Thursday, May 26, 2022

Why Is There a Baby Formula Shortage? It's Not Inflation

Baby Formula Shortage: We Know Exactly What's Causing It, and It Isn't Inflation

Dan Avery
May 25, 2022 2:15 p.m. PT
7 min read

The closure of a major manufacturing plant led to a serious formula shortage across the US.
Lindsey Nicholson/Getty Images

What's happening

A massive shortage in baby formula is causing outrage and concern as some parents struggle to find infant formula for their children.
Why it matters

In the US, 75% of babies consume formula by the time they're six months old, making the baby formula shortage a critical widespread issue.
What's next

The baby formula shortage has become a national concern, with the White House stepping in to help end the current shortage and prevent future scarcity.

While families continue to grapple with a nationwide infant formula shortage, the US Federal Trade Commission has kicked off an inquiry to find out what led to the crisis. The FTC will also be looking into any fraud, deception or scams people experienced when trying to buy formula.

On Sunday, a military plane carrying over 500,000 baby bottles' worth of specialty formula touched down in Indianapolis as part of President Joe Biden's plan, Operation Fly Formula. A second shipment is expected this week. To seek information about what led to the crisis, the US Federal Trade Commission has opened an inquiry into the infant formula shortage,

Government officials ramped up efforts to tackle the crisis last week. The Senate late last week by unanimous consent approved the Access to Baby Formula Act, which ensures low-income families can buy more types of formula. The bill, which previously cleared the House of Representatives, was signed by Biden on May 20.

Biden last week also invoked the Defense Production Act to force suppliers to prioritize the production of infant formula. He also authorized the Pentagon to use commercial flights to import supplies from abroad.

Another measure -- a $28 million emergency spending bill intended to increase the number of Food and Drug Administration inspectors, prevent unapproved formula from entering the country and improve data collection on the industry -- was approved by the House on May 18 but its fate in the Senate is less assured.

The shortfall dates back to a recall in February after possible contamination at a factory in Sturgis, Michigan, owned by Abbott Nutrition, the maker of Similac and other popular brands of baby formula.

According to retail market analysis firm Datasembly, ongoing supply chain constraints, product recalls and inflation concerns added to the scarcity of formula.

Here's what you need to know about the infant formula shortage, including what caused it, why it's so serious and when it may end.
Why do we have a baby formula shortage?

In September 2021, an infant in Minnesota given formula manufactured in Abbott's Michigan factory was diagnosed with Cronobacter sakazakii, a potentially lethal bacteria.

Cronobacter is rare, but it can cause sepsis or meningitis and even lead to death in infants.

Abbott Nutrition, the maker of Similac, is the largest manufacturer of baby formula in the US, with more than 40% of the market. Smith Collection/Gado/Getty Images

At least four more babies given formula from Abbott's Sturgis facility fell sick in the following months, three with Cronobacter sakazakii and one with Salmonella newport. Ultimately, two infants in Ohio died from Cronobacter infection. Another baby was hospitalized for three weeks before recovering.

As the infections were under investigation, the FDA received a report in October from an ex-employee alleging poor sanitation standards at the factory and the doctoring of records to hide inadequate quality checks.

After an FDA inspection of the facility in February, Abbott voluntarily recalled a number of batches of its Similac, Alimentum and EleCare infant formula brands. Abbott also ceased production at the factory.

Read more: How to Check if Your Baby Formula Has Been Recalled

In a May 16 statement, Abbott said it conducts microbiological testing on products before distribution "and no Abbott formula distributed to consumers tested positive for Cronobacter sakazakii or Salmonella." It added that an investigation by the Centers for Disease Control and Prevention found no link between Abbott formulas and infant illnesses.

Still, Abbott is the largest of only a handful of baby formula manufacturers in the US and accounts for more than 40% of the market. Thus the recall and plant closure cratered supply.

The crisis has also fueled formula hoarding, which has made the deficit worse, along with reports of price gouging. Some stores, including CVS and Walgreens, have limited customers to three formula purchases per visit.

Why is the formula shortage such a big deal?

Less than half of newborns in the US are breastfed exclusively in the first three months of life, according to the CDC, and one in five are given formula in the first few days. And by six months, 75% of babies receive some formula, according to the CDC.

Some mothers or babies have difficulty breastfeeding, and infants may be given formula to encourage weight gain. Changing formulas suddenly can cause digestive issues, and babies with allergies or certain medical conditions require specific formulas.

"If your baby is allergic to standard formulas and you need a broken-down formula, then it's critical that you stick to that same type of formula," Steven Abelowitz, medical director of Coastal Kids Pediatrics in Orange County, California, told CNET previously.

The shortage isn't impacting all Americans equally, either.

A few bottles of Similac on some nearly empty shelves at a Target in New Jersey on May 17. Tayfun Coskun/Getty Images

"The families who have fewer resources, have fewer options, who aren't able to pay premium prices are going to be more at risk," Ann Kellams, board president of the Academy of Breastfeeding Medicine, told Vox.

The Special Supplemental Nutrition Program for Women, Infants, and Children, a federal program commonly known as WIC, provides food assistance to low-income families. Individual states dictate which brand of formula is covered by WIC, and Abbott Nutrition's Similac formula, the leading brand in the US, is one of the major suppliers to the WIC program.

That means parents of the estimated 1.7 million infants in WIC haven't had a lot of options.

Read more: What to Do if You're Running Low on Formula
What did the whistleblower accuse Abbott of doing?

The whistleblower's report was first detailed by Politico in late April and later shared by Rep. Rosa DeLauro, chair of the House Appropriations Committee. Among other things, it alleges: Falsification of records. Among other charges, the whistleblower alleged that Abbott shipped untested formula and falsified maintenance records.
A lack of traceability. According to the report, the factory's automatic labeler frequently failed to work properly, making it difficult to track down potentially contaminated products.
An atmosphere of retaliation. The whistleblower maintained that "despite an admirable employment record at Abbott and elsewhere," he was terminated after raising concerns repeatedly.

In addition, the FDA's investigation found that Abbott "did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source."
How has Abbott responded to the allegations?

Abbott didn't respond to a request for comment. The company said in an April 28 statement that its focus "has, is and always will be to ensure safe food for families who rely on us for our high-quality nutrition products."

It maintains infant formula produced at the Sturgis facility "is not likely the source of infection."

No products from the plant tested positive for Cronobacter sakazakii or "any known infant illness," according to Abbott.

Inspectors found evidence of Cronobacter bacteria in the plant but not in any areas in contact with formula, Abbott said, and the strains that were detected didn't match those found in the infected children.

According to the release, the former employee had been "dismissed due to serious violations of Abbott's food safety policies."
Can the US import formula from other countries?

The FDA requires manufacturers to meet specific nutritional standards for infant formula that differ from guidelines in Canada, Europe and elsewhere. That makes bringing in formula from other countries difficult.

At a May 16 briefing, FDA Commissioner Robert Califf said the agency was loosening restrictions on imported infant formula products to improve supply "efficiently and safely."

"We anticipate that those products that can quickly meet safety and nutrition standards could hit US stores in a matter of weeks," Califf said.

In addition to setting health standards, the US government also levies heavy tariffs on imported baby formula -- up to 17.5%, according to the Cato Institute. And as part of a trade agreement negotiated by President Donald Trump in 2020, Canada agreed to impose a $7.26-per-pound surcharge if its global formula exports surpassed 44,620 tons annually.

Infant formula accounted 22% of all US dairy imports into Canada last year-- the largest product in the category -- but the US didn't import any from our neighbor to the north.

Abbot expects to reopen its plant and get formula onto store shelves within six to eight weeks. Delmaine Donson/Getty Images
When will the baby formula shortage end?

Abbott Nutrition announced an agreement with the FDA on May 16 that will allow it to resume production in the Michigan factory in about two weeks, meaning formula produced there could hit supermarket shelves in about six to eight weeks.

By that time, imported formula should also be available in US stores. (Abbott is also flying formula in from its plant in Ireland.)

On May 23, the first transported batch of Nestle formula arrived in Indiana from Switzerland; it will now be distributed to areas nationwide with the worst shortages. According to the White House, the effort will bring "up to 1.5 million 8-ounce bottles of three formulas -- Alfamino Infant, Alfamino Junior and Gerber Good Start Extensive HA -- all of which are hypoallergenic formulas for children with cow's milk protein allergy."
What is being done to prevent future shortages?

The $28 million emergency funding bill would help prevent future shortages, according to Rep. DeLauro, who is also challenging the FDA for reacting "far too slowly" in addressing possible contamination at the Michigan facility.

"Why did the FDA not spring into action?" DeLauro said in a statement on April 28. "Why did it take four months to pull this formula off store shelves? How many infants were fed contaminated formula during this time?"

House Speaker Nancy Pelosi (right) speaks with Rep. Rosa DeLauro at a press conference on legislation to help with the nationwide baby formula shortage. Anna Moneymaker/Getty Images

DeLauro, who is on the House Appropriations subcommittee that oversees the FDA, has requested the Department of Health and Human Services' Inspector General's office investigate the agency's actions.

She also indicated hearings will be held "to find answers into how this happened and how we can prevent it from ever happening again."

Speaker of the House Nancy Pelosi told reporters on May 17 that there "might be a need for indictment[s]" in the wake of the FDA investigation into Abbot Nutrition, but didn't specify who might be charged.

"The baby formula emergency also serves as a critical reminder of the urgent need to invest in strengthening our supply chains," Pelosi added.

First published on May 20, 2022 at 10:12 a.m. PT.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

Running Low on Baby Formula? Here's What You Can Do During the Shortage

We spoke with a pediatrician about where to look for baby formula, whether it's OK to switch brands and other FAQs.

Jessica Rendall
May 23, 2022 10:56 a.m. PT
5 min read

Towfiqu Barbhuiya/Getty Images

The ongoing baby formula shortage in the US, which stems from the recall and subsequent closure of a large formula plant, continues to make it exceptionally difficult for many parents to meet their babies' nutritional needs. The Senate on Thursday approved the Access to Baby Formula Act, and the Biden Administration's Operation Fly Formula initiative began flying in formula from Europe over the weekend.

The US Food and Drug Administration has announced plans to loosen some importation restrictions on formula from other countries and work with formula manufacturers to increase production.

Guidelines for WIC, the Special Supplemental Nutrition Program for Women, Infants and Children, have also been relaxed in some states, and all are encouraged to follow suit, per a request from the White House and the US Department of Agriculture. Parents should be able to return recalled formula in exchange for a wider variety of products, and requirements for medical waivers or other restrictions should be loosened, the USDA says. (Program details vary by the state -- find your local office here.)

If you're running low on formula, here's what pediatricians say to do and where to go. Delmaine Donson/Getty Images
Where to look for baby formula if yours is out of stock

Retailers including CVS, Walgreens and Target have all placed limits on how many products you can purchase at once. Despite this, shelves in some stores are bare.

If you can't find your formula, call your pediatrician to see if they have any in stock. Pediatricians often get samples of different formulas and may be able to help out, says Dr. Steven Abelowitz, pediatrician and medical director of Coastal Kids. Doctors also may have samples left over from formula representatives.

"Other places that folks can look at are different charities," Abelowitz said. Some charities or food assistance programs, such as the WIC nutrition assistance program have income requirements. However, given the shortage, some assistance programs may be more willing to expand eligibility, depending on the area or circumstance.

If you are a WIC member, contact your local office to find formula. WIC programs nationwide have been urged to loosen restrictions and help parents find alternatives.

The American Academy of Pediatrics also recommends checking smaller stores instead of the big retailers (like your local mom and pop shop or drug store). Social media groups dedicated to parenting may also have good resources for your area, and you may meet another parent with extra in stock.

But make sure to run any advice you get from parenting groups by your pediatrician, the AAP notes.

You can also safely feed formula made for babies who were born premature to full-term babies for a few weeks if your recommended formula isn't available, the AAP says.Is it OK to switch brands?

"Of course it's preferred to stick to the same formula," Abelowitz said, but the next alternative is finding a formula as similar as possible to the one you were using. Because there are so many formula brands, Abelowitz recommends reaching out to your pediatrician to see which formulas would be acceptable swaps.

Because not everyone has a pediatrician they can check in with, you can also call your local pharmacy and ask to speak with a pharmacist about an alternative formula for your child, Abelowitz says.

But you should really stay away from swapping between infant and toddler formula, he says. Baby formula and toddler formula are made to address different nutritional needs.

There are also exceptions if your child has allergies or a medical condition: "If your baby is allergic to standard formulas and you need a broken-down formula, then it's critical that you stick to that same type of formula," Abelowitz said. If this is the case for your child, make sure you talk to a pediatrician, family doctor or other expert before introducing a new food.

In emergency situations, you can call 211 or contact Feeding America to be connected to a community specialist who can help you find local resources, according to the Infant Nutrition Council of America.

You can also be connected with an expert through MyGerber Baby Expert to find a substitute for your formula. Finding an accredited breast milk bank may be an option for some parents in need, but you may need a prescription from a medical provider. SDI Productions/Getty Images
Is it OK to make your own baby formula?

"Never," said Abelowitz. It can be dangerous from a nutritional standpoint, in that the formula might be lacking essential nutrients, but it can also contain the wrong amount of electrolytes, which can cause health problems.

"Although recipes for homemade formulas circulating on the internet may seem healthy or less expensive, they are not safe and do not meet your baby's nutritional needs," the AAP said. "Infant deaths have been reported from use of some homemade formulas."
What about cow's milk as a substitute?

Cow's milk contains insufficient amounts of iron, Abelowitz says, and shouldn't be given to babies under 1 year old. Oat or other plant milks are also lacking in protein and minerals.

The AAP, however, says that whole milk from a cow (not the nonfat stuff) is OK to feed a baby 6 months and older "for a brief period of time in a pinch." That is, it's better than any other alternative -- including homemade formula. If it becomes necessary, the AAP says, incorporate iron-containing solid foods into your baby's diet or talk to your pediatrician about an iron supplement. Fortified soy milk (not almond or other milk substitutes) may also be an option "for a few days in an emergency" for babies who are close to 1 year old, the AAP says, but change back to formula as soon as possible.

But whatever you do, according to the AAP and Abelowitz, don't water down your baby's formula to make it last longer.

"This causes nutritional imbalances, and there is a thing called water intoxication, which can be very dangerous when there's too much water as opposed to formula," he said. Specifically, sodium levels can become too low, causing hyponatremia, he says.

One last formula tip from Abelowitz: Don't buy formula in bulk that you don't need.

"By hoarding up on it, you're obviously affecting a lot of other people," Abelowtiz said. To help ease the supply issue, the AAP advises buying no more than a 10- to 14-day supply of formula at a time.

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