Ultimate Resource On Baby Formula Shortage

Demand Is Up At Human Milk Banks Amid Baby Formula Crisis. Ultimate Resource On Baby Formula Shortage

Inquiries for pricey donor milk have risen, but banks are relatively scarce and can only service so many families.

Updated: 1-6-2026

Several Baby Formulas Recalled Over Toxin Presence!!!

Nestle recently issued a global recall of some baby formula products due to concerns over a toxin that can cause food poisoning.

Nestlé Infant Formula

Recall Date: January 6, 2026

Reason: Potential contamination with cereulide, a toxin that can cause food poisoning.

Affected Products: Specific batches of SMA infant formula and follow-on formula sold globally, including brands like Guigoz and Nidal in France, and Beba and Alfamino in Germany.

Action: Consumers should check batch numbers and discontinue use of affected products. Refunds are available.

Abbott Infant Formula

Recall Date: Ongoing since February 2022

Reason: Contamination concerns related to Cronobacter sakazakii and Salmonella Newport.

Affected Products: Certain Similac, Alimentum, and EleCare formulas with specific lot codes.

Action: Parents should not use affected formulas and check for specific lot codes.

Notably, a batch of Aptamil First Infant Formula in the UK was recalled due to the presence of a toxin called cereulide, and ByHeart infant formula was recalled due to a botulism outbreak linked to its products.

Recent Infant Formula Recalls

Aptamil First Infant Formula Recall

Product: Aptamil First Infant Formula

Manufacturer: Danone

Batch Code: EXP 31-10-2026

Issue: Contains cereulide toxin, which can cause vomiting.

Affected Sales Period: Sold between May and July 2025.

Action: Parents should return the affected batch for a full refund, with or without a receipt.

ByHeart Whole Nutrition Infant Formula Recall

Product: ByHeart Whole Nutrition Infant Formula

Issue: Linked to an outbreak of infant botulism, affecting 51 babies across 19 states.

Contamination Source: Dried milk powder tested positive for botulism bacteria.

Action: All ByHeart products have been recalled. Parents should stop using these products immediately and seek medical attention if symptoms develop.

Symptoms To Watch For

Cereulide Exposure: Nausea, vomiting, abdominal cramps.

Botulism Symptoms: Constipation, poor feeding, loss of head control, difficulty swallowing, which can progress to respiratory issues.

Recommendations For Parents

Check for the affected batches of Aptamil and ByHeart formulas.

If you have these products, do not use them and return them for a refund.

Consult a healthcare provider if your baby shows any concerning symptoms after consuming these formulas.

Meanwhile..

The worsening baby formula shortage is pushing more parents to explore an even pricier alternative: Human breast milk supplied by donor banks.

Inquiries for donor milk have risen by 20% since the beginning of the shortage, said Lindsay Groff, the executive director of the Human Milk Banking Association of North America.

That follows a record year of distribution: The HMBANA’s member banks dispensed 9.2 million ounces to the families and hospitals of babies in need in 2021, a 22% increase from 2020, Groff said. Calls from those who are interested in donating milk are picking up, too.

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Demand for donated milk is “likely to increase as these things go on and the shortage continues and people are feeling more stressed and scared and desperate,” Groff said.

The increased interest comes amid skyrocketing out-of-stock rates for formula that have put pressure on the White House to take steps to ease the supply crunch. Human milk banks, though, can only provide so much relief: They are relatively scarce in the US, and the cost of their offering is often greater than for formula.

There are 28 milk banks accredited by HMBANA in the United States, with an additional three in Canada. Banks accept donations that have been dropped off at specified locations or have been overnighted to a given facility, before being screened, tested, and pasteurized.

The US Food and Drug Administration recommends against using milk that has not been vetted, though it was not involved in establishing those guidelines.

Donor milk can cost anywhere from $3 to $5 an ounce. Some formula labels can cost $1 per ounce, while others sell for about 50 cents per ounce, Parents magazine notes. (That’s without any potential price increases due to scarcity or price-gouging.)

Milk banks often work with parents to address costs, such as sliding-scale programs and fundraising efforts to cover costs. And many parents consider the price tag worth it.

Laura Herold, a mom in Brooklyn, New York, said her five-month-old was first given donor milk in the hospital shortly after her birth. Herold kept purchasing it after being discharged.

“It wasn’t cheap,” she said. “At the time, we just didn’t care. We wanted to feed our baby.”

Donor milk is largely considered by experts to be the gold standard if breastfeeding is not an option, given its ability to decrease the risk of life-threatening diseases, especially for preemies. But doctors also warn against shaming parents for using formula, given the myriad cultural, economic, and biological hurdles that might make formula-feeding the only viable option.

Milk banks prioritize sourcing milk to what Groff with the HMBANA calls “medically fragile” babies, such as those born prematurely. Families and caregivers of healthy infants can receive up to 40 ounces of breast milk without a doctor’s prescription.

Serving all of those who are interested may prove challenging: Donations became scarcer earlier this year, coinciding with a widespread return to work — a shift that meant many lactating parents were coming back to workplaces that lack dedicated pumping rooms, sufficient breaks, or paid parental leave.

Doctors have recommend against both homemade formulas as well as diluting supplies on hand to stretch resources. Some retailers are currently limiting the maximum number of formula products to three per customer, and parents are setting up online alerts and coordinating with one another in Facebook groups and other forums for support.

Even when the formula supply chain improves, Groff expects resilient demand for donor milk. “Babies are born every day, and not every parent can breastfeed,” Groff said.

Updated: 5-18-2022

Here’s How To Buy Baby Formula Online During The Shortage

Finding baby formula amid the nationwide shortage takes patience and luck. These websites alert you to the availability of Similac, Enfamil and other brands at major online retailers.

If you’re one of the many parents looking for baby formula, there are automated services that will scour the internet for you. Just keep your credit card handy because retailers sell out quickly.

Free online inventory trackers—used by frenzied shoppers during the holiday season to track down Sony PlayStations and other hard-to-find hot gifts—have added baby formula to their radars.

After Abbott Laboratories recalled several powdered formulas in February, leading to nationwide shortages, parents began submitting requests to stock-monitoring platforms including NowInStock.net, ZooLert.com and HotStock.io. The websites, which also helped people find Covid-19 test kits amid scarcity, run software that recurrently checks inventory at major online retailers. (You can learn more about how this works in my video.)

“At first, only a few infant formulas were hard to find,” said Tony Nguyen, creator of ZooLert. “Now almost every one of them sells out quickly.” The website searches for inventory updates on the most popular products every 45 seconds.

Each of the three sites lists baby formula on the landing page, making the category easier to find. They also include links to items available for preorder and show the last time they were in stock.

Within seconds of product becoming available, the tracking websites can update and send alerts to users who sign up and opt in. On Monday, ZooLert indicated a 24-pack of Abbott’s Similac Total Care was available at Walmart. The ready-to-feed formula showed as sold out about a minute later. NowInStock showed a 12.6-ounce canister of Enfamil available at Target. It sold out the same day.

The Biden administration launched its own website Friday to point families toward local food banks and government-aid services that can help provide formula. The administration also said it is working with companies to get more formula on shelves more quickly, including flying in formula from overseas.

Meanwhile, trackers may help you find the scarce supplies locally. If you decide to use the trackers, getting an email or text about product availability is just the start. You’ll still need to respond to the alert fast. And don’t wait until you’re completely out of formula to use the trackers—alerts aren’t guaranteed, and not all retailers will deliver to your home at the same speed.

Here’s How To Use An Inventory Tracker To Find Baby Formula:

Register For An Account. To receive alerts from NowInStock, ZooLert and HotStock, you’ll need to sign up and tell the service which product you’re interested in. If you don’t register, you’ll have to leave a tracker’s webpage open on your browser and keep checking back for any changes. (Some services offer paid subscription features such as faster notifications.)

Create Accounts With Baby-Formula Retailers. The checkout process will go faster if the retailer already has your address and payment information stored. You can also use your browser’s autofill feature to quickly input your name and shipping information.

Choose Your Notification Type. ZooLert and NowInStock can send you an email or browser alert. (After you sign up, add the company’s email to your address book so messages won’t end up in spam.) The HotStock app can send push notifications to your phone.

Turn On Your Notifications. Make sure your smartphone or computer isn’t in Do Not Disturb mode. Turn up the volume so you can hear an alert. Also, make sure you don’t have your phone’s low-power battery-saver mode turned on because it can slow down notifications.

Be Patient. The tech isn’t failproof. You might not get formula the first (or second) time you try—either because other people moved faster, or because a bug sent a false alert. But they may save you time since you won’t have to keep refreshing each retailer’s website, just hoping that your formula shows up as available.

Biden Invokes The Defense Production Act To Increase Baby-Formula Supply

The administration is also authorizing flights to import baby formula from overseas.

The Biden administration is invoking the Defense Production Act to increase production of baby formula and launching a program that would use commercial aircraft to pick up overseas formula that meets U.S. standards, the White House said Wednesday.

Under the Korean War-era national security mobilization law, President Biden is requiring suppliers to prioritize giving resources to U.S. formula manufactures.

A new program called Operation Fly Formula would also direct the Defense Department to use its contracts with commercial air-cargo lines to pick up formula from other countries that meets U.S. health and safety standards. The White House didn’t specify any countries.

“Imports of baby formula will serve as a bridge to this ramped up production, therefore, I am requesting you take all appropriate measures available to get additional safe formula into the country immediately,” Mr. Biden said in a letter to Health and Human Services Secretary Xavier Becerra and Agriculture Secretary Tom Vilsack.

Last week, then-White House press secretary Jen Psakiplayed down the possibility that the U.S. could invoke the Defense Production Act to boost production of infant formula in the short term.

“The production of baby formula is so specialized and so specific, that you can’t say to a company that produces something else: Produce baby formula,” she said.

The White House has come under pressure in recent days to address a baby-formula shortage that was caused by a mix of supply-chain issues and a recall, which led to empty shelves at some stores, product restrictions and panic among parents and caregivers searching for formula to feed babies.

The White House’s moves are a positive step but won’t solve the problem overnight, said Kristin Rowe-Finkbeiner, executive director of MomsRising Together, an advocacy group for mothers and families. “The situation right now is alarming and too many moms, and especially those with children who have special needs, are struggling,” she said.

Charlie Hartig, chief executive of Hartig Drug Stores, said he expects larger national chains to be given priority to formula because of their logistics capabilities when the U.S. secures more products, with regional and smaller retailers like his receiving supplies later, as they did with other items earlier in the pandemic. Iowa-based Hartig has been trying to secure formula from various suppliers, he said.

Earlier this week, U.S. health regulators took steps to allow more foreign baby formula on American shelves, easing rules that had effectively prevented shipments from many overseas manufacturers. The Food and Drug Administration on Monday said it encouraged the overseas manufacturers to apply to ship their formula to the U.S.

Even with the change in rules, an FDA official said it could be weeks before the products arrive at U.S. store shelves. Manufacturers will first have to apply with the agency to be able to ship their products to the U.S., and then the agency will have to conduct a review to assure quality control and safety.

Later on Wednesday, the House passed legislation largely along party lines to give the FDA $28 million, which Democratic supporters of the bill said would enable the agency to hire staff to ensure the quality of new infant formula.

The House also overwhelmingly approved a separate bill that would allow people buying formula through the federally funded WIC program to switch brands during shortages.

Currently, states may obtain waivers enabling recipients to buy off-contract formula, but the process isn’t automatic during emergency periods. WIC is administered by the states, providing food assistance to pregnant and postpartum women and young children, subject to income caps.

Supplies of baby formula have been running low since late 2021, and shortages deepened after Abbott Laboratories, which makes Similac baby formula, in February halted production at its biggest factory while food-safety regulators investigated possible contamination.

Reckitt Benckiser Group PLC, maker of Enfamil products, has dealt with pandemic-driven shipment and transport delays, while smaller formula brands have been limited on how much they are able to increase production.

Abbott said Monday it had reached an agreement with the FDA to reopen the Sturgis, Mich., plant, and the company has said it is working to boost production of Similac at other facilities, while flying in some formula from Europe.

Reckitt is running plants seven days a week to produce more Enfamil, the company has said, and Gerber parent Nestlé SA has said it would bring in extra formula by plane from Switzerland and the Netherlands.

Administration officials previously said the White House had been working with Abbott and the three other formula makers to identify transportation, logistical and supplier hurdles to increasing production of formula at their U.S. and FDA-approved facilities.

The FDA on March 1 asked some retailers to limit customers’ formula purchases, and Walmart Inc., Target Corp., Kroger Co. and other retailers have implemented buying limits in stores and online. As of early May, about 21% of powdered baby formula was out of stock in U.S. stores, research firm IRI estimated.

Some retailers have sought alternate supplies, though with limited success. Some supermarket operators have tried to use store brands to fill the gaps, though those supplies have run short as well. Doctors and consumer groups have said buying limits prompted some consumers to buy as much as they could, making shortages worse, while resellers have purchased formula to sell online.

Updated: 5-19-2022

Baby-Formula Shortage Leaves Families Desperate, Prompting WIC Program Revamp

Families reliant on multibillion-dollar federal program say they have few alternatives as supplies of approved formulas run out.

A nationwide baby-formula shortage has exposed the shortcomings of a multibillion-dollar government program aimed at providing formula at no cost to families, said lawmakers and recipients, prompting efforts to revamp it.

Some low-income parents who rely on the federal Women, Infants and Children program said that shortages of approved baby formula have left them paying hundreds of dollars to purchase formula outside the program, while they navigate a patchwork of changes made to the WIC program in recent months in response to shortages.

U.S. baby-formula makers and lawmakers are working to resolve a formula crisis that has deepened in recent weeks. A February recall of Similac powdered infant formulas left grocery shelves largely bare in many states where that brand was dominant.

Other manufacturers, such as Enfamil supplier Reckitt Benckiser Group PLC, haven’t been able to make up the difference after Similac’s owner, Abbott Laboratories, paused production at the factory that made the recalled formula.

President Biden said Wednesday that he is requiring suppliers to send ingredients to infant-formula makers before other customers, invoking the Defense Production Act. The White House also directed government agencies to use Department of Defense commercial aircraft to pick up from overseas infant formula that meets U.S. standards.

Government officials have said the shortage is especially acute for families who rely on subsidies from the government’s WIC program, which provides food and health assistance.

Under WIC, which is federally funded but administered by the states, each state contracts with a single infant formula manufacturer to supply the program at a discount, and WIC recipients aren’t able to switch to a different brand if the state-contracted provider’s brand is sold out.

Michelle Richter, 35, receives WIC baby-formula vouchers for her 9-month-old son. In Nebraska, where she lives, she said she hasn’t been able to find formula at WIC-approved retailers even after the program added more brands and sizes.

As a result, Ms. Richter said, she has had to shop online for formula with her own money. Over the past month, Ms. Richter said, she ordered three cans of Enfamil formula for about $150 total from Amazon.com Inc.

“My mother has been helping a lot,” Ms. Richter said. “My boss actually gave me money to buy a can. I’ve had help here and there.”

About 21% of powdered baby formula was out of stock in U.S. stores as of early May, according to research firm IRI. More retailers, including Giant Eagle Inc. and Stop & Shop Supermarket LLC, are introducing purchase limits on formula, joining bigger chains such as Kroger Co. and Walgreens Boots Alliance Inc.

Supporting about half of the nation’s infants, WIC is the largest buyer of infant formula in the U.S., making up more than half of annual formula sales, according to the U.S. Department of Agriculture, which oversees the program. Of the $6 billion total program, roughly $1 billion is typically used on infant formula after rebates, according to market research and USDA data.

“Over the last several months, the federal government has worked round the clock to address the production shortfall brought about by the recall…and offer maximum flexibility, information, and support to WIC participants,” USDA officials said in a statement.

In response to the shortage, the USDA began working with states in February to allow WIC recipients to purchase alternative formulas, such as store brands, as well as different sizes or varieties that aren’t normally covered by WIC.

But the USDA said last week that not all states have enacted all of the waivers, which expire in August. The Biden administration last week called on the remaining states to adopt these changes and offered technical assistance to states’ WIC offices.

Abbott has contracts for supplying WIC in 34 states, all of which have adopted the waivers, according to the USDA.

Lawmakers are proposing longer-term changes to the program that would require manufacturers that win state WIC contracts to provide backup plans in the event of a recall, aimed at preventing future shortages.

The Senate passed a bill by unanimous consent Thursday that would allow participants using WIC benefits to purchase alternative brands and give the U.S. Department of Agriculture the ability to automatically waive restrictions that limit how much participants in a food nutrition program can spend on baby formula. The House passed the bill on Wednesday. It will now go to President Biden for his signature.

Historically, the system has created a greater reliance on WIC-approved formula manufacturers by requiring states to contract a single supplier, thus giving the winning company a majority of market share. The program requires retailers to stock more of WIC-approved brands, which leads to greater sales among non-WIC consumers, too.

The arrangement saves states money by incorporating volume discounts. In fiscal 2021, the rebates totaled $1.6 billion, the USDA said. But it leaves the system at risk of a meltdown if one of the few suppliers with these contracts can’t meet demand, lawmakers said.

Erin Harris, nutrition supervisor at Missouri’s Columbia and Boone County program for WIC, said Missouri switched to Abbott as its sole WIC provider from Reckitt Benckiser last year following a contract bidding process.

In response to the recall, Missouri in late February added larger sizes and other brands including Enfamil, Gerber and Parent’s Choice for WIC users, Ms. Harris said, adding that there have been also discussions to include nongrocery retailers such as pharmacies and dollar stores to the program.

“It has helped alleviate some of the crunch,” Ms. Harris said.

In Tennessee, Macie McGill, a WIC recipient, said she has been budgeting around formula for her 7-month-old infant as she pays for extra gas to drive around to secure formula. She said it got easier when WIC approved more products, and said it would have helped if she had learned about the flexibility around sizes sooner.

“I’m scared I’m buying formula with my money,” she said. Her friends and family have been looking for formula on her behalf, Ms. McGill said, and she has enough to last through June, when she plans to start looking for more.

WIC staff in Missouri have been monitoring formula availability on Facebook groups and other online resources, so that families don’t need to drive farther and spend additional money on gas, Ms. Harris said.

In Wisconsin, WIC nutritionists are sharing information on which stores have stock and are calling retailers to find products for families, said Camila Martin, pediatric dietitian at UW Health in Madison, Wis.

Liliana Cardona said she is buying whatever formula she can find near her home in Waterbury, Conn., sometimes purchasing products at stores like Rite Aid not covered by her WIC benefits. She said she has spent about $150 of her own money in one month on formula and is sometimes letting her monthly benefits expire unused.

She said that it has been nerve-racking trying different formulas with her 4-month-old son, and that the shortages have prompted her to try to reproduce breast milk again.

“I’m excited for him to be 6 months [old], so he can start eating solids,” Ms. Cardona said.

Updated: 5-20-2022

US Should Follow The EU Model For Baby Formula

American parents shouldn’t have to turn to Europe for the highest-quality products — nor rely on foreign supplies when their own market is disrupted.

Startup Bobbie introduced its infant formula product in January 2021, the first new brand to be approved for sale in nearly a decade. It was a small operator representing a tiny fraction of the $4 billion US formula market, but when shortages began roiling the industry in recent months, Bobbie offered at least one more option for rattled parents to turn to.

The story of this young company — and this critical moment of disruption — illustrates why innovation is desperately needed in an essential-food industry that’s both antiquated and paralyzed by consolidation.

Bobbie was created in 2018 when Laura Modi, an executive at Airbnb Inc. who had just given birth, found herself dissatisfied with the formula options available in American grocery stores.

Ireland-born and living in San Francisco, Modi found that many of her friends were buying European products off what she calls “the infant formula black market” — via third-party distributors such as EBay and through direct sales between moms meeting in online parent forums.

The EU formula had higher nutritional standards and healthier ingredients, and well-heeled moms were willing to pay a hefty premium to get it — even if it was contraband. EU-produced formula isn’t subject to Food and Drug Administration oversight, and therefore can’t be legally sold in the US.

Modi dived into research and found that US infant formula standards hadn’t (and still haven’t) been meaningfully updated since the Infant Formula Act of 1980. Meanwhile, EU infant formula standards were updated regularly as the science of infant health evolved.

Modi was convinced that the rising generation of young mothers would prefer innovative products over the Similac, Enfamil and Gerber brands that dominate 90% of the market. She quit her job, raised capital ($72 million to date) from investors including Goop CEO Gwyneth Paltrow and actor Laura Dern, and co-founded Bobbie with her Airbnb colleague Sarah Hardy, the startup’s chief operating officer.

Modi and Hardy entered a market struggling with a contradiction: On the one hand, it needs improved nutritional standards and better FDA oversight; on the other, the market needs new players and more competition.

Not only is the US infant formula industry — aka “Big Bottle” — heavily dominated by three aging brands, only seven production facilities have been approved by the FDA to manufacture all the powdered and liquid formulas sold nationwide.

These products are essential to the survival of millions of infants, yet the supply chain is extremely consolidated and therefore vulnerable.

In February, the industry was predictably thrown into chaos when Abbott Laboratories recalled some of its formula brands, including Similac, and shuttered its Michigan production facility to investigate contamination. In one fell swoop, a third of all infant formula products vanished from store shelves.

The challenge going forward for the Biden administration’s FDA is to simultaneously raise its quality standards for infant formula while also encouraging new young players to enter the market. This can be done. The evidence is clear in the European market — in particular in Germany, which has not only the world’s highest nutritional standards for infant formula, but also more available brands and more numerous and distributed production facilities.

The Biden FDA has made important progress in shoring up formula production in the past week, first having reached an agreement with Abbott on a plan to safely re-open its production facility, which should significantly restore product volume in the next two months. The administration has also eased restrictions on foreign imports of infant formula products that until now have not been allowed on American shelves.

On Wednesday, Biden invoked the Defense Production Act to help revive the supply chain for baby formula ingredients and authorized the use of military planes to fly in foreign-made products. Also critical was President Biden’s decision to increase funding to the FDA, a notoriously understaffed agency that had only nine people working to alleviate the infant formula shortage. With the new funding it has been able to hire four more.

But these are stopgap strategies. The agency needs to build long-term solutions to ensure the security of infant formula production in the future.

The administration should permanently allow for the sale of approved foreign-made baby formulas on the US market. It should also require that any company commanding more than 20% of the baby formula market maintain a backup supply of product in case of recall.

When the House Agriculture Appropriations Committee discussed the fiscal year 2023 budget of FDA Commissioner Robert Califf this week, members should have pushed for more significant long-term increases to FDA funding that can help usher in industry-wide reforms.

There’s no question that raising nutritional standards while also guiding new producers through the product approval process will take a substantially funded, better-staffed and more nimble FDA.

Infant formula falls right in the middle of drugs and food on the regulatory spectrum, which means it requires rigorous testing not just for nutritional quality, but for bacterial and heavy-metal contamination, as well as for shelf stability. Moreover — with the exception of Biden’s emergency measures — all infant-formula products sold in the US must be produced domestically.

Modi learned this the hard way: With such limited production capacity in the US, she produced her first run of products in 2018 in Germany, which she later had to recall. She spent another two years retooling her supply chain and working with her manufacturer to produce the formula in Vermont.

Over the last 40 years, scientists have identified the fatty acid DHA as a critical ingredient in infant formula to support infant brain development. In the US, infant formula companies aren’t required to include DHA. Some do include it, but in the EU, you can’t buy an infant formula without a high level of DHA.

The EU also puts a cap on the use of sugars, like corn syrup, and the US does not. All US products should be required to meet higher standards.

There will be a price to pay. Since Bobbie has based its products off the latest 2019 EU standards and established a resilient supply chain, its cost of production is higher than that of the major players, and even of smaller brands: $1.84 an ounce compared with other premium organic products such as Earth’s Best, which sells for $1.48.

The company’s rapid growth so far should allow these costs to come down with economies of scale. Bobbie’s sales reached $18 million in its first year, compared with the $4 million Modi originally projected, just by selling direct to consumers online. In 2022, Modi expects to quadruple that growth.

Bobbie shows there is a path forward in this nearly impenetrable US industry, while also revealing the challenges inherent in redefining an essential food. Both the Biden administration and its critics can learn from this young business to build a strategy to protect infant health while creating the conditions necessary for new players in the industry to succeed.

Why The Baby-Formula Market Is A Mess: Low Competition, High Regulation

The WIC program and regulations tamp down competition, resulting in Similac and Enfamil controlling the bulk of an inflexible, $4 billion U.S. formula market. It cracked when a major factory halted production.

U.S. officials acted this week to ease a nationwide shortage of baby formula. But none of the moves will create immediate relief for parents scrambling to find stocked shelves. And none fully address the underlying flaws of the more than $4 billion U.S. formula industry, in which business and government depend on one another to keep the country supplied.

Baby formula is one of the most tightly regulated food products in the country. That makes the barrier to new entrants high, and few brands have emerged as challengers to Similac and Enfamil, made by Abbott Laboratories and Reckitt Benckiser Group, respectively, since the two entered the market in the 1950s.

Abbott and Reckitt were responsible for roughly 80% of infant and toddler formula sales in the U.S. last year, according to market-research firm Euromonitor.

Regulations also limit international brands from entering the U.S. from other countries.

The federal government is the product’s biggest buyer, via the Women, Infants and Children supplemental nutrition program, which provides formula at no cost to families. The program’s exclusive sales contract system ensures that in each state, one of the major formula brands has the majority of market share.

The result is a marketplace with little competition and little flexibility, making it vulnerable when something goes wrong.

The supply chain for nutrition for our babies “is far more fragile than I think anyone would ever realize,” said Ron Belldegrun, founder and CEO of new formula maker ByHeart.

It took over $40 million and five years to open the company’s infant formula factory, which began production eight weeks ago, he said, and millions more were spent on research and development, clinical studies and a host of other Food and Drug Administration requirements.

Baby formula first became scarce on store shelves in early 2020, as the Covid-19 pandemic and lockdowns disrupted supply chains. Reckitt has faced shipment delays, as well as longer lead times for some raw materials and packaging, according to company officials.

Then, this February, Abbott halted production at its biggest factory—responsible for one-fifth of U.S. formula—and issued a voluntary recall while food-safety regulators investigated a possible deadly contamination.

The company said Monday that it reached an agreement with the FDA to reopen the Sturgis, Mich., plant. But it has said it would take two weeks to restart production, then six to eight weeks after that before new formula would hit store shelves.

On Wednesday, President Biden invoked the Defense Production Act, which will require suppliers to send ingredients to infant-formula makers before other customers.

The White House also directed government agencies to use Department of Defense commercial aircraft to pick up from overseas infant formula that meets U.S. standards.

On Thursday the administration said it had approved the first shipment—equivalent to up to 1.5 million 8-ounce bottles of hypoallergenic formula for children with medical needs—from Switzerland and is working to identify aircraft to fly it to Indiana.

Formula makers and retailers have said it could take months for supplies to fully recover as U.S. manufacturers face limits to ramping up production and challenges remain in getting the formula to the right places.

Katharine Watkins, who lives in Platte Woods, Mo., said she contacted her governor’s office after struggling to find formula for her 10-month-old daughter, Birdie. Birdie threw up after trying new formulas, so Ms. Watkins called her parents for help finding Birdie’s preferred brand, and they called their friends, too.

“I’m grasping at straws,” Ms. Watkins said. “The thought never crossed my mind that I would go to the store and not be able to find formula.”

State Exclusives

The Agriculture Department’s WIC program has deepened the hold that major manufacturers such as Abbott have over formula sales, in effect reducing the number of brands on offer.

About half of the baby formula sold in the U.S. is purchased through the WIC program, according to the Biden administration.

Under the program, which is federally funded but administered by states, states award exclusive sales contracts to a single formula manufacturer in exchange for discounts.

WIC program participants are required to use their vouchers for formula made by the winning manufacturer, dramatically increasing that company’s market share in a given state, while also boosting sales to non-WIC consumers because stores tend to stock and display the WIC brand.

Abbott has contracts with 34 states to supply Similac for WIC, according to the USDA; 10 states work with Reckitt for Enfamil; and six work with Nestlé SA, which makes Gerber products.

Due to the large portion of formula bought by WIC participants, stores offer WIC brands more shelf space and better product placement, according to the USDA. Participating stores are required to keep a minimum amount of the WIC formula brand in stock, and because smaller grocery stores have limited shelf space, those stores may stock the WIC brand exclusively.

Many hospitals have begun mirroring the federal program, contracting with just one formula manufacturer to get bulk discounts, said Steven Abrams, an infant-nutrition expert and professor of pediatrics at Dell Medical School at the University of Texas at Austin.

While WIC’s design helps keep costs down for taxpayers, Dr. Abrams said it can exacerbate shortages in the event of supply-chain problems by offering a single WIC brand dominance in a given state.

Lawmakers have proposed changes to WIC to prevent future shortages, including requiring formula manufacturers to outline in their WIC contracts a contingency plan in the event of supply disruptions.

The legislation, which awaits President Biden’s signature after passing in Congress this week, also gives the USDA expanded, permanent authority to offer waivers for WIC recipients to purchase a wider variety of formulas in a crisis.

Some consumer advocates say Congress and the White House waited too long to act, and that recent measures don’t address the longer-term, structural issues in formula production and infant nutrition.

“This has been a wake-up call to the systemic problems we have,” said Kristin Rowe-Finkbeiner, CEO of MomsRising, an advocacy group for mothers and families.

Government and industry officials say they have been working to alleviate the shortage since February, when the USDA initially allowed for flexibility in the WIC program and manufacturers, including Reckitt and Nestlé, began shipping more formula to fill the gap left by Abbott.

Barriers To New Competition

Beyond Abbott and Reckitt, other companies have had limited success breaking into the baby-formula market. Nestlé had a nearly 10% market share in the U.S. last year, according to Euromonitor, while store brands, such as Target’s or Walmart’s brand, made up about 5% and Danone SA, the owner of Happy Baby products, had a roughly 1% share.

Parents generally don’t switch formulas unless a baby isn’t responding well, and the makers of Similac and Enfamil have decades-old marketing programs that cultivate relationships with healthcare providers and send formula samples to new parents, helping maintain their dominance, doctors said.

A 1980 law governing infant formula established high regulatory hurdles, beyond typical FDA requirements for other foods.

Manufacturers seeking to create new formula brands must submit to the FDA detailed explanations for how their products are developed, studies regarding the nutrients included, details of quality-control measures in the manufacturing facility and more.

The FDA then inspects the facility, observes the production process and collects samples for nutrient and microbiological analyses, the agency said.

The FDA has struggled with a backlog of submissions for new formulas, extending the timeline for approvals, according to consumer advocates. The agency estimates it received 31 applications last year and reviewed 22, according to the FDA’s 2021 budget, which doesn’t indicate if the applications were approved.

Meanwhile, the U.S. formula market has seen less investment than other industries because demand has stagnated, as U.S. birthrates have dropped and rates of breast-feeding have risen in recent decades, said Lyman Stone, director of research for Demographic Intelligence, a forecasting firm that specializes in births and works with formula manufacturers including Abbott and Nestlé.

New entrants in the market have focused largely on specialty formulas, such as those that meet particular dietary, nutritional or medical needs, Mr. Stone said.

John Wallingford, a former formula executive at Wyeth Nutrition and FDA scientist who now consults with formula makers, noted that large formula manufacturers in the U.S. also make higher-profit medical devices and healthcare products.

“Companies that manufacture infant formula have to struggle to get investments for upgrading or building a new facility because they’re competing with dollars that will go to other, higher margin products,” Mr. Wallingford said.

Regulatory hurdles also mean little formula comes into the country from abroad, although the U.S. eased some rules this week. The U.S. typically produces about 98% of formula consumed domestically, according to the FDA.

Some formula is imported from Mexico, Ireland and the Netherlands, the FDA said, though some shipments are subject to strict FDA labeling and other requirements.

Infant formulas typically contain elements of cow’s milk plus vegetable oil and various vitamins and minerals. The American Academy of Pediatrics recommends that infants under about 6 months old consume only breast milk or formula.

The FDA this week said it encouraged overseas manufacturers to apply to ship their formula to the U.S. The agency will conduct a review to assure quality control and safety.

Some U.S. families order European formulas from third-party vendors, though this practice has prompted safety concerns, as U.S. consumers may not be aware if foreign products are recalled. U.S. Customs and Border Protection officers last year seized hundreds of cases of infant formula arriving from Germany and the Netherlands that the government said violated FDA import safety regulations.

Demand Shifts

Formula manufacturers have been particularly hard hit by trucking shortages during the pandemic, said Demographic Intelligence’s Mr. Stone. Because baby formula is a bulky, relatively low-price product by weight, formula makers’ bids for truck space are less competitive than producers of consumer electronics or other goods.

The supply shocks have been intensified by recent shifts in demand for formula, Mr. Stone said. Demand for baby formula has increased in recent months as U.S. birthrates ticked up slightly last year while breast-feeding rates have seemed to decline, he said.

From the start of this year through May 8, U.S. formula sales by volume rose 5.9%, according to market-research firm IRI. For several years leading up to the pandemic, sales volume of formula had been flat or declining. In 2020, it started increasing again, IRI said.

Dr. Abrams said some 80% of U.S. women breast-feed immediately after delivery, but that by the time children reach the age of 1, between 70% and 90% will receive some formula.

The shift is largely driven by social and economic factors including short, unpaid or nonexistent maternity leaves and lack of lactation support, and lower-income women are especially restricted in their choices around breast-feeding.

Specialized formulas for infants and children with severe allergies, intestinal failure or metabolic disorders have been especially constrained during this crisis, said University of Texas’ Dr. Abrams.

The formulas are produced in smaller quantities because they have fewer potential buyers and aren’t big moneymakers for manufacturers. These amino-acid based formulas make up less than 1% of formula sales, according to IRI.

The crisis hit home months ago for Emma Ibrahim, when the specialty formula she feeds her 2-year-old daughter, made by Abbott, disappeared from store shelves. Ms. Ibrahim offered another brand to her daughter, Mariam, who eats through a feeding tube due to a complex intestinal disease.

Mariam responded with vomiting and diarrhea, forcing doctors to boost her dosage of an intravenous food that carries risks of liver damage and infection, Ms. Ibrahim said.

Ms. Ibrahim said she felt she had no choice but to keep feeding her daughter the recalled formula while she waited for approved supplies to be back in stock. “It’s insane. It feels like a dream,” said Ms. Ibrahim, who lives in Chicago. “This is a first-world country. Why did we not have a backup plan?”

Here’s The Latest Ranking By City Of Baby Formula Shortages

Metro areas hardest hit include Nashville for the week ending May 14, with West Texas fairing best.

The number of US cities with severe baby formula shortages increased over the week ending on May 14.

There are now 11 cities with out-of-stock rates above 50% for the week ending May 14, up from eight the week prior. Hardest hit is Nashville, which jumped to over 57% from 52%, according to retail-tracking firm, Datasembly. The best supply is currently in West Texas, which saw a decrease in its out-of-stock rates from 33% to 26%.

The state with the strongest supply for the week ending May 14 is New Mexico with an out-of-stock rate of 28%, improved from 29% from the prior week. Virginia has the worst out-of-stock rate at 58%, a jump from 49%. Nationally, the out-of-stock rate is now at 45%, according to Datasembly.

The Biden Administration is taking several steps to combat the shortage. On Thursday, the administration announced it had secured from Nestlé S.A. 1.5 million 8-ounce bottles of formula for babies with cow milk allergies.

The formula is being flown on hundreds of pallets from Zurich, Switzerland, to Plainfield, Indiana, on Department of Defense aircraft. This follows President Joe Biden’s announcement on Wednesday of the creation of the Operation Fly Formula program to fly imports in from overseas.

Biden also invoked the Defense Production Act to boost production of baby formula domestically, and is working with the Food and Drug Administration to reopen Abbott Nutrition’s facility in Sturgis, Michigan, which closed in February due to an investigation of possible contamination of some of the company’s powdered infant products.

I’m taking two new steps to increase baby formula supply:

– Invoking the Defense Production Act to increase domestic production
– Launching Operation Fly Formula to use federal planes to fly formula in from abroad

We’re making sure safe formula gets to all who need it. pic.twitter.com/lnkxsaCY6T

— President Biden (@POTUS) May 18, 2022

On Thursday, Congress passed a bipartisan bill, the Access to Baby Formula Act, that requires baby formula manufacturers to prepare for future shortfalls and removes barriers to families purchasing formula on the Special Supplemental Nutrition Program for Women, Infants and Children, or WIC, program.

Updated: 5-22-2022

Abbott CEO Apologizes For Company’s Role In Baby Formula Shortage

Robert Ford says in op-ed that production would ramp up in June; First overseas shipments from Biden’s Operation Fly Formula arriving in U.S.

Abbott Laboratories Chief Executive Robert Ford apologized Saturday for his company’s role in the nationwide shortage of baby formula and promised production will ramp up again in June.

“We’re sorry to every family we’ve let down,” Mr. Ford wrote in a Washington Post op-ed.

Mr. Ford explained what led to his company’s voluntary recall of baby formula and detailed the company’s plan to avoid a similar shortage in the future.

“We are making significant investments to ensure this never happens again,” he wrote.

In February, Abbott Laboratories voluntarily recalled some of its Similac, Alimentum and EleCare formulas manufactured in its Sturgis, Mich., plant after Food and Drug Administration officials found a potentially deadly bacteria there.

That decision exacerbated an existing baby formula shortage created by supply-chain issues during the Covid-19 pandemic, Mr. Ford acknowledged.

“We take great pride in manufacturing nutrition and formula to feed America’s infants, including our most vulnerable,” Mr. Ford said.

Four infants who drank tainted baby formula were hospitalized and two of them died, however the FDA said the bacteria didn’t match the strains found at the Abbott plant.

Nonetheless, Mr. Ford wrote, issuing a voluntary recall was the right thing to do.

“The FDA’s investigation did discover a bacteria in our plant that we will not tolerate. I have high expectations of this company, and we fell short of them,” he wrote. “We will not take risks when it comes to the health of children.”

The shortage has led to empty shelves at some stores, product restrictions and panic among parents and caregivers searching for formula to feed their babies.

President Biden on Wednesday invoked the Defense Production Act to increase production of baby formula and launched a program—called Operation Fly Formula—that would bring supplies by cargo plane that meets U.S. standards from overseas.

On Sunday, Mr. Biden tweeted photos of the aircraft being loaded with supplies.

“Our team is working around the clock to get safe formula to everyone who needs it,” Mr. Biden wrote on Twitter, moments before the first formula shipment arrived in Indiana Sunday.

Mr. Biden also said Sunday that Operation Fly Formula secured a second flight to transport Nestlé SA specialty infant formula to Pennsylvania.

A top White House official on Sunday defended the administration’s approach to the shortage and blamed longer-term trends for the crisis.

‘We are making significant investments to ensure this never happens again,’ Abbott CEO Robert Ford said in an op-ed on the nationwide baby formula shortage.

Abbott LaboratoriesChief Executive Robert Ford apologized Saturday for his company’s role in the nationwide shortage of baby formula and promised production will ramp up again in June.