Fragmented FDA leadership contributed to formula failure

– OPINION –

By Scott Faber

America’s infant formula shortage has raised urgent questions about the safety of our food supply. Most Americans believe America has the safest food supply in the world. But, the tragic failure to address contaminated infant formula as well as a hard-hitting investigation about the failures at FDA’s food safety division has revealed danegrous holes in our food safety net.

Before I joined the Environmental Working Group, I was the vice president for federal affairs for the Grocery Manufacturers Association, now called the Consumer Brands Association. During my time with GMA, the food industry was buffeted by wave after wave of foodborne illness outbreaks, including a recall of contaminated peanut products that left nine people dead and hundreds sick. These and other outbreaks ultimately led to passage of the Food Safety Modernization Act (FSMA), which included sweeping bipartisan reforms supported both by industry and consumer groups. 

Despite getting new authorities and new tools, our food supply does not appear to be much safer. Since the enactment of FSMA in 2011, the number of outbreaks has gradually increased – at least until the COVID-19 pandemic dramatically changed our eating habits. And, there are still hundreds of recalls every year. 

What went wrong? 

First, as Congress finalized FSMA, key legislators refused to support the user fees that typically fund FDA activities (like drug and medical device reviews) despite the fact that those fees had the support of many industry leaders. Not long after, many of us worked to persuade Congress to provide more funding, but the FDA center charged with keeping our food safe remains a relatively low priority for Congressional appropriators. Funding for other FDA centers that review drugs and devices – which do have the benefit of industry user fees – has increased much faster. 

Second, the Trump FDA dismantled important reforms designed to make food safety a priority for the FDA. Obama’s FDA commissioner created a new deputy commissioner for food position with real power. But rather than give the deputy commissioner more power, especially over food safety inspections, Trump’s FDA reversed this decision, which likely contributed to FDA’s failure to quickly investigate the formula plant. 

Third, after years of delay, the FDA caved to pressure from farm interests and walked back a rule requiring fruit and vegetable farmers to test irrigation water – which is often contaminated with animal feces from nearby livestock. What’s more, the FDA has simply failed to implement a provision of FSMA making it easier to trace the origin of food safety outbreaks. More than any other provisions of FSMA, those that reduce pathogens on produce and help FDA quickly identify the source of outbreaks would help lower the number of people who get sick or worse. 

Fourth, we’re not inspecting enough food manufacturing facilities, and not making good enough use of the inspection resources we have. Despite FSMA’s inspection mandate and an increase in federal food safety spending, the percentage of food facilities inspected after passage of FSMA went down, according to HHS’ inspector general. The tragic failure to prevent the contamination of infant formula is evidence enough we’re getting it wrong. 

The problems plaguing the FDA are not limited to their failure to prevent, detect, and track pathogens. A recent report by two of my EWG colleagues found that 99 percent of the food chemicals that entered the food supply since 2000 were deemed “safe” by the chemical companies, not by the FDA. 

How do we fix it? 

For starters, policymakers need to make food safety a top priority for the FDA by addressing the fragmented leadership at the top of the agency and providing more funding for FDA’s food safety center. More funding, though important, is not enough. But, the Biden FDA has so far refused to make important changes at the top of the agency, despite calls from industry groups and consumer advocates to do so. The Biden FDA must also follow through on FSMA’s requirements to set tough standards for pathogens in produce and finally implement tools to quickly identify the source of an outbreak. The Biden FDA should also close loopholes that let chemical companies decide whether food chemicals are safe. 

Every year, thousands of Americans die from foodborne illness, thousands more are hospitalized, and millions get sick. Many of these illnesses are preventable, but only if we decide to make food safety a priority. Can Americans once again claim to have the “safest food supply” in the world? Not if the FDA’s fragmeneted leadership fails to inspect food manufacturers, lets farmers spray feces on our food, fails to quickly respond to outbreaks, and lets the chemical companies decide whether the chemicals in our food is safe.  

About the author: Scott Faber is the senior vice president for government affairs for the Environmental Working Group, He was the vice president for federal affairs for the Grocery Manufacturers Association from 2008 to 2012.

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