Politico's investigation into the silent F of the FDA:
How the FDA’s food division fails to regulate health and safety hazards
The long article has a takeaway summary:
4 takeaways from our investigation into the FDA's byzantine food arm
How the FDA’s food division fails to regulate health and safety hazards
By the time FDA officials figured out it was spinach that was making people sick in 10 states – sending three people into kidney failure – it was too late. It was mid-November 2021 and the packaged salad’s short shelf life had passed. There was no recall. By the time FDA officials got inspectors on the ground, spinach season was over. The fields and the production facilities were empty, which made it impossible to pinpoint the source of contamination.
Whatever caused the outbreak was likely never fixed.
There are also unique structural and cultural problems within CFSAN that have escaped any real scrutiny. One of the most pressing is an open power struggle between CFSAN’s director and FDA’s deputy commissioner for food policy – a vestige of a little-known reorganization of leadership during the Trump administration that was in part recommended by the consulting firm McKinsey & Co. While the goal at the time was to reduce bureaucracy and give then-Commissioner Scott Gottlieb more of a direct line into the various FDA centers, the change meant eliminating a powerful deputy commissioner position that used to oversee the entire foods program and left the decision-making structure unclear.
Under the new structure, Frank Yiannas is deputy commissioner for food policy and response, reporting directly to the commissioner, but his post doesn’t actually have authority over the foods program. Susan Mayne is the director of CFSAN, which means she oversees the foods program, but she also reports directly to the commissioner and doesn’t report to Yiannas. It’s an unconventional setup that tends to pit the two top officials against each other.
“It's a structure that's designed to fail,” said one former senior FDA official. “You couldn't come up with a better way to keep the program from working well.”
Cronobacter sakazakii – a rare but deadly bacteria – sparked a massive recall of infant formula, exacerbating already strained supply chains. The agency is still investigating the incident, but so far four hospitalizations and two deaths have been linked to formula produced by Abbott Nutrition at a single plant in Sturgis, Mich., including Similac, the most popular formula brand on the market.
The agency has so far refused to explain why it took months to inspect the plant and subsequently recall product. As POLITICO first reported, the first infant illness was reported to federal health officials in September. Inspectors were not sent to the plant to investigate until late January. Product was not recalled until February. A handful of key Democrats on Capitol Hill are now pressing for answers. DeLauro, the House Appropriations chair, recently requested an inspector general investigation into the agency’s response.
A year ago, however, FDA was in the hot seat over a completely different issue tied to babies: A congressional report had flagged concerns about heavy metals and other neurotoxins in baby food, sparking a wave of mainstream press coverage and throngs of furious parents.
Several years before this blew up, top FDA officials were on a call about the issue.
Advocates and members of Congress noted the lack of timelines or deadlines and criticized the agency for not committing to timely action. A month later, FDA tried again and rolled out a “Closer to Zero” action plan. By this point, the agency had, under pressure, set some deadlines, but its timeline extended out more than three years. The agency said that within a year it could set draft limits for lead in certain categories of foods for babies and young children. (The agency is on track to miss its April deadline, but said it's aiming for later this spring.) Draft limits for arsenic would come sometime between 2022 and 2024, FDA said. Other neurotoxic elements like cadmium and mercury are on even longer tracks, with the agency proposing, but not committing, to come up with draft limits sometime beyond 2024.
Advocates started to darkly joke about how old their kids and grandkids would be by the time there were standards in place for baby foods. “So let me get this straight, my kiddo is going to be in the second grade, and you're going to tell me what kind of baby food to give him?” Bowen said, of the lengthy timeline.
Meanwhile, the FDA lacks a strong track record of enforcing the one important baby food standard it put on the books: a suggested limit of 100 parts per billion for inorganic arsenic in infant rice cereal, which is the first solid food millions of families feed their babies.
The standard has, by all accounts, substantially helped to reduce arsenic levels in rice cereal. Food producers quickly cut down the average levels in rice cereals to be below that threshold, though many health advocates note the limit was based on what was feasible for industry and is still too high to be protective of babies’ health.
But it’s also not clear the agency is consistently enforcing that standard. The FDA does little routine testing of infant rice cereals. The congressional panel that’s been investigating baby foods issued a follow up report last fall revealing that testing done by the state of Alaska (which had been funded by FDA), flagged two products as being over the FDA’s limit for inorganic arsenic in the summer of 2021: Beech-Nut and Gerber brands. Beech-Nut responded by issuing a recall – the first ever under the arsenic standard – and went as far as to exit the infant rice cereal food market, citing difficulty obtaining rice that wasn’t too high in inorganic arsenic. Nestle, which owns Gerber, didn’t issue a recall at all. When POLITICO asked why, a spokesperson for the company said that FDA had told the company a recall wasn’t necessary.
The agency confirmed this.
The long article has a takeaway summary:
4 takeaways from our investigation into the FDA's byzantine food arm
1.
The food division has structural and leadership problems
What we found: Aside from the lack of attention to food at the top, there are also unique problems within the Center for Food Safety and Applied Nutrition, the branch that handles food issues. The division suffers from a deep-seated culture of avoiding hard decisions and a near-paralyzing fear of picking serious fights with the food industry.
A Trump-era change in leadership structure set up a power struggle between the two top officials, further strengthening the status quo of inaction. The agency is adrift without leadership and currently plagued by turf battles.
Why this matters: The friction makes it extremely difficult to make decisions or move policies forward. The setup is also confusing for those trying to work with the agency. Who is actually making decisions?
Where to read more: Check out the “IT’S A STRUCTURE THAT’S DESIGNED TO FAIL” section of the story.
2.
Congress asked FDA to regulate water to keep deadly pathogens out of produce. 11 years later, it still hasn’t.
What we found: In 2011, President Barack Obama signed a sweeping food safety reform bill into law that was supposed to help prevent deadly foodborne illness outbreaks. Since that time, FDA has failed to put in place safety standards for the water used to grow fresh produce, as mandated by that law, despite knowing that water is one of the main ways fresh fruits and vegetables become contaminated with deadly pathogens.
In December 2021, the FDA put out an updated proposed rule to address agricultural water, but the rule has not yet been finalized or implemented.
Why this matters: Foodborne illness outbreaks keep happening and it often takes the agency too long to respond, as more people become sick. Over the past decade, there have been several major outbreaks tied to fresh produce, including some deadly ones tied to contaminated water, which has long been known as a major source for contamination.
Where to read more: Check out the “A BIT OF A BLACK HOLE” section of the story.
3.
FDA made little progress on keeping toxic elements out of baby foods
What we found: The FDA has had a work group focused on toxic elements in the food supply since 2017, but has taken little action, even as concerns about heavy metals and other toxic elements in baby food have been repeatedly flagged by health groups and Congress.
Responding to enormous outside pressure, FDA in 2021 committed to setting standards for lead, cadmium, mercury and arsenic in some baby foods, but the timeline for action spans several years.
Why this matters: It’s important to keep babies’ exposure to heavy metals and other toxic elements as low as possible because they are particularly vulnerable to developmental and other effects. Lead exposure in children can cause behavioral problems and lowered IQ.
Where to read more: Check out the “THE RAGE OF A MILLION PARENTS” section of the story.
We want to hear from you: Have you complained to the FDA about the Similac recall or another infant formula recall? Tell us.
4.
FDA has not taken timely action to help cut sodium consumption
What we found: The FDA has for many years stated that cutting sodium across the food supply is a major public health priority. In 2010, the Institute of Medicine advised the agency to set mandatory sodium standards, estimating that cutting sodium intake nationwide could prevent more than 100,000 deaths and save billions in health care costs each year.
The agency decided instead to set voluntary reduction goals, an attempt to dial down sodium across food categories slowly over time. It’s taken the agency roughly a decade to get some of these sodium reduction goals out the door amid stiff industry opposition and changing administrations. Meanwhile, other countries moved on similar targets years ago.
Why this matters: A recent study, published in the journal Hypertension, estimated that the FDA’s most recent four-year delay finalizing the targets may result in more than 250,000 unnecessary deaths over about a decade and a half.
Where to read more: Check out the “OUR FOOD IS KILLING US” section of the story.