FDA asks (not tells) formula makers to disclose contamination

FDA outlines food safety concerns in infant formula plants, urges industry to follow rules. A campaign to take the F out of FDA. Biden’s budget calls for increases at FDA, USDA.

Baby hands folded in front of a bottle of formula on its side.s

Note: This post has been updated to include statements from FDA clarifying that the agency does not have the authority to require infant formula makers report when they find contaminated product.

This post will be further updated if formula companies respond to questions from Food Fix about whether they will voluntarily comply with FDA’s ask.

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Alright, let’s get to it –



Today, in Food Fix: 

– FDA outlines food safety concerns in infant formula plants, urges industry to follow rules

– A campaign to take the F out of FDA

– Biden’s budget calls for increases at FDA, USDA


FDA asks formula makers to disclose contamination

FDA sent a letter this week to infant formula manufacturers and others in the industry asking them to voluntarily notify the agency when products test positive for either Salmonella or Cronobacter sakazakii, the pathogen that sparked the infant formula crisis.

If you’re thinking, Wait, isn’t this already mandated? It’s not. As I’ve previously reported, infant formula makers are not required to notify the agency of positive tests; however, they are required to halt shipment of products that test positive. FDA typically learns about a plant’s positive test results later during routine annual inspections. One potential problem with the current approach: If the agency ultimately determines a plant didn’t hold back enough product to ensure nothing contaminated made it onto the market, well … that’s not something FDA would know about until long after the fact.

FDA said in a statement late Friday that the agency does not currently have the authority under federal law to require notification unless the product has left the manufacturer’s plant.

“Congress alone can change that provision, not the FDA,” an agency spokesperson said.

Voluntary, not mandatory? I asked Steven Abrams, one of the country’s foremost experts on formula and a professor in the department of pediatrics at Dell Medical School at the University of Texas at Austin, what he thought about this letter – and he did not hold back.

“Why in God’s name are they asking for voluntary notification as opposed to mandatory notification?” Abrams said. “The answer, I believe, is they don’t have the legal authority, they’d have to go through the rulemaking process. But there’s an organization in Washington that doesn’t have to go through a rulemaking process called Congress.”

“Why not make it mandatory?” Abrams continued. “For the past 14 months the FDA has wanted this information. Why 14 months later are they asking for this voluntarily? Why haven’t they started that rulemaking process?”

An agency spokesperson responded in a statement late Friday: “Without statutory authority, we are not in the position to undertake rulemaking to require such reporting.” FDA in a budget document released on Thursday asked Congress for the authority to require this notification (I had missed this). The agency did not immediately respond to questions about whether this authority had ever been previously requested. The ask was not in FDA’s budget request last year.

Will the industry comply? I reached out to several major infant-formula makers to ask if they will voluntarily report their positive test results, as FDA has asked. I did not get a response from Abbott, Reckitt, Perrigo or Bubs. I’ll update this post if I do.

The Infant Nutrition Council of America (INCA), an industry trade group, said in a statement to Food Fix the group supports FDA, “in its mission to ensure food safety and promote nutrition for all consumers.”

“INCA Members take seriously their responsibility and work every day to provide quality nutrition to America’s most vulnerable population,” the group said. “As we review the FDA’s powdered infant formula safety learnings, we look forward to continuing to work with the FDA to ensure the safety of infant formula products.”

Why is this letter being sent now? It’s not entirely clear, but the FDA is under substantial pressure not only to fix its dysfunctional foods division, but also to get a better handle on infant formula safety in the wake of the crisis. 

As I recently reported for Politico, little has changed to prevent infant formula outbreaks in the past year. The industry isn’t under any new regulatory requirements – nor have any been proposed – though FDA has released a high-level draft strategy aimed at preventing Cronobacter illnesses. The agency has also been reviewing infant formula plant records more thoroughly during inspections, and in some cases this has sparked formula recalls months after problems were discovered. 

A closer look: Over the past year, FDA has also caught up on infant formula plant inspections after missing a whole bunch during the pandemic. After taking a closer look at plant conditions, the agency’s letter this week was a de facto report card for the industry – and the grade was basically: Do better.  

The agency specifically called out five areas “for improvement” across the industry, including better controlling water in dry production areas (important because moisture can help bacteria grow) and taking “appropriate corrective actions” after a pathogen is found either in a plant environment or a product sample, among other issues. For those non-food safety experts: Yes, this is just as basic as it sounds.

“FDA calls on all members of the infant formula industry to use the information in this letter to take prompt action to improve processes and programs for the protection of our most vulnerable population,” read the letter from FDA.

Mitzi Baum, CEO of Stop Foodborne Illness, a food safety group representing victims of outbreaks, issued a statement this week expressing concern about the letter, which essentially reminds the industry to follow existing federal rules.

“It is unfortunate infants had to get sick and die in order for the FDA to request companies to ‘ensure full compliance with all relevant regulations,’” Baum said. “This letter is alarming and should be a call to action for consumers.”


A campaign to take the F out of FDA

Plaintiffs attorney Bill Marler, who specializes in foodborne illness litigation, told me this week that when he read the aforementioned letter FDA sent to infant formula makers, it reminded him of a similar letter the agency sent to the leafy greens industry back in 2005. 

At the time, FDA wrote that it had “serious concern” about just how many outbreaks had been linked to lettuce and other greens. 

Déjà vu? “We encourage firms to consider modifying their operations accordingly to ensure that they are taking the appropriate measures to provide a safe product to the consumer,” the agency wrote to the industry.

This letter was sent right before the deadly 2006 E.coli O157:H7 spinach outbreak hit, an incident that was catastrophic both for the victims – 276 people were sickened and three people died – and the spinach industry, which took several years to recover financially. Outbreaks tied to leafy greens continue regularly.

“The FDA letter to the infant formula manufacturers is the same BS – it is only when, not whether, there will be another outbreak leading to empty shelves,” Marler said. (Disclosure: Marler is the publisher of Food Safety News, where I worked 10 years ago).

Swinging for the fences: Marler, like many others in the food space, has become extremely fed up with FDA’s slowness on just about every issue. This week, he kicked off his own campaign to wrest food out of the FDA – a longshot idea that’s getting a bit more traction as advocates and industry leaders fume over the agency’s direction

Michael Taylor, former deputy commissioner for foods and veterinary medicine at FDA, is among the most prominent voices backing this idea. “I believe the long-term solution to fixing FDA is to break it up and create a separate agency dedicated solely to oversight of food,” Taylor wrote last year in Politico.

This week, Marler began running ads in Politico and the Hill under the headline, “Get the F out of the FDA,” and he’s sending T-shirts to lawmakers on Capitol Hill with the same slogan. (A more than $50,000 project, he said.) He’s been flooded with hundreds of requests for the shirts, including from current USDA and FDA employees who asked for the shirts to be mailed to their home addresses. “I’m going to have to buy more shirts,” Marler said. 

An advertisement featuring a photo of a baby drinking out of a bottle. Bold red text reads: Get the F out of the FDA. "Americans - including babies - are dying for a real, dedicated Food Agency."
Credit: Bill Marler

About that F in FDA: It appears the brash new campaign is on FDA Commissioner Robert Califf’s radar. “There should be no question in anyone’s mind that the F in FDA is a top priority for me,” Califf wrote in a lengthy Twitter thread this week. 

“Creating a new foods agency isn’t in the FDA’s purview and would take years to put in place and distract from the important work that needs to be done today,” he added.


Biden’s budget calls for increases at FDA, USDA

President Joe Biden requested a bump in discretionary spending at both FDA and USDA in the fiscal year 2024 budget he unveiled on Thursday. 

Significant increase for FDA foods: The plan called for an increase of $133 million to “strengthen FDA’s food safety and nutrition capacity, demonstrating the administration’s ongoing commitment to these responsibilities.” The agency said it is seeking more resources to “modernize oversight of infant formula, empower consumers to make healthier food choices, and reduce exposure to toxic chemicals in the food supply.”

Overall, the budget calls for $7.2 billion for FDA, including a roughly 10 percent increase in discretionary spending. (For the non budget wonks: Discretionary is what’s appropriated by Congress. FDA is also substantially funded by industry user fees, though its foods program is funded almost exclusively through appropriations, not user fees.)

Growth for USDA, kind of: The budget seeks a more than 14 percent increase to discretionary spending at USDA. The vast majority of USDA spending, however, is through mandatory programs, so USDA’s overall spending is projected to decrease – from $261 to $228 billion –  largely due to shrinking costs for SNAP, the Supplemental Nutrition Assistance Program. 

SNAP costs are projected to decrease due to the end of the emergency allotments – AKA the SNAP benefits cliff – and fewer individuals participating in the program in an improving labor market. 

Expanding free lunch: One policy proposal of note: The budget proposes $15 billion to expand free school meals access to 9 million more school children by increasing participation in what’s known as the Community Eligibility Provision (CEP), which allows higher-need schools to serve free school meals to all students.

Who cares about the budget: It’s important to recognize that a president’s budget is always dead-on-arrival in Congress – it’s up to Congress to actually set spending levels – but it’s still an important document, as it publicly outlines the administration’s priorities. 

More details to come: The nitty gritty details of the president’s budget won’t come out until next week. Pro tip: The good stuff is always in the appendix… which is not yet available.


What I’m reading

A new digital hunger museum (MAZON). I got an early look at a virtual museum launched this week by anti-hunger group MAZON: A Jewish Response to Hunger. Its storytelling of the history and politics of hunger is super interesting! The group hired an architect to design a real building and place it symbolically between the U.S. Holocaust Memorial Museum and the USDA in Washington, D.C. (though the experience is purely virtual).

Kroger taps Boehner for merger push (Politico). “Grocery giant Kroger is bringing in the big guns in its bid to secure federal approval to merge with rival grocery chain Albertsons, enlisting former House Speaker John Boehner and a team of bipartisan lobbyists at Squire Patton Boggs to rally support for the deal despite antitrust concerns,” reports Caitlin Oprysko. “The former speaker still has no plans to register to lobby on the merger, and will instead serve as a strategic adviser to the grocer.”

WeightWatchers to enter prescription drug weight loss business (Associated Press). “WeightWatchers shares soared Tuesday after the company said it was getting into the prescription drug weight loss business with the acquisition of Sequence,” reported Michelle Chapman. Sequence, a telehealth operator, says that its specialists can prescribe medications under brand names including Ozempic, Wegovy and Trulicity.”


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