Two weeks after a nationwide recall of infant formula tied to five hospitalizations and two deaths, the FDA is refusing to answer questions about why it took months to take action, while parents, lawmakers and advocates ratchet up pressure on the agency.
As POLITICO recently reported, the FDA, CDC and formula maker Abbott Nutrition knew about the first infant seriously sickened by Cronobacter sakazakii, a rare bacteria, in September. It was more than four months before FDA sent inspectors to investigate the plant where the formula was made. It took another three weeks to order a recall. The timeline has raised questions about the government’s response and whether quicker action could have prevented illnesses and deaths.
“It's kind of alarming that we know more about Russian military tactics in Ukraine than we do about FDA's actions regarding the Abbott facility,” said Brian Ronholm, director of food policy at Consumer Reports.
POLITICO has repeatedly asked the FDA to explain why there was a monthslong lag between illnesses being reported, an inspection and then ultimately pulling products off the market. The agency has repeatedly declined to do so.
“We know there have been questions about the timeline,” FDA said in a statement. “However, this remains an open inspection with many moving parts. Our top priority is ensuring that any recalled product produced at this facility is taken off the market.”
The FDA said it would conduct a review once the investigation is over.
A handful of Democrats on Capitol Hill are raising concerns about the incident Sen. Patty Murray (D-Wash.), chair of the Senate Health, Education, Labor and Pensions Committee, and Sen. Bob Casey (D-Pa.), a senior member on the committee, wrote to Abbott Nutrition demanding documents and other information by March 10. House Appropriations Committee Chair Rosa DeLauro (D-Conn.) on Thursday asked the Health and Human Services office of the inspector general to investigate whether the FDA “took prompt, appropriate, and effective action” in the lead-up to the massive recall.
The three brands that were recalled — Similac, Alimentum and EleCare — are all major players in the infant formula market. Similac is also a top supplier to the WIC program, which provides millions of low-income parents with formula and nutritious food staples. The illnesses tied to Abbott Nutrition’s products, all manufactured at a single plant in Sturgis, Michigan, include four cases of Cronobacter and one of Salmonella Newport. All five infants were hospitalized between September and January.
The FDA has shared details on which lots of formula have been recalled here.
As pressure builds on FDA, throngs of parents have taken to social media to express their anger toward Abbott, toward the government and in many cases to report that their babies also got sick. While CDC’s official count is that there are five hospitalizations as part of this outbreak, a spin through Instagram and TikTok reveals dozens of unconfirmed yet detailed and heartbreaking reports of babies hospitalized for Salmonella and other bacterial infections after reportedly consuming recalled formula, using hashtags like #similac #screwyou.
POLITICO spoke with several families who believe contaminated formula sickened their baby, in some cases almost killing them.
Deborah Rossick, a mother of two in Lakeland, Florida, said she started buying EleCare late last summer because her then 4-month-old baby Arya was showing signs of dairy intolerance. (EleCare is hypoallergenic.) When Arya started getting sick in late August, Rossick said, she quickly started consulting doctors to try to figure out what was wrong. By early October Arya was diagnosed with Salmonella, Rossick said. After weeks of being sick, in and out of the hospital, Arya got much worse. She ended up with meningitis — a type that is caused by Salmonella — she started seizing, stopped breathing, had a stroke and was intubated. She was in a coma for nine days.
“Doctors told me she wasn't going to make it,” Rossick said. When Arya woke up, doctors learned she had suffered severe neurological damage. She is also now blind and deaf.
“I have my baby,” Rossick said, choking back tears. “I almost lost my baby — I still have her. But she is a completely different baby.”
When Rossick saw the news about the recall Feb. 17, she said she was “completely appalled.” Every single can of formula that Rossick had fed Arya has now been recalled, she said. She said she’s planning legal action to cover hundreds of thousands of dollars in medical bills and extensive care that will be needed for Arya over her lifetime.
Abbott Nutrition said in a statement, “We are very sympathetic to the families. We value the trust parents and caregivers place in us and ensuring the safety and quality of our products is our top priority.”
Rossick’s tragedy also raises questions about the country’s public health surveillance system. Cronobacter sakazakii is a rare bacteria and it has not been deemed a notifiable disease, which means that health providers aren’t required to report cases to CDC. Salmonella is a notifiable disease, however, which means every case is supposed to reported into CDC’s surveillance system. Arya’s case was reported and the Polk County Health Department interviewed Rossick in October. She said she told health officials that her daughter only consumed EleCare formula and she only used bottled water, so she could not figure out how she could possibly contract Salmonella.
“I know cross contamination,” said Rossick, a trained pastry chef. “I'm not going to cut raw chicken and touch my baby's bottle. I'm thinking: my dog ate a frog and then kissed her on the mouth. I'm thinking of every possible alternative as to how my baby got salmonella. And it has everything to do with me giving it to her.”
A Florida Health Department spokesperson told POLITICO the state has no cases connected to the outbreak. An FDA complaint coordinator, however, told Rossick there are several reports currently being investigated in Florida, she said. Arya’s case is among them.
In epidemiology, it’s long been known that for every case of foodborne illness that’s detected and linked to an outbreak, there are many others that will not be accounted for. CDC estimates that for every lab-confirmed case of Salmonella there are 30 that go undetected. In the current outbreak, CDC has connected one case of Salmonella Newport to the outbreak. The infant was hospitalized.
There are many more parents wondering if their childrens’ recent illnesses might be explained by contaminated formula.
Paige Goitia, a mother of two in Sparta, New Jersey, said she woke up at 3 a.m. in late January to find her 7-month-old baby Adrien was completely covered in vomit. He was violently — and silently — vomiting on himself in a way that alarmed her. She got him out of his crib and gave him a bath. Soon thereafter, he started having diarrhea. Another bath. Adrien was extremely sick like this for several days, Goitia said. He ended up in the hospital and was put on fluids, but doctors chalked it up to a virus and told Goitia to prepare for the rest of her family to catch it, too, they said. She was skeptical. No one else got sick. Adrien slowly recovered, but it was a horrific ordeal.
Three weeks later, when Goitia saw the recall announcement and it included Adrien’s formula — Similac Pro-Sensitive — she was furious. She called Abbott’s phone line they set up for consumers and waited what seemed like forever to talk to a representative. “I asked, where is everybody getting off that this just affected a couple babies? Where is that coming from?” she recalled, noting that a scroll through the company's social media account uncovered numerous parents with similar complaints.
Goitia said she is still traumatized by the incident. She shudders to think what might have happened if she hadn’t found Adrien the first night he got sick.
“It scares me to this day and I actually have him sleep right by me now by the bed because this incident has terrified me,” she said. “He could have choked on his own throw-up. He couldn't roll over to his side yet. I was livid. I blamed myself — he could have died.”
After she learned about the recall, Goitia decided to get Adrien tested for Salmonella. She has not yet gotten the results.
Parents are increasingly turning to lawyers. A pre-suit petition has been filed in Texas on behalf of a baby that was hospitalized for weeks with Cronobacter, racking up hundreds of thousands in medical bills. A class action with 18 cases so far, from parents across several states, has been filed in the U.S District Court Southern District of Florida.
Abbott Nutrition responded in a statement, saying “the cases are under investigation and at this time the cause of the infants’ infections have not been determined. All infant formula products are tested for Cronobacter sakazakii, Salmonella and other pathogens and they must test negative before any product is released. The company keeps retained samples of each batch. We tested retained product samples related to the complaints for Cronobacter sakazakii and Salmonella, and they tested negative.”
The day after the sweeping recall was announced, FDA answered a few of POLITICO’s questions about the investigation timeline, but after that did not address several specific follow up questions about why the recall took months.
Last September, the Minnesota Department of Health investigated a case of an infant who was sickened by Cronobacter sakazakii. State health officials in Minnesota — a state known for its diligence in investigating foodborne illnesses — ascertained that the infant had consumed powdered formula produced at an Abbott Nutrition facility in Sturgis, Michigan, and shared this information with FDA and CDC in September, the state agency said, as POLITICO previously reported.
“It often takes time to gather enough information to put the pieces of a puzzle together — or at least enough pieces to make clear the actions needed to protect public health,” said Doug Schultz, a spokesperson for the Minnesota Department of Health, explaining why one illness might not spark a recall. State agencies can’t institute national recalls; only the FDA has that power.
The FDA initiated an inspection of the facility on Jan. 31, a spokesperson told POLITICO. Inspectors found Cronobacter sakazakii in several environmental samples taken at the plant, FDA said. They also found records suggesting the company had been finding the bacteria in the plant and had destroyed product because of the issue, according to the agency. The FDA issued its warning to consumers and a voluntary recall from Abbott Nutrition the evening of Feb. 17, nearly three weeks after initiating the inspection.
In 2017, an inspector general report found that FDA had serious deficiencies with its food recall process. “Recalls were not always initiated promptly because FDA does not have adequate procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls,” the report concluded.
The agency has since tried to shore up its foodborne outbreak response. In December, the agency released a plan aimed at solving outbreaks faster and said it had expanded its rapid response teams to help federal and state officials work better together, among other changes.
Lawmakers and consumer advocates are also raising questions about FDA’s inspection history of the Sturgis, Michigan plant. FDA was actually in the plant for a routine inspection a few days after the first case was reported to FDA and CDC in September, but it doesn’t appear inspectors were looking for Cronobacter. During that inspection, FDA uncovered several issues, including lapses in basic plant sanitation and handwashing. The agency has so far declined to answer specific questions about the September inspection and whether inspectors were told about the reported illness.
“The FDA’s ongoing inspection of the Abbott facility in Sturgis, Michigan is part of an open investigation, which we cannot comment on,” the agency said in a statement.
Infant formula plants are usually inspected once a year because they serve such a vulnerable population. The Michigan plant was not inspected in 2020, likely due to Covid-19.
As questions about the government’s timeline in the infant formula recall have intensified, the FDA has largely clamped down. Key congressional aides in the House and Senate said their questions have not been answered. Consumer advocates have not gotten responses, either.
“The recent infant illnesses and deaths with exposure to certain recalled powdered infant formulas produced at an Abbott facility is tragic and of great concern to us all,” said Frank Yiannas, deputy commissioner for food policy and response at FDA. “Our first and foremost priority is ensuring that any recalled product is taken off the market and working with the USDA and manufacturers to ensure that parents have access to alternative, safe infant formula.”
Consumer advocates are pressing for a clearer explanation of why the timeline spans months.
“There are many more questions here than answers,” said Michael Taylor, former FDA deputy commissioner for foods and veterinary medicine, who is now a board member of Stop Foodborne Illness, which works with victims of foodborne illness. “It’s urgent for the health of babies and consumer trust that FDA get to the bottom of what happened internally and at Abbott, fix the problem, and be transparent with the public.”
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By: Helena Bottemiller Evich
Title: ‘I almost lost my baby’: Parents demand answers from FDA
Sourced From: www.politico.com/news/2022/03/05/formula-recall-fda-abbott-nutrition-00014413
Published Date: Sat, 05 Mar 2022 07:00:00 EST
