By Emily Goodin, Senior U.S. Political Reporter and Katelyn Caralle, U.S. Political Reporter and Geoff Earle, Deputy U.S. Political Editor For Dailymail.com and Natasha Anderson
Published: 11:36 EDT, 12 May 2022 | Updated: 17:48 EDT, 12 May 2022
Republicans are sounding the alarm after discovering baby formula is being sent to border facilities while American mothers are facing empty shelves amid massive shortages.
And President Joe Biden's administration is struggling to respond, unable to reassure parents when there will be more formula on empty grocery store shelves and where they can turn to for help.
GOP Representative Kat Cammack tweeted Thursday two images, one showing full shelves of baby formula and food from a processing center at the southern border and another showing empty shelves where baby formula was supposed to be at an American grocery store.
'The first photo is from this morning at the Ursula Processing Center at the U.S. border. Shelves and pallets packed with baby formula,' Cammack wrote. 'The second is from a shelf right here at home. Formula is scarce.'
'This is what America last looks like,' she added.
Meanwhile, concerned parents are begging the U.S. Food and Drug Administration (FDA) to reopen the nation's largest baby formula plant after the nationwide shortage has left their infants hungry and ill.
But the White House on Thursday defended the closure of the Abbott plant but officials couldn't say when it would reopen.
'The reason we're here is because the FDA took a step to ensure that babies were taking safe formula. There were babies who died from taking this formula so they were doing their jobs,' White House press secretary Jen Psaki said at her daily press briefing.
President Joe Biden got personally involved on Thursday when he met with executives from infant formula manufactures and retailers including Target, Walmart and Nestle's Gerber to discuss the issue.
Biden spoke with manufacturers Reckitt and Gerber about their efforts to increase production.
'Both companies stated that they are operating 24/7 with Gerber, increasing the amount of their infant formula available to consumers by approximately 50% in March and April. Reckitt is supplying more than 30% more product year to date,' the White House said in a readout of the president's meeting.
And his administration announced additional steps it was taking to boost the production of baby formula.
But officials were short on specifics. They couldn't say when the Abbott plant would reopen, they couldn't say when more baby formula would be for sale and Psaki couldn't offer any options when asked who parents can call for help.
The White House defended the FDA's closure of the Abbott plant that resulted in a shortage of baby formula; 'There were babies who died from taking this formula so they were doing their jobs,' White House press secretary Jen Psaki said
GOP Representative Kat Cammack tweeted Thursday outrage over border centers being fully stocked with baby formula while American grocery stores are seeing massive shortages and empty shelves where formula should be
The administration did acknowledge the frustration.
'We absolutely recognize the frustration of parents and family,' a senior administration official said on a briefing call with reporters but added: 'I don't have a particular timeline for you' when asked when parents would see some relief.
The officials also didn't know when Abbott Nutrition's Sturgis, Michigan, plant - one of the largest producers of formula - would be back online.
'We do not today have an estimate for accessibility will come on line. But as we just said that the administration is working around the clock to do everything we can to to bring as much production to market,' the official said.
Abbott said that pending FDA approval, 'we could restart the site within two weeks.'
Once production began, it would take six weeks to eight weeks for the baby formula to be available on shelves.
Among the steps the administration announced was cutting red tape when it comes to the size of the formula.
'We recognize that this is certainly a challenge for people across the country, something the President is very focused on and we're going to do everything we can to cut red tape and and take steps to increase supply on the marketplace,' Psaki said.
Manufacturers typically make multiple sized containers of the product and government programs like WIC often limit what size can be purchased. The administration is working to change those limits to ease the burden on manufactuers and let them rush out one size.
Officials also said the administration would work to increase the imports of baby formula but would have more details available on that at a later date.
And the administration is calling on state attorneys general to crack down on price gouging. Formula has been going for up to $120 a can as desperate parents try to feed their children.
Biden sent a letter on the matter to the Federal Trade Commission Chair Lina Khan on Thursday.
'It is unacceptable for families to lose time and spend hundreds of dollars more because of price gougers’ actions,' he wrote.
'I therefore ask that the Commission further examine whether there is price gouging in infant formula occurring, thoroughly investigate complaints brought to you through channels such as your fraud hotline, and that you bring all of the Commission’s tools to bear if you uncover any wrongdoing. We know State attorneys general are also examining this issue and may be valuable partners in this effort.'
Republican Senators Josh Hawley of Missouri and Marco Rubio of Florida have called on the administration to use the Defense Production Act to get more formula produced.
The White House did not rule it out.
'We're gonna keep every option on the table,' the senior administration official said.
Psaki also said it was an option.
'You have to ensure that it would actually achieve what you're trying to achieve,' she said of using the act.
The formal shortage came in part due to a voluntary recall of several lines of powdered formula from Abbott Nutrition, which is the largest formula manufacturer in the U.S.
Meanwhile, more than 100 House Republicans are demanding that the administration do more to address the crisis.
'This issue is a matter of life and death, and it is time this administration treats it with the appropriate urgency it deserves,' the GOP lawmakers said in the letter to the president on Wednesday.
House Speaker Nancy Pelosi said Thursday that there needs to be immediate action to address the baby formula shortage in the U.S., but Congress isn't holding hearings on the issue until the end of the month as mothers scramble to feed their babies.
'You know, everybody has suggestions about 'we make sure it never happens again.' And that's important,' she said during her weekly briefing Thursday.
'But right now, the baby's crying, the baby's hungry. We need to address it right now,' she added. 'And I think we have good focus on it.'
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
President Biden has directed his administration to work urgently to ensure that during the Abbott Nutrition voluntary recall, infant formula is safe and available for families across the country. Today, President Biden spoke with retailers and manufacturers, including Wal-Mart, Target, Reckitt, and Gerber, to discuss ways we can all work together to do more to help families access infant formula.
On February 17, the largest infant formula manufacturer in the country—Abbott Nutrition—initiated a voluntary recall of several lines of powdered formula. This came after concerns about bacterial contamination at Abbott's Sturgis, Michigan, facility after four infants fell ill and two died. The federal government—including the Food and Drug Administration (FDA), Department of Agriculture (USDA), Department of Justice (DOJ), Department of Transportation (DOT), U.S. Trade Representative (USTR), Department of Homeland Security (DHS), Department of Commerce (DOC), and the White House—has worked diligently over the last few months to address the shortfall in infant formula production while the Sturgis plant remains offline, including working with other infant formula manufacturers to increase production, expediting the import of infant formula from abroad, and calling on both online and in store retailers to establish purchasing limits to prevent the possibility of hoarding. As a result, more infant formula has been produced in the last four weeks than in the four weeks preceding the recall — despite one of the largest infant formula production facilities in the U.S. being offline.
Families across the country remain concerned about the availability of infant formula—especially families that depend on specialty formulas for which the Sturgis facility is a key supplier. These 20 specialty formulas are used by about 5,000 infants as well as some older children and adults with rare metabolic diseases, and Abbott Nutrition is the only supplier for some of these formulas.
Today, President Biden is announcing additional steps to bolster our work to get infant formula onto store shelves as quickly as possible without compromising safety. These steps include:
To help further increase manufacturers' ability to meet demand and distribute formula, USDA is working with states to make it easier for vulnerable families to purchase the formula they need with their WIC benefits. USDA is urging states to allow WIC recipients to use their WIC benefits on a wider variety of products so that if certain sizes or types of formula are out of stock, they can use their benefits on those that are in stock. And, USDA is urging states to relax their requirements that stores keep a certain amount of formula in stock. This will offer relief to retailers and allow companies to manage inventories to meet demand. Some states are already doing this. All fifty states should. These actions will make it easier for vulnerable families to get the necessary nutritional support for their infants.
More information on actions that the FDA announced earlier this week to address the shortage of infant formula can be found here. The Biden-Harris Administration will continue to monitor the situation and identify other ways it can support the safe and rapid increase in the production and distribution of baby formula.
Despite the calls for immediately figuring out the shortage, Democrats in Congress have not shown urgency in their policy – instead spending the week focusing on passing $40 billion in aid to Ukraine and pushing for action on codifying Roe v. Wade.
'For a long time now Congresswoman Rosa DeLauro, of the Appropriations Committee... has been addressing this issue,' Pelosi said on the topic of baby formula shortage. 'And when I say addressing that includes investigating, looking for other possibilities because – in anticipation just to make sure that something like this would not happen.'
'And we look forward to what the President has to say,' she added, indicating that action won't come from Congress until a White House plan is laid out.
Product recalls, supply chain shortages, and other factors have set off a scramble by some parents to locate enough formula to feed their young children.
The Virginia firm Datasembly released a report revealing a nationwide out-of-stock rate of 43 per cent for formula, putting low income families and those with special needs at risk.
President Joe Biden will meet with industry leaders amid the baby formula shortage as mothers and fathers scramble to find food for their infants
Lawmakers are also pressing for action, but have scheduled hearings that don't start for weeks as the severe shortage continues.
They will hold a hearing in two weeks on infant formula shortages, the House Energy and Commerce Committee said on Wednesday, as it called the situation 'increasingly alarming.'
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.
The hearing will 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.
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.
Lawmakers will hold a hearing in two weeks on infant formula shortages
House Energy and Commerce Committee will hold hearing on May 25
'The nationwide infant formula shortages are increasingly alarming and demand Congress' immediate attention,' said Rep. Frank Pallone, chair of the committee
Meanwhile, Sen. Mitt Romney slammed the Food and Drug Administration (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.
'The responsibility falls on the FDA and the United States Department of Agriculture (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.'
Romney wants the agencies 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 Abbott Laboratories plant in Sturgis, Michigan.
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.
The company said on Wednesday it could resume infant formula production within two weeks at its Michigan plant as it works with the FDA. From then, it would take six to eight weeks before the product is available on store shelves.
Sen. Mitt Romney (pictured on May 4) slammed the Food and Drug Administration (FDA) for 'risking the lives of infants across the nation' by forcing America's biggest baby formula plant to stay closed while parents across the nation are scrambling to feed their children.
Food safety experts are also demanding the FDA reopen America's biggest baby formula plant - the Abbott Laboratories plant in Sturgis, Michigan
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
'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.
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
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
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.
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.'
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.
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.'
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.
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
Baby formula is stored in a locked case, with shelves half empty, at a Walmart store on Tuesday
Brian Dittmeier, Senior Director of Public Policy at the 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.'
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