Who is the Person in Charge of Making Sure Infant Formula is Safe?

No one. And that's just one of many structural problems that ensures another Cronobacter outbreak will happen.

It was announced last week that Abbott is now under criminal investigation by the Department of Justice for the deaths of two infants and serious illness of four others (that we know about) after last year’s Cronobacter outbreak. 

Before we continue, the phrase “serious illness” that the media uses in reports about this (preventable)  tragedy is a whitewash. Here’s what serious illness means: a NICU baby who had to have 75 percent of the left side of his brain removed because of a bacterial infection, a baby girl who is now blind, deaf, and epileptic and so on. 

The news of a criminal investigation is some good news but ultimately won’t fix overall systemic problems. And they are as follows. 

What’s the name of the person in charge of making sure infant formula is safe?

No one.

There is not one clearly identified person who leads the Human Foods Program, the D division in charge of safeguarding infant formula at the FDA. According to an expert panel report, the lack of one person in charge has led to “overlapping roles and competing priorities that result in what is perceived as constant turmoil.” 

Neat.

I don’t know if you’ve ever worked somewhere where responsibility is ill defined and there’s little motivation for any one to step up or speak out about things that are going amiss. It’s demoralizing, messy, and everyone is typically worse off for it. Ok, so take that dynamic, multiply it by a factor of 1,000 and put it smack dab in the middle of the department responsible for babies not getting poisoned by a $43 billion dollar pharmaceutical company. 

This lack of leadership is also cited as a big part of the reason why the FDA was so slow to respond to the crisis in the first place.

Why does FDA take the same approach to a freshman year group project as they do safeguarding infant formula? 

Just last month, ByHeart, the organic baby formula that Chrissy Teigan has been shilling for, recently found Cronobacter in five of its lots. The company did its own voluntary recall. And if it hadn’t? Who is to blame? Where does the proverbial potentially-fatal-to-infants buck stop?

So to date, there is no single person in charge of making sure this sort of thing happens again. Which means, this sort of thing is bound to happen again. 

Babies are going to die or, if they’re lucky, have a portion of their brain removed. 

Cronobacter Sakazaii is NOT on the CDC National Alert List (!?!)

Ok, let’s say the FDA gets a formula Czar, the employees start cooperating across their silos, they’re are motivated to think critically and act proactively. Terrific, but if there’s another Cronobacter outbreak, your local public health department probably wouldn’t know about it. 

When there is a case of botulism, measles, listeria, congenital syphilis, toxic shock syndrome the CDC puts out a notification to all public health departments who then turn around and inform local health officials and practitioners. 

Cronobacter is not on that list, despite the fact that a Cronobacter infection in an infant almost always comes from tainted formula and that a swift response is necessary if you want to prevent more death and injuries to babies. The formula crisis of 2022 could have been averted if this sort of alert went out when babies started to get sick in the fall of 2021. This isn’t speculation on our humble Substack newsletter’s part, according to recent top notch reporting in POLITICO: “Top health officials have acknowledged that their investigation into the Sturgis incident was hampered by the fact that Cronobacter infections are not a nationally notifiable disease, which means such cases are not required to be reported up the chain to the Centers for Disease Control and Prevention.”

Are you mad? You can sign this petition demanding that a Cronobacter be added to the list of Notifiable diseases. I don’t know if it will do anything but I sure as hell signed it. 

Why doesn’t the FDA hold infant formula to the same standard as canned fucking corn!?

Here’s three things to know about Cronobacter:

• It’s a common bacteria that factory workers can bring in on their shoes, hands, and clothes. For most people who inadvertently ingest the bacteria it doesn’t pose any problem but for babies it can be lethal. 

• Cronobacter likes to hide in small pockets of powder. When factories test their product they test 300 grams, that’s less than a pound, off a 40,000- 50,000 pound lot. So a negative reading doesn’t mean the whole lot is safe, just that small clump is clear. 

• Cronobacter is named after the Greek god Cronus, who devoured his own children after they were born. I point this out because infant death is in the fucking name. 

Here’s what’s baffling, the FDA already has a playbook on how to approach another rare but lethal bacteria in food: botulism. 

The federal regulations for manufacturing canned foods are very strict, requiring a kill step, such as high-heat, to ensure there’s no bacteria in the food before it’s canned. With powdered infant formula, there is no kill step required.

If there is always a threat of Cronobacter lurking in powdered infant formula, why isn’t there a kill step? If Elon Musk can figure out how to pull on his own pud while orbiting the stratosphere how is it possible that we can’t figure out how to sterilize powder or, better yet, not sell it all? Why not just sell sterilized liquid formula?

Maybe the fact that the largest purchaser of powdered infant formula is…the federal government, accounting for $1.5 billion in sales! Which brings us to the most depressing part of this story.

“I never made enough milk”

If you can stomach the details (and photos) of baby Ryker’s story, I encourage you to read it. The most devastating aspect for me was the reason why Ryker’s mom, Kelly, ended up using formula. 

Kelly had lost two other pregnancies to placental abruption. Her baby Ryker was delivered at 35 weeks via c-section to avoid similiar complications. He was born 5 pounds with a high AGPAR score of 9 out of 10, he spent one week in the NICU and was discharged. Kelly said he was “good as gold.” 

Kelly attempted to breastfeed but, as she says, “I never made enough milk.” So doctors prescribed her Similac Neosure, a powdered formula made specifically for premature infants. Kelly was given vouchers for the formula from the WIC program, a government subsidy program for needy mothers and children. 

When Ryker started vomiting and strange bruise appeared on his body, Kelly booked it to the ER.

From POLITICO:

While Ryker was in the hospital being treated for his infection, Knight said, doctors had mentioned that moms of very young infants “probably want to go with liquid versus powder formula” because liquid formula is sterile.

“I’d never in my life heard that,” Knight said. “If I’d known that, none of [my kids] would have been on powdered formula at all.”

Everything about Ryker’s infection could have been avoided. Had his mother had support to breastfeed or use donor milk, had the doctors who operated on her bothered to mention using sterile formula, that Kelly’s WIC vouchers only covered powdered formula, meanwhile government officials don’t bother putting a lethal pathogen on their alert list, and formula companies make billions off a system that no one seems in any rush to fix. 

We have known that Cronobacter hides in powdered formula ever since the first case of neonatal meningitis linked to tainted formula in 1953.  Formula companies still cannot produce a powder product that is free of bacterial contamination from this lethal pathogen.

Why even produce powdered formula if it can kill a single baby?

Two babies died last year because from tainted formula.  How many more deaths does there need to be before the cost benefit analysis washes out? How bottomless is the devouring god of marketplace?