The baby formula disaster is certainly peculiar. Apparently the FDA reported potentially dangerous manufacturing practices at Abbott's Sturgis plant as far back as September. But nobody did anything, and another FDA visit in February provoked the formula recall:
In February, the FDA warned parents not to use certain popular powdered infant formulas manufactured at Abbott's Sturgis plant after receiving four reports of infants who were hospitalized with bacterial infections after consuming formula from the facility. Two of the infants died.
Last month, however, the FDA and Centers for Disease Control and Prevention told NBC News none of the bacterial strains taken at the Abbott plant matched those collected from the infants, and the agencies haven't offered an explanation for how the contamination occured. For its part, Abbott says its formula “is not likely the source of infection,” though the FDA says its investigation continues.
Government officials’ tests of unopened formula containers at the homes of the four sick babies were all negative for cronobacter, Abbott said, and one of three open containers from the homes tested positive. The positive one contained two different strains of cronobacter: one that matched the strain that caused the infant’s infection and another matching germs found on a bottle of distilled water used to mix the formula, Abbott said.
But new formula is coming soon—depending on your definition of soon:
Abbott said it was hoping to restart the Sturgis factory in two weeks, pending approval from the Food and Drug Administration. Abbott added that baby formula would probably take six to eight weeks to reach stores. “We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas,” it said.
So was there ever any evidence that the Abbott formula had been contaminated in the factory? Was the recall actually necessary? And what has the FDA been doing for the past three months?
I'm not saying the FDA was wrong. I don't know. But I'd certainly like to have a little more information about what really happened here.
Don't forget the whistleblower complaints:
https://www.cnn.com/2022/04/28/health/baby-formula-whistleblower/index.html
I doubt they'll be able to nail down the source of this outbreak, assuming there is just one source. It did bring to light the problems at this facility, though, which made it the main suspect.
The problem with high market concentrations is that one company's, even just one plant's, issues can be devastating for the entire market segment. It also leads to regulatory capture--so the rules are not written so much to actually prevent these problems but to raise the cost of entry to keep competitors out.
I'm not sure, and the reporting sure is opaque because no one will talk on record, but it appears that this is a case of the FDA getting some unclear results from its testing, but the bureaucrats in charge as well as Abbot management not wanting to take any chances because no-one wants to be accused of letting a spoiled product poison babies, so everyone slow-walks everything as part of a massive cya operation.
I think a bigger question is why such a huge percentage of a key nutritional supplement for the nation's infants relies on a single manufacturing facility.
For the same reason why apparently half the nation’s imports go through a single port in Southern California. It’s cheaper for everyone involved… until it fails spectacularly. Redundancies in complex systems is costly.
Time to blame Wall Street and the MBA's and shareholder value. If you wring "excess costs and capacity" out of the system to return "value" to the shareholders, when something goes South cooperate ability to response is limited.
It is not just the Port of LA/Long Beach. Railroads, trucking. oil refineries, and now baby formula.
Not to mention the popular "Just In Time" theory of ordering raw matierials and component parts.
Why is this such a cata?
It’s quite possible to make it yourself. It’s not that complicated.
This is a recipe in English
https://www.westonaprice.org/health-topics/childrens-health/formula-homemade-baby-formula/
Have a nice day today
Public service announcement: Please DO NOT try to make your own baby formula at home. You could make your baby very sick. Here's why: https://www.nytimes.com/2022/05/11/well/homemade-baby-formula.html?searchResultPosition=4
Is this real or is it like Europeans don't wash eggs or how American doctors think circumcision is healthy but European doctors think they are insane? In both cases btw, Europeans are right.
I don’t believe the recipe I found contained sea moss, hemp seeds or coconut water…
Huge list of ingredients, most of which you won't find at the local super- I wouldn't know where to buy bifidobacterium infantis for example.
Does raise an interesting question though. I've got to assume baby formula did not exist through most of human history, and in many parts of the world today. How did (do) babies survive without it?
Pretty much babies died. If mom's milk wasn't enough for a baby homemade formulas would be tried but they are risky so a lot of babies died that would have lived with safe formula.
Many didn't survive. Many of those who did survive were not as healthy as they otherwise could have been.
People often used wet nurses. In the past there were plenty of poor women available who could be hired fairly cheap, or you might have a family member who was still nursing their own child and who could take on another infant who needed to be fed. Or they'd use animal milk and pap (bread and milk mix).
Here's a whole article on it! https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684040/
Or a woman might be available as a wet nurse because her own baby had died. Historically, a lot of babies didn't see their first birthdays.
Infant survival was about 50/50 though once you could prevent diarrhea dehydrating infants and killing them that was the single biggest advance.
Oh, yeah! You just know it's safe when they tell you to start with raw milk!
/s
This is a great example of a story where I presume the underlying questions have been answered and I just havent taken the time to look into it, but then it turns out, nope. Tons of stories are being written yet none of the stories contain these critical answers, or even ask present them as unanswered questions. Where are all the actual investigative journalists?
ITER tariff schedule of imported baby formula, in CH 19 -- https://hts.usitc.gov/current
Except for a handful of countries, all other imports are subject to 17.5% tariffs, and then further quota limited, above which the tariff rises to 35%.
Just saying, if Biden wanted to temporarily pause tariffs on baby formula, it could, given the national emergency with limited supplies and the USDA having to issue guidance changes to acceptable substitutes for WIC-qualified baby formula.
The FDA requires regulated products to be produced via will defined protocols. It doesn't matter if the infants died of an infection from the baby formula or from something else, if the FDA finds you are not following your own procedures and there is significant risk to the public they will declare you "out of control" and shut you down till you prove you have taken corrective action and fixed the problem.
OK, but 1) was there a finding that they were failing to follow manufacturing and QA SOPs? and 2) if so, what was the basis of a "significant risk" finding that would justify the shutdown? As far as I've seen, these questions haven't been answered.
J Frank
But the USDA has inspectors ON SITE in slaughterhouses etc
The FDA has to wait to get a complaint, an illness or death to be reported as being caused by something before they begin an investigation.. By THAT time it is too late and the cost of the recall is very expensive.
In a USDA controlled facility they test, test test and if something is unsanitary they shut the production lines down.
A baby formula manufacturing facility SHOULD have on site inspectors but the FDA does NOT operate that way
I have many years working in Pharma manufacturing.
When FDA finally showed up in the plant in February, they found conditions that clearly created risk of contamination. Water standing on the manufacturing suite floor, for example. Sloppy gowning procedures by employees. That kind of thing. So even though you can't connect the infant deaths specifically to the plant, there were plenty of problems that needed attention. FDA requires, not only that the observed problems be corrected, but that there are concrete changes to whatever management systems allowed the problems to begin with.
The bigger question for me is why FDA hasn't been willing to allow formula from the EU into the US, even on an emergency basis. I get that an EU product won't meet US labeling requirements, but hungry babies is a big deal.
The babies who died might not have been killed by contaminated baby food made at the Abbott factory. Nevertheless, it's clear that the factory wasn't following its own safety protocols and the FDA found multiple sources of potential contamination.
Imagine if several people come down with hepatitis and it's discovered that they all ate at the same restaurant. The Health Department visits the restaurant and is unable to confirm the source of the outbreak. Still, during their inspection they discover unsafe food handling practices and multiple code violations. They shut the restaurant down while the code violations are remedied and the employees retrained.
I think the situation with the Abbott factory is analogous, and the FDA decision was correct, even if they should have acted on the whistleblower report months earlier.
To err is human.
To really foul things up requires a bureaucracy.
I frankly could care less about this.
If you could care less, then why don't you.