit. Despite the increase in food imports, the Food and Drug Administration conducted far fewer than the annual goal of 19,200 inspections, according to FDA data.
The FDA has not met its domestic and foreign inspection targets since fiscal year 2018, a Jan. 8 report by the Government Accountability Office said. This is not the first time the GAO has warned that the FDA is slipping further behind in its inspection duties.
The FDA Food Safety Modernization Act (FSMA) directs FDA to inspect so-called high risk domestic food facilities (those with past inspection problems) at least once every three years and each non-high-risk facility (those with no past inspection problems) at least once every 5 years. The GAO report said the FDA almost met its inspection numbers in fiscal years 2018 and 2019, but everything fell apart in 2020 due to the pandemic. The FDA failed to inspect about 7% of high-risk domestic facilities during fiscal year 2019 but that number hit 49% in 2021.
The FDA considers the existing targets to be unrealistic and unachievable. Still, FDA has not yet identified an appropriate annual target, as the GAO recommended inJanuary 2015.
The highest annual number of facilities inspected by the FDA came in fiscal year 2019 when 1,727 foreign facilities were visited, or just 9% of the annual target. As of March 2023, approximately 125,000 foreign food facilities were subject to FDA inspection. And the FDA projected it would be able to conduct only 1,008 foreign inspections in fiscal year 2024 based on its existing staff and financial resources.
The FDA is responsible for ensuring the safety of nearly 80% of the nation’s food supply. GAO put FDA’s inspection problems on its High-Risk List first in 2007. It was listed again in 2023.
FDA officials told the Government Accountability Office in August 2024—nearly 10 years after it recommended setting a target for foreign inspections —that they do not intend to take any further action. The GAO maintains that identifying an appropriate annual target for conducting foreign inspections and using it to assess FDA’s performance in safeguarding imported food is important. “Without pursuing (this option and others), the FDA will remain unable to measure the performance of its overall foreign inspection efforts or assess whether such efforts are achieving intended results— protecting U.S. consumers,” the January 8th GAO report stated.
The GAO said FDA officials it interviewed do not plan to take additional actions to address the GAO’s recommendations on inspections. Legislative action by Congress would help ensure that the FDA provides Congress with the information it needs to assess the FDA’s foreign inspection program and decide whether FDA’s annual target for conducting these inspections should be updated.
The GAO analyzed assorted FDA data on foreign food safety inspections from fiscal year 2018 through fiscal year 2023 for the January report.
Improving food safety and pharmaceutical lab inspections were both on the GAO’s High Risk List in 2023
The FDA has faced similar complaints about overseas inspections of generic drug manufacturers. Hearings were held on this last year in Congress.
In 1998, the GAO said the FDA had problems with the timeliness with which investigators submitted inspection reports, their frequency of routine inspections, and delays in taking prompt enforcement action against foreign drug manufacturers. In 2007, the GAO complained that the FDA did not know how many foreign manufacturers were even subject to inspection, and that the agency inspected relatively few foreign labs. In a 2022 report, the GAO noted that the FDA was struggling to inspect those labs and hold foreign drug makers accountable when their labs failed inspection.
In 2023, a ProPublicainvestigation revealed that the FDA’s inspections of overseas drug manufacturers dropped even as the number of manufacturers remained relatively steady. In fiscal year 2019, the year before the pandemic, the FDA inspected 37% of the nearly 2,500 overseas manufacturers and in 2022, it inspected a reported 6% of 2,800 labs on its list. In India, where most generic drugs are made, the FDA inspected only 3% of approved labs in 2022 — less than in 2019, when only 45% of plants were reviewed.
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As Food Imports Rise, FDA Drops Ball on Food Inspections Worldwide
Food imports into the U.S. are on the rise. The trend now is for agricultural commodity trade deficits, rather than surpluses, with key commodities like beef usually in a deficit. Despite the increase in food imports, the Food and Drug Administration conducted far fewer than the annual goal of 19,200 inspections, according to FDA data.
The FDA has not met its domestic and foreign inspection targets since fiscal year 2018, a Jan. 8 report by the Government Accountability Office said. This is not the first time the GAO has warned that the FDA is slipping further behind in its inspection duties.
The FDA Food Safety Modernization Act (FSMA) directs FDA to inspect so-called high risk domestic food facilities (those with past inspection problems) at least once every three years and each non-high-risk facility (those with no past inspection problems) at least once every 5 years. The GAO report said the FDA almost met its inspection numbers in fiscal years 2018 and 2019, but everything fell apart in 2020 due to the pandemic. The FDA failed to inspect about 7% of high-risk domestic facilities during fiscal year 2019 but that number hit 49% in 2021.
The FDA considers the existing targets to be unrealistic and unachievable. Still, FDA has not yet identified an appropriate annual target, as the GAO recommended in January 2015.
U.S. Faces Record Agricultural Imports, Worst Trade Deficit in History
The United States is now on pace to reach a $39 billion agricultural trade deficit in 2024 amid all-time record imports.
Foreign food suppliers were inspected less.
The highest annual number of facilities inspected by the FDA came in fiscal year 2019 when 1,727 foreign facilities were visited, or just 9% of the annual target. As of March 2023, approximately 125,000 foreign food facilities were subject to FDA inspection. And the FDA projected it would be able to conduct only 1,008 foreign inspections in fiscal year 2024 based on its existing staff and financial resources.
The FDA is responsible for ensuring the safety of nearly 80% of the nation’s food supply. GAO put FDA’s inspection problems on its High-Risk List first in 2007. It was listed again in 2023.
The GAO said FDA officials it interviewed do not plan to take additional actions to address the GAO’s recommendations on inspections. Legislative action by Congress would help ensure that the FDA provides Congress with the information it needs to assess the FDA’s foreign inspection program and decide whether FDA’s annual target for conducting these inspections should be updated.
The GAO analyzed assorted FDA data on foreign food safety inspections from fiscal year 2018 through fiscal year 2023 for the January report.
Improving food safety and pharmaceutical lab inspections were both on the GAO’s High Risk List in 2023
The FDA has faced similar complaints about overseas inspections of generic drug manufacturers. Hearings were held on this last year in Congress.
In 1998, the GAO said the FDA had problems with the timeliness with which investigators submitted inspection reports, their frequency of routine inspections, and delays in taking prompt enforcement action against foreign drug manufacturers. In 2007, the GAO complained that the FDA did not know how many foreign manufacturers were even subject to inspection, and that the agency inspected relatively few foreign labs. In a 2022 report, the GAO noted that the FDA was struggling to inspect those labs and hold foreign drug makers accountable when their labs failed inspection.
In 2023, a ProPublica investigation revealed that the FDA’s inspections of overseas drug manufacturers dropped even as the number of manufacturers remained relatively steady. In fiscal year 2019, the year before the pandemic, the FDA inspected 37% of the nearly 2,500 overseas manufacturers and in 2022, it inspected a reported 6% of 2,800 labs on its list. In India, where most generic drugs are made, the FDA inspected only 3% of approved labs in 2022 — less than in 2019, when only 45% of plants were reviewed.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
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