- Abbott Laboratories claims its Michigan plant is not responsible for bacteria that killed at least two infants
- The baby formula manufacturer alleged an FDA investigation revealed ‘infant formula produced at our Sturgis facility is not the likely source of infection’
- Abbott claims products from the facility did not cause any bacterial outbreak
- The plant still remains closed despite the findings after shutting down in February amid a major product recall
- Abbott says it’s ‘working closely with the FDA to restart operations’ at the plant as parents across the nation are struggling to get formula for their babies
- Are you a parent struggling to get hold of formula milk? Contact firstname.lastname@example.org
The biggest baby formula supplier in the U.S. has denied its Michigan plant is responsible for the deaths of two children despite the FDA closing it down.
The plant was shutdown nearly three months ago after a bacterial infection caused the deaths and other serious illnesses.
In mid-February Abbott Laboratories issued a nationwide baby formula recall and ceased operations at its plant in Sturgis, Michigan amid reports of babies contracting bacterial infections from its products.
An Abbott spokesperson told DailyMail.com Tuesday that ‘thorough investigation’ by the U.S. Food and Drug Administration (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’.
However, despite the findings of the investigation, the plant remains shuttered nearly three months later, fueling the nationwide baby formula shortage.
The FDA – which said it found food safety violations at the plant, as well as five strains of Cronobacter, a bacteria that can cause blood infections and meningitis – has refused to say when the plant can resume operations.
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.
The formula shortage, which has become a national crisis, was triggered by supply chain issues, but spiked with the closure of the Abbott plant.
Abbott alleges that none of the formula distributed to consumers tested positive for Cronobacter or Salmonella.
The manufacturer claims the FDA and Abbott officials both tested retained products for the bacterias and yielded negative results.
Abbott notes no trace of Salmonella was found at the Sturgis plant and the Cronobacter that was found in environmental testing during the investigation was in non-product contact areas of the facility.
The company alleged the traces of Cronobacter at their plant have ‘not been linked to the two available patient samples or any other known infant illness.’
February’s recall, which is isolated to powder formulas, including Similac, Alimentum and EleCare, manufactured only at the Sturgis plant has significantly disrupted the supply chain.
The nationwide share of out-of-stock baby formula hit 40 percent in April. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.
As shelves across the country meant to carry baby formula remain largely barren, retailers including Target, CVS and Walgreens are limiting the amount of formula consumers can purchase.
Concerned parents, especially those whose children have unique medical and dietary needs, have expressed feelings of hopelessness and are calling on the government to take action to ‘ensure critical, life-sustaining supply chains don’t break down.’
However, an Abbott spokesperson alleged the recall ‘does not include any metabolic deficiency nutrition formulas, Abbott’s liquid formulas or other Abbott nutrition powders or brands.’
The company is reportedly ‘doing everything it can to address the infant formula supply shortage across the U.S.’ This includes ‘prioritizing production of infant formula products to help replenish the supply in the market’ and shipping products in from overseas.
Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent
Last month, the FDA announced it had ‘no objection’ to Abbott releasing limited quantities of nutrition products ‘to individuals needing urgent, life-sustaining supplies of the specialty and metabolic formulas’.
The manufacturer, which was permitted to supply consumers with the speciality formulas on a ‘case-by-case basis,’ claims no formula being distributed has tested positive for bacteria.
Abbott phone representatives have also been telling parents the FDA is ‘holding back’ metabolic formula made during the recall period, which is why the current supply hasn’t gone out, Politico reported.
The FDA, disputing the company’s allegations, issued a statement to the newspaper on Saturday reading: ‘The FDA has not delayed the release of any specialty and metabolic infant formula products and the agency strongly disagrees with this characterization of events.
‘The agency has been working with Abbott since the Feb. 17 recall on ways to resume production. These are complex discussions, but from the beginning the agency has been committed to making these infant formula products, including specialty and metabolic products, available again as quickly as possible.’
Despite the Abbott’s efforts, Americans are still struggling to feed their children.
The Similac maker is the leading supplier of milk formula in the U.S. with a market share of about 42 percent in 2021, followed by British consumer goods firm Reckitt Benckiser with a nearly 38 percent share, according to Euromonitor data.
About 40 percent of baby formula products were out of stock across the the nation last month.
While all parents are feeling the impacts of the disruptive supply chain, those whose children have special medical needs say they are worried about sustaining their kid’s nutrition.
‘If this doesn’t get fixed soon, I don’t know how my son will survive,’ Phoebe Carter, whose five-year-old son has a rare digestive and immune system disease and relies on formula for all of his nutrition, told Politico. ‘I just can’t stress that enough.’
Carter is rallying concerned parents and caregivers in an effort to put pressure on Congressional leadership to address the shortage by facilitating formula production at other plants.
The outraged mother, who has created a website to organize caretakers, slammed national leadership, claiming they would take action if America’s upper echelon were being directly impacted by the formula shortage.
‘If, God forbid, a family member of President Joe Biden or Jeff Bezos or someone influential had one of these diseases, this crisis wouldn’t have made it to Day Two,’ she argued. ‘Because no one understands this issue and knows it’s happening, there’s no hope for us — that’s how it feels.’
Due to his condition, an allergic exposure causes Carter’s son debilitating pain that can last anywhere from a few days to weeks.
He was placed on an amino acid formula, which provides 100 percent of his nutrition, after all other treatments failed.
Carter said the formula, which breaks proteins down to their most basic form, put his disease into remission within two months.
Unfortunately, Abbott’s Sturgis plant is responsible for the manufacturing of 75 percent of all amino acid formulas in the U.S. Although her son’s formula, prescription brand Neocate, is produced by Nutricia, she is unable to get the product for her child.
Carter claims the recall and shutdown has forced an increase demand of other brands and there ‘just isn’t enough overall supply to keep up.’
Neocate, issuing a statement on its website, confirmed the company’s supply is very strained, alleging the Abbott recall and the search for replacement formulas has ‘created unprecedented demand for amino acid-based formula products.’
‘While we are taking urgent measures to get more products into the market, current product availability is low and, in some cases, you will see that our products are out of stock,’ the statement said.
Experts allege the shortage is greatly impacting patients with metabolic, gastrointestinal and allergic disorders.
The most common metabolic disorder, Phenylketonuria, approximately affects 17,000 people nationwide.
Another disorder, MSUD, is estimated to impact 2,000 Americans and is ‘so severe’ that amino acid formula is the ‘only means of survival’ for those with the condition.
‘Children, babies and adults throughout the world are suffering because of this,’ Columbia University faculty member and dietician Karen Reznik Dolins argued.
‘I’ve never seen anything like this ever in my career,” echoed dietitian Leah McGrath. ‘If babies are not getting what they’re supposed to be getting, or they’re getting less than, or there’s just the trauma of switching back and forth to different formulas, this has really long term implications in terms of their health and their growth and development, as the first 1,000 days of life are known to be the most crucial.’
A coalition of metabolic patient organizations recently probed its communities about the impacts of the formula shortage and claims it received more than 50 alarming messages.
‘Please help us. We are in a place of desperation,’ one parent reportedly wrote. ‘I cannot begin to explain the stress that accompanies the fear of running out of a product that is essential for the brain health of my children.
‘I have been in a panic over this shortage.’
Abbott, in response to the crisis, told Politico it opened a special phone line last Friday to ‘field requests from patients for the metabolic nutrition formulas.’
‘We’ve also been engaging with doctor groups and health care professionals. We’ve received dozens of inquiries and are coordinating with metabolic centers and healthcare professionals to fulfill requests based on need and on a case-by-case basis,’ a spokesperson said.
‘We understand that every patient who relies on these important products has critical needs and we are working diligently to provide product as needed.’
Brian Dittmeier, Senior Director of Public Policy at the National Women, Infants, and Children (WIC) Association told DailyMail.com in a statement Tuesday that the ‘unprecedented scope of this infant formula recall has serious consequences for babies and new parents.’
‘Assurances from manufacturers that production has ramped up have not yet translated to new product on the shelf. Each day that this crisis continues, parents grow more anxious and desperate to find what they need to feed their infants,’ the statement said.
‘Unlike other food recalls, shortages in the infant formula supply affects a major – or even exclusive – source of nutrition for babies. Inadequate nutrition could have long-term health implications for babies. Supply shortages are particularly acute for infants who require specialty formulas to address allergies, gastrointestinal issues, or metabolic disorders; adequate substitutes with other brands may not be easily identifiable.
‘Every day, we hear from parents who are hurt, angry, anxious, and scared. The lives of their infants are on the line. It is time for answers and accountability as we all work to improve the supply and ease the worries of parents enduring this national crisis.’
The FDA told DailyMail.com its priority was to ensure recalled products remained off shelves while they worked with manufacturers to find alternative baby formulas.
‘Following the Feb. 17 FDA warning, Abbott’s voluntary recall and decision to voluntarily cease production to address significant issues that could impact the quality of the product, the FDA has been working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands,’ a spokesperson said.
The authority, in a recent budget document, asked Congress to give the agency new authorities to prevent a critical shortage from occurring in the future.
‘No law requires manufacturers of infant formulas or essential medical foods to notify FDA when they become aware of a circumstance that could lead to a shortage of these products,’ the agency penned, noting it would like to see new protocols requiring companies to notify the FDA of anticipated supply chain interruptions.
White House press secretary Jen Psaki said Monday the Biden administration is working with manufacturers to ensure baby formula makes it back on empty shelves as frantic parents work to ensure their children are fed.
‘Ensuring the availability of these products’ is a ‘priority’ for the FDA, Psaki said at her daily press briefing, noting ‘they’re working around the clock to address any possible shortage.’
It is unclear if the administration’s response will include need requirements for manufacturers, as the FDA requested.
FDA’S COMPLETE STATEMENT ON THE ABBOTT PLANT CLOSURE
The FDA remains committed to using all available tools to oversee the safety, effectiveness and quality of FDA-regulated products and help ensure that Americans have access to essential and safe products. Our first and foremost priority is ensuring that any recalled product remains off the market and are working with the U.S. Department of Agriculture and manufacturers to ensure that parents have access to alternative, safe infant formula. We will and must continue focusing on taking all steps possible to protect the health of those who rely on safe powdered infant formula.
Following the Feb. 17 FDA warning, Abbott’s voluntary recall and decision to voluntarily cease production to address significant issues that could impact the quality of the product, the FDA has been working with Abbott Nutrition to better assess the impacts of the recall and understand production capacity at other Abbott facilities that produce some of the impacted brands. The FDA has also been meeting with several other infant formula manufacturers on a weekly basis to try to increase production capacity. This includes discussions with both Abbott and other manufacturers to increase production of different specialty and metabolic products for use by those who are able to transition from their Abbott-branded product. In addition, the FDA is partnering with the USDA’s Food and Nutrition Service (FNS) to monitor the impact of the recall on The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Program.
On Friday, April 29, 2022, the FDA announced that it had informed Abbott Nutrition that the agency had no objection to the company releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at the company’s Sturgis, MI facility since Feb. 17. The risk of not having certain specialty and metabolic products available could significantly worsen underlying medical conditions, and in some cases, pose life-threatening risks for individuals who rely on these products. In these circumstances, the benefit of allowing parents, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.
Abbott has confirmed that the company is releasing these products on a case-by-case basis, depending on product availability and the severity of the individual’s need. Patients and caregivers seeking access to these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876.
The FDA has reached out to retailers’ stakeholder groups to request that their members consider placing purchase limits on some products in order to protect infant formula inventories for all consumers.
Finally, the FDA is continuing to work diligently to ensure the safe resumption of production of infant formula at Abbott Nutrition’s Sturgis, Michigan facility. The plant remains closed as the company works to rectify findings related to the processes, procedures, and conditions that the FDA observed during its inspection of the facility from January 31 – March 3, 2022, which raised concerns that powdered infant formula produced at this facility prior to the FDA’s inspection carry a risk of contamination. The FDA remains in close communication with Abbott to ensure that the FDA’s regulations and standards are met in order to resume production safely.