FDA Celebrates 10-Year Anniversary of a Food Safety Law That Hasn't Made Our Food Safer

The Food Safety Modernization Act is all hat and no cattle.


In a week when hundreds of President Trump's supporters stormed the U.S. Capitol as part of an effort to overturn the legitimate results of the 2020 presidential election—the latter of which Congress subsequently confirmed was won handily by President-elect Joe Biden—you'd be forgiven if it escaped your notice that one of the country's worst food laws, the Food Safety Modernization Act (FSMA), just celebrated the 10th anniversary of its signing.

FSMA, which was signed into law on January 4, 2011, by President Obama, gave the Food and Drug Administration (FDA) "more power to crack down on food-safety scofflaws and decrease the incidence of foodborne illness across the country," I detailed in a 2012 law-review article, The Food-Safety Fallacy: More Regulation Doesn't Necessarily Make Food Safer.

Before madness overtook the Capitol this week, the FDA was celebrating the law's birthday.

"It's not enough to respond to outbreaks of foodborne illness," said Frank Yiannas, the FDA's deputy commissioner for food policy, in a statement this week. "We must prevent them from happening in the first place."

That shift from a reactive to a proactive agency, Yiannas notes, was Congress's mandate to the FDA in passing FSMA, the most noteworthy update of agency food-safety enforcement in decades. So how's it going?

Yiannas describes what he sees as FSMA's key accomplishments, including that food businesses "are now taking concrete steps every day to reduce the risk of contamination" and that the law has caused a "bigger conversation about the importance of food safety," strengthened agency partnerships with business and civil society, "advanced food safety," and fostered "safer food in this country."

But has it really done that?

In 2011, before FSMA was implemented, the Centers for Disease Control, which tracks and responds to foodborne illness outbreaks, estimated that tainted food causes around 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths in the United States each year. Today, a decade on, those CDC estimates remain unchanged. Lest you think those CDC estimates merely haven't been updated in some time, the agency reported earlier this year that "[t]he incidence of most infections transmitted commonly through food has not declined for many years."

So if FSMA has not reduced cases of foodborne illnesses, hospitalizations, and deaths, then what was it all for?

Well, it turns out the law wasn't really designed to reduce those illnesses, hospitalizations, or deaths. Indeed, the idea that FSMA would revolutionize the FDA by changing it from a reactive to a proactive agency always rang hollow. The FDA predicted that FSMA's best-case reductions in foodborne illness would be an annual decline between 3.7 percent and 5.4 percent. Even that didn't happen.

The FDA knows FSMA is failing to achieve its objectives. Consider that nearly any time the agency discusses FSMA, it refers to foodborne illness as "a significant public health burden that is largely preventable." In 2015, Dr. David Acheson, a former FDA associate commissioner for foods, rightly argued that the key marker for FSMA's success would be whether the law "drive[s] down foodborne illness" and yields "the public health gains that this is all about." But in 2018, a FSMA working group reported that using cases of foodborne illness to assess FSMA's efficacy is "a high bar to prove a relationship to the FSMA rules."

That may be true. But FSMA cannot be a success if overall foodborne illness numbers don't fall. Dramatically. And they have not.

To be fair, FSMA isn't all bad. The law did give the FDA one important power—the authority to order a recall of foods that are adulterated (tainted) or misbranded (labeled inaccurately), either of which could sicken or kill one or more persons. And though FSMA is a needless burdensome, clearly ineffective, and costly law that should be repealed forthwith, that's not to say all federal food-safety laws or programs are wrongheaded. They're not.

For example, I've explained previously that the CDC's PulseNet tracking program, which "prevents more than 275,000 cases of foodborne illness each year," is a smart and highly successful program for tracing, combating, and limiting foodborne illness outbreaks. It's also inexpensive and doesn't impose additional regulations on food producers.

Toward the end of Yiannas's statement this week on FSMA, he references a new FDA approach he's championing: the New Era of Smarter Food Safety.

That evolving approach, which I explained last year will "ramp[] up the use of technology to improve traceability and reduce the spread and impact of future cases of foodborne illness," is at odds with the proactive approach implemented under FSMA.

That fact alone makes the New Era of Smarter Food Safety sound both realistic and promising. And it reiterates—along with CDC data and other factors—that a decade on, FSMA has failed to meet the lofty food-safety goals its supporters argued it would achieve.