Last week, the Food and Drug Administration (FDA) announced the agency has sought an external review of its approach to food safety. The surprising announcement, issued by FDA commissioner Dr. Robert Califf, says the review will look primarily at work carried out by the FDA's Office of Food Response and Policy (OFPR) and Center for Food Safety and Applied Nutrition (CFSAN).
In his announcement, Califf stresses that America's food supply is safe. But he also notes issues with the agency's food-safety inspection regime and says "the increasing diversity and complexity of the nation's food systems and supply chain" have raised fundamental "questions about the structure, function, funding[,] and leadership" of the FDA.
As Politico, The New York Times, and others have reported, the external FDA review comes as the agency is hammered for its role in an ongoing shortage of baby formula. But suggestions that this review is all (or even largely) about baby food are likely off base. Consider that Califf's announcement didn't mention baby formula. What's more, the it's-the-baby-formula crowd suffers from recency bias. In fact, there's no shortage of non-formula reasons why the FDA's food-safety oversight is in critics' crosshairs.
Last year, for example, the FDA celebrated the ten-year anniversary of the Food Safety Modernization Act (FSMA), which the agency and many of the law's supporters have touted as the most extensive, impactful, and important overhaul of the FDA's food-safety authority in more than 75 years. It's not. As I noted in a column marking FSMA's first (and hopefully last) decade, CDC estimates of the number of annual cases of foodborne illness in America have remained unchanged in the wake of FSMA's passage and implementation.
"Lest you think those CDC estimates merely haven't been updated in some time," I wrote, "the agency reported [in 2021] that '[t]he incidence of most infections transmitted commonly through food has not declined for many years.'" That means a decade on that the big, signature FDA approach to preventing foodborne illness before it happens has been costly but has not made people or food safer. Why not? That's because FSMA's shortcomings are baked into the law.
"Even if implemented to absolute perfection"—as I detail in my book, Biting the Hands that Feed Us: How Fewer, Smarter Laws Would Make Our Food System More Sustainable— "the FDA's own best-case scenario is that [two key FSMA rules pertaining to human food] would spur a 2.6% reduction in total annual foodborne illness cases," I've explained. But FSMA hasn't even achieved that underwhelming improvement.
I know FSMA stinks. But does the FDA?
Even before FSMA's ten-year anniversary, some within the agency were busy looking for a better approach. One such plan, which I detailed in a 2020 column, involves what the FDA refers to as a "New Era of Smarter Food Safety," an approach another senior FDA official—Frank Yiannas—identified as "the approach FDA will take over the next decade" to improve food-safety outcomes.
Yiannas's proposal was light on details. But I explained it appears intended to ramp up the use of technology to improve traceability and reduce the spread and impact of future cases of foodborne illness.
If FSMA was about preventing foodborne illness from happening, the "New Era" is about what the FDA should do when foodborne illness does happen. For an agency that touted the preventative nature of FSMA as the biggest food-safety improvement in 75 years—along with its allies in corporate America, the food-safety establishment, and Congress—the "New Era", coupled with news of the external review, appears to be an acknowledgement that FSMA has been a catastrophe.
More recently, in April, an in-depth Politico investigation into the FDA found numerous problems within the same exact OFPR and CFSAN offices that Califf identified this month as now subject to the external review. The excellent Politico investigation, which I detailed in a column, concluded the FDA is "failing to meet American consumers' expectations on food safety." Critics quoted in the Politico piece characterized the agency's regulation of the food supply invariably as "ridiculous," "impossible," "broken," "byzantine" and "a joke."
This month's FDA announcement about the external food safety review also comes as Congress once again ponders stripping the agency of its food-safety oversight, in favor of a unitary, new food-safety agency. The proposal is the work of food-safety advocates who blindly saw FSMA as a panacea rather than as the albatross it was and is.
"The FDA is failing to uphold its most basic food safety responsibility: inspecting facilities," Sen. Dick Durbin (D-IL) said in support of the new bill. "Over the past decade, the number of inspections it performs has fallen by nearly 60 percent. And to add insult to injury: The decline happened after Congress passed the FDA Food Safety Modernization Act, or FSMA, a 2011 bill which I authored that instructed the FDA to increase the number of inspections it performs."
There's nothing inherently wrong with any entity—be it public or private, big or small—reevaluating its approach to some of its key activities. But this is the FDA—which regulates around 80% of the nation's food supply and which has been charged for decades with overseeing the safety of that food supply. The fact the FDA has now effectively thrown up its hands over its most important food-related role is not a sign the agency—or lawmakers or consumers—should have much confidence in its abilities. What's more, as Politico also reports, the congressionally created group that will conduct the "external" review of the FDA—the Reagan-Udall Foundation for the FDA—has "a close relationship with high-ranking agency officials."
"I will be eager to learn more details about how the foundation will ensure that their process is independent, especially considering that the foundation's purpose is to support the mission of the FDA," Brian Ronholm, a former USDA official, told Politico. While we're on the topic of missions, the FDA is failing at this most important one: to improve food safety in America.