America’s largest baby formula manufacturer warned it could take more than two months to get their products back on retail shelves once the Food and Drug Administration (FDA) gives the go to reopen its Michigan plant.
Abbott Laboratories, which shut down its major plant in Sturgis, Michigan in February, announced Wednesday that with FDA approval the site could be restarted in two weeks.
However, the manufacturer claims it will take another eight weeks before stocks of baby formula are replenished – a devastating blow for parents scrambling to find the product amid supply disruptions and Abbott’s massive safety recall.
‘We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage,’ the company said in a statement Wednesday. ‘We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.’
The news comes amid a nationwide infant formula shortage and just hours after lawmakers on Capitol Hill announced the House Energy and Commerce Committee will hold a hearing in two weeks to address the ‘increasingly alarming’ situation.
The House of Representatives panel, which is scheduled to meet May 25, did not name any company executives or other witnesses, but said it would release more details before the meeting.
Meanwhile, Republican Sen. Mitt Romney slammed the FDA for ‘risking the lives of infants across the nation’ by forcing America’s biggest baby formula plant to stay closed while desperate parents scramble to feed their children.
Abbott Laboratories warned it could take more than two months to get their products back on retail shelves once the FDA gives the go to reopen its Michigan plant
Abbott Laboratories, which shut down its major plant in Sturgis, Michigan (pictured) in February, announced that with FDA approval the site could be restarted in two weeks
Abbott, after nearly three months of being shutdown, addressed the FDA’s investigation into its plant on Wednesday.
The regulatory agency concluded its inspection of the plant on March 18, according to Abbott, issuing a list of observations identifying where the company did not follow processes and could improve its systems and protocols.
The manufacturer, announcing it formally responded to the FDA’s report on April 8, said it takes the matter ‘very seriously’.
‘Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action,’ Abbott shared, noting officials started by reviewing and updating education, training and safety procedures for both employees and visitors.
Plant officials also updated their protocols regarding water, cleaning and maintenance at the facility.
The company says it ‘immediately implemented’ corrections to address the concerns raised by the FDA, adding they are aware their shut down and product recall had worsened the nationwide baby formula shortage.
‘We’ve been seeing and hearing the stress and despair of parents who are facing empty shelves,’ Abbott said. ‘We deeply regret the situation and since the recall, we’ve been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum.
‘We also began releasing metabolic formulas that were on hold earlier this month at FDA’s request to those who need these unique formulas.’
Abbott released a statement Wednesday detailing its response to the FDA’s investigation of its plant. The company ‘immediately implemented’ corrections to address the agency’s concerns
Abbott’s statement comes as about 40 percent of large retail stores are out of stock of baby formula, up from 31 percent in mid-April, according to Datasembly, a data analytics firm.
More than half of U.S. states are seeing out-of-stock rates between 40 percent and 50 percent, according to the firm, which collects data from 11,000 locations.
Retailers including Target, CVS and Walgreens have started limiting formula purchases to three containers per customer.
Congress will hold a hearing to focus on the shortage’s causes, efforts to increase production, and what action is needed ‘to ensure access to safe formula across the nation,’ the committee chair, Representative Frank Pallone, a Democrat, said in a statement.
‘The nationwide infant formula shortages are increasingly alarming and demand Congress’ immediate attention,’ he said.
White House spokesperson Karine Jean-Pierre on Wednesday also said it was a top priority to ensure that baby formula is available amid the shortage.
‘This is an urgent issue that the FDA as you all know and the White House is working 24/7 to address they are committed to pulling every lever and are ready to making progress and getting more supply onto the market,’ she said.
Pallone said lawmakers stood ready to work with President Joe Biden’s administration to resolve the shortage, although it is unclear what specific steps Congress or the White House can take to boost supplies near-term.
About 40% of large retail stores are out of stock of baby formula, up from 31% in mid-April
Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50%
Meantime, Sen. Romney wants the FDA and the United States Department of Agriculture (USDA) to do more to ensure the availability of baby formula, citing ‘serious implications of the current shortage on infant health,’ and asked for an update on the investigation into the alleged contaminated formula that forced the recall and shutdown of the plant.
‘The responsibility falls on the FDA and the USDA to protect infant health by ensuring they have access to safe formula,’ Romney penned Tuesday in a letter to FDA Commissioner Robert Califf and Secretary of Agriculture Tom Vilsack.
‘Given the serious implications of the current shortage on infant health, I am deeply concerned about the apparent lack of an effective mitigation strategy and urge both agencies to move as fast as possible to safely resolve this situation.’
The plant ceased operation nearly three months ago after a bacterial infection caused deaths of two children and other serious illnesses. Abbott has since denied its plant is responsible for the deaths.
The manufacturer also issued a nationwide recall on its powder baby formulas in February, exacerbating months of spot shortages at pharmacies and supermarkets.
Now, pediatricians, healthcare experts and politicians are urging the FDA to reopen the plant and distribute Abbott’s formula to families in need.
‘There’s still some risk from the formula because we know there are problems at the plant and FDA hasn’t identified a root cause,’ said Sarah Sorscher of the Center for Science in the Public Interest. ‘But it’s worth releasing because these infants might die without it.’
The FDA issued a statement to DailyMail.com on Tuesday, alleging it was working with U.S. manufacturers to increase their output and streamlining paperwork to allow more imports.
An Abbott spokesperson also confirmed the manufacturer was ‘doing everything we can to address the infant formula supply shortage,’ which includes priorities production of formula products and importing products from the company’s FDA-registered facility in Ireland on a daily basis.
Abbott’s statement came just hours after Rep. Frank Pallone (left) and other lawmakers on Capitol Hill announced the House Energy and Commerce Committee will hold a hearing in two weeks to address the ‘increasingly alarming’ formula shortage. The response also came after Sen. Mitt Romney (right) slammed the FDA for ‘risking the lives of infants across the nation’
Retailers including Target, CVS and Walgreens have begun limiting formula purchases to three containers per customer. An barren shelf meant to store formula is pictured Tuesday at a Target store in Tulsa, Oklahoma
Sen. Romney argues the FDA and USDA have a ‘responsibility’ to mitigate the impacts of the shortage.
‘Please provide a comprehensive update on the progress of the investigation, estimated timeline to completion, efforts to coordinate with other federal agencies, including the USDA, and any other authorities that may be necessary to help relieve the formula shortage,’ he urged.
‘Between the risk of ingesting contaminated formula, and the risk of malnutrition from an inability to receive said formula, the FDA is an exceedingly difficult position protecting infant health.
‘I appreciate the FDA’s efforts to support case-by-case release of essential product, but the pace of release is far slower than demand felt across our nation. In its attempt to balance safety from contaminated product and safe infant development through formula access, FDA is achieving neither objective.’
The Republican legislator also criticized the quality of the FDA’s inspections at the Abbott plant, citing instances of possible contamination dating back to 2019.
‘I am alarmed to see documented instances of non-descript contamination in September 24, 2021, and inadequate sample testing to prove formula products met microbiological quality standards in 2019,’ Romney wrote.
Sen. Mitt Romney has questioned the FDA’s inspection process and is demanding to know what steps were taken to ensure the ‘contaminated products did not leave the facility’ after initial inspections in 2019 and 2021
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.
‘This documentation suggests FDA’s routine inspection authority is insufficient to meet consumer safety demands, yet its hammer of near-shutdowns of facilities causes a ripple effect throughout the country.’
The FDA, which claims Abbott failed to maintain sanitary conditions and procedures at its Michigan manufacturing plant that was linked to a cluster of infant Cronobacter sakazaki infections, published its initial inspection findings in March 2022.
The findings showed the facility didn’t maintain clean surfaces used in producing and handling the powdered formula.
Additionally, inspectors found a history of contamination with the bacteria, including eight instances between fall 2019 and February of this year.
An Abbott spokesperson told DailyMail.com Tuesday that ‘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’.
Regardless, Romney has questioned the FDA’s inspection process and is demanding to know what steps were taken to ensure the ‘contaminated products did not leave the facility’ after initial inspections in 2019 and 2021.
Despite the results of the investigation and please from legislators, it remains unclear when Abbott’s Michigan plant might reopen.
The FDA said the company is still working ‘to rectify findings related to the processes, procedures and conditions’ but refused to say when the plant can resume operations.
Other infant formula makers are ‘meeting or exceeding capacity levels to meet current demand,’ the agency stated Tuesday.
Among other steps, the FDA said it was waiving enforcement of minor product labeling issues to increase availability of both U.S. and imported products.
‘We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it,’ FDA Commissioner Robert M. Califf, M.D. told DailyMail.com in a statement.
‘Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA.
‘Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.’
For now, pediatricians and health workers are urging parents who can’t find formula to contact food banks or doctor’s offices.
They warn against watering down formula to stretch supplies or using online DIY recipes.
‘For babies who are not being breastfed, this is the only thing they eat,’ said Dr. Steven Abrams, of the University of Texas, Austin.
‘So it has to have all of their nutrition and, furthermore, it needs to be properly prepared so that it’s safe for the smallest infants.’
The shortages are especially dangerous for infants who require specialty formulas due to food allergies, digestive problems and other conditions.
‘Unfortunately, many of those very specialized formulas are only made in the United States at the factory that had the recall, and that’s caused a huge problem for a relatively small number of infants,’ Abrams said.
After hearing concerns from parents, the FDA said last month that Abbott could begin releasing some specialty formulas not affected by the recalls ‘on a case-by-case basis.’
The company is providing them free of charge, in coordination with physicians and hospitals.
Food safety advocates say the FDA made the right call in releasing the formula, but that parents should talk to their pediatricians before using it.
‘Always talk with your pediatrician if you have concerns about your baby’s nutrition and feeding your baby,’ Dr. Sarah Abrams, of Akron Children’s Hospital in Ohio, told Fox News.
‘Switch to other formula brands or types of formula,’ she advised to parents struggling to find product. ‘But talk to your pediatrician first, especially if your baby must use a hydrolyzed or amino acid-based formula.’
The pediatrician also shared that due to the Abbott recall, parents have been fearful of that other brands of formula may have been contaminated.
‘I have been told that due to the recall, [parents] were afraid to use the formula they had, even if it wasn’t one that was recalled,’ she explained.
‘And if they do find formula, they worry about the limits of how much formula they can buy at one time. They are calling our office and we are helping them by reaching out to local formula representatives.’
Baby formula is particularly vulnerable to disruptions because just a handful of companies account for almost the entire U.S. supply, analysts allege.
More than half of U.S. states are seeing out-of-stock rates between 40 percent and 50 percent, according to the firm, which collects data from 11,000 locations. This photo, taken Tuesday, shows a barren Walmart shelf meant to hold baby formula
Industry executives say the constraints began last year as the COVID-19 pandemic led to disruptions in ingredients, labor and transportation. Supplies were further squeezed by parents stockpiling during lockdowns.
Then in February, Abbott recalled several major brands and shut down its Sturgis, Michigan, factory when federal officials concluded four babies suffered bacterial infections after consuming formula from the facility. Two of the infants died.
When FDA inspectors visited the plant in March they found lax safety protocols and traces of the bacteria on several surfaces. None of the bacterial strains matched those collected from the infants, however, and the FDA hasn’t offered an explanation for how the contamination occurred.
For its part, Abbott says its formula ‘is not likely the source of infection,’ though the FDA says its investigation continues.
Abbott said Tuesday they are ‘working closely with the FDA to restart operations’ at the plant, with the spokesperson on Tuesday 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’.
A nearly empty baby formula display shelf is seen Sunday at a Target store in Orlando, Florida
Baby formula is stored in a locked case, with shelves half empty, at a Walmart store on Tuesday
#Abbott #warns #TEN #WEEKS #baby #formula #shelves #FDA #reopens #factory