FDA Lacks Resources and Power to Prevent Foodborne Outbreaks: Report

The U.S. Food and Drug Administration (FDA) needs a massive dose of both resources and power in order to properly protect America’s food supply, according to a new report by medical and scientific policy experts. 

Researchers from the Institute of Medicine and the National Research Council say that the FDA needs to be reorganized and reinvigorated so that it can properly ensure food safety. It also needs the ability to force mandatory food recalls, as opposed to recommending or trying to leverage companies into voluntary recalls during foodborne illness outbreaks or contamination events, the report says.

There are approximately 76 million foodborne illnesses each year in the United States, according to the new report, “Enhancing Food Safety: The Role of the Food and Drug Administration,”  which was requested by Congress. Those illnesses cause more than 300,000 hospitalizations and 5,000 deaths annually.

For the FDA to properly regulate an estimated 80% of the nation’s food supply, the agency’s food safety departments need to be restructured to fit a risk-based approach that coordinates data and expertise to quickly find the weak links in the food production and distribution chains where contamination and other problems are most likely to occur. Then the agency would be able to quickly and efficiently target the problem areas with the necessary resources and increase its chances of catching dangerous, and sometimes deadly, food outbreaks before they occur.

But, such a task is not easy, and may not be possible in the FDA’s current form, the report warns. The FDA is responsible for monitoring compliance of 150,000 food production facilities, more than 1 million restaurants, more than 2 million farms and millions of tons of foreign imports. Currently, it does not have the resources to do that job properly, analysts determined.

Where it is simply impractical to provide the FDA with all the resources it needs, such as in its ability to perform regular inspections, the FDA should work with states and delegate more inspection responsibilities. The agency could provide proper training for state inspectors and increase their role in monitoring food facilities, the report noted.

The agency also needs to be able to force companies to recall products, experts said. Currently, recalls are voluntary, though they often come due to intense pressure from FDA.

The call for increased recall power mirrors similar statements being made by lawmakers about the FDA’s ability to issue drug recalls. At a congressional hearing last month, Representative Edolphus Towns said he intends to introduce legislation that gives the FDA the power to force drug recalls when the drugs are found to be dangerous.

The calls for more FDA power have been increasing throughout this congress, with Senator Tom Harkin, chairman of the Senate Committee on Health, Education, Labor and Pensions, writing to FDA Commissioner Margaret Hamburg last month regarding the recall of 136 million bottles of children’s liquid medications by Johnson & Johnson subsidiary, McNeil Consumer Healthcare. In the letter Harkin repeatedly asked if the FDA had sufficient power to handle drug recalls, and whether the power to force drug recalls would be beneficial to achieving the agency’s goals.