Baby formula plant FINALLY reopens: FDA clears Abbott’s site in Michigan to pump out urgently needed food four months after deadly contamination closed plant
- Abbott has resumed baby formula production at its plant in Sturgis, Michigan
- The plant is prioritizing production of speciality and metabolic formulas
- Consumers can expect to see these products on shelves in three weeks
- It will take up to eight weeks for all Abbott products to be replenished in stores
- The factory shut down in February amid an FDA bacterial infection investigation
- Fours infants were sickened, and two of them died, after consuming formula
The largest baby formula factory in the US has restarted production at its previously shuttered Michigan plant.
Abbott Laboratories reopened infant formula production at its facility in Sturgis on Saturday having met FDA requirements agreed to last month.
The plant will first restart production of specialty and metabolic formulas, with consumers expected to see these products on store shelves around June 20.
Abbott will then resume production of all other formulas, with the plant having previously said it will take six to eight weeks before stocks are replenished at stores.
A nationwide baby formula shortage was triggered when Abbot closed the Sturgis plant in February after a bacteria contamination and has since worsened nationally.
Out-of-stock rates climbed to 74 percent across the US for the week ending May 28, according to data from Datasembly – up four percent from the week before.
Additionally, 10 states now have out-of-stock rates at 90 percent or greater, including Arizona, Mississippi, California, Nevada, Tennessee, Rhode Island, Louisiana, Florida and Washington.
Georgia is the hardest hit at 94 percent, up from 74 percent the week before.
In an effort to curb the shortage, the FDA has worked to make it easier for foreign-produced baby formula to be imported.
Meanwhile Biden’s administration announced Friday it would bring in 1.3 million cans of Gerber formula from Mexico beginning next month.
Abbott Laboratories restarted infant formula production at its facility in Sturgis, Mich. on Saturday after having met FDA requirements agreed to last month
Out-of-stock formula rates climbed to 74 percent nationally for the week ending May 28, according to data from Datasembly – that’s up 4 percent from the week before
Hundreds of boxes of infant formula arrived from Switzerland on May 22 as part of Biden’s Operation Fly Formula, an operation to quickly import infant formula to the U.S.
An almost empty baby formula shelf at a grocery store in New York City is pictured on May 31
Abbott announced the reopening on its Sturgis plant on Saturday, taking a step toward easing the nationwide supply shortage expected to persist into the summer.
The February shutdown of the largest formula factory in the country led to the supply problems that have forced some parents to seek formula from food banks, friends and doctor’s offices.
Abbott will initially prioritize production of its EleCare specialty formulas for infants with severe food allergies and digestive problems who have few other options for nutrition.
The company said it will take about three weeks before new formula from the plant begins showing up on store shelves.
‘We will ramp production as quickly as we can while meeting all requirements,’ a company statement read.
‘We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America.’
Abbott added: ‘We’re committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years.’
Abbott is one of just four companies that produce about 90 percent of U.S. formula.
The company’s recalls and shutdown triggered a cascade of effects. Retailers have limited customer purchasing to conserve supplies and parents have been told to switch brands to whatever formula is in stock.
Abbott announced the reopening on its Sturgis plant on Saturday, taking a step toward easing the nationwide supply shortage expected to persist into the summer. The company promised to ‘ramp production as quickly as we can while meeting all requirements’
Michelle Saenz of Santee, California buys baby formula at a grocery store in Tijuana, Mexico on May 24 after being unable to find the product in the U.S.
FDA Commissioner Robert Califf recently told lawmakers it could be about two months before formula supplies return to normal levels.
The agency has waived many of its regulatory requirements to accept more formula from the United Kingdom, Australia and other nations.
U.S. manufacturers, including Reckitt and Gerber, have also stepped up production, running plants 24/7 and sourcing more formula from alternate facilities.
News of Abbott’s reopening comes just one day after the Biden Administration announced it was bringing in baby formula from Mexico as part of Operation Fly Formula.
Nestle will send nearly 33 million full-size, 8-ounce bottles of Gerber Good Start Gentle general formula from its Mexico plant beginning in July. The shipments would continue through October.
‘The U.S. Department of Health and Human Services is evaluating options for getting the products to the U.S. as quickly as possible,’ the agency said in Friday’s statement.
The administration invoked the Defense Production Act to speed production of formula and launched Operation Fly Formula to import formula from abroad in May.
Already, two shipments of formula have come in from Europe under that operation. The two flights brought in total of 1.5 million, 8-ounce bottles of formula.
Third and fourth shipments were detailed this week as the administration tries to show it has the situation in hand.
The third shipment will bring in Kendamil infant formula from the UK to the U.S. The shipments start June 9 and will contain 3.2 million 8-ounce bottle equivalents of Kendamil Classic Stage 1 and 540,000 8-ounce bottle equivalents of Kendamil Organic.
United Airlines has agreed to transport Kendamil formula free of charge. The formula will be on Target shelves ‘within weeks’ of its arrival into the United States.
The administration also announced a fourth flight – this time with formula from Australia. The 380,000 pounds of Bubs Australia infant formula, approximately 4.6 million 8-ounce bottles, will arrive in Pennsylvania and California on June 9 and June 11 respectively.
Meantime, the administration faces criticisms about its handling of the formula shortage with officials struggling to answer why Biden wasn’t made aware of the crisis until two months after it started.
Abbott closed the Sturgis factory in February after the FDA began investigating four bacterial infections among infants who consumed powdered formula from the plant. Two of the babies died.
The company continues to state that its products have not been directly linked to the infections, which involved different bacterial strains.
FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols.
The FDA has faced intense scrutiny for taking months to close the plant and then negotiate its reopening. Agency leaders recently told Congress they had to enter a legally binding agreement with Abbott to assure all the problems were fixed.
In a meeting with formula manufacturers at the White House on Wednesday – where Abbott Nutritional was notably absent – the executives told the president they knew as soon as the Abbott plant in Strugis, Michigan, closed in February that there would be a shortage.
Their comments raised questions about why Biden and his administration didn’t act faster to get more formula produced and onto store shelves. The closure resulted in a bare grocery store shelves, a major hike in formula prices and frantic parents worried about feeding their children.
Biden, who has faced criticism over the baby formula shortage, defended his administration’s response to the problem, saying they ‘kicked everything into gear’ when they knew how bad the problem was. He is pictured during a press briefing on Wednesday
Biden defended his administration’s response, saying they ‘kicked everything into gear’ when they knew how bad the problem was.
‘I don’t think anyone anticipated the impact of one facility,’ the president said on Wednesday, referring to the closure of Abbott’s Michigan plant.
‘Once we learned of the extent of it, and how broad it was, we’ve kicked everything in the gear. And I think we’re on the way to be able to completely solve the problem,’ he said in response to reporters’ questions.
But when asked why the administration didn’t act sooner, given the executives’ warnings, Biden said he didn’t know about it.
‘They did, but I didn’t,’ he said. He revealed he first learned of the issue in April.
Robert Cleveland, an executive at Reckitt, told Biden that his company anticipated the impact the Abbott formula recall in February would have and they reached out retailers immediately.
‘We knew from the very beginning this would be a very serious event,’ he said during Wednesday’s zoom meeting. ‘We were aware of the general impact that this would have.’
He said they advised retailers like Target and Walmart to order more formula and to push everything in inventory onto the shelves.
And Murray Kessler, CEO of Perrigo Company, which manufacturers generic brands of formula, said they knew there would be a ‘shortage.’
‘The very first thing we did when we heard about the Abbott recall was we could foresee that this was going to create a tremendous shortage,’ Kessler said.
He said they warned the Food and Drug Administration.
‘We began communication with the FDA immediately, we began collaborating closely with the FDA, our retail customers and other stakeholders to identify and prioritize what was most critical,’ he said.
Meanwhile, White House press secretary Karine Jean-Pierre wouldn’t say on Thursday why the president wasn’t informed about the baby formula shortage until April.
Jean-Pierre was quizzed repeatedly during her daily press briefing on what the president knew, when he knew it, and who exactly told him.
And she gave evasive answers, saying it was ‘senior staff’ who went through ‘regular channels’ to deliver the information.
Her lack of details prompted one White House correspondent to warn her that the journalists would keep pressing her for specifics.
It’s not unusual for senior staff to be aware of an issue before the president is made aware of it, given the variety of items an administration deals with on any day. The Biden administration was also dealing with the war in the Ukraine, rising inflation, and supply chain issues. Biden also traveled to Brussels and Poland in March.
But Jean-Pierre also wouldn’t say who decided to bring it to Biden, what date it happened, and how it’s determined to flag information for the president.
‘The president deals with issues on a regular basis, and that boils up to him. And it’s just – there’s no specific person that I can call out to you. But it’s the regular way that we move forward through the regular channels. I don’t have a specific person but that’s kind of how it goes on any issue, not just this one. It goes through regular channels and senior White House staff,’ she said.
It was the second day in a row Jean-Pierre struggled to answer questions about the administration’s response to the crisis as the White House has come under fire for not acting quickly enough to get formula on shelves.
She was grilled by reporters on Wednesday and had no additional answers when asked about the issue again on Thursday.
Jean-Pierre, the chief spokesperson for the president, didn’t answer when repeatedly asked when the president was told and if he was disappointed or frustrated the information took so long to reach him – particularly after formula manufacturers told him during a meeting on Wednesday they predicted the shortfall as soon as Abbott Nutrition closed its plant.
A sign notifies customers of purchase limits for baby and toddler formula at a Walgreens store in Las Vegas, Nevada on May 29
She also blamed the crisis on Abbot and the Food and Drug Administration.
‘The FDA moved too slowly,’ she said.
Washington Post’s Tyler Pager followed up, saying she wasn’t answerng his question: ‘That doesn’t answer the question about when the president was informed and whether or not he is satisfied with his staff.’
‘I’m telling you the process. I’m telling you what happened. I’m telling you that the FDA moved too slowly. I’m telling you that this happened on the side of Abbott and this what FDA tried to do,’ Jean-Pierre responded. ‘You may not like my answer, but that is the way that we see it in answering your question there.’
When asked by another reporter, she gave a similar answer: ‘There’s no specific person that I can call out to you. But it’s the regular way that we move forward through the regular channels. I don’t have a specific person. But that’s kind of how it goes on any issue, not just this one. It goes through regular channels, and senior White House staff usually brief him on different issues.’
NBC’s Kelly O’Donnell asked her again, saying without a specific answer it looked like the administration was being ‘evasive.’
‘Can we asked you to go back on the issue of who briefed the president on baby formula. To say there was no specific person is not a satisfactory answer. When you have senior assistants to the President. There is a paper trail I’m sure about briefings to the president. There’s a Domestic Policy Council. There’s a Chief of Staff. At some point we need to know who would have been the most likely person to talk to him,’ she said.
Jean-Pierre responded: ‘I think what what I’m trying to say there’s so many issues that come up.’
O’Donnell pressed her again.
‘It looks evasive not to not have the most senior people in the White House willing to say I had a conversation with the president about it,’ she said, adding: ‘We’re also all reporting on the consumer side of it, of what you’re doing, putting out and trying to get information. But we’re also trying to understand the information flow in this White House and it’s important for us to get that answer which is why we’re going to keep asking.’
‘You have every right to keep asking,’ Jean-Pierre told her. ‘That’s why I’m here.’
TIMELINE SHOWS HOW AMERICA’S LARGEST BABY FORMULA PLANT CEASED PRODUCTION
Abbott Laboratories, the biggest baby formula supplier in the U.S., ceased production at its Michigan plant in February 2022 amid reports of fatal bacterial infections.
A timeline of events shows reveals the shut down was the plant had previously been under scrutiny by the U.S. Food and Drug Administration (FDA).
September 2021: The FDA conducted a four-day inspection of the Abbott Laboratories plant in Sturgis, Michigan.
The inspection report revealed the plant ‘did not maintain’ clean and sanitary conditions in at least one building that manufactured, processed, packaged or held baby formula.
FDA officials also observed poor hand washing among Abbott plant staff who ‘worked directly with infant formula.’
The FDA also noted an instance of improper equipment maintenance and temperature control.
October 2021: A whistleblower sends the FDA a 34-page document outlining potential concerns with the Sturgis plant.
The document, which was made public by Congresswoman Rosa DeLauro in April 2022, was written by a former plant employee.
The employee accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula, and hiding information during an FDA audit in 2019, among other issues.
January – March 2022: The FDA conducted multiple inspections at the Sturgis plant over the course of three months in 2022. A ten-page inspection report revealed multiple violations at the facility.
The agency alleged the plant failed to ensure that all surfaces that contact infant formula were maintained to prevent cross-contamination.
The report states the facility ‘did not establish a system of process controls’ to ensure the baby formula ‘does not become adulterated due to the presence of microorganisms in the formula or the processing environment.’
Officials also alleged the plant failed to disclose in an investigation report whether a health hazard existed at the facility.
Additionally, the report stated plant workers were did not wear the ‘necessary protective material’ when working directly with infant formula.
February 17: U.S. health officials urgently warn parents against using three popular baby formulas manufactured at the Abbott plant in Michigan. Investigators claim the products were recently linked to bacterial contamination after an infant died and three others fell ill.
Abbott voluntarily recalled several major brands and shut down its Sturgis plant.
The FDA also said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died.
February 28: Abbott Laboratories expanded its recall of Similac baby formulas after a second infant who was exposed to the powdered baby formula died.
April 15: Abbott releases a statement alleging it is working closely with the FDA to restart operations at the Sturgis plant.
Week of April 24: The nationwide share of out-of-stock baby formula hit 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.
May 10: Abbott releases a statement to DailyMail.com claiming ‘thorough investigation’ by the FDA and Abbott revealed ‘infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was not an outbreak caused by products from the facility’.
Abbott claims they are ‘working closely with the FDA to restart operations’ at the plant, with the spokesperson noting: ‘We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall’.
The FDA told DailyMail.com it was holding discussions with ‘Abbott and other manufacturers to increase production of different specialty and metabolic products’ but refused to say when the Sturgis plant could reopen.
Sen. Mitt Romney issued a letter to the FDA and U.S. Department of Agriculture (USDA) urging leaders to address the formula shortage and work to prevent future threats to infant health.
May 11: Lawmakers on Capitol Hill announce plans to hold a hearing in two weeks on infant formula shortages.
Abbott announced it would take up to ten weeks for the company to get baby formula to retailers once the Sturgis plant reopens.
Abbott also said: ‘After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.’
May 12: White House Press Secretary Jen Psaki defends the government’s closure of the Abbott plant.
President Joe Biden met with executives from infant formula manufactures and retailers to address the shortage.
May 13: Biden addresses the formula crisis during a press briefing, saying: ‘We’re going to be, in a matter of weeks or less, getting significantly more formula on shelves.’
The FDA announced it was working to streamline a process that will get more products to consumers – while also meeting safety, quality and labeling standards
May 16: Abbott and the FDA reach agreement to reopen baby formula facility in Michigan.
However, the FDA has yet to disclose a timeframe for allowing the plant to resume production.
The FDA also implemented new measures, in effect for 180 days, to increase imports of baby formula produced overseas.
May 18: Biden invoked the Defense Production Act to boost baby formula production and issued a directive for planes to bring in supplies from overseas, after growing pressure from Congress.
June 3: White House press secretary Karine Jean-Pierre is grilled by reporters about who told the president about the shortage, when he was told and the process used to determine when information gets to the presidential level.
She dodged multiple questions on the topic and wouldn’t give any specifics.
‘There’s no specific person that I can call out to you. But it’s the regular way that we move forward through the regular channels. I don’t have a specific person. But that’s kind of how it goes on any issue, not just this one. It goes through regular channels, and senior White House staff usually brief him on different issues,’ she said.
June 4: Abbott restarts production at its Michigan plant.
The plant is first prioritizing production of specialty and metabolic formulas, with consumers expected to see these products on store shelves around June 20.
Abbott will then resume production of all other formulas, with the plant having previously said it will take six to eight weeks before stocks are replenished at stores.
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