Is There A Baby Formula Shortage?
Yes. As much as 30% of popular baby formula brands might be sold out in the US (as of March 2022), according to research firm Datasembly. (1)
The formula supply shortage is alarming, particularly because the CDC (Centers for Disease Control and Prevention) estimates that as many as 75% of babies in the US are likely given formula by six months of age. (2)
Shortage Affects Hospitals & Families
According to the latest news, parents are getting stressed trying to find baby formula products. Hospitals are also having difficulties finding baby formulas for in-patient families. (3)(4)(5)
The following states could be among the hardest hit, with the out-of-stock percentage higher than 40% during the week of March 13, 2022: (1)(6)(7)
- Minnesota (highest hit at 54%)
- Rhode Island
- South Dakota
- North Dakota
These cities have the highest out-of-stock rates in Datasembly’s March figures: (1)(6)(7)
- San Antonio (56%)
- Minneapolis (55%)
- Moines (50%)
Tips To Deal With The Shortage: What Can I Give My Baby If I Run Out Of Formula?
The CDC and many pediatricians agree that breast milk remains the best option to give your baby. Breastfeeding can help you deal with the shortage; however, it isn’t viable for many moms.
With your pediatrician’s approval, you can try these options:
Is It Okay To Try Different Formulas?
If your formula is affected by a recall, you can try other options from the same manufacturer or other formula brands, but make sure to consult your pediatrician.
Provided you have the go-ahead from your pediatrician, your options can also include US-made options such as:
- Bobbie Organic Infant Formula
- Serenity Kids A2 Toddler Formula (Use our code MHC for 15% off first-time orders, too!)
- ByHeart Baby Formula
You can also try some European brands such as:
*Note that many European brands aren’t FDA approved, though still many parents opt for these products over commercial American options.
The AAP (American Academy of Pediatrics) also suggests doing the following: (8)
- Switching to a store brand, unless your baby needs specialized formulas like Elecare, which doesn’t have equivalent store brands.
- Checking smaller pharmacies and stores that might still hold more stocks than bigger, more popular stores.
- Checking social media groups for information from other parents about where they got their formulas.
However, the AAP reminds everyone to check with their pediatricians before switching to another formula even with the shortage.
It’s also important to follow the package instructions on how to prepare the formula instead of adding more water to stretch it out. (8)
Can I Give My Baby Evaporated Milk Instead Of Formula?
It’s not advisable. Many infants were given evaporated milk in the 1920s, but it led to higher incidents of iron deficiency. (9)
According to a 1999 study, evaporated milk is still used in many parts of Canada. But babies consuming this milk might be more likely to have iron deficiency and require iron supplementation. (10)
What Did Babies Drink Before Formula?
Wet nursing (a breastfeeding mom nursing another mom’s baby) was the most common way of feeding a baby before formulas were invented. The practice was prevalent from 2000 BC up to the early 19th century. (11)
Animal’s milk was also used, depending on the availability: (11)
Pap (bread soaked in water or milk), broth, and panada (cereals cooked in broth) were also used to supplement animal milk. (11)
Evaporated milk was also used as a homemade formula in the 1920s. (6)
Baby Formula Alternatives: What You Shouldn’t Do
Can Infants Drink Canned Milk?
Don’t give cow’s milk or any milk that isn’t specifically made as infant formula if your baby is below one year of age. It puts them at risk for serious illness.
Cow’s milk contains too many minerals and proteins that your baby’s kidneys can’t handle. It can cause intestinal bleeding, which is life-threatening. (12)
Other milk alternatives to avoid unless you have your pediatrician’s approval: (12)
- Soy milk
- Almond milk
- Oat milk
- Rice milk
- Cashew milk
- Coconut milk
Why Is Condensed Milk Not Advisable To Infants?
Condensed milk has high sugar content but limited nutritional value. So, it shouldn’t be given as a milk substitute for young children. (13)
High sugar consumption can lead to heart disease, type 2 diabetes, weight gain, and obesity. (14)
Be Cautious With Donor Breastmilk
Well-meaning moms offer extra breastmilk to help other moms handle the baby formula shortage.
Studies show that pasteurized donor human milk can be an alternative if a mom’s own breastmilk isn’t available. (15)
However, the FDA advises against using donor breastmilk unless necessary. (16)
Possible health risks of donor breast milk, especially from unscreened donors: (14)
- Infectious diseases such as HIV (human immunodeficiency virus)
- Prescription drugs or hormonal supplements that can affect your baby – examples can include Brexanolone, an FDA-approved drug for postpartum depression treatment
- Chemical contaminants such as illegal drugs
Also, there’s a high risk of contamination if the breastmilk isn’t stored properly or past the expiration date: (17)
- Freshly pumped – up to four hours at room temperature
- Stored in the fridge (40°F) – up to four days
- Frozen (0°F or lower) – within six months to one year
Why Is There A Shortage Of Baby Formulas?
Datasembly’s chief executive officer Ben Reich explained that several factors led to the infant formula shortage: (1)
- The massive Similac recall in February 2022
- Supply chain issues before the recall due to the COVID-19 pandemic
2022 Formula Recall: Why Is There A Similac Shortage?
It was due to possible contamination with Cronobacter sakazakii and Salmonella bacteria.
The baby formula recall was issued after four babies were hospitalized, and one died of bacterial infection after drinking possibly contaminated formula. (3)
On February 28, Abbott Nutrition added Similac PM 60/40 to the list of recalled baby formulas following the death of another infant.
In March, the latest news revealed possible lapses of the FDA (Food and Drug Administration) in preventing the Abbott Nutrition powdered formula contamination.
The FDA failed to stop production despite safety inspections showing several issues at the plant, including failure to maintain sanitary conditions. (3)
Abbott Nutrition hasn’t issued the total number of recalled cans and packages of these formulas, but the recall affected the market supply.
Shortage Before The 2022 Recall
Even before the Similac 2022 recall, infant formula stocks were already problematic.
Chains like CVS Health Corp. and Walmart Inc. blamed the manufacturers for having supply issues. However, the manufacturers blamed the retailers for not delivering and promptly putting the stocks on their store shelves. (4)
Reich explained that the out-of-stock rates were “stable” at around 2-8% during the first seven months of 2021. However, the numbers quickly increased to double digits for the rest of the year. (1)(5)
It rose to as high as 23% in January 2022. The Infant Nutrition Council of America blamed it on the supply chain shortages. (4)
Manufacturers & Retailers Try To Solve The Shortage
Manufacturers said they’re increasing production. But it could take several weeks, even some months, before the rising supply demands are met. (6)(7)
A spokesperson from Enfamil maker Reckitt Benckiser said that they’ve increased production and currently shipping 30% more of their usual product volume to address the shortage ASAP. (6)
Retailers also announced that they’re working closely with vendors to increase the number of formulas on their shelves.
Shortage Causes Formula Rationing & Rising Prices
Formula Hoarding & Stockpiling
Many panicked parents scrambled to buy as many formula cans as they could. However, California pediatrician Dr. René Bravo advises against hoarding and stockpiling baby formula. (7)
He explained that these could worsen the shortage.
Rationing & Limits
To “improve inventory,” some stores have resorted to rationing and limiting the number of cans customers can buy:
- Walgreens now limits shoppers to three baby and toddler formulas per transaction. (1)
- Target limits customers to four baby formula products per transaction. (18)
CVS limits customers to three infant formula products per purchase (stores and online). (18)
Formula Shortage News Updates
FDA Official Resigns Over Formula Shortage
Update: January 26, 2023
A month after the FDA was criticized for its handling of the formula shortage crisis by an independent review, deputy commissioner Frank Yiannas of the agency’s Office of Food Policy and Response announced his resignation, effective February 24. (19)
The outside review was requested by Commissioner Robert Califf and organized by the nonprofit Reagan-Udall Foundation. It called for the appointment of “a strong leader” and reorganization of the food program. (19)
In response, Yiannas explained in his resignation letter that he inherited a “decentralized structure of the foods program.” He said that this kept his office from operating as an integrated team and protecting the public. (19)
Abbott Under Criminal Investigation Over Baby Formula Shortage
Update: January 24, 2023
The US Justice Department’s consumer protection branch is reportedly conducting a criminal investigation over Abbott’s role in the formula shortage. (20)
The company is believed to have played a big role in the shortage, especially because it took several months before it reopened. (20)
The shutdown from February to June 2022 was especially more difficult for children who relied on specialty formulas that were only manufactured by the company. (20)
Abbott spokesperson Scott Stoffel said that they’ve been informed about the investigation by the Justice Department and are “cooperating fully.” (20)
In previous investigations conducted by the FDA (Food and Drug Administration), Abbott reportedly had several violations, including lax safety protocols and bacterial contamination. (20)
Reckitt Benckiser (Enfamil): Formula Shortage To Last Until Spring
Update: December 4, 2022
It’s been a year since the formula shortage crisis started in the US, yet the end doesn’t appear to be in sight despite efforts by the government to increase supplies by flying formula from across the world and formula makers ramping up productions. (21)
Enfamil maker Reckitt Benckiser even predicts that this formula crisis will last until spring. (21)
The brand now enjoys the top spot as the US’ largest formula supplier (previously held by Similac), but Reckitt Benckiser’s ramped-up productions by operating formula factories 24/7 aren’t enough to fill the shelves with enough infant formula to meet the higher demand. (21)
Abbott Plans To Open New Formula Plant
Update: October 20, 2022
As the US formula shortage continues, Abbott Nutrition announced their plan to open a $500-million nutrition plant for specialty and metabolic infant formulas to increase domestic production. (22)
Abbott Nutrition Chairman and CEO Robert Ford explains that they came up with the plan to build the new plant in response to their analysis of the formula market. He said that the country will benefit from the increased formula manufacturing capacity. (22)
The announcement comes after FDA Commissioner Dr. Robert Califf said that the supply chain needs more diverse manufacturers because the available manufacturers still can’t meet demands despite stepping up productions. (22)
New Abbott Nutrition Recall 2022: Ready-to-Feed Liquid Products
Update: October 16, 2022
Abbott Nutrition voluntarily recalled some ready-to-feed (2 fl oz bottles) liquid products, including formulas, because some bottles might have caps that weren’t sealed completely. The manufacturing defect can lead to possible spoilage. (23)
The company warns parents not to feed their babies any of these recalled products because the spoiled items can cause diarrhea, vomiting, or other gastrointestinal symptoms. (23)
These recalled products were manufactured by the Abbott facility in Columbus, Ohio, and cover the following brands: (23)
- Pedialyte Electrolyte Solution
- Similac Stage 1
- Similac NeoSure
- Similac Water (Sterilized)
- Similac Special Care 24
- Similac 360 Total Care
- Similac 360 Total Care Sensitive
- Similac Pro-Total Comfort
Considering the ongoing formula shortage, many parents are worried that this new recall might further affect the short supply. (24)
An Abbott spokesperson claims that the new recall only affects around “less than a day’s worth” of the total baby formulas used in the US, so it shouldn’t affect the overall supply. (24)
Abbott assures the public that the recall only affects “a small percentage” of their ready-to-drink products distributed to some retailers, distributors, doctor’s offices, and hospitals in the following areas: (23)(24)
- Puerto Rico
- Dominican Republic
- St Thomas
- St Croix
- Trinidad & Tobago
Abbott Nutrition also clarifies that the recall only affects a small number of lots of the ready-to-drink products.
See our Similac recall article for the complete list of affected bottle lots or case/carton numbers.
You can also call Abbott Nutrition for more information:
- 1-800-986-8540 (US)
Troubled Abbott Plant Finally Reopens After Flooding
Update: July 11, 2022
The troubled Abbott plant in Sturgis, Michigan, which shut down just weeks after finally reopening following the recall, was able to reopen again last July 1, 2022. They’re restarting EleCare production and will soon produce specialty and metabolic formulas. (25)
Overseas Formula Shipments To Continue Beyond Shortage
As a way to stop a similar crisis from happening again, the FDA plans to extend formula importation beyond the initial target in mid-November. (26)
The importers currently supplying the baby formulas were given a temporary permit, but this might be extended to a permanent one.
According to the FDA, they will issue the official guidance in September so these importers companies could meet the requirements to continue supplying formulas to the US. (26)
Is Operation Fly Formula Failing?
Update: June 22, 2022
A month after President Joe Biden launched Operation Fly Formula and invoked the Defense Production Act to help solve the baby formula shortage, store shelves reportedly remain empty in many parts of the country. (27)
Military planes traveled across the world to bring millions of infant formula products to the US these past weeks. However, most of these stocks were sent through a distribution pipeline that served home health companies, hospitals and clinics, and the WIC programs (Women, Infant, and Children). (27)
Most stores continue to impose the purchase limits, while many keep formulas behind the counter due to the limited stocks.
Although we acknowledge the government’s efforts to bring formulas from across the world, many parents remain worried about the supply and question when these products will reach the store shelves. (27)
16 Million 8-oz Baby Formula Bottles To Be Imported From Mexico
Abbott’s Sturgis plant remains closed after the floods, and US officials scramble to bring more formulas from plants across the world in a bid to solve the shortage crisis.
The White House announced Operation Fly Formula’s tenth flight, which will bring around 1 million pounds of Gerber Good Start Gentle baby formula from Mexico. It’s estimated to be equivalent to around 16 million 8-oz bottles. (28)
The first shipment from Mexico will arrive in Fort Worth, Texas, beginning on June 24. (28)
FDA Probes Another Possible Abbott Formula-related Baby Death
Last June 10, the FDA received a new report of another baby who died last January after reportedly consuming infant formula made by Abbott Nutrition. (29)
The FDA has launched a probe to investigate the circumstances of the baby’s death, the federal agency announced. However, there’s no word on whether they will also investigate the other deaths also reported by news outlets these past weeks. (29)
Recalled Abbott Baby Formulas Mistakenly Sold In Canada
Update: June 20, 2022
Recalled products are supposed to be discarded or returned to the manufacturer for proper disposal.
However, the CFIA (Canadian Food Inspection Agency) warned consumers that some Abbott products recalled in February 2022 were mistakenly sold by Shoppers Drug Mart due to an “online error.” (30)
Check the bottom of the package or container for the following codes if you bought products from the retail pharmacy giant:
- The first two numbers start from 22 to 37
- The code contains any of these: K8, SH, or Z2
- The expiration date code is from 4-1-2022 (APR 2022) or subsequent dates
The Canadian retail pharmacy giant store issued a secondary recall of these recalled infant formulas and warned consumers against using any of these formulas. (30)
More Formulas Flown To The US From Across The World
President Joe Biden launched “Operation Fly Formula” to facilitate the fast shipment of formulas from across the world to help solve the formula crisis.
In the middle of June, 44,000 lbs of Nestlé Health Science Alfamino and Alfamino Junior (both are specialty infant formulas) equivalent to approximately 548,000 eight-ounce bottles arrived from Switzerland at the Louisville International Airport. (31)
Two shipments bringing 380,000 lbs of Bubs formula equivalent to approximately 4 million eight-ounce bottles arrived from Australia. (31)
Around 95,000 cans of these baby formulas arrived in LAX from Australia in the middle of June. They’re set to be delivered to Walmart, Albertsons Companies, and The Kroger Company. (31)(32)
On Father’s Day, Vice President Kamala Harris greeted the shipment of 200,000 8-ounce bottles of Kendamil formulas at Dulles International Airport in Virginia. This shipment came from the United Kingdom. (33)
More Kendamil formulas are expected to arrive on three more Operation Fly Formula flights in the coming weeks.
Other June & Summer Arrivals
Before the end of June, Abbott will begin importing Similac NeoSure (formula for premature and low birthweight babies ) and Similac Total Comfort (formula for infants with sensitive tummies) from their manufacturing facility in Granada, Spain. (34)
These shipments will include 686,350 cans which can be used to prepare around 16.5 million 8 fl oz bottles of formula. (34)
In July, Danone will ship 750,000 cans of different formulas equivalent to 19 million 8-ounce bottles the company’s manufacturing plant in Ireland. (33)
The first Danone shipment will be Aptamil First Infant Milk Stage 1. It’s designed for healthy infants but isn’t ideal for premature babies and those with metabolic or digestive issues. (33)
Newly Reopened Abbott Facility Closes Again Due To Flooding
Abbott Nutrition’s newly reopened Sturgis plant had to close down again just days after production resumed. Like other places in Michigan, the plant was hit by floods affecting the area. (34)
Prior to the flooding, severe thunderstorms hit the state. It also resulted in massive power outages.
Due to flooding in different areas of the Abbott plant, the company needs to resanitize the plant and conduct comprehensive testing with an independent third party before they can get the FDA’s approval to reopen.
The company has already informed the FDA about this new setback, adding that production is likely going to be delayed for a few more weeks. Before the natural disaster, the company had hoped to release newly produced EleCare formulas by June 20. (34)
Once the FDA certifies that the plant is safe, Abbott plans to resume EleCare production, then begin production of Similac and other formula products. (34)
More Baby Deaths Reported Amid Abbott Investigation
Update: June 11, 2022
From December 1, 2021, to March 3, 2022, a total of nine formula-related baby deaths were reported to the FDA, with two among the four confirmed Cronobacter sakazakii infections cited as the reason behind the Similac recall in February. (35)
Based on the FDA’s investigation, none of the infant deaths had DNA sequences that matched Abbott’s products. However, all the babies were fed Abbott formula: (35)
- Similac Total Comfort Easy-to-Digest Gentle Protein & Prebiotics
- Similac Pro-Total Comfort (Powder) infant formula
- Similac Advance
- Similac Pro Advance infant formula
- Similac PM 60/40
- EleCare infant formula
Aside from Cronobacter, some of the babies tested positive for Salmonella, Escherichia coli, and other pathogens. (35)
EleCare Production Begins As Abbott Reopens Sturgis Plant
Update: June 6, 2022
Abbott Nutrition has restarted its facility in Sturgis, Michigan, on June 4, 2022, with the production of EleCare. The plant will also prioritize other specialty or metabolic formulas that are meant for babies with severe food allergies and digestive problems. (36)
The Sturgis plant was the center of the massive Similac recall announced back in February, which also worsened the US formula shortage.
With the plant now back in action, it’s expected to produce enough formula to help alleviate the shortage. However, Abbott clarified that it will take around three weeks or by June 20 before the first formulas will hit market shelves. (36)
The company will prioritize EleCare and similar specialty formulas before resuming the production of Similac and other formulas.
Formula Shortage Hits 70% In May, More Foreign Companies Promise To Help
Update: May 31, 2022
The formula shortage in the US continues to worsen, with the out-of-stock rates going up to as high as 70% across the country, according to retail data firm Datasembly. This is for the week ending on May 22. (37)
To help solve the shortage and in response to US President Biden’s call for help, a number of foreign baby formula companies promised to help ship products to the US. They were assured by the FDA that some regulations will be relaxed (but the products should still meet US standards) to solve the crisis.
Kendal Nutricare, the UK manufacturer of Kendamil, announced that it will send products to fill around 100 trucks to help fill the need over the next six months. (38)
Bubs Australia assured Australian parents that it has enough stocks for everyone as it announced the plan to send at least 1.25 million cans of infant formula to the US. (39)
Babies Are Getting Hospitalized Due To Formula Shortage
Update May 24, 2022
In various parts of the US, there have been reports of several babies and even older children hospitalized amid the formula shortage.
Tennessee: Children Hospitalized Over Out-Of-Stock Specialty Formula
In Tennessee, at least two children have been hospitalized due to the formula shortage.
A pediatric gastroenterologist at Le Bonheur Children’s Hospital in Memphis, Dr. Mark Corkins, admitted two patients (a toddler and a preschooler) because their specialty formula was out of stock. (40)
Both children have short bowel syndrome and were using EleCare, a specialty formula made of amino acids (protein building blocks) because they couldn’t absorb full-size proteins. (40)
They relied on the amino acids from EleCare for nourishment because these didn’t have to be digested. However, the formula was recalled in February, so they had to try other formula options. Unfortunately, they couldn’t tolerate other options, which led to dehydration. (40)
According to Dr. Corkins, the toddler was only hospitalized for about a week. However, the preschooler has been admitted since April and is still in the hospital.
He added that these kids didn’t have other illnesses. They could have stayed at home, but had to be hospitalized for nourishment.
South Carolina: Babies Hospitalized For Intolerance & Mineral Imbalances
Doctors at the Medical University of South Carolina Shawn Jenkins Children’s Hospital in Charleston confirmed that at least three babies have been hospitalized due to the shortage. Three of the babies had an intolerance to the new formula given by their parents or caregivers. (41)
Another had mineral imbalances after their caregiver created their own formula. (41)
Georgia: Undisclosed Number Of Hospitalized Children
A spokesperson for the Children’s Healthcare of Atlanta in Georgia revealed that several children have been hospitalized for malnutrition. Some were admitted back in February after the Abbott plant was closed. (42)(43)
The exact number of hospitalized kids wasn’t disclosed but all had specific dietary needs. These kids need to be carefully monitored after making changes to their formula to ensure they could tolerate it. (42)
For many of these hospitalized kids, finding the right formula is a long, complicated process. The formula has to meet their nutritional needs but shouldn’t trigger any potentially dangerous reaction, such as dehydration or diarrhea.
According to the hospital’s spokesperson, these kids ranged from babies to older children. Thankfully, all have been discharged. (42)
Wisconsin: Undisclosed Number Of Hospitalized Children
Children’s Wisconsin Clinical Nutrition Manager Jennifer Crouse disclosed that several children have been treated at the ER or admitted to their hospital, also due to the formula shortage. (43)
Most of these kids were malnourished or failed to thrive after taking homemade formula or other inappropriate substitutions. (43)
The doctor didn’t disclose the exact number of children hospitalized relating to the formula shortage, but they’ve had several of these admissions.
Children’s Wisconsin warns against giving your baby homemade formula. It can cause liver and/or kidney damage. It might even lead to an imbalance in their body, which can cause their heart to stop. (43)
She also shared that some parents watered down their formula to stretch their supply. However, formula dilution can lead to possible organ failure or brain swelling. (43)
Dr. Crouse encourages parents to ask their pediatrician before modifying or giving any kind of formula substitute to their babies.
Pelosi Eyes Criminal Charges Over Infant Formula Shortage
House Speaker Nancy Pelosi said that they might be pressing charges and there might be a need for indictment when the US baby formula shortage is resolved. (44)
Pelosi didn’t specify the details of the possible “indictment” but called the shortage “unconscionable and tragic,” She clarified, however, that her remarks about the criminal charges aren’t associated with any of her colleagues. (44)
She explained that it’s important to first solve the problem as quickly as possible. Urgent action is necessary to protect the hungry, crying babies, but she believes that the indictment is also necessary to prevent a similar shortage from happening again. (44)
Biden Invokes Defense Production Act
President Joe Biden invoked the Defense Production Act on May 18, 2022, to directly address the formula shortage. (45)
Under the Defense Production Act, suppliers should prioritize orders from baby formula manufacturers before any other customer who might have ordered the same goods. (45)
The first two authorizations are “priority orders” for Abbott Nutrition and Reckitt Benckiser (Mead-Johnson’s Enfamil): (46)
- For Abbott Nutrition – raw materials, including sugar and corn syrup
- For Reckitt – single-use products, such as filters needed to generate certain oils for formula production
These priority shipments are expected to help increase production by one-third once the Abbott plant resumes operations. (46)
Also, Reckitt facilities can operate at their maximum capacity following these priority shipments. (46)
Biden Launches “Operation Fly Formula”
Aside from encouraging increased production for the infant formula manufacturers, Biden also launched “Operation Fly Formula.”
The president directed various government agencies to use military planes of the Department of Defense to pick up formulas that meet US standards overseas and fly these back to the country to help restock shelves. (45)
These special flights speed up shipments that normally take two weeks to reach the US to within just 72 hours. (41)
European Formula Stocks To Help With US Shortage
The Biden administration plans to increase formula importation as a measure to help ease the ongoing shortage in the US. (47)
Nestle responded immediately by importing Alfamino from Switzerland and Gerber Good Start Extensive HA from the Netherlands. (48)
These products serve a critical medical purpose for babies with cow’s milk protein allergies, according to a Nestle representative.
The quick response to Biden’s call for increased shipments was possible because both formulas were already being imported even before the shortage, the company representative explained. (48)
They have also “worked round the clock” and increased production to help meet the demand. (46)
The company representative added that they’re also checking whether they could tap into the Nestle global nutrition network for other baby formulas to import. This is possible, thanks to the FDA’s announcement that companies are given temporary flexibility to import baby formulas to address the shortage. (48)
To speed up the process, the FDA is also trying to update its review process for more foreign manufacturers to ship their formula products to the US. (48)
First European Shipment Arrives In The US
The first batch of specialty infant formulas amounting to 78,000 lbs arrived in the US through the “Operation Fly Formula.” (46)
According to White House National Economic Council director Brian Deese, the Air Force cargo plane carried around 15% of specialty medical-grade baby formulas needed in the US.
This shipment included 132 pallets of Nestle Health Science Alfamino Infant and Alfamino Junior formulas. (41)
These specialty formulas were prioritized because they serve a critical medical purpose for babies with cow’s milk protein allergies.
These products originated from Zurich, Switzerland, and were brought to Ramstein Air Base, Germany. These were loaded on one C-17 cargo plane and flown to Indianapolis where a Nestle distribution center is just about a mile away. (46)
The new shipment was taken to the distribution center for standard quality control checks.
However, these specialty formulas won’t hit retail store shelves, a Biden administration official said. Instead, these will be distributed to hospitals, pharmacies, and doctor’s offices first, with priority given to worst-hit regions. (46)
This first batch can provide enough formula for about 9,000 babies and 18,000 toddlers for approximately one week, according to Agriculture Secretary Tom Vilsack. (41)
More Formula Shipments Expected To Arrive Soon
The White House added that another shipment of Gerber Good Start Extensive HA formula (114 pallets) from the Netherlands is expected to arrive within May through the second flight of Operation Fly Formula. (46)
This shipment from Ramstein Air Base in Germany is expected to land in Pennsylvania. It will be distributed by the Nestle facility in the area. (46)
The White House also announced that the first round of flights will carry formula equivalent to 1.5 million doses (eight-ounce bottles). (41)
Danone Increases US Formula Shipments
Danone SA, the makers of Aptamil, increased their baby formula shipments to the US in 2022 to help with the shortage. (49)
From January to May 2022, Danone’s Nutricia North America arm more than tripled its imports to the region. About 90% of these formulas were delivered to the US. (49)
Customs data showed that the brand shipped (through ocean freight) as many as 2.4+ million cans from January to May 2022, several times the shipment for the same period in 2021, which was just around 770,000 cans. (49)
The data is just for ocean shipments. Customs didn’t have data on air freight for Danone.
The exact product names or nature of the items weren’t specified in the customs data. However, these cargos were described as “medical nutrition products” and “clinical nutrition powder.” (49)
House Passes Bills To Help Ease Formula Shortage
Two Democrat-sponsored House bills were passed to address the formula shortage.
One grants the Department of Agriculture secretary the permanent power to issue waivers in supply disruption. This measure will allow WIC participants to buy any formula from any available supplier, instead of being limited by the WIC-approved but unavailable brand. (48)(50)
This move is significant because the WIC (Special Supplemental Nutrition Program for Women, Infants, and Children) program accounts for as high as 50% of baby formula sales in the US. (45)
The bill also requires manufacturers to create a contingency plan protecting against supply disruptions if there’s a recall to prevent a similar shortage from happening again. (50)
This bill was passed in the House with a bipartisan majority vote and was also quickly approved by the Senate. It’s now up to Biden to sign it into law. (51)
The second bill (emergency spending bill) was received with resistance from the Republican representatives but was still passed into law. Its fate in the senate remains unknown.
In this bill, the Democrats proposed a $28 million emergency spending bill to boost the FDA’s resources, including hiring more staff. (45)
The chair of the House Appropriations Committee, Democrat Rep. Rosa DeLauro, explained that this additional budget will increase the FDA’s staff so that there are more of them who can do the following: (45)
- Acquire better data on the marketplace
- Inspect domestic and international suppliers
- Prevent fraudulent products from reaching the store shelves
However, the bill was met with resistance from Republican lawmakers such as Rep. Bill Huizenga who said that boosted formula production is necessary, not more FDA staff. (45)
The chair of the Appropriations subcommittee that funds the FDA, Rep. Andy Harris, claimed that it wasn’t a money problem for the FDA but a leadership issue. (50)
So, Republican House representatives filed a counter bill, instead. They call it “Babies Need More Formula Now Act.” It aims to obtain formulas from overseas sources. (51)
Rep. Elise Stefanik, the Republican Conference Chair, blamed America’s baby formula crisis on Biden’s “failed leadership.” (51)
As many as 192 Republican lawmakers voted against the Democrats’ emergency bill, saying that “throwing millions of dollars at the problem won’t fix it.” (51)
The House’s budget measure is expected to meet stronger resistance in the Senate. Republican senators have questioned the FDA’s lack of accountability for the shortage and its possible lapses that may have led to the deaths of the two babies linked to the recalled Abbott products. (52)
FDA Commissioner Faces Congress
FDA Commissioner Dr. Robert Califf faced Congress in the baby formula shortage investigation, becoming the first administration official to do so.
In a May 2022 bipartisan hearing, lawmakers like Rep. Rosa DeLauro repeatedly asked the FDA commissioner why the agency took months to investigate the whistleblower complaint on alleged safety violations at Abbott’s plant. (53)
However, the FDA head reportedly sidestepped these by saying that he couldn’t share details of the agency’s pending investigation. (53)
He admitted that he read the complaint but didn’t specify when he did so or what steps he took to address the issue immediately.
During the hearing, Califf announced that Abbott could restart production in a week or two, but pending safety upgrades and certifications. (53)
Consolidation Made The Formula Market Vulnerable
The lawmakers and Commissioner Califf agreed that consolidation (it happens when strong market players take over smaller competitions) made the formula market vulnerable to disruptions. (53)
Before the shortage, as much as 90% of the US formula market is dominated by four players: (53)
- Abbott Nutrition (Similac)
- Reckitt Benckiser (Mead-Johnson’s Enfamil)
These major companies also dominate the WIC program’s federal contracts for low-income families, which accounts for as much as 50% of the US formula productions. (53)
So, disruptions in these companies’ supplies, including a massive recall, can greatly affect the formula supply in the market.
For example, Abbott Nutrition continually topped the spot with 40% of the market share before the massive Similac recall. It was closely followed by the long-time number two player in the US, Enfamil. (49)
Reckitt Benckiser claims that it now has 50% of the market share after Abbott’s plant closure. (49)
Enfamil production increased to 30% to meet the increased demands, the company added. (49)
Groups Call on FDA To Make Food Safety A Priority To Avoid Formula Crisis Repeat
Congressional leaders and various groups want to hold the FDA accountable for its possible lapses or any responsibilities it might have overlooked that led to babies’ deaths, the Abbott plant closure, and infant formula shortage.
Several groups also called on the FDA to restore the deputy food commissioner position, which was removed during the Trump administration. The groups believe that having one leader in this position can help unify and improve the FDA’s food program. (54)
FDA Asks For More Budget
In response to these calls, FDA Commissioner Califf asked lawmakers to increase the agency’s budget during the hearing before the House subcommittee. The proposed budget increase is from $2.1 billion (last year) to $8.4 billion, which will be used for food safety and nutrition. (52)
The huge increase also includes a $76 million increase towards the food safety funding. It will be used to improve technology to quickly trace the foodborne illness sources and upgrade other efforts to reduce toxins in food. (52)
Califf explained they need a budget increase to fund major improvements because they needed the right resources and consistent leadership. He added that it’s not because his people were bad. (53)
Abbott Needs To Comply With Court’s Consent Decree Before Production Resumes
A federal judge at the US District Court for the Western District of Michigan has signed off a 33-page agreement between Abbott Nutrition and the FDA, detailing steps the company must comply with before the plant production can resume. (55)(56)
Some of the steps in the consent decree include the following: (55)(56)
- Cleaning and sanitizing the entire facility and all equipment
- Restarting all equipment and doing test runs
- Conducting multiple tests across the production line
- Checking all the ingredients
- Hiring third-party independent expert to review the company’s processes
Abbott is also required to review and change these: (55)
- Employee training programs
- Product sampling and testing plans
- Environmental monitoring program
Under the court’s consent decree, the company is also required to immediately stop production and quickly notify the FDA of any contamination detected. (56)
Abbott CEO Apologizes, Details “Serious Steps” To Address Formula Shortage
Robert Ford, CEO of Abbott Laboratories, apologizes to the public for the company’s role in the formula shortage. It happened after the recall of Similac, Elecare, and Alimentum products back in February 2022. (57)
With Abbott having a 40% share of the US baby formula market, the recall and plant shutdown badly affected the formula supply. This worsened the formula shortage which already began in 2021. (58)
Abbott’s CEO said that they believe the voluntary recall was the right thing to do, adding that they didn’t want to risk the children’s lives and health. However, he clarified that none of the bacterial strains which caused the infection of four infants (and killed two babies) were found in their products. (57)
He explained that data collected during the investigation, including genetic sequencing of their retained product samples and the available products from the four complaints, didn’t show any connection. (57)
Still, because the FDA discovered bacteria in their plant, Ford said he wouldn’t tolerate it because that meant they fell short of his personal and the public’s high expectations of the company. (57)
Ford detailed the “serious steps” that Abbott is taking to address the baby formula shortage: (57)
- “Rigorous inspections” of their products
- Acceleration of the production processes
- Creation of a $5 million fund for children hospitalized due to the lack of specialized products
- Conversion of adult nutrition product production lines at their facility in Columbus, Ohio, to prioritize production of ready-to-feed liquid infant formulas
- Air-shipment of millions of the most widely used powdered infant formulas from in Ireland (an FDA-approved facility) to the US
Ford said that they will do the following once production started: (57)
- More than double their current production rate
- Make significant investments in their facilities to ensure this issue doesn’t happen again
- Upgrade their safety and quality equipment and processes
FDA Refutes Abbott’s Claim On Bacterial Strains
Abbott maintains that the bacterial strains from the alleged formula-related infant deaths and illnesses are different from those sampled at their facility in Sturgis, Michigan. (45)
However, FDA officials refuted this claim, explaining they were unable to collect bacterial strains from two other patients. (45)
Susan Mayne, the FDA’s food director, explained that they were unable to link the Abbott products with the babies’ cases because they only had sequences from the two babies. (45)
Still, whatever the outcome of the FDA’s investigation, the FDA explained that it will take time before Abbott can reopen their plant. So, even if they can’t be linked to the infant deaths, they can’t immediately help ease the formula shortage.
Mayne added that companies are required to retrain their staff, exhaustively clean their facility and equipment, and repeatedly conduct tests to prove there isn’t any contamination before they can reopen. (45)
Under its new import policy, the FDA will also require imported products to meet the highest safety standards by providing documentation of their factory’s inspections. (45)
Groups Claim Abbott Prioritized Shareholders While Plant Needed Repairs
Abbott reportedly enjoyed profits as high as 94% between 2019 and 2021 even when bacteria were already detected in its products in the same period. (59)
Two years before the February 2022 recall, Abbott’s net profits nearly doubled from $3.6 billion to $7.1 billion, based on Securities and Exchange Commission records. (59)
When news of the product issues hit, the company increased its shareholders’ dividends by over 25% and offered a stock buyback program worth $5 billion. (59)
This alarmed Groundwork Collaborative, a progressive economic advocacy group, whose chief economist, Rakeen Mabud, pointed out that instead of improving its facilities and making productive investments, the company chose to prioritize its shareholders. (59)
American Economic Liberties Project senior fellow Moe Tkacik accused Abbott and similar companies of using their products as “personal ATMs.” She added that the buybacks were illegal until 1982 because they were considered a form of manipulation. (59)
She also believes that restrictions should be imposed on companies receiving federal funding or those whose largest customers are federal programs like the WIC. The latter category applies to Abbott. (59)
However, Abbott denies that its buyback program hurt the products’ safety. A company spokesperson explained that the company’s “strong balance sheet” allowed them to invest in their facilities even with the stock buybacks.
Still, the situation motivated economists to call for bans on all buybacks, stricter antitrust enforcement, and putting limits on shareholder dividends. (59)
Senate To Investigate Abbott’s Safety Improvements & Buyback Program
Senator Ron Wyden of the Senate Finance Committee announced that they’re investigating Abbott’s investments in the plant’s safety improvements amid record revenues. (52)
Wyden reportedly requested Abbott for more information about their stock buyback program. (59)
Scammers Take Advantage Of The Formula Shortage
The FTC (Federal Trade Commission) warns parents against paying hefty prices for baby formulas through fraudulent online stores because scammers are taking advantage of the situation. (60)
Some of these scammers created fake websites or social media accounts mimicking recognizable formula brand logos to sell highly marked-up products. (60)
Many unsuspecting customers paid for their orders from the legitimate-looking “official” sites, but their products never arrived.
How To Avoid Scammers
Some of the FTC’s tips to avoid getting scammed: (60)
- Research about the brand, company, and product with terms like “review,” “scam,” or “complaint.”
- Don’t pay using gift cards, cryptocurrency, or money transfers.
- Know your rights, especially over shipments and refunds.
- Credit card payments are preferable because most offer buyer protection so you can process a refund if your order doesn’t arrive.
- Check local resources. Your local WIC office or pediatrician’s clinic might have available stocks.
Importing Baby Formula From Other Countries
The FDA’s specific nutritional standards differ from those followed by Canada, the European Union, and other places. This makes importation difficult because the imported formulas should still meet the FDA’s standards. (61)
The US also levies heavy tariffs (as high as 17.5%) on imported infant formula. (61)
On May 16, 2022, FDA Commissioner Robert Califf announced that they’re “loosening” restrictions on imported baby formulas to “efficiently and safely” improve the local supplies. (61)
However, the FDA’s published guidance continues to require manufacturers to meet the minimum requirements for specific nutrients, package labeling, and product safety tests. (62)
FDA Reportedly Continues To Seize European Baby Formula Amid Shortage
The FDA announced that it will streamline regulatory approvals for imported formulas. This will make it easier for popular European brands like Hipp, Holle, and Kendamil to obtain permission to sell in the US. (63)
The FDA explained that these European formulas: (63)
- Don’t meet FDA labeling requirements (including formula-preparation instructions in English, instructions on how to store the product, or specific labeling on iron content)
- Might need different temperature conditions for storage
- Require less water per scoop than US formulas
- Don’t have a system to notify US consumers of recalls
However, these formulas remain unregistered, so the FDA reportedly continues to crack down on legitimate sellers offering these products. (63)
Some parents who ordered the formulas directly from Europe had their orders seized at the border and destroyed by US customs agents. (63)
Still, parents pointed out that even if major European producers didn’t comply with FDA regulations, they’re regulated by European regulatory authorities. So, they are surely safe for babies to consume. (63)
Studies show that most of these products meet FDA-required nutrient levels, although some don’t have iron levels that meet the FDA’s minimum.
For many desperate parents, however, the European formulas can help with the formula shortage. They hope that the FDA can find another approach instead of destroying precious formulas.
As the federal agency continues to crackdown against these European formulas, many US parents hope that the FDA will try these options instead: (63)
- Coordinate with European regulatory authorities on recalls
- Provide English-language instructions (already offered by some European formula importers)
- Explain European health and safety standards
- Convert to American-size scoops
Harmful DIY Baby Formula Recipes Go Viral
Amid the shortage, harmful DIY baby formula recipes have gone viral as desperate parents seek alternatives. (64)
According to a Bloomberg report, Twitter posts about homemade baby formula increased by as much as 2,100% (around 5,000 tweets) beginning the second week of May. (64)(65)
However, the FDA advises parents or caregivers against making homemade baby formula. It could lack vital nutrients needed to support a baby’s growth.
At least one baby has been hospitalized due to mineral imbalances from consuming any homemade formula. (41)
After Bloomberg published its report, some social media platforms removed or labeled these baby formula recipes: (64)(65)
- Several YouTube and TikTok videos or posts were removed, including all the videos flagged by Bloomberg
- Under their Harmful & Dangerous policies, YouTube removed content that promotes, sells, or provides instructions for making homemade baby formula (64)
- Twitter didn’t consider these posts a breach of their misinformation policy; however, they told Bloomberg they’ll review their practices “over time.” (64)
- Facebook’s parent company Meta told Bloomberg they’re using external content reviewers to include warning labels on the posts containing baby formula misinformation (64)
AAP Lowers Age Recommendation For Cow’s Milk
Amid the formula shortage, the AAP (American Academy of Pediatrics) lowered its age recommendation for cow’s milk to six months of age. It was previously recommended only for children over one year old. (66)
A Pediatrician’s Warning
Bronson Methodist Hospital pediatrician Dr. Megan Sikkema disagrees with the lower age recommendation. She warned parents to only follow this as a last resort. (67)
She added that if you can’t really help but give your baby cow’s milk, then make sure it’s only for as short a time as possible. Once you find formula, switch back immediately.
A Pediatrician’s Recommendation
Dr. Hanna Jaworski, the division chief for Pediatrics at Spectrum Health, explained that although cow’s milk has risks (such as an increased likelihood of anemia), it can be a better option than watered-down formula. (67)
She recommends choosing cow’s milk over diluted or homemade formula but added that it should only be as a “bridge” given for a day or two until you can find your baby’s regular formula. (67)
The pediatrician also recommends keeping it at 24 oz or less, and offering your baby with their formula or another close alternative as soon as possible. (67)
She warns, however, that cow’s milk should never be given to babies with special health needs, especially those using specialty formulas for allergies.
Viral Post Mistakenly Blames Formula Shortage On Ukraine Relief
A Mississippi-based nonprofit organization is being cursed at by angry US parents on social media after mistakenly getting blamed for the formula shortage because of their Ukraine relief shipments. (68)
Kathy Cadden actually founded Operation Ukraine 22 years ago after learning of the sad plight of the orphanages in the war-torn country after the Soviet Union breakup.
When the Ukraine war began, the organization sent baby formula and has since shipped a total of around 60,000 four-ounce servings. However, they suspended collecting formula donations when the US shortage began. (68)
The group’s donations to the Ukraine relief are but a small fraction of the US formula production. However, a viral post showed screen grabs of news reports about the Ukraine relief just days before the formula shortage report. It made people hate Cadden and her group.
Even though she explained that she didn’t create the problem, Cadden still received threats from people who accused her of “killing American babies” and “working for Satan.” (68)
Infant Formula Shortage Rate Goes Up To 43%
Update: May 12, 2022
The infant formula out-of-stock rates have gone up from 30% in March 2022 (discussed below) to as high as 43% in the first week of May 2022 as formula manufacturers struggle to keep up with the demands. (69)
Last month, April, the rates soared to 50% in the following states: (69)
- South Dakota
- North Dakota
As major retailers, stores, and pharmacies across the US ran out of stocks, the Biden administration says it’s working to help ease this problem for American parents and caregivers. (69)
White House press secretary Jen Psaki said that the FDA (U.S. Food and Drug Administration) is trying to make sure infant formula is available to consumers.
Some areas, including Texas and West Virginia, have also expanded the brands for WIC (Women, Infants and Children program). (70)(71)
Abbott Nutrition Releases Some On-hold Formulas Amid Shortage
Update: May 4, 2022
Amid the baby formula shortage, the FDA reportedly requested Abbott Nutrition to release some specialty and metabolic nutrition formulas needed particularly by babies in hospitals and others with special dietary considerations. (73)
So, Abbott announced that they’re releasing some of these specialized formula products to fulfill the FDA’s request.
The metabolic nutrition formulas will be provided for free to patients. However, because stocks are limited, they’re only available on need (case-by-case basis) and in coordination with healthcare professionals. (73)
The company clarified that these nutrition and specialty formulas are available in limited quantities because they haven’t resumed production at the Sturgis facility. These products are those put on hold amid the recall.
Abbott assures customers that all these products have been tested. The items comply with all the release requirements before product distribution. (73)
The main products included in the February 2022 recall (Similac, Alimentum, and EleCare powder formulas) won’t be included in the release.
However, because only one lot of Similac PM 60/40 was affected by that, the stocks from other lots will be released again. (73)
Products for release: (73)
- Calcilo XD
- Cyclinex-1 and 2
- Glutarex-1 and 2
- Hominex-1 and 2
- I-Valex-1 and 2
- Ketonex-1 and 2
- Phenex-1 and 2
- Propimex-1 and 2
- Similac PM 60/40
- Tyrex-1 and 2
In the press release, Abbott explained that they’re still working with the FDA to address the situation and make corrective actions at the facility before production resumes. (73)
However, the company explained that it would take at least 6-8 weeks after production resumption before any of the newly produced infant formula products would be available for distribution.
Health Risks Of Infant Formulas
Studies show that premature babies fed with infant formula have a higher risk of developing NEC (necrotizing enterocolitis). It’s a serious gut disease caused by bacteria invading the intestinal walls. (73)(74)