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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.

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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* Campaigns For “More Mother-Fed Babies” And Pure Cows’ Milk

* The Fall And Rise Of Breastfeeding Initiation Rates

* Human Milk And Human Health: A Dose–Response Relationship

* Increasing Breastfeeding Rates Today

* Can History Inform Breastfeeding Campaigns Today?

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.

Ultimate Resource On Baby Formula Shortage

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.

Ultimate Resource On Baby Formula Shortage

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:

 

Ultimate Resource On Baby Formula Shortage

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.

Ultimate Resource On Baby Formula Shortage

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%.

Ultimate Resource On Baby Formula Shortage

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.

Ultimate Resource On Baby Formula Shortage

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.

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.

“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.
Loading tweet…

“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.

“How did we end up in a market where we have three companies that control 90% of the market?” the director of the White House National Economic Council, Brian Deese, said on CNN’s “State of the Union,” adding that officials were weighing steps to open up that market to more competition.

“We’re going to have to work on that,” Mr. Deese said.

Mr. Deese also said that the first shipment of formula brought to Indiana from Germany accounted for around 15% of the national need, and that he expected additional such flights early this week.

“We’re going to keep ramping that up until we get there,” he said.

Abbott’s Mr. Ford said the company plans to restart its Sturgis facility in early June after entering into a consent decree with the FDA. It will take six to eight weeks from when production begins to get products on the shelves.

“When we are operating our Michigan facility at full capacity, we will more than double our current production of powdered infant formula for the United States,” he wrote. “By the end of June, we will be supplying more formula to Americans than we were in January before the recall.”

Meanwhile, he said, the company is putting baby formula production ahead of all its other adult products at its Ohio plant and has flown in supplies from its facility in Ireland.

Specialized baby formula known as EleCare, for infants or children who can’t digest other formulas and milks, is the priority, Mr. Ford said.

Given their unique needs, children who lose access to it can require medical supervision until the formula is returned to the shelves,” he wrote.

Consumers can feel safe buying Abbott Laboratories products currently in stores, Mr. Ford said.

“What is available has passed rigorous inspections and is ready for your babies,” he said.

US Gets First 70,000 Pounds Of Baby Formula To Ease Shortage

* Military Plane Touches Down In Indianapolis After Biden Order
* White House Says Product To Be In Stores As Early As This Week

A planeload of more than 70,000 pounds (32 metric tons) of baby formula arrived in the US, starting an emergency program to alleviate a national shortage that has left some parents scrounging to feed their children.

More formula will start arriving in stores “as early as this week,” Brian Deese, President Joe Biden’s top economic adviser in the White House, said on CNN’s “State of the Union.” The plane that landed in Indianapolis on Sunday will address “15% of the overall national volume that we need,” he said.

Faced with pressure by Republicans and Democrats to address the crisis, Biden last week ordered the use of government planes to airlift infant formula to the world’s richest country. He also invoked emergency powers under the Defense Production Act to spur domestic manufacturing.

The US Air Force cargo plane from Ramstein Air Base in Germany delivered 132 pallets of Nestlé Health Science Alfamino Infant and Alfamino Junior formula. A second flight of Nestlé formula for children with cow’s milk protein allergy will depart Ramstein for Pennsylvania in the coming days, the White House said in a statement.

Supply-chain snarls that reduced formula availability across the US turned into a full-blown crisis in February when Abbott Laboratories, the largest supplier of powdered infant formula, issued a voluntary recall and closed a plant after four infants fell ill.

“Our team is working around the clock to get safe formula to everyone who needs it,” Biden wrote on Twitter on Sunday.

Deese said the shortage highlights how few companies are making baby formula.

“How did we end up in a market where we have three companies that control 90% of the market?” he said. “It goes back to this question of how we can bring more competition in our economy, have more providers of this formula, so that no individual company has this much control over supply chains.”

Congress last week 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.

Abbott Chief Executive Officer Robert Ford apologized for worsening the shortage in a column for the Washington Post and said the company will make “significant investments” to prevent a recurrence. Available data didn’t find evidence that Abbott products caused the illnesses, he said.

Meanwhile, desperate parents have turned to the internet for solutions and alternatives. Medical experts warn that homemade versions of baby formula come with serious health risks.

FDA Says Senior Officials Didn’t Receive Infant Formula Whistleblower Report Due To ‘Mailroom Issues’

The FDA’s top official will acknowledge a string of failures that contributed to the current infant formula shortages when he faces lawmakers on Capitol Hill on Wednesday.

In their prepared testimony released Tuesday evening, FDA Commissioner Robert Califf and several senior officials for the first time lay out a timeline of the agency’s response to reports last fall that infants had been hospitalized after consuming formula made at an Abbott Nutrition plant in Sturgis, Mich.

And they say a whistleblower report alleging food safety problems at the plant, which was mailed in October, did not reach the FDA’s highest rungs until mid-February, despite being sent directly to then-acting Commissioner Janet Woodcock and others.

The Abbott plant was temporarily shut down in February, after an FDA inspection in January found five different strains of a potentially deadly bacteria known as Cronobacter sakazakii, the bacteria that sickened the four infants.

Two of those infants died. At the same time, Abbott also issued a recall of some formula made at the plant, exacerbating a shortage of infant formula that began during the pandemic.

The FDA now finds itself at the center of a political firestorm over the shortages, which have sent parents scrambling for alternative sources. The need is particularly acute for infants and children who rely on specialty formulas due to health conditions — a growing number of infants with special dietary needs have been hospitalized.

Up until now, however, FDA officials declined to comment on why it took months between the first report of a bacterial infection linked to the plant last September, their inspection this winter, which turned up a range of food safety problems, and the recall.

But the new details aren’t likely to tamp down the criticism of the agency, rather, they are already fueling further outrage from lawmakers.

“The FDA, at every step of this process, dropped the ball,” Rep. Rosa DeLauro (D-Conn.), chair of the House Appropriations Committee, told POLITICO in an interview about the new details revealed in the testimony. “It put infants at risk.”

The FDA timeline laid out in the prepared testimony acknowledges the FDA didn’t hold interagency discussions about potential supply chain disruptions until Feb. 14, three days before the Abbott Nutrition plant at the center of the current shortages shut down and issued a formula recall.

And the agency didn’t notify the Agriculture Department, which oversees a critical federal nutrition program that purchases about half of the nation’s infant formula, about potential disruptions until a week before the Abbott plant shut down.

The program, known as WIC, serves 1.2 million infants from low-income families. Abbott supplies nearly half of all infant formula provided through WIC state contracts.

The testimony also blames “mailroom issues” for the fact that senior FDA officials, including Woodcock and FDA’s top food safety official, Susan Mayne, did not receive hard copies of the whistleblower report from last October detailing alarming concerns about the Abbott plant, including poor food safety practices and that officials there had falsified documents and intentionally information from FDA inspectors. The FDA did not interview the whistleblower until December.

According to Califf’s testimony, Woodcock and Mayne eventually received the whistleblower report via email from another FDA staffer on Feb. 14, three days before the recall.

The agency says copies of the whistleblower report sent to Mayne and another FDA official were found in the FDA’s mailroom in May, but officials have yet to locate the copy sent to Woodcock. It was “likely due to COVID-19 staffing issues” and “a mailroom analysis is underway,” the prepared remarks state.

The FDA timeline does say other FDA officials overseeing infant formula and regulatory affairs received a copy of the 34-page report last October.

Mayne and Frank Yiannas, FDA’s deputy commissioner for food policy and response, will testify alongside Califf on Wednesday. As POLITICO has reported, Mayne and Yiannas do not get along and it’s created tension at the senior levels of an agency already struggling to make decisions.

But Woodcock, whom Califf assigned to help oversee the agency’s food divisions in the midst of the formula fallout, will not appear before the committee.

Senior leaders at Abbott and two other major formula manufacturers will also testify before Congress on Wednesday.

DeLauro was not satisfied with the agency’s explanation for its slow response to the whistleblower report. “Take responsibility.

If you are the director, if you are the acting director, then you have to know what the hell is going on,” said DeLauro, who has criticized the FDA for allowing Woodcock to also lead the internal review of its response.

“Who told staff that they could interview the whistleblower? You know what, let me step back a second, who’s in charge?” DeLauro added.

Califf’s testimony also addresses why it took the FDA until the end of January to begin its inspection of Abbott’s Sturgis plant, despite receiving warnings last fall.

For several months after the initial reports of bacterial infections, Califf says the FDA struggled to match formula samples to the specific bacterium, which is known to grow in infant formula and cause rare but potentially fatal illnesses in babies. A Covid-19 outbreak among the plant’s staff in early January further pushed back the inspection’s launch.

When the FDA’s inspection team finally entered the plant on Jan. 31, they “observed significant operational deficiencies,” according to the testimony.

“The totality of evidence obtained during our inspection caused FDA to conclude that infant formulas produced at this plant were produced under insanitary conditions and may be contaminated with Cronobacter,” the testimony says.

When the FDA got back positive samples of Cronobacter from the January inspection, Califf says they alerted Abbott and told the company it should issue a recall.

Despite the delays detailed in the timeline, the testimony argues that FDA “since the first day…has worked tirelessly with U.S. government partners to mitigate the supply chain disruption for both regular and specialty formulas.”

But lawmakers have questioned why it wasn’t until May 16 that the FDA and Abbott agreed on a deal to reopen the Sturgis plant.

White House and USDA officials have privately complained about the FDA’s decision not to warn other parts of the administration earlier, while allowing the situation to grow into a food security crisis for American families and a political crisis for President Joe Biden, just months ahead of the November midterms.

The White House has also ducked questions about its own timeline in responding to the recall and ensuing shortages. Asked by POLITICO about when the FDA told the White House of the issues at the Sturgis plant and any concerns about potential shortages, a senior administration official said they would not comment on “internal communications.”

“The recall became public on February 17 and we certainly have been very public about our activity in this space since then,” the official added.

 

Updated: 5-25-2022

FDA Chief Takes Aim At Abbott Laboratories As He Signals Potential Reforms To Food Safety Division

The commissioner said the division needs a ‘stronger team at the high levels,’ as part of a revamping of the entire food program.

U.S. Food and Drug Administration Commissioner Robert Califf signaled potential reforms to his agency’s food safety division, even as he took aim at “shocking” safety lapses at Abbott Laboratories’ Michigan baby formula plant.

In a five-hour hearing before congressional lawmakers Wednesday, Mr. Califf blamed outdated technology and coordination breakdowns for delays in responding to warnings about infant formula safety. He also indicated the food division of the agency needed new leadership.

“These problems that we’re describing are systemic and they weren’t fixed,” he said. “We definitely need a stronger team at the high levels on the food side as part of a revamping of the entire food program.”

Mr. Califf said his agency was too slow to respond to a whistleblower report about safety failures at the Abbott manufacturing plant in Sturgis, Mich., which exacerbated infant formula shortages when it was shut down.

The report, released last month by Rep. Rosa DeLauro (D., Conn.), alleged a long list of safety lapses at the Sturgis facility, including the release of untested formula. An FDA inspection earlier this year also found problems at the plant, including the presence of dangerous bacteria and standing water on the floor.

“Frankly the inspection results were shocking,” Mr. Califf said, comparing the conditions in Abbott’s plant to a muddy kitchen. “We had no confidence in the integrity of the Abbott quality program at this facility.”

But Mr. Califf said he met with Abbott executives Tuesday and was sure they were taking careful steps to reopen the facility by the first week of June.

Mr. Califf testified before the House Energy and Commerce Committee’s oversight and investigations subcommittee about the closure of the plant and the attempts to address the short supply. The Energy and Commerce panel oversees the FDA, which regulates baby formula.

The FDA’s discovery of bacteria at the plant prompted Abbott in February to recall some products and shut down the plant.

Christopher Calamari, Abbott’s senior vice president for U.S. nutrition, told lawmakers his company wasn’t aware of the whistleblower complaint until it was made public by Congress in April. He said his company’s policy is to encourage employees to report safety problems.

“The whistleblower allegations—we don’t know them to be true. That’s an open investigation, and it’s ongoing,” Mr. Calamari said. “What I can tell you is that I was at Sturgis last week, and the employees I saw are committed to the highest quality.”

Mr. Califf defended his agency’s handling of the formula shortages that followed the plant closure, but said that the agency needs more data from industry to be able to prevent and prepare for future shortages.

“The industry has fought us tooth and nail in requiring that there be insight into their supply chains,” Mr. Califf said.

Lawmakers in the hearing expressed dismay at the FDA’s slow response to safety warnings at the Abbott plant and inability to alleviate shortages more quickly.

“I’m actually pretty furious about the FDA’s lack of food safety leadership,” said Rep. Jan Schakowsky (D., Ill.).

Rep. Larry Bucshon (R., Ind.) said he can see both parties in Congress backing a move to give the FDA more authority over supply chains. “With the pandemic, we’re going to have a lot more interest, with Congress and supply chains, not only in this area, but everywhere,” he said.

Abbott, Reckitt Benckiser Group and Nestle SA produce most of the formula sold in the U.S.

The hearing is the latest in Congress on the short supplies of a crucial baby product, which have left some store shelves empty, triggered an outcry from parents and prompted the Biden administration to try to address the problem.

Some families rely on formula to feed and provide nutrition to their babies. Stocks started running short in 2020 after the Covid-19 pandemic disrupted supply chains.

Starting last year, four infants were hospitalized with cronobacter bacteria infections after consuming Abbott formula, and two died. Abbott has denied that the cronobacter infections were caused by contamination at its plant.

The Centers for Disease Control and Prevention said genetic testing on the bacteria strains in two of the hospitalized infants didn’t match the bacteria discovered at the plant. This month, Abbott reached agreement with the FDA on the steps needed to reopen the company’s Michigan plant under agency supervision.

Formula makers have said it could take months to eliminate the shortages. Meanwhile, the White House has arranged for Defense Department commercial aircraft to fly in formula that meets U.S. standards from overseas.

The Biden administration also said it would use the Defense Production Act to make sure formula makers have the ingredients they need to increase production.

Also, the FDA temporarily eased baby-formula import rules to permit the distribution of more products to the U.S.

Updated: 5-26-2022

National Baby-Formula Stockpile Is Urged by FDA Commissioner

Agency head says he expects a surplus of formula in about two months because of government, company efforts.

Food and Drug Administration Commissioner Robert Califf proposed a national stockpile of baby formula that authorities could tap to ease future shortages.

Dr. Califf said in a hearing Thursday before the Senate Health, Education, Labor and Pensions Committee that he expects recent government and private sector moves will produce a surplus of formula in about two months.

“The question is should we maintain that surplus as a government activity for the foreseeable future,” he said.

To be prepared for shortages or other emergencies, the U.S. maintains strategic stockpiles including for petroleum and antibiotics.

Dr. Califf didn’t discuss the specifics of stockpiling formula, which even if unopened, eventually expires. National stockpiles for medical products, in particular, are regularly monitored to make sure they remain stable and could be used if needed.

Republicans and Democrats on the committee criticized the pace of FDA’s inspection process and response to a whistleblower report about safety lapses in the Michigan factory where Abbott Laboratories makes a large share of its baby formula.

“Complacency is apparently the FDA’s catchphrase when it comes to infant formula,” said Sen. Richard Burr (R., N.C.).

Dr. Califf said his agency was too slow to respond to safety warnings, and he promised reform. “There are systemic issues within FDA and in our interactions with the industry,” he said.

Abbott voluntarily closed its Sturgis, Mich., facility in February after FDA inspectors found bacterial contamination and other violations, worsening formula shortages that began earlier in the year due to supply chain issues.

Company officials have said they expect the plant to reopen June 4.

Meantime, the Biden administration has arranged shipments of formula from overseas, loosened import regulations and invoked the Defense Production Act to speed supplies to manufacturers in the U.S.

Abbott, Nestle SA and Reckitt Benckiser Group produce most of the formula sold in the U.S. The formula makers told House lawmakers Wednesday that they have stepped up production and will try to do so more.

Updated: 5-28-2022

Baby-Formula Shipments Come With High Security To Deter Cargo Thieves

Logistics companies are using tracking technology and special locks to protect deliveries of infant formula from criminals.

Efforts to rush baby formula to depleted U.S. stores are triggering a range of security steps aimed at protecting the shipments from potential theft, logistics security experts said, including measures normally taken when moving pharmaceuticals and electronics.

The precautions range from paying special attention to who is handling and transporting the formula to adding tracking technology and special locks. Security experts said these procedures have been used for years in protecting goods from semiconductors to household staples that have been targeted by cargo thieves.

Baby formula has long been attractive to criminals, along with other food and beverages, a category that was the No. 1 theft target from 2010 to 2020, according to cargo-security experts. Food and drinks overtook electronics as the most popular target for cargo thieves in the aftermath of the 2007-09 financial crisis, when household incomes dived and staples were in high demand, cargo-security executives said.

The shortage in infant formula across the U.S., caused by a mix of supply-chain issues and a recall, has made the product an even bigger target for cargo thieves, as panicked parents and caregivers search for formula to feed their babies.

“Anytime we see a situation with a high-value cargo where there is the scarcity we are experiencing now, that concerns us,” said Zak Bowyer, vice president of sales support operations at Total Quality Logistics, a Cincinnati-based freight broker whose customers include makers of infant formula.

For Total Quality Logistics, which contracts with independent drivers to handle shipments, the enhanced measures range from what Mr. Bowyer calls “extreme vetting” of carriers to physical security such as special locks on trailers and tracking systems embedded in the shipments.

“We would move it with the same security that we apply to pharmaceuticals and electronics and other shipments that may be targeted,” he said.

A can of baby formula might cost far less than an iPhone, but experts say food-and-beverage shipments can be easily resold, are hard to trace, and can be held over time and shipped over long distances without spoiling. The products are later consumed, leaving no evidence behind.

“Infant formula, the Enfamil, Similac and the others, has always been at high risk for theft,” said Keith Lewis, vice president of operations at CargoNet, a logistics-security unit of Verisk Analytics Inc., a Jersey City, N.J.-based risk-assessment business.

Companies including Abbott Laboratories Inc., the maker of Similac, are working to ramp up production. Switzerland-based Nestlé SA, the third-largest player in the U.S. baby-formula market after Abbott and Enfamil maker Reckitt Benckiser Group PLC, is also increasing production and has flown formula from Europe into the U.S. under special rules adopted by the Food and Drug Administration.

The flow of those shipments into U.S. distribution channels should start growing in the coming weeks as output from plants increases, bringing logistics operators into the effort to solve the shortage.

Logistics companies have developed security protocols over time through a central group, the Transported Asset Protection Association, and say they have implemented them as the attention of cargo thieves has shifted over the years.

During the Covid-19 pandemic, items favored by thieves included the paper goods and cleaning supplies that were in high demand and hard to find.

“We were seeing things like hand sanitizers and masks targeted,” Mr. Bowyer said. “It wasn’t about the price of the product but the scarcity of it. And that’s something we are seeing now with the anxiety of parents who are looking for formula.”

Updated: 5-29-2022

Baby-Formula Shortage Worsened By Drop In Breast-Feeding Rates

Ultimate Resource On Baby Formula Shortage

Covid-19 restrictions, pandemic disruptions caused shift in how parents feed their babies, health experts say.

One of the contributing factors in the U.S. baby-formula shortage is a significant shift in the way parents feed their babies: Breast-feeding declined during the pandemic, reversing a decadeslong trend, health practitioners say.

Since 2020, the share of breast-fed one-year-olds has plummeted from an estimated 34% to an estimated 14% this year, according to surveys conducted by Demographic Intelligence, a forecasting firm that specializes in births and works with formula manufacturers including Abbott Laboratories and Nestlé SA. Because of the small sample size, the firm’s 2022 estimate has a range of error of plus or minus 6 percentage points.

Government officials and formula manufacturers are working to address a nationwide shortage that in recent months has resulted in empty shelves at some stores. Causes for the shortage include pandemic-related supply-chain snarls, a February recall by Abbott, as well as the closing of one of its factories.

An increase in demand for formula, driven by the decline in breast-feeding, has exacerbated the problem, according to Lyman Stone, director of research for Demographic Intelligence.

After Covid-19 restrictions were introduced in March 2020, many new mothers had shorter hospital stays and were discharged before their milk had come in or their baby had latched successfully to their breast, breast-feeding experts say. Some infants weren’t given skin-to-skin contact with their mothers after birth because of concerns about Covid-19 transmission.

Some lactation consultants were furloughed, redeployed or designated nonessential personnel; others offered only virtual appointments. Parents had less access to in-person assistance from doulas and peer-support groups. They also had less help from family and friends, who stayed away to avoid exposing newborns to the coronavirus.

Parents who want to breast-feed need a strong support network, said Diane Spatz, a professor of perinatal nursing at the University of Pennsylvania and a nurse scientist at Children’s Hospital of Philadelphia. In the first few days after birth—a critical period for establishing a mother’s milk supply—many families need help troubleshooting. And more broadly, if a mother spends time with other breast-feeding parents, she is likely to nurse her child longer.

“It takes a village,” Dr. Spatz said. During the pandemic, she said, “all the in-person, peer-to-peer support went away.”

Nicole Snyder’s son, Gavin, was born prematurely last September in Kansas City, Mo. For two weeks while he was in the neonatal intensive-care unit, she tried to pump breast milk every two hours. Lactation consultants were on hand to help.

But her mother-in-law, who is a nurse, was barred from visiting her in the hospital, along with her mother and other family members. That heightened Ms. Snyder’s feelings of stress and isolation, which she said contributed to her inability to produce more than a few ounces of milk a day. She and her husband now feed Gavin an Enfamil-brand formula.

“If I could have had visitors, I might have had a little more sanity,” said Ms. Snyder, 34, who works as a middle-school art teacher. “I had a lot of things working against me.”

The American Academy of Pediatrics recommends breast-feeding exclusively for the baby’s first six months, then continuing to breast-feed while introducing complementary foods until the child is at 12 months or older.

Some parents can’t breast-feed their children; others choose not to. Infant formula is the only safe alternative to human breast milk for babies under a year old, health officials say.

Breast-feeding rates in the U.S. reached a low point in the 1970s, when many doctors told parents that formula was the best food for babies. Then a movement to promote breast-feeding, and growing research showing the benefits of breast-feeding over formula, led to a decadeslong increase in breast-feeding.

Ultimate Resource On Baby Formula Shortage

Typical dairy barn with filthy floor, walls, and ceiling, circa 1900. “This is the kitchen where baby’s breakfast is prepared,” complained one doctor. Source: Milk and Its Relation to the Public Health. Washington, DC: Government Printing Office; 1908.

The share of one-year-olds who are fed with at least some breast milk climbed from 16% in 2001 to 36% in 2017, then plateaued in 2018 and 2019, according to latest data from the Centers for Disease Control and Prevention.

The recent drop in breast-feeding has been particularly steep among lower-income families and people of color, Dr. Spatz said.

Ultimate Resource On Baby Formula Shortage

Top: This Chicago Department of Health poster urged mothers to breastfeed and traced the perilous path of cows’ milk from rural dairy farm to urban consumer. Source: Bulletin: Chicago School of Sanitary Instruction (June 3, 1911).

Bottom: A Chicago Department of Health poster explains to mothers how to make cows’ milk safer for bottle-fed babies. Source: Bulletin: Chicago School of Sanitary Instruction (August 31, 1912).

Ultimate Resource On Baby Formula Shortage

At Children’s Hospital of Philadelphia’s largest pediatric primary-care center, which serves those populations, the percentage of breast-fed babies fell sharply in 2020, Dr. Spatz said. Since then, the share of breast-fed babies at the center has risen but hasn’t returned to prepandemic levels, she said.

The pandemic wasn’t a barrier to breast-feeding for all families. For some, it offered advantages, allowing mothers to nurse for longer because they were working from home, said Kim Hekimian, an assistant professor of nutrition at Columbia University Irving Medical Center.

Other families found workarounds to pandemic restrictions, talking with experienced relatives on video calls, scheduling virtual appointments with lactation consultants and calling support-group help lines.

Ultimate Resource On Baby Formula Shortage

And the expansion of insurance coverage for telehealth visits might have made lactation consultants accessible to more families than before the pandemic, Dr. Hekimian said.

Still, the pandemic placed heavy burdens on parents.

Jessica Hernandez, who lives in rural Washington state, stopped breast-feeding two weeks after the pandemic lockdown began in March 2020. She didn’t have the time to sit still for 40-minute stretches nursing her then-five-month-old baby Teo while trying to home-school a four-year-old and a seven-year-old.

“There was no way that I could keep up with everybody,” Ms. Hernandez said. Once she switched to formula, she said, she could hand Teo to her oldest daughter and say, “OK, feed your brother.”

 

References:

1. Bulletin: Chicago School of Sanitary Instruction 14 (3June1911).
2. Bulletin: Chicago School of Sanitary Instruction 15 (31August1912): 140. []
3. In this era before access to ice and refrigeration, breastfeeding was especially important during hot weather. Therefore, mothers never weaned during the summer and customarily breastfed their babies through at least 2 summers. Marylynn Salmon, “The Cultural Significance of Breastfeeding and Infant Care in Early Modern England and America,” Journal of Social History 28 (Winter 1994): 247–269. []
4. “The Care of Infants Historical Data,” Journal of the American Medical Association 59 (1912): 542–543. []
5. Letter from Martha Luey Parish to Lestern, Annie and Father, November 2, 1884, Parish Family Letters, Newberry Library, Chicago.
6. “The Mother’s Parliament,” Babyhood 3 (April1887): 170. []
7. Josephine K. Laflin Diary, 1903–1907, March 31, 1903 entry, Laflin Family Papers, Chicago Historical Society.
8. For a more detailed explanation of the complex reasons behind women’s changing infant feeding habits than what is contained in this paragraph, see Jacqueline H. Wolf, Don’t Kill Your Baby: Public Health and the Decline of Breastfeeding in the 19th and 20th Centuries (Columbus: Ohio State University Press, 2001), 9–41.
9. Maria M. Vinton, “Baby’s First Month,” Mother’s Nursery Guide 9 (February1893): 69. []
10. “Nursery Problems,” Babyhood 2 (July1886): 291. For more on the growing intimacy between husbands and wives, see John D’Emilio and Estelle B. Freedman, Intimate Matters: A History of Sexuality in America (Chicago: University of Chicago Press, 1997). []
11. Many cities housed Little Mothers Clubs, organizations customarily affiliated with public schools or settlement houses. These clubs trained young girls to better care for the infant siblings so often left in their charge. See Rima D. Apple, Mothers & Medicine: A Social History of Infant Feeding 1890–1950 (Madison: University of Wisconsin Press, 1987), 102–103; Wolf, Don’t Kill Your Baby, 21–22, 120–121.
12. Samuel H. Preston and Michael R. Haines, Fatal Years: Child Mortality in Late Nineteenth-Century America (Princeton, NJ: Princeton University Press, 1991), 27.
13. Infant deaths from diarrhea soared in big cities each summer. One study conducted in Berlin in 1901, however, showed that these summer deaths were virtually nonexistent among breastfed children. See Preston and Haines, Fatal Years, 27–28. In another study of almost 2000 infants who died of “degenerative disturbances,” physicians noted that only 3% had been breastfed. In an additional study of 718 babies who died of diarrhea, only 4% were breastfed. Frank Spooner Churchill, “Infant Feeding,” Chicago Medical Recorder 10 (February1896): 102–114. []
14. Nathan Allen, “The Decline of Suckling Power Among American Women,” Babyhood 5 (March1889): 111–115. []
15. S. T. Rorer, “The Proper Food for a Child in Summer,” Ladies’ Home Journal 17 (July1900): 26. []
16. For a history of wet nursing and its ramifications for both the wet nursed infants and the infants of wet nurses, see Janet Golden, A Social History of Wet Nursing in America: From Breast to Bottle (New York: Cambridge University Press, 1996); Wolf, Don’t Kill Your Baby, 132–157.
17. Report of the Department of Health of the City of Chicago for the Years 1907, 1908, 1909, 1910 (Chicago, 1911), 174.
18. For a complete explanation of these statistics, see Wolf, Don’t Kill Your Baby, xiv, 208–211.
19. Effa V. Davis, “Breast Feeding,” Bulletin: Chicago School of Sanitary Instruction 13 (8June1910): 2. []
20. Ira S. Wile, “Educational Responsibilities of a Milk Depot,” in Prevention of Infant Mortality, Being the Papers and Discussion of a Conference Held at New Haven, Connecticut, November 11, 12, 1909 (N.p., n.d.), 139–153.
21. W. Thornton Parker, “The Refusal to Nurse and Its Consequences,” Babyhood 3 (August1887): 313. []
22. Henry L. Coit, “The Effects of Heated and Superheated Milk on the Infant’s Nutrition (Recent Investigations),” Transactions of the American Pediatric Society 24 (1912): 128–138. []
23. “Dorothy Reed Mendenhall’s Autobiography,” 1939, typed manuscript, Dorothy Reed Mendenhall Papers, Sophia Smith Collection, Neilson Library, Smith College, Northampton, Mass.
24. Family tree and letters dated July 10, 13, and 16, 1901, Mary Scofield and Family Papers, Minnesota Historical Society, St. Paul, Minn.
25. “Scarcely Any Pure Milk,” Chicago Daily News (September 1, 1892), 2; “Stop the Bogus Milk Traffic,” Chicago Tribune (September 23, 1892), 4.
26. In Chicago, the milk crusades began in 1892 and continued for more than 30 years. There was no legal requirement to seal milk vats until 1904, to bottle milk in individual bottles until 1912, to pasteurize milk until 1916, to keep milk cold during shipping until 1920, or to test cows for bovine tuberculosis until 1926. For more on the milk crusades in Chicago, see Wolf, Don’t Kill Your Baby, 42–73. For the story of pure milk campaigns in other cities, see Judith Walzer Leavitt, The Healthiest City: Milwaukee and the Politics of Health Reform (Madison: University of Wisconsin Press, 1982), 156–189; Richard A. Meckel, Save the Babies: American Public Health Reform and the Prevention of Infant Mortality, 1850–1929 (Baltimore: Johns Hopkins University Press, 1990), 62–91.
27. “Infant Welfare Service 1909–1910,” in Report of the Department of Health of the City of Chicago for the Years 1907, 1908, 1909, 1910 (Chicago, 1911), 170–180.
28. Letter to Mrs. Ba. A. Eckhart from Edna L. Foley, January 16, 1923, Visiting Nurse Association of Chicago Papers, Chicago Historical Society. For more on the attention paid by public health departments to the infants of immigrants at the expense of their Black and native-born White counterparts, see Lynne Curry, Modern Mothers in the Heartland: Gender, Health, and Progress in Illinois, 1900–1930 (Columbus: Ohio State University Press, 1999), 10–11, 35–36.
29. Posters appeared in English, Bohemian, Croatian, German, Italian, Lithuanian, Polish, Serbian, Swedish, and Yiddish.
30. Julius Parker Sedgwick, “Maternal Feeding,” The American Journal of Obstetrics and Diseases of Women and Children 66 (1912): 857–865. []
31. Julius Parker Sedgwick, “A Preliminary Report of the Study of Breast Feeding in Minneapolis,” Transactions of the American Pediatric Society 32 (1920): 279–291. []
32. J. P. Sedgwick and E. C. Fleischner, “Breast Feeding in the Reduction of Infant Mortality,” American Journal of Public Health 11 (1921): 153–157. This was especially significant because as late as 1948 the law did not require that milk sold in Minneapolis be pasteurized. [PMC free article] [PubMed] []
33. “Infant Welfare Field Work,” Report and Handbook of the Department of Health of the City of Chicago for the Years 1911 to 1918 Inclusive (Chicago, 1919), 567.
34. E. J. Huenekens, “Breast Feeding,” American Journal of Nursing 24 (1924): 751–757. []
35. N. C. Rudd, “Breast Feeding in Minneapolis,” Mother and Child 2 (1921): 171–173. []
36. E. J. Huenekens, “Breast Feeding From a Public Health Standpoint,” American Journal of Public Health 14 (1924): 391–394. For a more detailed analysis of the work in Minneapolis, see Jacqueline H. Wolf, “ ‘Let Us Have More Mother-Fed Babies’: Early Twentieth-Century Breastfeeding Campaigns in Chicago and Minneapolis,” Journal of Human Lactation 15 (1999): 101–105. [PubMed] []
37. “Are Infant Feeding Methods Changing?” Public Health Nursing 23 (1931): 581–585. []
38. “Slaughter of the Innocents,” Chicago Tribune, 23August1892, 6.
39. Allan S. Ryan, David Rush, Fritz W. Krieger, and Gregory E. Lewandowski, “Recent Declines in Breast-Feeding in the United States, 1984 Through 1989,” Pediatrics 88 (1991): 719–727. [PubMed] []
40. North Country Co-op (Minneapolis, Minn) Records, 1972–2000, Minnesota Historical Society, St. Paul, Minn.
41. Alan S. Ryan, “The Resurgence of Breastfeeding in the United States,” Pediatrics 99 (1997): E12, available at: www.pediatrics.org/cgi/content/full/99/4/e12, accessed October 10, 2002. []
42. Alan S. Ryan, Zhou Wenjun, and Andrew Acosta, “Breastfeeding Continues to Increase Into the New Millennium,” Pediatrics 110 (2002): 1103–1109. [PubMed] []
43. Ryan et al., “Resurgence of Breastfeeding”; Ryan et al., “Breastfeeding Continues to Increase”; Alain Joffe and Susan M. Radius, “Breast Versus Bottle: Correlates of Adolescent Mothers’ Infant-Feeding Practices,” Pediatrics 79 (1987): 689–695; Ryan et al., “Recent Declines in Breast-Feeding”; Christine E. Peterson and Julie DaVanzo, “Why Are Teenagers in the United States Less Likely to Breast-Feed Than Older Women?” Demography 29 (1992): 431–450; Ayala Gabriel, K. Ruben Gabriel, and Ruth A. Lawrence, “Cultural Values and Biomedical Knowledge: Choices in Infant Feeding,” Social Science and Medicine 23 (1986): 501–509; Natalie Kurinij, Patricia H. Shiono, and George G. Rhoads, “Breast-Feeding Incidence and Duration in Black and White Women,” Pediatrics 81 (1988): 365–371. []
44. Kurinij et al., “Breastfeeding Incidence”; Ryan et al., “Recent Declines in Breastfeeding”; Renata Forste, Jessica Weiss, and Emily Lippincott, “The Decision to Breastfeed in the United States: Does Race Matter?” Pediatrics 108 (2001): 291. –296.
45. Forste et al., “Decision to Breastfeed.”
46. Marilyn Elias, “US Breast-Feeding Rate Soars,” USA Today, 1December2002, available at: http://www.usatoday.com/news/health/2002-12-01-feeding-usat_x.htm, accessed December 2, 2002.
47. American Academy of Pediatrics, “Breastfeeding and the Use of Human Milk,” Pediatrics 100 (1997): 1035–1039; World Health Organization, “The Optimal Duration of Exclusive Breastfeeding,” Note for the Press No. 7, April 2, 2001, available at: www.who.int/inf-pr-2001/en/note2001-07.html, accessed October 10, 2002; Ryan et al., “Breastfeeding Continues to Increase.” []
48. Li Ruowei, Cynthia Ogden, Carol Ballew, Cathleen Gillespie, and Laurence Grummer-Strawn, “Prevalence of Exclusive Breastfeeding Among US Infants: The Third National Health and Nutrition Examination Survey (Phase II, 1991–1994),” American Journal of Public Health 92 (2002): 1107–1110. [PMC free article] [PubMed] []
49. Ryan, “Resurgence of Breastfeeding.”
50. For information on the relationship between formula feeding and otitis media, see Nancy F. Sheard, “Breast-Feeding Protects Against Otitis Media,” Nutrition Reviews 51 (1993): 275–277; B. Duncan, J. Ey, C. J. Holberg, A. L. Wright, F. D. Martinez, and L. M. Taussig, “Exclusive Breast-Feeding for at Least 4 Months Protects Against Otitis Media,” Pediatrics 91 (1993): 867–872; G. Aniansson, “A Prospective Cohort Study on Breast-Feeding and Otitis Media in Swedish Infants,” Pediatric Infectious Disease Journal 13 (1994): 183–187. For information on the relationship between formula feeding and gastrointestinal disease, see A. S. Goldman, “Modulation of the Gastrointestinal Tract of Infants by Human Milk, Interfaces and Interactions: An Evolutionary Perspective,” Journal of Nutrition 130 (2000): 426S–431S; L. K. Pickering and A. L. Morrow, “Factors in Human Milk That Protect Against Diarrheal Disease,” Infection 2 (1993): 355–357; Amal K. Mitra and Fauziah Rabbani, “The Importance of Breastfeeding in Minimizing Mortality and Morbidity From Diarrhoeal Diseases: The Bangladesh Perspective,” Journal of Diarrhoeal Diseases Research 13 (1995): 1–7. For information on the relationship between lower respiratory tract infections and formula feeding, see A. L. Wright, C. J. Holberg, F. D. Martinez, W. J. Morgan, and L. M. Taussig, “Breast Feeding and Lower Respiratory Tract Illness in the First Year of Life,” British Medical Journal 299 (1989): 946–949; Y. Chen, “Synergistic Effect of Passive Smoking and Artificial Feeding on Hospitalization for Respiratory Illness in Early Childhood,” Chest 95 (1989): 1004–1007; A. L. Wright, C. J. Holberg, L. M. Taussig, and F. D. Martinez, “Relationship of Infant Feeding to Recurrent Wheezing at Age 6 Years,” Archives of Pediatric and Adolescent Medicine 149 (1995): 758–763. See also Paula D. Scariati, Laurence M. Grummer-Strawn, and Sara Beck Fein, “A Longitudinal Analysis of Infant Morbidity and the Extent of Breastfeeding in the United States,” Pediatrics 99 (1997): E5, available at www.pediatrics.org/cgi/content/full/99/6/e5, accessed October 11, 2002. []
51. Coit, “Effects of Heated and Superheated Milk.”
52. B. Alm, G. Wennergren, S. G. Norvenius, et al., “Breast Feeding and the Sudden Infant Death Syndrome in Scandinavia, 1992–95,” Archives of Disease in Childhood 86 (2002): 400–402. One recent article in Pediatrics argues that the race gap in infant mortality in the United States is directly linked to the race gap in breastfeeding rates; see Forste et al, “Decision to Breastfeed.” [PMC free article] [PubMed] []
53. Rüdiger von Kries, Berthold Koletzko, Thorsten Sauerwald, et al., “Breast Feeding and Obesity: Cross Sectional Study,” British Medical Journal 319 (1999): 147–150; Matthew W. Gillman, Sheryl L. Rifas-Shiman, Carlos A. Camargo Jr., et al., “Risk of Overweight Among Adolescents Who Were Breastfed as Infants,” Journal of the American Medical Association 285 (2001): 2461–2467. []
54. A. Bener, S. Denic, and S. Galadari, “Longer Breast-Feeding and Protection Against Childhood Leukaemia and Lymphomas,” European Journal of Cancer 37 (2001): 234–238. [PubMed] []
55. W. H. Oddy, P. G. Holt, P. D. Sly, et al., “Association Between Breastfeeding and Asthma in 6 Year Old Children: Findings of a Prospective Birth Cohort Study,” British Medical Journal 319 (1999): 815–819; S. Dell, “Breastfeeding and Asthma in Young Children: Findings From a Population-Based Study,” Archives of Pediatrics & Adolescent Medicine 155 (2001): 1261–1265. See also K. A. W. Karunasekera, J. A. C. T. Jayasinghe, and L. W. G. R. Alwis, “Risk Factors of Childhood Asthma: A Sri Lankan Study,” Journal of Tropical Pediatrics 47 (2001): 142–145. []
56. Erik Lykke Mortensen, Kim Fleischer Michaelsen, Stephanie A. Sanders, and June Machover Reinisch, “The Association Between Duration of Breastfeeding and Adult Intelligence,” Journal of the American Medical Association 287 (2002): 2365–2371. See also S. W. Jacobson and J. L. Jacobson, “Breastfeeding and IQ: Evaluation of the Socio-Environmental Confounders,” Acta Paediatrica 91 (2002): 258–260; Ann Reynolds, “Breastfeeding and Brain Development,” Pediatric Clinics of North America 48 (2001): 159–171; N. Gordon, “Nutrition and Cognitive Function,” Brain & Development 19 (1997): 165–170; C. I. Lanting, S. Patandin, N. Weisglas-Kuperus, B. C. Touwen, and E. R. Boersma, “Breastfeeding and Neurological Outcome at 42 Months,” Acta Paediatrica 87 (1998): 1224–1229. Researchers have also demonstrated that the higher IQs of breastfed babies are linked to undetermined properties in human milk rather than the act of breastfeeding. See A. Lucas, R. Morley, T. J. Cole, G. Lister, and C. Leeson-Payne, “Breast Milk and Subsequent Intelligence Quotient in Children Born Preterm,” Lancet 339 (1992): 261–264. In this study, premature infants fed human milk only by gavage scored significantly higher on IQ tests in later years than premature infants fed formula by gavage. []
57. T. Zheng, L. Duan, Y. Liu, et al., “Lactation Reduces Breast Cancer Risk in Shandong Province, China,” American Journal of Epidemiology 152 (2000): 1129–1135; Collaborative Group on Hormonal Factors in Breast Cancer, “Breast Cancer and Breastfeeding: Collaborative Reanalysis of Individual Data From 47 Epidemiological Studies in 30 Countries, Including 50,302 Women With Breast Cancer and 96,973 Women Without the Disease,” Lancet 360 (2002): 187–195. See also T. Zheng, T. R. Holford, S. T. Mayne, et al., “Lactation and Breast Cancer Risk: A Case–Control Study in Connecticut,” British Journal of Cancer 84 (2001): 1472–1476. []
58. Studies demonstrate this. See, for example, R. Cohen, M. B. Mrtek, and R. G. Mrtek, “Comparison of Maternal Absenteeism and Infant Illness Rates Among Breast-Feeding and Formula-Feeding Women in Two Corporations,” American Journal of Health Promotion 10 (1995): 148–153; C. Hoey and J. L. Ware, “Economic Advantages of Breast-Feeding in an HMO Setting: A Pilot Study,” American Journal of Managed Care 3 (1997): 861–865; Thomas M. Ball and A. L. Wright, “Health Care Costs of Formula-Feeding in the First Year of Life,” Pediatrics 103 (1999): 870–876; Thomas M. Ball and David M. Bennett, “The Economic Impact of Breastfeeding,” Pediatric Clinics of North America 48 (2001): 253–262. []
59. American Academy of Pediatrics, “Breastfeeding and the Use of Human Milk.” [PubMed]
60. Electronic and print media around the country and the world covered the announcement of the AAP’s new breastfeeding guidelines, including ABC World News Tonight, The Today Show, CNN, MSNBC, National Public Radio, United Press International, Associated Press, the London Daily Mail, Time magazine, and the New York Times. Articles included the following: Laura Githens, “Breast-Feeding for a Year? Easier Said Than Done,” Buffalo News, December 3, 1997, 1D; “Longer Time Urged for Breastfeeding,” Los Angeles Times, December 3, 1997, 14; Sharon Voas, “Babies Need Mom’s Milk; 1 Year Minimum, Pediatricians Urge,” Pittsburgh Post-Gazette, December 3, 1997, A1; Jim Ritter, “Moms Urged to Breast-Feed Babies Longer; Doctors Push 1-Year Minimum,” Chicago Sun-Times, December 2, 1997, 1; Marilyn Elias, “Nurse for Full Year, Moms Urged,” USA Today, December 2, 1997, 1A; “Pediatrics Group Endorses 1 Year of Breast-Feeding,” Washington Post, December 2, 1997, A14.
61. HHS Blueprint for Action on Breastfeeding (Washington, DC: Department of Health and Human Services, Office on Women’s Health, 2000).
62. On June 19, 2002, the Ad Council issued a press release announcing plans for the formulation of 3 new public service announcements: to promote interracial cooperation, to improve literacy rates, and to educate Americans about breastfeeding. See http://www.adcouncil.org/about/news061902, accessed June 27, 2002. For information on the Ad Council and its work, see www.adcouncil.org.
63. Diane Wiessinger, “Watch Your Language!” Journal of Human Lactation 12 (1996): 1–4. [PubMed] []
64. American Academy of Pediatrics, “Breastfeeding and the Use of Human Milk.” [PubMed]
65. A few representative headlines in the immediate aftermath of the AAP announcement include the following: “Mothers Urged to Breast-Feed a Year,” Portland Press Herald, December 3, 1997, 7A; Marilyn Elias, “Breastfeeding Urged for First 12 Months,” Denver Post, December 2, 1997, A4; “Guidelines Urge Moms to Breast-Feed to Year,” Dayton Daily News, December 3, 1997.
66. Ryan et al., “Breastfeeding Continues to Increase.”
67. A. L. Wright, “The Rise of Breastfeeding in the United States,” Pediatric Clinics of North America 48 (2001): 1–12; I. B. Ahluwalia, I. Tessaro, L. M. Grummer-Strawn, C. MacGowan, and S. Benton-Davis, “Georgia’s Breastfeeding Promotion Program for Low-Income Women,” Pediatrics 105 (2000): E85, available at: http://www.pediatrics.org/cgi/content/full/105/6/e85, accessed February 24, 2003. []
68. Carol L. Wagner, Thomas C. Hulsey, W. Michael Southgate, and David J. Annibale, “Breastfeeding Rates at an Urban Medical University After Initiation of an Educational Program,” Southern Medical Journal 95 (2002): 909–913. [PubMed] []
69. G. L. Freed, S. J. Clark, J. Sorenson, J. A. Lohr, R. Cefalo, and P. Curtis, “National Assessment of Physicians’ Breast-feeding Knowledge, Attitudes, Training and Experience,” Journal of the American Medical Association 273 (1995): 472–476. [PubMed] []
70. Laura Duberstein Lindberg, “Trends in the Relationship Between Breastfeeding and Postpartum Employment in the United States,” Social Biology 43 (1996): 191–202. [PubMed] []
71. It is not affected by part-time employment, however. Part-time work can be an effective strategy if a mother wants to combine breastfeeding and work. See Sara B. Fein and Brian Roe, “The Effect of Work Status on Initiation and Duration of Breast-Feeding,” American Journal of Public Health 88 (1998): 1042–1046. [PMC free article] [PubMed] []
72. Joan Y. Meek, “Breastfeeding in the Workplace,” Pediatric Clinics of North America 48 (2001): 461–474. [PubMed] []
73. For discussions of the history of mothers and infant nurture, as well our knowledge of infant needs, see Sarah Blaffer Hrdy, Mother Nature: A History of Mothers, Infants, and Natural Selection (New York: Pantheon Books, 1999); Deborah Blum, Love at Goon Park: Harry Harlow and the Science of Affection (Cambridge, Mass: Perseus Publishing, 2002). Hrdy in particular takes contemporary feminists to task for their denial of infants’ needs. Most developed countries have taken the needs of working mothers and their infants into account via legislation. In Europe, for example, where paid maternity leave is the norm, there is not only the legal requirement that women must be treated equally, women are also given special protections in areas where their unique ability to bear and breastfeed children might put them at a disadvantage. This is antithetical to US policy guaranteeing women equal treatment—that is, the same treatment as men—in the workplace. This puts women with very young children at an inherent disadvantage to men. See Nora V. Demleitner, “Maternity Leave Policies of the United States and Germany: A Comparative Study,” New York Law School Journal of International and Comparative Law 13 (1992): 229–255.
74. Meek, “Breastfeeding in the Workplace,” 465.
75. Wagner et al., “Breastfeeding Rates at an Urban Medical University”; Ryan et al., “Breastfeeding Continues to Increase.” For more on the historical role of visiting nurses in lowering infant mortality and increasing breastfeeding rates, see Meckel, Save the Babies, 135–139; Wolf, Don’t Kill Your Baby, 105–111; Wolf, “Let Us Have More Mother-Fed Babies.”

 

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