WASHINGTON (AP) — The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.

A 10-page report from the agency offers its first formal account of the factors that led to the ongoing shortage, which has forced the U.S. to airlift millions of pounds of powdered formula from overseas.

The review zeroed in on several key problems at the agency, including outdated data-sharing systems, inadequate staffing and training among its food inspectors, and poor visibility into formula supply chains and manufacturing procedures.

“For things that are critical to the public health, if you don’t have some understanding of how all the pieces fit together, then when you get into a crisis or a shortage you have a real problem,” FDA Commissioner Robert Califf told The Associated Press in an interview. “To a large extent that’s what happened here.”

Califf said the FDA will seek new authority to compel companies to turn over key information.

One consumer advocate said the evaluation doesn’t go far enough to fix the problems.

“This internal evaluation treats the symptoms of the disease rather than offering a cure,” Scott Faber of the Environmental Working Group said in a statement. “Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures.”

The FDA report was overseen by a senior official who interviewed dozens of agency staffers. It comes nearly eight months after the FDA shuttered Abbott’s Michigan plant due to safety concerns, quickly slashing domestic production within the highly concentrated formula industry.

A company whistleblower had tried to warn the FDA of problems at the plant in September 2021, but government inspectors didn’t investigate the complaints until February after four infants became sick, resulting in two deaths. The FDA is still investigating links between those illnesses and the formula.

The FDA previously told Congress that top agency officials didn’t learn about the complaint until February because of mail delays and a failure to escalate the Abbott employee’s allegations. The new report stated that FDA’s “inadequate processes and lack of clarity related to whistleblower complaints,” may have delayed getting inspectors to the plant.

“Whistleblower complaints come into the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the review. “One of the actions we’ve already taken is to make sure that however they come into the agency, they get triaged and escalated to the right leadership levels.”

FDA inspectors collected bacterial samples from the plant for testing, but shipping issues by “third party delivery companies” delayed the results, according to the report. The FDA also faced challenges ramping up its testing capacity for cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula.

The FDA also noted that it had to reschedule its initial inspection of the Abbott plant due to cases of COVID-19 among company staff. That delay came on top of earlier missed inspections because the agency pulled its inspectors from the field during the pandemic.

The report concluded by listing new resources that Congress would need to authorize to improve infant formula inspections and standards, including:

— Increased funding and hiring authority to recruit experts to FDA’s food division;

— Improved information technology to share data on FDA inspections, consumer complaints and testing results;

— New authority to compel manufacturers to turn over samples and records on manufacturing supply chains, manufacturing quality and safety.

U.S. inventories of baby formula have been improving, hitting in-stock rates above 80% last week, according to IRI, a market research firm. That’s up from a low of 69% in mid-July. The U.S. has imported the equivalent of more than 80 million bottles of formula since May, according to White House figures, and the Biden administration is working to help foreign manufacturers stay on the market long term to diversify supply.

Califf has commissioned a separate external review of FDA’s food division citing “fundamental questions about the structure, function, funding and leadership” of the program. That review is being led by former FDA commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.

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WASHINGTON (AP) — The head of the Food and Drug Administration told lawmakers Thursday that a shuttered baby formula factory could be up and running as soon as next week, though he sidestepped questions about whether his agency should have intervened earlier to address problems at the plant that have triggered the national shortage.

FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a major political liability for President Joe Biden.

The problems are largely tied to Abbott Nutrition’s Michigan formula plant, the largest in the U.S., which has been closed since February due to contamination problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications.

“We had to wrestle this to ground with Abbott,” Califf told members of a House subcommittee “I think we are on track to get it open within the next week to two weeks.”

After production resumes, Abbott has said, it could take about two months until new formula begins arriving in stores. Califf said it will be “a few weeks” before supplies return to normal levels, especially in rural areas that aren’t near distribution hubs.

When lawmakers asked why it took the FDA months to investigate a whistleblower complaint about safety violations at Abbott’s plant, Califf said he couldn’t share details due to the agency’s ongoing investigation. Several lawmakers rejected that response.

“It’s not acceptable to say you just can’t comment on it,” said Rep. Mark Pocan, D-Wis. “This is a problem I’ve seen over and over with the FDA: You guys aren’t good at communicating.”

Califf is the first administration official to testify before Congress on the shortage, which has left some parents hunting for formula and become a political talking point for Republicans. On Wednesday evening Biden announced sweeping new steps to improve U.S. supplies, including invoking the Defense Production Act and flying in imported formula from overseas.

Rep. Rosa DeLauro, D-Conn., repeatedly asked Califf to explain what the FDA did after receiving a whistleblower complaint in October alleging numerous safety violations at Abbott’s plant, including employees falsifying records and failing to properly test formula before releasing it. The former Abbott employee wasn’t interviewed by the FDA until late December and the plant wasn’t closed until mid-February, she noted.

“It all begs the question, why did the FDA not spring into action?” DeLauro asked. “Who in the leadership had access to that report — who didn’t have access to the report — and why was there no reaction?”

Califf said he had reviewed the complaint but didn’t specify when or what immediate steps were taken.

“I am committed to getting back to you on specifics of what happened, I’m just not prepared to today,” Califf said.

One point on which lawmakers and Califf agreed is that consolidation in the U.S. formula market makes it highly vulnerable to disruption. Just four companies produce an estimated 90% of U.S. formula, including Abbott, Gerber, Perrigo and Reckitt. Those companies also dominate federal contracts that provide about half of all U.S. formula through a program called WIC, for low-income mothers, infants and children.

Abbott shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. All four were hospitalized and two died. The first of those cases was reported to the FDA in September, but agency staff didn’t begin inspecting the facility until late January.

Califf said earlier this week that the agency hasn’t yet reached a conclusion on whether bacteria from the plant caused the infant infections. Abbott has said there is no direct evidence linking its products to the illnesses.

The baby formula shortage is the first major crisis for Califf since returning to the FDA in February. He briefly led the agency under President Barack Obama and was tapped for the job again based on his past experience leading the sprawling agency, which regulates food, drugs, medical technology and tobacco.

Thursday’s hearing was scheduled to review the FDA’s budget request for next year, and Califf asked lawmakers for $76 million in new funding for food safety and nutrition.

“I was very well aware coming in that we need to do major improvements on the food side of the FDA — not because the people are bad — but there is a need for consistent leadership and the right resources,” Califf told lawmakers.

The funding request comes amid longstanding concerns that the FDA’s food program — which oversees most U.S. foods except meat, poultry and eggs — has been chronically underfunded and undermanaged compared to its medical divisions.

On Wednesday evening, House Democrats passed a $28 million spending bill that would boost FDA funding to inspect domestic and international formula producers. Its fate in the Senate is uncertain.

The subcommittee’s top Republican, Rep. Andy Harris of Maryland, said many of the problems facing the FDA could be “solved by strong leadership, rather than money.”

While supporting increased funding, DeLauro also said the problems in the agency’s food center run deeper.

“You have serious structural, leadership issues,” she told Califf. “Someone at this agency needs to have serious, relevant food credentials. Otherwise, food will be a second class citizen at the FDA.”

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WASHINGTON (AP) — Under fire from parents and politicians, President Joe Biden’s administration announced steps Monday to ease a nationwide shortage of baby formula, including reopening the largest domestic manufacturing plant and increasing imports from overseas.

The Food and Drug Administration said it was streamlining its review process to make it easier for foreign manufacturers to begin shipping more formula into the U.S.

“The FDA expects that the measures and steps it’s taking with infant formula manufacturers and others will mean more and more supply is on the way or on store shelves moving forward,” FDA Commissioner Robert Califf told reporters.

Califf said the U.S. will prioritize companies that can provide the largest shipments and quickly show documentation that their formulas are safe and compatible with U.S. nutrition standards. The policy is structured as a temporary measure lasting six months.

The imports announcement came shortly after regulators said they’d reached a deal to allow Abbott Nutrition to restart its Sturgis, Michigan-based plant, which has been closed since February due to contamination issues. The company must overhaul its safety protocols and procedures before resuming production.

Neither step will have an immediate effect on tight supplies that have left many parents searching for formula online or in food banks.

After getting the FDA’s OK, Abbott said it will take eight to ten weeks before new products begin arriving in stores. The company didn’t set a timeline to restart manufacturing.

Getting imports into the U.S. supply chain will also take several weeks, according to administration officials. Products from Australia, New Zealand and the U.K. are expected to meet the standards needed for importation.

But regulators said national industry data shows most U.S. stores, on average, still have 80% of their formula inventory in stock. They suggested some of the empty shelves seen in recent days may be due to panic buying by parents.

Monday’s announcement was previewed last week by the White House, which has been leaning on the FDA and formula makers to quickly find ways to alleviate the shortage. Outrage over the issue has quickly snowballed and handed Republicans a fresh talking point to use against President Biden ahead of November elections.

The shortage stems from a February recall by Abbott that exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on stores shelves across much of the country. The shortage has led retailers like CVS and Walgreens to limit how many containers customers can purchase per visit.

Abbott’s voluntary recall was triggered by four illnesses reported in babies who had consumed powdered formula from its plant. All four infants were hospitalized with a rare type of bacterial infection and two died.

After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary standards and a history of bacterial contamination in several parts of the plant. Under Monday’s agreement, Abbott must regularly consult with an outside safety expert to restart and maintain production.

Chicago-based Abbott has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from two babies by federal investigators.

But FDA officials pushed back on that reasoning Monday on a call with reporters— their first time publicly addressing the company’s argument. FDA staffers noted they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match

“Right from the get-go we were limited in our ability to determine with a causal link whether the product was linked to these four cases because we only had sequences on two,” FDA’s food director Susan Mayne said.

Fixing the violations uncovered at Abbott’s plant takes time, according to former FDA officials. Companies need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.

As part of the FDA’s new import policy, regulators said companies would need to provide documentation of their factory’s inspections.

Pediatricians say baby formulas produced in Canada and Europe are roughly equivalent to those in the U.S. But traditionally, 98% of the infant formula supply in the U.S. is made domestically. Companies seeking to enter the U.S. face several major hurdles, including rigorous research and manufacturing standards imposed by the FDA.

San Diego father Steven Hyde has faced heart-wrenching challenges finding formula for his medical fragile daughter, who was on an Abbott formula but has had to switch with the recall and subsequent shortages in other brands.

Zoie Hyde was born 19 months ago with no kidneys, a rare life-threatening condition that requires dialysis and a feeding tube until she weighs enough for a kidney transplant.

Hyde said he used an organic brand from overseas until costs and customs hurdles made that too difficult. Friends and strangers from out of state have sent him other brands, but each time she switches requires more blood tests and monitoring, Davis said.

Despite her challenges, Zoie is walking, talking and “doing pretty good” on other developmental milestones, Davis said.

“She’s a shining light in my life,” he said.

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WASHINGTON (AP) — Many parents are hunting for infant formula because of a combination of short- and long-term problems that has hit most of the biggest U.S. brands.

Millions of babies in the U.S. rely on formula, which is the only source of nutrition recommended for infants who aren’t exclusively breastfed.

Here’s a look at what’s behind the problem and what parents can do:

WHY IS THERE A SHORTAGE?

Ongoing supply disruptions have combined with a recent safety recall to leave many pharmacy and supermarket shelves bare.

The problems began last year as the COVID-19 pandemic led to disruptions in labor, transportation and raw materials — economy-wide issues that didn’t spare the formula industry. Inventory was further squeezed by parents stockpiling during COVID-19 lockdowns.

Then in February, Abbott Nutrition recalled several major brands of powdered formula and shut down its Sturgis, Michigan, factory when federal officials began investigating four babies who suffered bacterial infections after consuming formula from the facility.

Abbott is one of only a handful of companies that produce the vast majority of the U.S. formula supply, so their recall wiped out a large segment of the market.

WHAT IS IN BABY FORMULA?

Most formulas contain protein from cow’s milk that’s been altered to be easier to digest and enhanced with extra nutrients needed for growth and development. The Food and Drug Administration sets specific nutritional requirements, including minimum amounts of protein, fat, calcium and a number of vitamins. Formula makers achieve those levels by adding various sugars, oils and minerals.

The formulas are designed to mimic breast milk, though studies have repeatedly shown better health outcomes for babies who are breastfed.

WHY CAN’T ALL MOTHERS RELY ON BREAST MILK?

Health professionals recommend exclusively breastfeeding babies until they are 6 months old. But federal figures show that only 1 in 4 are relying solely on breast milk at that age.

Mothers face a number of challenges to long-term breastfeeding, including returning to work and finding the time and equipment needed to pump breast milk. About 60% of mothers stop breastfeeding sooner than they had planned, according to the Centers for Disease Control and Prevention.

State and federal laws have been enacted to encourage breastfeeding by requiring break time and accommodations for mothers of infants.

Rates of breastfeeding have consistently been lower among Black babies than other groups. About three quarters of Black babies are breast fed in infancy, below the national average of 84%, according to the CDC.

WHAT SHOULD PARENTS DO IF THEY ARE HAVING TROUBLE FINDING FORMULA?

Talk with your pediatrician or call a local food bank to see if they can help locate some options. Experts also recommend checking with smaller stores and pharmacies, which may still have supplies when larger stores run out.

Most regular baby formulas contain the same basic ingredients and nutrients, so parents shouldn’t hesitate to buy a different brand if they’re having trouble finding their regular one.

Some infants require specialty formulas due to allergies, digestive problems and other medical conditions. Parents should talk to their doctor if they can’t find those products, which manufacturers usually distribute through pharmacies and clinics.

Families that qualify for WIC — a federal program similar to food stamps that pays for about half the formula used in the U.S. — can also contact their local agency.

Health officials also warn against buying formula via social media websites or outside of conventional retailers because they could be counterfeit.

WHY ARE PARENTS TOLD NOT TO USE MAKE-YOUR-OWN FORMULA RECIPES ONLINE?

Many do-it-yourself formula recipes are made from cow’s milk and granular sugar that may be difficult for young babies to digest. They also lack the specific vitamins and proteins found in breastmilk and FDA-approved formulas that are needed for basic nutrition.

“Particularly for small babies, many of these formulas and mixtures that are found online don’t contain even the most basic nutrient mixes that babies need to survive,” said Dr. Steven Abrams, a pediatrician at the University of Texas, Austin.

Abrams also stressed that parents should never dilute infant formula.

WHAT ARE RETAILERS DOING TO KEEP FORMULA IN STOCK?

Several national chains have limited the number of containers customers can purchase in stores and online. For CVS and Walgreens, the limit is three per customer. Target limits purchases to four per person when buying online.

Amazon said Thursday it is working to keep the products available on its website and monitoring third-party sellers for price-gouging.

“If we identify a price that violates our policy, we remove the offer and take appropriate action with the seller,” a company spokesperson said in a statement.

WHEN ARE SUPPLIES LIKELY TO IMPROVE?

Health regulators recently announced several steps designed to boost supply, including allowing faster importation of formula made overseas. Typically, 98% of baby formula consumed in the U.S. is made domestically, according to federal officials.

The FDA is working with Abbott to fix the violations that triggered the shutdown of its Michigan plant, which produces Similac, EleCare and several other leading powdered formulas.

The company says its products have not been directly linked to the bacterial infections in children, pointing out that genetic samples collected from its factory did not match those found in several infants who got sick.

The Chicago-based company said this week that, pending FDA approval, it could restart manufacturing at its plant within two weeks. After that it would take another six to eight weeks before new products hit store shelves.

But even then, experts caution that many of the industrywide issues will continue to restrain supplies.

“This is going to be a problem and it’s not going away for at least a period of several months,” Abrams said.

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WASHINGTON (AP) — Parents across the U.S. are scrambling to find baby formula because supply disruptions and a massive safety recall have swept many leading brands off store shelves.

Months of spot shortages at pharmacies and supermarkets have been exacerbated by the recall at Abbott, which was forced to shutter its largest U.S. formula manufacturing plant in February due to contamination concerns.

On Monday, White House press secretary Jenn Psaki said the Food and Drug Administration was “working around the clock to address any possible shortages.”

On Tuesday, the FDA said it was working with U.S. manufacturers to increase their output and streamlining paperwork to allow more imports.

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.”

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.

Trying to keep formula in stock, retailers including CVS and Walgreens have begun limiting purchases to three containers per customer.

Nationwide about 40% of large retail stores are out of stock, up from 31% 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% and 50%, according to the firm, which collects data from 11,000 locations.

Baby formula is particularly vulnerable to disruptions because just a handful of companies account for almost the entire U.S. supply.

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.

Chicago-based Abbott said it is increasing production at its other facilities to fill the gap, including air-shipping formula from a plant in Ireland.

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.

“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.”

It’s unclear when the Abbott plant might reopen.

The FDA said the company is still working “to rectify findings related to the processes, procedures and conditions.” Other infant formula makers are “meeting or exceeding capacity levels to meet current demand,” the agency said.

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.

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