The Formula Shortage

The ongoing infant formula shortage is history in the making. Events are still unfolding as I write this but I thought the situation merited more than the Rabbit Hole segment from last week.

Edit: I’ve decided to add to this post instead of making new ones as I get more information.

Table of Contents


Unclean Practices

On September 20th the first reports from Minnesota’s Department of Health were made about a baby hospitalized with a Cronobacter sakazakii bacterial infection after consuming formula manufactured at Abbott Nutrition’s Sturgis, Michigan factory.

While adult foodborne illnesses are difficult to trace due to the wide variety of foods consumed, babies under six months are only supposed to consume breastmilk and/or formula and with formula, usually, it’s one brand. According to Politico, Cronobacter sakazakii is known to grow in infant formula and cause rare but potentially fatal illnesses. (If you want a short but technical explanation of the bacterium, check out this post on the blog Mechanisms of Pathogenicity.)

“Cronobacter sakazakii is a rare but serious foodborne pathogen that can cause ‘severe, life-threatening infections’ including sepsis and meningitis as well as bowel damage, according to FDA.”

Helena Bottemiller Evich, “FDA learned of suspected infant formula illness four months before recall” Politico, 18 Feb 2022.

The Sturgis factory, the FDA, and the CDC were sent copies of the report on Sept 20th, but during a routine inspection that same week, the plant officials (allegedly) withheld information about the report from FDA inspectors who found sanitation issues at the factory.

Bacterial colonies of C. sakazakii on a Petri dish after a three day incubation at 25 °C on trypticase soy agar. Source: Public Health Image Library, Center for Disease Control, Dr. J.J. Farmer (1978).

Whistleblower

In October, a whistleblower alerted the FDA about the factory covering up the contamination of baby formula among other things:

“[…] 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 [withheld] information from FDA inspectors.”

Meredith Lee, “FDA says senior officials didn’t receive infant formula whistleblower report due to ‘mailroom issues’” Politico, 25 May 2022

In April of this year, Politico reported that the whistleblower said he was fired after repeatedly raising his concerns about food safety compliance. In his report he said that the fear of retaliation in the factory “was palpable”, made more so because Abbott is the biggest and best-paying employer in the area. Abbott’s spokesperson claimed that the whistleblower was a disgruntled former employee, fired for health and safety violations. (At present, OSHA is investigating his termination.)

FDA

Due to many issues which are currently being investigated, the whistleblower’s report didn’t reach FDA officials for weeks, the whistleblower wasn’t interviewed by the FDA until December and they didn’t investigate the plant until January 31st. During this time two babies of the four babies hospitalized after consuming formula made at the factory had died.

Abbott maintains that no infants were made ill by their products. However, the FDA determined that the infant formula sampled during the January 31st inspection were produced under “insanitary” conditions and were contaminated with five strains of Cronobacter sakazakii. The FDA told Abbott they needed to issue a recall, so Abbot made a “voluntary” recall of some of their products in the US and in Canada on Feb 17th.

“Abbott initiated a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare, manufactured in Sturgis, Michigan, one of the company’s manufacturing facilities. […] Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.”

similacrecall.com Feb 17th 2022

PR Spin

In an op-ed in the Washington Post, Robert Ford, the CEO of Abbot Nutrition spun this situation as though their voluntary recall was a necessary evil only to meet their high standards:

“We believe our voluntary recall was the right thing to do. We will not take risks when it comes to the health of children. The data collected during the investigation, genetic sequencing, retained product samples and available product from the four complaints did not find any connection between our products and the four reported illnesses in children. However, 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.”

Robert Ford, “Abbott CEO: We’re sorry about the formula shortage. Here’s what we’re doing to fix it” Washington Post 21 May 2022

He did apologize to the families of babies hospitalized… for lack of Abbott Nutrition’s products. No word about the whistleblower or the months-long cover-up of contamination at the factory. However, he did give some specifics on the shortages: they have shifted some of the production of their adult formula manufacturing plant in Ohio for ready-to-feed infant formula. And they have already shipped products from their FDA-approved warehouse in Ireland to the US. They expect to re-open the Sturgis plant in the first week of June, with plans to double production (higher than January) with products on shelves by July– more on that later.

Supply Chains

Abbott’s Similac brand represents 40% of the infant formula market in North America and according to the Whitehouse, is the only supplier of speciality formulas for around 5000 people in the US (infants, older children and some adults) with rare metabolic conditions. Since the pandemic, supply chains globally and nationally have had issues due to illnesses, deaths, and lockdowns. There were occasional formula shortages and purchase limits by retailers across the US last year.

“In the fall, when our baby struggled to gain weight in the first week after her birth, my husband searched unsuccessfully for Similac, at our pediatrician’s direction, at every Duane Reade, CVS, and bodega he could find within a mile; it was sold out everywhere including Amazon. And that was before the recalls.”

Jen Weiczner, “My Life Revolves Around Breastfeeding” in The Cut, 22 May 2022

These random shortages are believed to have caused parents to hoard supplies when they were available, making the current issue worse. I have my doubts here, I think the current shortage was inevitable given the market share of one company and its one (shady-ass, allegedly) factory. Though I can imagine the Costco shoppers a-top their horde of formula bins grinning like Tolkein’s Smaug these past few weeks. If you are among the fortunate well-stocked: first, check that you don’t have a bunch of recalled formula and second, maybe consider sharing some of your stash with a local food bank?

/shakily/ It was j-j-just a suggestion. Pleasedontroastme.

But seriously, it’s recommended that if you can find formula at your local store and they don’t already have a limit, to not buy more than a few days worth so that other people can get some too.

What to feed babies in the meantime?

Many parents are concerned about switching formulas: babies can be picky eaters, and they may not physically tolerate different formulations. But for healthy babies without known allergies to formula ingredients, switching brands is safe. If you have a baby under six months of age and cannot access formula, call your healthcare provider’s office as they may have samples and/or local information on where to get some, as well as recommendations for other brands for your baby’s needs. Otherwise, in the US, check out the Department of Health and Human Services website.

What is not safe is watering down formula. Why? Babies are very sensitive to electrolyte imbalances because their kidneys aren’t as efficient as adults. Extra water will cause a reduction in electrolytes leading to low blood pressure, which can result in death. ERs are already reporting on limp babies being brought in with hyponatremia and hypocalcemia because parents watered-down formula in an effort to extend supplies.

Homemade Formula

Homemade formulas can be even more dangerous–appeals to nature or tradition be damned–it doesn’t matter if it’s what you think grandma did (she probably didn’t) or if it’s keto and vegan: homemade baby formula is unsafe and can result in illness or even death.

I know it seems straightforward: feeding the baby is better than starving the baby, right? A lot of new parents have this revelation after struggling to breastfeed before switching to formula. But homemade formula isn’t a stopgap, it can be actively harmful. The wrong proportions of water to protein for the baby’s age can result in low blood pressure or diarrhoea; these products are more likely to have the kind of bacterial contamination that the Sturgis plant was shut down for (which is often benign for older children and adults but potentially fatal for babies).

We’ve learned a lot about infant development, digestion, and nutrition in the last 60 years and there are zero reputable dietetic or pediatric associations that recommend homemade baby formula. (Ah, the good ole days when babies were operated on without anaesthetic because they couldn’t feel pain, and corn syrup and evaporated milk were considered baby food. Just don’t. Please.)

When arrogance and ignorance combine: babies get hurt.

Do you remember when the CDC finally realized that masks might be a good thing for reducing the spread of an airborne respiratory virus (6 months after the rest of the freegin’ planet) but by then the situation was so dire that they encouraged cloth masks, providing instructions for making homemade masks? If homemade formula were safe, it would be recommended by reputable dietary/pediatric sources: the FDA, the AAP, or the WHO would have put out recipes and methods for the safe preparation and storage of homemade baby formula. But they haven’t and they won’t because it’s not safe. So don’t do it.

Cow Milk

Instead of homemade formula, and underscoring the dire situation faced by US parents, the AAP put out a statement saying that for healthy babies over six months of age (preferably closer to 1 year) without a dairy intolerance–parents who cannot access any formula–may use full-fat (and pasteurized ffs!) cows milk temporarily, with an iron supplement.

The Canadian Paediatric Society, meanwhile, has urged parents not to use cow’s milk for babies under 1 year despite formula supply issues because the protein in cows milk (which is modified in dairy-based infant formula) causes intestinal bleeding in children under 1 year, which can lead to anaemia (thus the AAP recommending an iron supplement).

Non-Dairy Milk

The AAP also included lactose intolerant or vegan infants in their recommendation: for babies near 1 year of age who cannot access formula can be fed calcium-fortified soy milk, not homemade, and not other non-dairy milks, especially not nut milks which lack protein and calories.

Goatmilk

A Seattle Times article noted that goatmilk is also not recommended for under 1s, despite the formula shortage, because it’s not nutritionally sound for infants. This 2016 article from Intermountain Healthcare goes into more detail. However, there are goatmilk based formulas available in other countries–as they are formulas, the goatmilk has been modified and fortified to meet an infant’s nutritional needs.

But what about breastfeeding?

This is a reasonable question. For people who can exclusively breastfeed through six months and continue to provide breastmilk for their babies through 1 year of age (or longer), that’s great. And unusual. According to CBS News, three-quarters (75%) of American babies receive some amount of formula within the first 6 months of life. Even people who want to breastfeed aren’t always successful for many reasons (medications, physical issues on either side, etc).

One big reason for low breastfeeding rates in the US is that the US is the only high-income nation without paid parental leave as Aljazeera pointed out. Even for those fortunate enough to have some paid leave through their employer, it’s usually only two weeks. That is barely enough time to recover from childbirth let alone establish breastfeeding or pumping. And while WIC will cover formula they will not cover breast pumps or all the kit that goes into bottle feeding breastmilk (if I am mistaken, please let me know. I scoured the WIC breastfeeding support website and found nothing covering costs. I would like to be wrong about this.) Once at work, few employers offer breaks for pumping or storage of the milk, and fewer still allow parents to have their baby with them for direct feeding. In The Cut article by Jen Wieczner, she goes into detail about the challenges of pumping for her daughter despite having a decent income and a work-from-home job and childcare.

And there are adoptive parents, some of whom lack the… equipment. And some folks have no interest in breastfeeding, which is okay. In nations with clean drinking water on tap (or areas of nations, eh-hem, Flint, Michigan) formula feeding is as safe as breastfeeding…. provided the baby has a steady supply of the stuff and it’s used as instructed.

Peer-to-Peer Breastmilk

Buying or getting free breastmilk off the internet is not recommended, period. There are many reasons: from not knowing the supplier’s health status (many STIs are transmitted in breastmilk), meds/drug/supplement use, diet, or lifestyle (despite what they claim or what you or they believe), to not knowing how the milk was handled from their breast to your possession. It’s anecdotal, but I have personally known women who donated their breastmilk via peer-to-peer sharing groups who felt they were doing good but did not know their own health status (had not had STI checks or even a routine physical before sharing breastmilk with strangers) and whose homes were condemnable: cat and child faeces all over their homes, a perpetual pile of dirty dishes and rotting food in their kitchens, rodent and insect infestations, including fleas and lice– pumping for donation with unwashed equipment into storage bags from boxes found under dirty laundry, then left out of refrigeration for hours or even overnight (“iT hAs GoOd BaCtErIa!”). And they looked like the perfect crunchy mamas on social media and could rattle off all the up-to-date breastmilk handling safety guidelines. Breastmilk banks carefully screen donors and pasteurize the milk for a reason, and they are the safest source of breastmilk, check out the Human Milk Banking Association of North America for more info on milk banks in the US or Canada.

Relactation

For parents who did breastfeed but chose to or were forced to stop, those advocating for re-lactation in an emergency, it’s a bit like telling starving people to just eat cake. The only answer to this crisis is more formula and fast.

Government Response

Low-Income Families

For low-income families in the US and Canada, the formula shortage has hit hardest. They are often unable to afford other brands or travel to other stores or to shop online; their babies are the first to go hungry. And then there is the issue of price gouging by unscrupulous retailers.

Price Gouging

President Biden enacted the Defense Production Act (DPA), which has provisions for punishing those who price gouge materials or goods deemed “scarce” however, infant formula wasn’t considered scarce (??). Last Friday, two federal price-gouging bills were introduced in the house. The “Price Gouging Prevention Act of 2022” is not just for infant formula as the National Law Review explains,

“The bill prohibits ‘unconscionably excessive price[s]’ at any point in a supply chain or distribution network during an ‘exceptional market shock’ triggered by a range of events – including public health emergencies. The law would apply to any good or service offered in commerce, and would authorize the Federal Trade Commission and State Attorneys General to enforce the prohibition.”

Price Gouging Prevention Act of 2022, described in National Law Review

Foodbanks

Foodbanks have been hard-hit both by the recall, forcing them to throw out tons of formula and by the growing demand for formula. If you have extra in-date and unused formula, please consider donating to your local food bank. Tangentially, while researching how foodbanks are handling this crisis I learned about the ongoing debate around whether foodbanks should be allowed to offer formula at all, which is particularly strong in the UK due to UNICEF UK’s Baby Friendly Initiative guidelines that promote breastfeeding by reducing manipulative formula marketing (i.e. the siren song of free formula samples). Check out this article in the Oxford Student for more information.

WIC

In the United States, Similac is a major partner with WIC (stands for [pregnant] women, infants, and children) a social safety net program that provides food for low-income pregnant people and young children, but unlike the wider SNAP (Supplemental Nutrition Program) beneficiaries are required to buy specific brands, styles and sizes of a product (it’s a bit of a racket IMO, allegedly.) According to the May 12th 2022 Whitehouse briefing, WIC recipients account for half of the formula used in the US and half of that is Abbott’s Similac. When the specific brand required is not available, WIC families either pay out of pocket for a different brand or they go without.

In response, the Federal government passed the bipartisan /applauds/ “Access to Baby Formula Act” to allow WIC families more flexibility in purchasing infant formula–with the caveat, that it’s only “during a public health emergency or supply chain issues such as a product recall.” Personally, I think a brand needs to earn the right to partner with WIC, to feed and shape the palates of our most vulnerable citizens. Abbott Nutrition, by trying to cover up deadly infant formula contamination, only discovered thanks to a whistleblower, should lose that privilege.

To Get More Formula

Manufacture It

While Abbott has the highest percentage of the US market, there are other manufacturers of infant formula in the US: Reckitt produces Enfamil, Nestle produces Gerber, and Perrigo which produces store brands of infant formula for Walmart, Target, Sam’s Club, Amazon, and Kroger. Together, these four companies (including Abbot) supply 90% of the US market’s infant formula. Last week, the Whitehouse enacted the Defense Production Act (DPA) in order to direct money and resources to get manufacturers to produce more formula faster. However, this may be difficult due to pandemic related shortages of the raw ingredients used to manufacture formula, according to a Global News article. Shoppers should start seeing more infant formula available in a couple weeks.

Import It

To sell infant formula in the United States a manufacturer has to be approved by the FDA which is an extremely costly and time-consuming process. This has already led to a grey market for illegally imported infant formula, especially those for premature babies. (After the issues with adulterated and contaminated infant formula in China, wealthy Chinese parents started illegally importing formula from Australia.) The current formula shortage has affected Canadians but not nearly as hard as the US because they have different import rules when it comes to infant formula.

Operation Fly Formula

With this in mind, the US government created “Operation Fly Formula”, (terrible name) importing 1.8 million 8oz bottles worth of hypoallergenic formula (lfamino Infant, Alfamino Junior, and Gerber Good Start Extensive HA) from Nestle in Switzerland– made needlessly dramatic with the use of US military equipment and personnel (because photo-ops). The imported formula will be distributed to US hospitals for babies with cow-milk allergies.

“Pics or it didn’t happen.”

Effective Regulation

In an effort to prevent this scenario from happening in the future the House passed a spending bill to provide $28 million in emergency funding for the FDA. However, it is not expected to pass in the Senate, which is republican led and opposed to strengthening federal regulators.

And finally, circling back around to Abbott’s still-shuttered Sturgis, Michigan factory at the root of this debacle: the FDA provided them with specific requirements to reopen which it is believed they will meet within two weeks, however, market analysts say their products are not expected to reach shelves for a few months after they reopen.

But have they learned anything? Or do they think they’re too big to fail?

I would like to know what can be done to build in redundancies–why is one factory and one company responsible for so much of the North American supply of infant formula? and the only supplier of formula for folks with rare metabolic disorders?


I would love to hear from you about all of this: how have you been affected? what are you seeing in your area? Please leave a comment or send me a message. If you would like to support my work, consider becoming a patron on Patreon.

Sources:

Abrams, Steven A. 9 May 2022. “Is Homemade Baby Formula Safe?” Healthy Children.

AFP Staff. 18 May 2022. “Fact Check: Pediatricians say homemade baby formula unsafe.” France 24.

Assistant Secretary for Public Affairs (ASPA). 24 May 2022. “Find Formula During the Infant Formula Shortage.” US Dept of Health and Human Services.

Bottemiller, Helena Evich. 18 Feb 2022. “FDA learned of suspected infant formula illness four months before recall.” Politico.

Bottemiller, Helena Evich. 28 April 2022. “Whistleblower warned FDA about formula plant months before baby deaths.” Politico.

Cataudella, Kimberly. 13 May 2022. “‘Please … do not make baby formula at home,’ warns Duke doctor. What to do instead.” News & Observer.

Cerullo, Megan. 10 May 2022. “The nationwide baby formula shortage is getting worse.” CBS News.

Do, Emma. 23 July 2015. “China Has a Grey Market for Australian Baby Formula.” Vice.

Ford, Robert. 21 May 2022. “Abbott CEO: We’re sorry about the formula shortage. Here’s what we’re doing to fix it.” Washington Post.

Hatch, Jessie. 15 June 2016. “Mom Talk: Should I Give My Baby Goat’s Milk?” Intermountain Healthcare.

Hobbins, Kate. 18 May 2022. “FDA implements increased flexibilities for foreign importation of infant formula.” Contemporary Pediatrics.

Kosma, Marietta. 20 Feb 2021. “How the baby formula debate is harming food banks.” Oxford Student.

Landry, Kathryn, Natalia Lorenc, and Fiona Chan Pak Choon. 3 Dec 2019. “Cronobacter Sakazakii.” Mechanisms of Pathogenicity.

Lee, Meredith. 25 May 2022. “FDA says senior officials didn’t receive infant formula whistleblower report due to ‘mailroom issues’.” Politico.

Marks, Andrea. 22 May 2022. “Influencers Are Posting Potentially Dangerous Baby Formula Recipes, Despite Safety Warnings.” Rolling Stone.

Mason, Jeff, Susan Heavey, and Trevor Hunnicutt. 18 May 2022. “Biden presses companies on infant formula, FDA eyes more imports.” Reuters.

Ondeck, Christopher E, John R Ingrassia, Timothy M Burroughs, Bryan A Cruz. 20 May 2022. “Price Gouging Updates: Federal Price Gouging Legislation; Addressing Infant Formula Shortages; Resolution of Online Merchants Guild.” National Law Review, 7(144).

Rodriguez McRobbie, Linda. 29 July 2017. “When babies felt no pain.” Boston Globe.

Russell, Nicole. 10 May 2022. “How could we possibly have a nationwide baby formula shortage crisis in America?” Star Telegram.

Similac Recalls:

https://www.similacrecall.com/ca/en/home.html https://www.similacrecall.com/us/en/home.html

Staff. 20 May 2022. “Infant Formula.” The Flip Side.

Staff. 15 May 2022. “Powdered Infant Formula Recall: What to Know.” FDA.

Staff. 12 May 2022. “FACT SHEET: President Biden Announces Additional Steps to Address Infant Formula Shortage.” Whitehouse.gov

Staff. 18 May 2022. “FACT SHEET: President Biden Announces New Actions to Address Infant Formula Shortage.” Whitehouse.gov

Staff. Updated 20 May 2022. “Cow’s Milk and Milk Alternatives.” CDC.

Szklarsk, Cassandra. 18 May 2022. “Canadian pediatricians hold firm on stance against cow’s milk despite U.S. advice.” Canadian Press 24, Bell Media.

Weiczner, Jen. 24 May 2022. “My Life Revolves Around Breastfeeding.” The Cut.

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