‘Lessons have not been learned’: FDA knew of positive test months before latest infant formula recall

Mar 30, 2023

The lag time, which mirrors the agency’s slow response ahead of last year’s historic recall, shows the agency still isn’t vigilant enough in protecting infants, critics say.

A recent recall of infant formula was announced nearly three months after Food and Drug Administration officials first learned that some products at a major plant had tested positive for bacteria — a delay that mirrors the agency’s slow response to reports of food safety problems and infant deaths ahead of last year’s massive recall over the same type of bacteria.

In late February, formula giant Reckitt issued a press release recalling 145,000 cans of Enfamil ProSobee Simply Plant-Based Infant Formula over the “possibility of cross-contamination with Cronobacter sakazakii” — the deadly pathogen that sparked the infant formula crisis last year. Dozens of news outlets covered this as breaking news, recommending parents and caregivers toss the products or return them for a refund.

FDA inspectors, however, had become aware of the positive test that ultimately sparked this recall in November, an FDA spokesperson confirmed to POLITICO.

Reckitt had found Cronobacter sakazakii in a batch of formula made at its Zeeland, Mich., plant, during internal testing conducted in early September. The batch that tested positive was destroyed, but the FDA later determined that not enough cleaning had been done following the positive test. Two batches of formula made right after the contaminated batch would ultimately be recalled on February 20 — more than five months after the products had been distributed nationally, including in Guam and Puerto Rico.

The revelation that this recall took months to announce comes more than a year after a massive infant formula recall from Abbott Nutrition, renewing questions about FDA’s oversight of formula and whether enough has changed in the wake of this crisis to prevent another one. There have been four formula recalls over Cronobacter contamination in the past year — more formula recalls than there have been in the last decade combined.

The Reckitt recall in February was relatively small compared to the Abbott recall — which was likely the largest in history — and both FDA and the company maintain there have been no reports of illness related to this incident. For food safety advocates, however, it feels like a test that the agency didn’t pass.

“It’s stunning that it’s almost identical to what happened in 2021,” said Mitzi Baum, CEO of STOP Foodborne Illness, a group that advocates on behalf of victims of outbreaks, referring to the lengthy timeline from positive test to recall. “Lessons have not been learned.”

“FDA continues to be reactive,” Baum added. “It’s the internal processes that have not been fixed, if this is happening again.”

A House oversight subcommittee has scheduled a hearing on the agency’s handling of the infant formula crisis on Tuesday. Food safety advocates are eager for Congress to look into the problems, though they are wary of the issue becoming partisan. The committee also last week sent a letter to top agency officials seeking a trove of documents and communications.

Reckitt did not respond to multiple requests for comment.

The FDA, for its part, has over the last year been taking a closer look at formula makers’ own records during food-safety inspections as a response to last year’s incident, which was initially set in motion by reports of four infant illnesses, including two deaths, from Cronobacter infections. FDA officials later found serious food safety violations at Abbott’s Sturgis, Mich., plant, which was shuttered for months for cleaning and upgrades, fueling a national shortage and a major disruption to the market because the plant had once made roughly a fifth of the U.S. supply. The FDA also found Cronobacter in 20 places in the plant, though none of the strains matched the illnesses.

One of the biggest unanswered questions remaining from the formula crisis of last year is why FDA inspectors had missed major food safety problems at Sturgis, including things like roof leaks — conditions that FDA Commissioner Robert Califf later characterized as “egregious.”

The agency has not provided a full explanation for why these issues were not found during a routine inspection five months prior to the recall. The FDA also did not heed a detailed warning from a whistleblower about the plant, a revelation that was first reported by POLITICO.

In the case of Reckitt’s Zeeland plant, FDA inspectors initially “made note” of the positive Cronoacter test in November while they were in the facility for a “limited inspection” that was sparked by a “non-illness” complaint FDA had received related to the plant, the agency said.

The formula recall didn’t happen, however, until FDA inspectors went back to this plant for a follow up inspection in February — a visit that was scheduled because agency inspectors found food-safety problems when they were in the plant for a routine inspection in July, the agency said.

It was during this February follow-up visit that inspectors “obtained additional information which, when combined with the positive sample, led to the agency’s concerns about the adequacy of cleaning in relation to the production of these two product lots that are the subject of the recall,” a spokesperson said.

The FDA determined the plant did not perform a sufficient “sanitation break” — an industry term for a thorough cleaning — to essentially make sure all food contact surfaces were properly sanitized after the contamination.

The FDA said it didn’t follow up more fully on the issue in November because it was a “limited inspection” and the company was still investigating the root cause of the contamination when inspectors were there.

Food safety experts POLITICO spoke with described the agency’s timeline as “baffling” and “inexcusable” and said the fact that the company was still investigating shouldn’t have prevented further action from the agency.

The FDA, for its part, said that inspections provide “only a single snapshot in time of the operations, preventive controls, and compliance at a firm. The firm ultimately has a responsibility to implement a constant system of sanitation and food safety controls to produce a safe product in compliance with FDA regulations.”

FDA declined a request for an interview about the agency’s timeline of its oversight of infant formula.

“They need to do better,” said Sarah Sorscher, deputy director of regulatory affairs at the Center for Science in the Public Interest. Sorscher pointed to the fact that the FDA had waited six months to re-inspect the Zeeland plant after having found significant food safety problems in an earlier inspection last July.

At that earlier inspection, the Zeeland plant was cited for failing to maintain the building in “a clean and sanitary condition” and for not establishing a full system of process controls “designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” per FDA inspection records. The citations were serious enough to warrant what’s known as an OAI, or official action indicated.

“If something like that is coming up, FDA should be back in there sooner to ensure that the corrective actions were adequate,” Sorscher said. “That’s a problem.”

Reckitt said in its recall announcement that the company had “identified the root cause” of the contamination, which was “linked to a material from a third party.”

“We have taken all appropriate corrective actions, including no longer sourcing this material from the supplier,” the company said in February.

A spokesperson for FDA argued that the recent uptick in recalls — earlier this month, Perrigo recalled some Gerber formula over the same bacteria — were essentially a sign of an improved system because the recalls were smaller than the historic recall and plant shutdown last year.

“As part of the FDA’s oversight to ensure safe and nutritious infant formula, the agency’s more recent engagements with manufacturers through inspections and ongoing meetings has limited the scope of these recalls and minimized disruptions to the market,” a spokesperson said. “Compared to the Abbott recall and the temporary closure of the Sturgis facility, the recent recalls are much narrower in scope, only impacting a few weeks of product with no additional facility closures.”

Following the slew of Cronobacter recalls over the past year, FDA this month wrote to infant formula manufacturers and others in the industry urging them to follow federal safety rules. The agency also asked companies to voluntarily report any positive tests for Salmonella or Cronobacter to the agency, even if the product hadn’t shipped out — something that could have prevented the delayed Reckitt recall.

FDA officials contend this reporting is also important because positive tests can be an early sign of larger problems in a facility.

“The FDA remains committed to strengthening the resiliency and safety of infant formula in the U.S., however there are significant gaps in data and authority that we have identified and are seeking support to address,” wrote Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, in a recent op-ed defending the agency’s work on the issue.

The FDA has determined the agency does not have the authority to require this reporting, and no formula companies have yet said publicly whether they will voluntarily comply with the agency’s request. The agency recently asked Congress for this authority in the Biden administration’s budget request. Asked why the agency did not request this authority earlier, a spokesperson said the agency’s “thinking on this need evolved following our investigation at Sturgis and other facilities.”

FDA said in a statement that it lacks the authority under federal law to mandate the notification unless the product has been shipped. “Congress alone can change that provision, not the FDA,” the spokesperson said.

Some consumer advocates, however, disagree with the agency’s assertion that it doesn’t already have this authority.

Thomas Gremillion, director of food policy at Consumer Federation of America, believes FDA’s lawyers are interpreting the law far too narrowly, essentially concluding that inspectors can have access to testing records only when they are physically present, not upon request, or otherwise.

“Consumer groups support expanding FDA’s authority to require infant formula pathogen testing records, but it would be nice if FDA just used its existing authority,” Gremillion said.

The FDA has insisted repeatedly the agency does not have the authority to mandate this reporting and that Congress must change the law.

A spokesperson for FDA said that the statutory language Gremillion is looking at “identifies a manufacturer’s obligation to retain records and provide those on request, not to the manufacturer’s obligation to proactively notify the agency of a possibly adulterated or misbranded product.”

Gremillion said he doesn’t accept the agency’s interpretation of the law and has raised this issue directly with top officials over the past several months, he said.

“They have the authority to tell the plants to hand over their testing records,” he said. “FDA has bent over backwards to interpret the law in a way that justifies the inaction.”

Read the full article at Politico