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Former employee blows whistle on baby formula production plant tied to outbreak

283 points by droopyEyelids 4y ago

OrvalWintermute 4y ago
There was no match between strains in the lab, dead infant #1, & dead infant #2 So, they shut down the lab for nothing, rather than merely taking corrective action. This is beyond crazy and it is not good science.
- sofixa 4y ago
  But there were 5 other strains, of acceptable 0.
  - OrvalWintermute 4y ago
    If it was the same strain as genotyped, it would have been an outbreak. Considering that bacteria is everywhere, if it was an actual outbreak it would be the same strain. Now, there should be as little contamination as possible, but the reality is that levels of sterility always vary, and it is a certain amount of contaminants in PPM or PPB.
    - LorenPechtel 4y ago
      The plant doesn't have anything that matches and no contamination of the remaining formula was found, but we do seem to have a common point of contagion. This makes me think that perhaps what's really going on is the actual problem was not contamination of the formula, but contamination of the packaging coupled with imperfect handling.
      - OrvalWintermute 4y ago
        Even if it was contamination of the packaging, it would be the same strain. What we appear to have instead is an unfortunate tragedy. While the facility may need some better procedures and a cleanup, it apparently is not a contamination issue starting at the facility, and being linked through the identical strain to the deaths.
        LorenPechtel 4y ago
        What I'm saying is that there might have been more general contamination in areas that weren't required to be clean. They might not even have searched as there's no expectation of sterility of the outside of the container. From a practical standpoint we normally do not care if our hands touch an apparently clean container and then have contact with food but that is a possible route of contamination. A clean, dry container is very unlikely to harbor a pathogen that poses a threat so we do not normally act as if it's a contaminated surface--but that doesn't mean it's impossible for it to pose a hazard.
TimPC 4y ago
Republican who opposes funding the FDA complains they can’t do their job quickly enough.
- ratsmack 4y ago
  Aside from politics, there is a great deal of bloat and complacency in all government agencies. Just funneling more money to them does not make it better. If government agencies were run like a business, half of the staff would be laid off.
  - mmastrac 4y ago
    How do you run a consumer protection agency when shareholder value is the #1 concern? Genuinely curious.
    - ratsmack 4y ago
      Most companies are not "public" and are not beholden to the overly zealous profit driven mentality. Many private companies are very efficient and would be a good model for how a government agency should be run.
  - human_person 4y ago
    Efficiency isn’t the goal of government. Serving everyone /every edge case is. A classic example is usps vs fedex. The postal service has to deliver to everyone. Not just people living in high density areas. Fedex can choose to only deliver to profitable areas or use the usps for delivering to more rural areas. Not to mention we don’t actually want the govt working at maximum efficiency. That implies that in an emergency there isn’t any slack left in the system to offer help where it is needed.
    - junofan 4y ago
      You’re describing “universal service obligation.” It’s not a feature of all government services. You can get a landline at nearly any address from a private company. Whereas if you call the police, they can use discretion on whether to provide service.
grogenaut 4y ago
This title reads like the whistleblower caused the outbreak and is different than the actual title "Former employee blows whistle on baby formula production plant tied to outbreak" which I feel is more clear. The article talks about how slow the FDA was to react to a report about issues at the plant and many issues at the plant outlined in the report.
icegreentea2 4y ago
Here's a copy of the referenced redacted complaint: https://www.marlerblog.com/files/2022/04/Redacted-Confidential-Disclosure-re-Abbott-Laboratories-10-19-2021_Redacted-1.pdf https://www.marlerblog.com/files/2022/04/Redacted-Confidenti...
shkkmo 4y ago
This title is confusingly ambiguous. Can we change it to the article heading: "Former employee blows whistle on baby formula production plant tied to outbreak"
- OrvalWintermute 4y ago
  There was no outbreak. There was a strain detected in the lab, and there are 2 dead infants. There was no match of strain type between ANY of them. No outbreak. If it was an outbreak you'd see the same strain in the lab, in the infants, and getting cultured from more sick babies. It isn't happening. Non-event.
  - uoaei 4y ago
    How do people find these gigs as shills, and how can it possibly pay high enough to spend your Saturday mornings on it?
    - OrvalWintermute 4y ago
      > How do people find these gigs as shills, and how can it possibly pay high enough to spend your Saturday mornings on it? Guidelines. https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html
mmastrac 4y ago
I think this is a key reminder of how important the American FDA, EPA and other consumer protection agencies are and how terrible it is for politicians to consider gutting or neutering them.
- petermcneeley 4y ago
  There are other ways to deal with these kinds of issues: https://www.theguardian.com/world/2009/jan/22/china-baby-milk-scandal-death-sentence#:~:text=A%20Chinese%20court%20has%20condemned,and%20made%20almost%20300%2C000%20sick https://www.theguardian.com/world/2009/jan/22/china-baby-mil....
  - jvanderbot 4y ago
    why not both?
  - hn_throwaway_99 4y ago
    Seems like very different circumstances in the Chinese case. In that case, the condemned knowingly mixed a poison with milk intended for baby formula - IMO this crosses the line from negligence to murder. But I agree, even if you don't go all the way to the point of executing offenders, making more execs personally liable when there are gross cases of neglect would be an improvement.
  - KennyBlanken 4y ago
    Meanwhile, in the US, the FDA publishes a notice that is written by the company: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant https://www.fda.gov/safety/recalls-market-withdrawals-safety... Read through and carefully notice things like: > Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. > It's important to follow the instructions for proper preparation, handling and storage of powder formulas. ...and paragraphs of text explaining how they test for this stuff and found no evidence of contamination. It's also pretty infuriating that companies get to claim their recalls are "voluntary" when they're anything but. The agency comes to them, says "recall or we will" and the company gets to save face and call it voluntary and act like they're heroes. By the time the FDA is involved, it's because the company didn't act voluntarily when it had evidence of product contamination.
rob_c 4y ago
and people wonder where conspiracy theories come from... please stop being horrible people and own up to mistakes, we all make them.
photochemsyn 4y ago
Food safety in processed foods in the USA is a major issue, and the fact is, preventing microbial contamination in the pipeline leading from raw ingredients to final product is an expensive proposition. To have any chance of catching problems before they hit the public, you really need an onsite QA lab capable of doing microbial contamination tests (and heavy metal contamination tests) at every step of the process. In-house labs are notoriously subject to corporate pressure to pass product through (consider the expense of having to toss an entire production run), and this leads to the promotion of those who don't back up production by waving red flags when product fails tests. One solution is aggressive testing and auditing by the FDA, i.e. swooping in and grabbing samples of product, but this is where political pressure to deregulate industries comes into play, and again, anyone at the FDA promoting this approach won't get promoted up the government ladder. Another solution might be legislation requiring independent accredited labs to be involved in the testing process, but again you can have massive problems here as the labs that pass questionable product are the ones who get their contracts renewed. It's probably the best option - but my advice is to just avoid highly processed foods as much as possible.
- dpierce9 4y ago
  If you need baby formula you can’t avoid baby formula. Not all mothers can or want to breast feed. Mothers are not always available when babies need to be fed. Any supply chain for secondary breast milk is going to have similar contamination and cold chain management issues.
  - ThePowerOfFuet 4y ago
    > Not all mothers can or want to breast feed. Those that don't want to should probably reconsider having kids. > Mothers are not always available when babies need to be fed. This is why pumps exist. No problem. > Any supply chain for secondary breast milk is going to have similar contamination and cold chain management issues. It's often frozen.
    - leaflets2 4y ago
      Agree, And I wonder, how does it matter if the milk is frozen? (Can't they put it in the micro? I guess I'm misunderstanding something)
Throwawayaerlei 4y ago
This essay claims to explain what's going on right now with the US baby formula shortages: https://mattstoller.substack.com/p/big-bottle-the-baby-formula-nightmare?s=r https://mattstoller.substack.com/p/big-bottle-the-baby-formu... Some things are obviously overstated or cited for propaganda value. For example with our ability to detect elements in parts per billion or less, it matters very much how much arsenic etc. is in them, I doubt it makes any sense to reduce those to 1 part per trillion or less. TL:DR: Demonstrably the existing big three, Abbott Labs and Mead Johnson produce(d) 80% of the US market share, Nestle another 18% are very weakly regulated by the FDA. The hurdles for starting up in the US market are astronomical, and there's only one contract manufacturer Perrigo Nutritionals which not surprisingly has a large minimum order size. ByHeart became the 4th brand to have its own factory, first in 15 years. Half of all formula is bought by the Federal WIC program, and states negotiate a monopoly with one firm. All of the above results in prices double that in Europe, although I'd add we and the FDA are generally much more paranoid than they are, be it thalidomide long ago or COVID vaccines in the last couple of years.
- manachar 4y ago
  > The hurdles for starting up in the US market are astronomical, and there's only one contract manufacturer Perrigo Nutritionals which not surprisingly has a large minimum order size. ByHeart became the 4th brand to have its own factory, first in 15 years. The regulatory hurdles for starting a brewery are even more intense (likely one of the most regulated of any consumable product short of marijuana), yet there's not been a shortage of new ones of those starting even during this current pandemic. I think the article leans too heavily on "heavily regulated" as a blame for lack of new players in the game and ignores the economic aspects are probably the bigger player. That division of a mature market seems fairly standard for a consumer food product. I suspect you could say much the same about peanut butter or cream cheese (both of which have had some shortages).
  - Throwawayaerlei 4y ago
    "The regulatory hurdles for starting a brewery are even more intense" What I was able to find just now says that's a qualitatively different thing, mostly pertaining to Prohibition and its end and taxes, and does not require a proctological safety exam of your supply chain, manufacturing, etc. As in, get a lawyer and jump through various hoops, as well as maybe some lower level government food safety licencing. It obviously makes a difference when you're selling something that's intrinsically poisonous to microbes by what a chemist once told me was merely the least toxic alcohol. Plus the difference in risks we're willing to have adults vs. babies take. And of course this is just one of many issues in the market, some of which I outlined, see also the subthread starting with a _Reason_ Volokh Conspiracy column and its links.
KennyBlanken 4y ago
It is amazing how despite regularly checking news.google.com, reading the NY Times periodically, listening to two daily morning news podcasts, and listening to NPR in the car, that a)I only just heard about a formula shortage yesterday and b)only now heard that there was a food pathogen at the Abbott plant, and that recall is the principal cause. The NPR story yesterday made it sound like this was just supply chain issues. Not a single fucking word about a recall or contamination incident causing a plant shutdown. I'm guessing this is the result of the finest public relations money can buy?
- unethical_ban 4y ago
  I'm wondering the same. National food shortage, has been happening for at least a week or more, and this is the first i hear that it is due to recall.
- icegreentea2 4y ago
  I'm certain there's some PR crap going on, but a shortage was building even before the recall (mid-feb). From https://datasembly.com/news/out-of-stock-rate-in-april-2022-copy/ https://datasembly.com/news/out-of-stock-rate-in-april-2022-... (referenced from https://arstechnica.com/science/2022/05/baby-formula-shortage-worsens-as-national-out-of-stock-rate-hits-43/ https://arstechnica.com/science/2022/05/baby-formula-shortag...), we can see out of stock rates were already climbing to the 20-30% range in Feburary. It really ignites in April, as the recall affects products with expiry date after April 1 2022.
  - LorenPechtel 4y ago
    It occurs to me that this might even date from last year. Their IT systems have been abysmal, last year I placed an order for one of their specialty products. They had replaced the IT system and not even ported over the account data, I had to set up a new account. Well, welcome to the modern age, on-line ordering is actually functional! However, I was limited to ordering one case. At the time I didn't think much of it, just figured it was applying some dollar limit to what a new customer could order. Earlier this year I found it was still only possible to buy one case and an error code was configured for trying to order more than one--no explanation.
deleted 4y ago
[deleted]
gzer0 4y ago
What are the legal ramifications for this? Will anyone who willfully allowed for this to happen see jailtime? Will there be massive financial repercussions? The allegations are damning. Falsification of records, lying to auditors, releasing tainted batches... the list goes on. This is criminal. Unfortunately, no one will see jailtime, lawyers will settle out of court, and Abbott will continue it's bullshit ways.
- literallyWTF 4y ago
  Only way any C-suite in america goes to jail is if their actions resulted in harm to a member of Congress or the rich. So…no. No way in hell anyone goes to jail.
  - flavius29663 4y ago
    and if they threaten to harm more than just a couple, they end up committing suicide, while on suicide watch in jail, and so it happens that the CCTV was off or the data was deleted by mistake.
lghh 4y ago
I’m so worried about this. We are having our second child in a few months. Our first was on special (ie expensive) formula due to an intolerance. There’s a good chance our second child will have the same intolerance. The only formula he could eat was the first pulled from the shelf. Breastfeeding isn’t an option for us. No idea how he’s going to eat if this is still going on (probably will be) and he has the intolerance (he probably will). Does he starve? I don’t know.
- bell-cot 4y ago
  It's probably difficult (at best) to arrange here & now...but my grandmother (in small town America, close to a century ago) served as wet nurse to a neighbor woman who was unable to feed her baby. I don't know what money or favors changed hand, but grandma was probably a touch higher in social status than the neighbor.
  - triyambakam 4y ago
    My wife pumped milk for a baby whose teen Mom had run away. The grandmother of the baby paid my wife for it, too.
  - lghh 4y ago
    While not impossible, the person we’d buy milk from would also have to abstain from the things he would be intolerant too. No impossible, but it makes it trickier.
    - bell-cot 4y ago
      Also tricky - asking your donor to be tested for diseases which can be passed via breast milk. Such as AIDS...
- yyyk 4y ago
  I can't know whether the medical situation allows this, but Human milk banks exist and provide service, e.g.: https://www.hmbana.org/ https://www.hmbana.org/
- 4y ago
thrill 4y ago
An approach is to legislate the amount of bonding required in processed foods to be significant enough that the bond seller has a proper incentive to ensure their risk-to-reward calculation is reasonably accurate by hiring their own agencies to perform adequate testing.
ekianjo 4y ago
FDA as useless as ever...
legitster 4y ago
This reminds me of every food production facility I worked at. When I flipped burgers, some people went entire shifts doing fake temperature checks. When I worked at a processing plant, people would smoke and chew right on the line. Quality control is hard. I'm fully convinced you could have a "whistleblower" on any given facility in The world. And any perfection is an invitation to complacency.
dv_dt 4y ago
While the one plant going down is a major problem, there are assessments that say we still make more than enough baby formula in the US, and that logistical issues (and regulatory capture and anti-trust issues) make the system slow to respond. https://mattstoller.substack.com/p/big-bottle-the-baby-formula-nightmare https://mattstoller.substack.com/p/big-bottle-the-baby-formu...
- LorenPechtel 4y ago
  The real problem is the specialty formulas. AFIAK they are the sole source for some types of products.
FunnyBadger 4y ago
Lendal 4y ago
> 6. Lack of Traceability This relates directly to what I do for a living. Product tracking in the manufacturing process can be very difficult & expensive, depending on how complicated the process is, but is very important and is critical to product safety & recalls. If you don't get it right babies could literally die, like what happened here. I work in the pharma/med-tech area but I'm sure this applies to food as well. They're both under FDA. Whether traceability is given the proper resources to get done right goes directly to company culture which is set at the top. The money to get it done comes from the top. You can't blame the peons, because all we can do is either blow the whistle or work for free. Those are the choices. Product tracking starts with data acquisition at the PLC/sensor level, gets stored in a database somewhere, and retrieved these days usually with a web-based interface.
georgia_peach 4y ago
First item for preventing cronobacter infections: Breastfeeding. This is one of the best things that can do for the infant's health, and benefits include preventing many kinds of infections. Reports Cronobacter infections among infants who were fed only breast milk and no formula or other foods are rare. https://en.wikipedia.org/wiki/Infant_food_safety#Infection_prevention https://en.wikipedia.org/wiki/Infant_food_safety#Infection_p... I wonder how long we will continue with this whack-a-mole debugging of systems regulating systems regulating systems before people broadly realize that evolution has already done a damn fine job--one that is awfully hard to improve upon.
- mmastrac 4y ago
  Perhaps the parental leave policies in the United States need to account for this, then? There's no social security net that will allow babies to be breastfed in the majority of all cases, so we shouldn't be surprised that parents choose formula.
  - georgia_peach 4y ago
    - mmastrac 4y ago
      - georgia_peach 4y ago
        ok_dad 4y ago
        georgia_peach 4y ago
cameldrv 4y ago
"The FDA has found five strains of cronobacter at the Sturgis facility, but none match the outbreak strain. The discovery of the five types of cronobacter does however, suggest an ongoing problem at the facility and not just a single incident." This certainly doesn't look good, but as far as we know it didn't make anyone sick. Risk calibration by the government seems significantly off when contamination that doesn't make anyone sick causes a nationwide baby formula shortage, but any number of things that could mitigate covid, which is killing hundreds of people per day, aren't being done.
modriano 4y ago
The lesson I've had to keep learning (at least over the past few years) is the value of "trust". I've been able to go into any supermarket and not have to think too much about the safety of each individual product because I've trusted a mixture of * capitalism (to leverage the profit motive to pressure companies to keep quality high enough that a competitor can't take their market share), * government (to fund centralized agencies that develop subject matter experts who act as OSS maintainers of vital public infrastructure and OSINT researchers who are authorized to explore a lot of ~~CSS~~ close sourced situations and enforce quality requirements for the American project), and * journalism (to listen for problems and sound the alarm when appropriate) to liberate myself from the need to evaluate the safety of each product. If even a small fraction of US consumers lost that trust and had to think about the safety of every product before putting it in their cart, it would shake up at least tens of billions of dollars of annual food spending (a ~$1.7 trillion per year sector), redirecting spending towards less processed foods. The added fear and decision fatigue could even cause consumers to simply end up buying less. Empirically, the capitalism mechanism works pretty well most of the time, but when it fails, ideally a government agency would be sufficiently empowered to A) accurately identify such situation and B) intervene in time to prevent harm to people or markets, but even there, there has to be some level of trust, because the cost of regulations strong enough to overcome the most skillfully engineered fraud would be paralyzing to productivity and starve consumers. In this case, the FDA was notified of the issues and audited but the facility's management was actively hostile to oversight and falsified records to conceal their dangerous failures. From here, there are two reasonable ways to proceed, and a sad and unreasonable way I fear we'll go: Reasonable way 1. Treat these deaths as negligent homicides, open very well resourced federal investigations into the situation, federally fund criminal prosecutions at whichever level is most painful (municipal or federal), pierce the corporate veil if there's even a whiff of C-level culpability, and generally make a loud and public example of the consequences for evading oversight through fraudulent means. Reasonable way 2. Significantly expand the resources available to federal agencies and rework incentive structures so that failures like this will taint involved bureaucrats (thereby impeding their career progression both within their agency and as a lobbyist). Politicians who starve agencies of resources or authority will also be held to account for the impacts of their actions in a sufficiently public way that it will stain their wikipedia page forever. Sad and unreasonable way: news coverage of this topic will focus on shortages, angry consumers, and Joe Biden's poll numbers, while coverage of the crimes at the root of the shortage go unmentioned in major reporting.
fuzzfactor 4y ago
I would ask when was this facility built? And has it always produced baby formula? "Clean-in-place" has not always been a thing, and when it arose it was kind of expected to become a more feasible approach as newer facilities were built which had the concept in mind to begin with.

283 points by droopyEyelids 4y ago

There was no match between strains in the lab, dead infant #1, & dead infant #2 So, they shut down the lab for nothing, rather than merely taking corrective action. This is beyond crazy and it is not good science.

sofixa 4y ago
But there were 5 other strains, of acceptable 0.
- OrvalWintermute 4y ago
  If it was the same strain as genotyped, it would have been an outbreak. Considering that bacteria is everywhere, if it was an actual outbreak it would be the same strain. Now, there should be as little contamination as possible, but the reality is that levels of sterility always vary, and it is a certain amount of contaminants in PPM or PPB.
  - LorenPechtel 4y ago
    The plant doesn't have anything that matches and no contamination of the remaining formula was found, but we do seem to have a common point of contagion. This makes me think that perhaps what's really going on is the actual problem was not contamination of the formula, but contamination of the packaging coupled with imperfect handling.
    - OrvalWintermute 4y ago
      Even if it was contamination of the packaging, it would be the same strain. What we appear to have instead is an unfortunate tragedy. While the facility may need some better procedures and a cleanup, it apparently is not a contamination issue starting at the facility, and being linked through the identical strain to the deaths.
      - LorenPechtel 4y ago
        What I'm saying is that there might have been more general contamination in areas that weren't required to be clean. They might not even have searched as there's no expectation of sterility of the outside of the container. From a practical standpoint we normally do not care if our hands touch an apparently clean container and then have contact with food but that is a possible route of contamination. A clean, dry container is very unlikely to harbor a pathogen that poses a threat so we do not normally act as if it's a contaminated surface--but that doesn't mean it's impossible for it to pose a hazard.

TimPC 4y ago

Republican who opposes funding the FDA complains they can’t do their job quickly enough.

ratsmack 4y ago
Aside from politics, there is a great deal of bloat and complacency in all government agencies. Just funneling more money to them does not make it better. If government agencies were run like a business, half of the staff would be laid off.
- mmastrac 4y ago
  How do you run a consumer protection agency when shareholder value is the #1 concern? Genuinely curious.
  - ratsmack 4y ago
    Most companies are not "public" and are not beholden to the overly zealous profit driven mentality. Many private companies are very efficient and would be a good model for how a government agency should be run.
- human_person 4y ago
  Efficiency isn’t the goal of government. Serving everyone /every edge case is. A classic example is usps vs fedex. The postal service has to deliver to everyone. Not just people living in high density areas. Fedex can choose to only deliver to profitable areas or use the usps for delivering to more rural areas. Not to mention we don’t actually want the govt working at maximum efficiency. That implies that in an emergency there isn’t any slack left in the system to offer help where it is needed.
  - junofan 4y ago
    You’re describing “universal service obligation.” It’s not a feature of all government services. You can get a landline at nearly any address from a private company. Whereas if you call the police, they can use discretion on whether to provide service.

grogenaut 4y ago

This title reads like the whistleblower caused the outbreak and is different than the actual title "Former employee blows whistle on baby formula production plant tied to outbreak" which I feel is more clear. The article talks about how slow the FDA was to react to a report about issues at the plant and many issues at the plant outlined in the report.

icegreentea2 4y ago

Here's a copy of the referenced redacted complaint: https://www.marlerblog.com/files/2022/04/Redacted-Confidential-Disclosure-re-Abbott-Laboratories-10-19-2021_Redacted-1.pdf https://www.marlerblog.com/files/2022/04/Redacted-Confidenti...

shkkmo 4y ago

This title is confusingly ambiguous. Can we change it to the article heading: "Former employee blows whistle on baby formula production plant tied to outbreak"

OrvalWintermute 4y ago
There was no outbreak. There was a strain detected in the lab, and there are 2 dead infants. There was no match of strain type between ANY of them. No outbreak. If it was an outbreak you'd see the same strain in the lab, in the infants, and getting cultured from more sick babies. It isn't happening. Non-event.
- uoaei 4y ago
  How do people find these gigs as shills, and how can it possibly pay high enough to spend your Saturday mornings on it?
  - OrvalWintermute 4y ago
    > How do people find these gigs as shills, and how can it possibly pay high enough to spend your Saturday mornings on it? Guidelines. https://news.ycombinator.com/newsguidelines.html https://news.ycombinator.com/newsguidelines.html

mmastrac 4y ago

I think this is a key reminder of how important the American FDA, EPA and other consumer protection agencies are and how terrible it is for politicians to consider gutting or neutering them.

petermcneeley 4y ago
There are other ways to deal with these kinds of issues: https://www.theguardian.com/world/2009/jan/22/china-baby-milk-scandal-death-sentence#:~:text=A%20Chinese%20court%20has%20condemned,and%20made%20almost%20300%2C000%20sick https://www.theguardian.com/world/2009/jan/22/china-baby-mil....
- jvanderbot 4y ago
  why not both?
- hn_throwaway_99 4y ago
  Seems like very different circumstances in the Chinese case. In that case, the condemned knowingly mixed a poison with milk intended for baby formula - IMO this crosses the line from negligence to murder. But I agree, even if you don't go all the way to the point of executing offenders, making more execs personally liable when there are gross cases of neglect would be an improvement.
- KennyBlanken 4y ago
  Meanwhile, in the US, the FDA publishes a notice that is written by the company: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-voluntarily-recalls-powder-formulas-manufactured-one-plant https://www.fda.gov/safety/recalls-market-withdrawals-safety... Read through and carefully notice things like: > Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. > It's important to follow the instructions for proper preparation, handling and storage of powder formulas. ...and paragraphs of text explaining how they test for this stuff and found no evidence of contamination. It's also pretty infuriating that companies get to claim their recalls are "voluntary" when they're anything but. The agency comes to them, says "recall or we will" and the company gets to save face and call it voluntary and act like they're heroes. By the time the FDA is involved, it's because the company didn't act voluntarily when it had evidence of product contamination.

rob_c 4y ago

and people wonder where conspiracy theories come from... please stop being horrible people and own up to mistakes, we all make them.

photochemsyn 4y ago

Food safety in processed foods in the USA is a major issue, and the fact is, preventing microbial contamination in the pipeline leading from raw ingredients to final product is an expensive proposition. To have any chance of catching problems before they hit the public, you really need an onsite QA lab capable of doing microbial contamination tests (and heavy metal contamination tests) at every step of the process. In-house labs are notoriously subject to corporate pressure to pass product through (consider the expense of having to toss an entire production run), and this leads to the promotion of those who don't back up production by waving red flags when product fails tests. One solution is aggressive testing and auditing by the FDA, i.e. swooping in and grabbing samples of product, but this is where political pressure to deregulate industries comes into play, and again, anyone at the FDA promoting this approach won't get promoted up the government ladder. Another solution might be legislation requiring independent accredited labs to be involved in the testing process, but again you can have massive problems here as the labs that pass questionable product are the ones who get their contracts renewed. It's probably the best option - but my advice is to just avoid highly processed foods as much as possible.

dpierce9 4y ago
If you need baby formula you can’t avoid baby formula. Not all mothers can or want to breast feed. Mothers are not always available when babies need to be fed. Any supply chain for secondary breast milk is going to have similar contamination and cold chain management issues.
- ThePowerOfFuet 4y ago
  > Not all mothers can or want to breast feed. Those that don't want to should probably reconsider having kids. > Mothers are not always available when babies need to be fed. This is why pumps exist. No problem. > Any supply chain for secondary breast milk is going to have similar contamination and cold chain management issues. It's often frozen.
  - leaflets2 4y ago
    Agree, And I wonder, how does it matter if the milk is frozen? (Can't they put it in the micro? I guess I'm misunderstanding something)

Throwawayaerlei 4y ago

This essay claims to explain what's going on right now with the US baby formula shortages: https://mattstoller.substack.com/p/big-bottle-the-baby-formula-nightmare?s=r https://mattstoller.substack.com/p/big-bottle-the-baby-formu... Some things are obviously overstated or cited for propaganda value. For example with our ability to detect elements in parts per billion or less, it matters very much how much arsenic etc. is in them, I doubt it makes any sense to reduce those to 1 part per trillion or less. TL:DR: Demonstrably the existing big three, Abbott Labs and Mead Johnson produce(d) 80% of the US market share, Nestle another 18% are very weakly regulated by the FDA. The hurdles for starting up in the US market are astronomical, and there's only one contract manufacturer Perrigo Nutritionals which not surprisingly has a large minimum order size. ByHeart became the 4th brand to have its own factory, first in 15 years. Half of all formula is bought by the Federal WIC program, and states negotiate a monopoly with one firm. All of the above results in prices double that in Europe, although I'd add we and the FDA are generally much more paranoid than they are, be it thalidomide long ago or COVID vaccines in the last couple of years.

manachar 4y ago
> The hurdles for starting up in the US market are astronomical, and there's only one contract manufacturer Perrigo Nutritionals which not surprisingly has a large minimum order size. ByHeart became the 4th brand to have its own factory, first in 15 years. The regulatory hurdles for starting a brewery are even more intense (likely one of the most regulated of any consumable product short of marijuana), yet there's not been a shortage of new ones of those starting even during this current pandemic. I think the article leans too heavily on "heavily regulated" as a blame for lack of new players in the game and ignores the economic aspects are probably the bigger player. That division of a mature market seems fairly standard for a consumer food product. I suspect you could say much the same about peanut butter or cream cheese (both of which have had some shortages).
- Throwawayaerlei 4y ago
  "The regulatory hurdles for starting a brewery are even more intense" What I was able to find just now says that's a qualitatively different thing, mostly pertaining to Prohibition and its end and taxes, and does not require a proctological safety exam of your supply chain, manufacturing, etc. As in, get a lawyer and jump through various hoops, as well as maybe some lower level government food safety licencing. It obviously makes a difference when you're selling something that's intrinsically poisonous to microbes by what a chemist once told me was merely the least toxic alcohol. Plus the difference in risks we're willing to have adults vs. babies take. And of course this is just one of many issues in the market, some of which I outlined, see also the subthread starting with a _Reason_ Volokh Conspiracy column and its links.

KennyBlanken 4y ago

It is amazing how despite regularly checking news.google.com, reading the NY Times periodically, listening to two daily morning news podcasts, and listening to NPR in the car, that a)I only just heard about a formula shortage yesterday and b)only now heard that there was a food pathogen at the Abbott plant, and that recall is the principal cause. The NPR story yesterday made it sound like this was just supply chain issues. Not a single fucking word about a recall or contamination incident causing a plant shutdown. I'm guessing this is the result of the finest public relations money can buy?

unethical_ban 4y ago
I'm wondering the same. National food shortage, has been happening for at least a week or more, and this is the first i hear that it is due to recall.
icegreentea2 4y ago
I'm certain there's some PR crap going on, but a shortage was building even before the recall (mid-feb). From https://datasembly.com/news/out-of-stock-rate-in-april-2022-copy/ https://datasembly.com/news/out-of-stock-rate-in-april-2022-... (referenced from https://arstechnica.com/science/2022/05/baby-formula-shortage-worsens-as-national-out-of-stock-rate-hits-43/ https://arstechnica.com/science/2022/05/baby-formula-shortag...), we can see out of stock rates were already climbing to the 20-30% range in Feburary. It really ignites in April, as the recall affects products with expiry date after April 1 2022.
- LorenPechtel 4y ago
  It occurs to me that this might even date from last year. Their IT systems have been abysmal, last year I placed an order for one of their specialty products. They had replaced the IT system and not even ported over the account data, I had to set up a new account. Well, welcome to the modern age, on-line ordering is actually functional! However, I was limited to ordering one case. At the time I didn't think much of it, just figured it was applying some dollar limit to what a new customer could order. Earlier this year I found it was still only possible to buy one case and an error code was configured for trying to order more than one--no explanation.

deleted 4y ago

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gzer0 4y ago

What are the legal ramifications for this? Will anyone who willfully allowed for this to happen see jailtime? Will there be massive financial repercussions? The allegations are damning. Falsification of records, lying to auditors, releasing tainted batches... the list goes on. This is criminal. Unfortunately, no one will see jailtime, lawyers will settle out of court, and Abbott will continue it's bullshit ways.

literallyWTF 4y ago
Only way any C-suite in america goes to jail is if their actions resulted in harm to a member of Congress or the rich. So…no. No way in hell anyone goes to jail.
- flavius29663 4y ago
  and if they threaten to harm more than just a couple, they end up committing suicide, while on suicide watch in jail, and so it happens that the CCTV was off or the data was deleted by mistake.

lghh 4y ago

I’m so worried about this. We are having our second child in a few months. Our first was on special (ie expensive) formula due to an intolerance. There’s a good chance our second child will have the same intolerance. The only formula he could eat was the first pulled from the shelf. Breastfeeding isn’t an option for us. No idea how he’s going to eat if this is still going on (probably will be) and he has the intolerance (he probably will). Does he starve? I don’t know.

bell-cot 4y ago
It's probably difficult (at best) to arrange here & now...but my grandmother (in small town America, close to a century ago) served as wet nurse to a neighbor woman who was unable to feed her baby. I don't know what money or favors changed hand, but grandma was probably a touch higher in social status than the neighbor.
- triyambakam 4y ago
  My wife pumped milk for a baby whose teen Mom had run away. The grandmother of the baby paid my wife for it, too.
- lghh 4y ago
  While not impossible, the person we’d buy milk from would also have to abstain from the things he would be intolerant too. No impossible, but it makes it trickier.
  - bell-cot 4y ago
    Also tricky - asking your donor to be tested for diseases which can be passed via breast milk. Such as AIDS...
yyyk 4y ago
I can't know whether the medical situation allows this, but Human milk banks exist and provide service, e.g.: https://www.hmbana.org/ https://www.hmbana.org/
4y ago

thrill 4y ago

An approach is to legislate the amount of bonding required in processed foods to be significant enough that the bond seller has a proper incentive to ensure their risk-to-reward calculation is reasonably accurate by hiring their own agencies to perform adequate testing.

ekianjo 4y ago

FDA as useless as ever...

legitster 4y ago

This reminds me of every food production facility I worked at. When I flipped burgers, some people went entire shifts doing fake temperature checks. When I worked at a processing plant, people would smoke and chew right on the line. Quality control is hard. I'm fully convinced you could have a "whistleblower" on any given facility in The world. And any perfection is an invitation to complacency.

dv_dt 4y ago

While the one plant going down is a major problem, there are assessments that say we still make more than enough baby formula in the US, and that logistical issues (and regulatory capture and anti-trust issues) make the system slow to respond. https://mattstoller.substack.com/p/big-bottle-the-baby-formula-nightmare https://mattstoller.substack.com/p/big-bottle-the-baby-formu...

LorenPechtel 4y ago
The real problem is the specialty formulas. AFIAK they are the sole source for some types of products.

FunnyBadger 4y ago

Lendal 4y ago

> 6. Lack of Traceability This relates directly to what I do for a living. Product tracking in the manufacturing process can be very difficult & expensive, depending on how complicated the process is, but is very important and is critical to product safety & recalls. If you don't get it right babies could literally die, like what happened here. I work in the pharma/med-tech area but I'm sure this applies to food as well. They're both under FDA. Whether traceability is given the proper resources to get done right goes directly to company culture which is set at the top. The money to get it done comes from the top. You can't blame the peons, because all we can do is either blow the whistle or work for free. Those are the choices. Product tracking starts with data acquisition at the PLC/sensor level, gets stored in a database somewhere, and retrieved these days usually with a web-based interface.

georgia_peach 4y ago

First item for preventing cronobacter infections: Breastfeeding. This is one of the best things that can do for the infant's health, and benefits include preventing many kinds of infections. Reports Cronobacter infections among infants who were fed only breast milk and no formula or other foods are rare. https://en.wikipedia.org/wiki/Infant_food_safety#Infection_prevention https://en.wikipedia.org/wiki/Infant_food_safety#Infection_p... I wonder how long we will continue with this whack-a-mole debugging of systems regulating systems regulating systems before people broadly realize that evolution has already done a damn fine job--one that is awfully hard to improve upon.

mmastrac 4y ago
Perhaps the parental leave policies in the United States need to account for this, then? There's no social security net that will allow babies to be breastfed in the majority of all cases, so we shouldn't be surprised that parents choose formula.
- georgia_peach 4y ago
  - mmastrac 4y ago
    - georgia_peach 4y ago
      - ok_dad 4y ago
        georgia_peach 4y ago

cameldrv 4y ago

"The FDA has found five strains of cronobacter at the Sturgis facility, but none match the outbreak strain. The discovery of the five types of cronobacter does however, suggest an ongoing problem at the facility and not just a single incident." This certainly doesn't look good, but as far as we know it didn't make anyone sick. Risk calibration by the government seems significantly off when contamination that doesn't make anyone sick causes a nationwide baby formula shortage, but any number of things that could mitigate covid, which is killing hundreds of people per day, aren't being done.

modriano 4y ago

The lesson I've had to keep learning (at least over the past few years) is the value of "trust". I've been able to go into any supermarket and not have to think too much about the safety of each individual product because I've trusted a mixture of * capitalism (to leverage the profit motive to pressure companies to keep quality high enough that a competitor can't take their market share), * government (to fund centralized agencies that develop subject matter experts who act as OSS maintainers of vital public infrastructure and OSINT researchers who are authorized to explore a lot of ~~CSS~~ close sourced situations and enforce quality requirements for the American project), and * journalism (to listen for problems and sound the alarm when appropriate) to liberate myself from the need to evaluate the safety of each product. If even a small fraction of US consumers lost that trust and had to think about the safety of every product before putting it in their cart, it would shake up at least tens of billions of dollars of annual food spending (a ~$1.7 trillion per year sector), redirecting spending towards less processed foods. The added fear and decision fatigue could even cause consumers to simply end up buying less. Empirically, the capitalism mechanism works pretty well most of the time, but when it fails, ideally a government agency would be sufficiently empowered to A) accurately identify such situation and B) intervene in time to prevent harm to people or markets, but even there, there has to be some level of trust, because the cost of regulations strong enough to overcome the most skillfully engineered fraud would be paralyzing to productivity and starve consumers. In this case, the FDA was notified of the issues and audited but the facility's management was actively hostile to oversight and falsified records to conceal their dangerous failures. From here, there are two reasonable ways to proceed, and a sad and unreasonable way I fear we'll go: Reasonable way 1. Treat these deaths as negligent homicides, open very well resourced federal investigations into the situation, federally fund criminal prosecutions at whichever level is most painful (municipal or federal), pierce the corporate veil if there's even a whiff of C-level culpability, and generally make a loud and public example of the consequences for evading oversight through fraudulent means. Reasonable way 2. Significantly expand the resources available to federal agencies and rework incentive structures so that failures like this will taint involved bureaucrats (thereby impeding their career progression both within their agency and as a lobbyist). Politicians who starve agencies of resources or authority will also be held to account for the impacts of their actions in a sufficiently public way that it will stain their wikipedia page forever. Sad and unreasonable way: news coverage of this topic will focus on shortages, angry consumers, and Joe Biden's poll numbers, while coverage of the crimes at the root of the shortage go unmentioned in major reporting.

fuzzfactor 4y ago

I would ask when was this facility built? And has it always produced baby formula? "Clean-in-place" has not always been a thing, and when it arose it was kind of expected to become a more feasible approach as newer facilities were built which had the concept in mind to begin with.