Food safety experts are demanding the Food and Drug Administration (FDA) reopen America’s biggest baby formula plant as parents across the nation are scrambling to feed their children because supply disruptions and a massive safety recall have swept many products off store shelves.
The Abbott Laboratories plant in Sturgis, Michigan 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 and healthcare experts 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.
Food safety experts are demanding the Food and Drug Administration (FDA) reopen America’s biggest baby formula plant – the Abbott Laboratories plant in Sturgis, Michigan
Parents across the nation are scrambling to feed their children because supply disruptions and a massive safety recall have swept many products off store shelves
Nationwide 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.
White House press secretary Jenn Psaki said Monday the Food and Drug Administration was ‘working around the clock to address any possible shortages,’ however shelves across the country meant to carry formula remain largely barren.
Retailers including Target, CVS and Walgreens have begun limiting formula purchases to three containers per customer.
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
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.
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.
‘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.’
Despite the results of the investigation and pressure from experts and concerned parents, 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.’
Baby formula is particularly vulnerable to disruptions because just a handful of companies account for almost the entire U.S. supply, analysts allege.
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 claims 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’.
Meanwhile, parents are across the nation are issuing alarming calls for help as they try to find ways to nourish their children.
Laura Stewart, a 52-year-old mother of three who lives just north of Springfield, Missouri, has been struggling for several weeks to find formula for her 10-month-old daughter, Riley.
Riley normally gets a brand of Abbott’s Similac designed for children with sensitive stomachs. Last month, she instead used four different brands.
‘She spits up more. She’s just more cranky. She is typically a very happy girl,’ Stewart said. ‘When she has the right formula, she doesn’t spit up. She’s perfectly fine.’
A small can costs $17 to $18 and lasts three to five days, Stewart said.
Like many Americans, Stewart relies on WIC – a federal program similar to food stamps that serves mothers and children – to afford formula for her daughter. Abbott’s recall wiped out many WIC-covered brands, though the program is now allowing substitutions.