Baby botulism outbreak: FDA still doesn’t know cause—or how to prevent it

In the end, the three companies involved all point the finger at each other.

See full article...

 

[balthazarr]

What an embarrassment. Clearly, the answer is to further gut all these regulatory agencies. Can't have them investigating and coming up with no answers... may as well just not investigate to get no answers and save those taxpayer dollars (for slush funds and ballrooms and Arcs and other miscellaneous grifting).

/s - well, except for the grift part. Sigh.

 

[rainynight65]

In the meantime, each of the three companies is shirking blame. ByHeart released a statement this week saying “FDA has shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.”

Bill Van Ryn, an owner of Organic West Milk, previously stressed in media reports that “nothing has been proven about our milk yet.” Likewise, Dairy Farmers of America blamed Organic West, saying its processing met all required tests. “Manufacturers of end-use consumer products have a responsibility to properly process ingredients to ensure product safety,” Dairy Farmers of America said in a statement.

Conclusion: All three missed something but aren't willing to look closely at their processes, much less improve them. They'd rather point fingers. Hold all three equally responsible.

 

[SixDegrees]

Well, I mean, RFK doesn't believe bacteria cause illness, so this result is no surprise. If babies get botulism, they should just crawl it off.

 

[Eurynom0s]

My friends with a small kid are so relieved she can eat regular food now. She was super picky about baby formula, and during the big shortage a few years ago I wound up having to ship them like a year's supply of the one she'd eat from Los Angeles to Boston because they absolutely could not find any locally while I just happened to see several at local CVSs.

 

[Randomizer]

Conclusion: All three missed something but aren't willing to look closely at their processes, much less improve them. They'd rather point fingers. Hold all three equally responsible.

I can't REALLY blame them. Even the tiniest crack the facade of perfection will open them up to tremendous legal liabilities, so there is very strong incentive NOT to look hard to find mistakes, because even an internal investigation can leak. This is a huge downside of the litigious and wildly unpredictable culture in the US and the ability for courts to grant absolutely devastating fines in some cases, while not taking any meaningful action in others.

 

[kzooshoo]

It seems that the issue here is a lack of testing for pathogens at any point in the supply chain. And they obviously don’t keep file samples at the milk stages either, or the parent lots could have been tested once the contamination was found in the formula. While it may not be possible to determine the root cause (source) in this case, it is most certainly possible to implement testing and/or sample retention to help prevent future recurrences. That the FDA did not require additional testing is not right (although not surprising in the current environment).

 

[Fatesrider]

I can't REALLY blame them. Even the tiniest crack the facade of perfection will open them up to tremendous legal liabilities, so there is very strong incentive NOT to look hard to find mistakes, because even an internal investigation can leak. This is a huge downside of the litigious and wildly unpredictable culture in the US and the ability for courts to grant absolutely devastating fines in some cases, while not taking any meaningful action in others.

There's a stronger incentive not to be the one caught out by not properly fixing the problem, even if they claim it wasn't them.

Blame all of them, then, equally. Make them all clean their shit up. If one won't take responsibility they have to share it.

I imagine that will end up redefining their working relationships, but fuck 'em all for denying it. They're the ones who bear the blame collectively if one of them doesn't step up to shoulder it alone. This sounds more like a CYA kind of thing to future-proof another incident than it does anyone actually innocent being indignant. The whole point is to have a safe product. Denying their product are unsafe isn't a good enough excuse.

Prove it's safe, guys. Deliver that instead.

 

[LesMilpool____]

Good thing we got RFK Jr on the case - I’m sure the solution has to do with low sperm count

 

[graylshaped]

Conclusion: All three missed something but aren't willing to look closely at their processes, much less improve them. They'd rather point fingers. Hold all three equally responsible.

Yes.

Paraphrasing Arnold Toht: Shoot them. Shoot all three of them.

 

[Person_Man]

FWIW, my background is in canning and food processing and know a bunch about botulism. It sounds like the companies were probably doing everything they're supposed to, but the regulations need updating. Botulism spores are extremely hardy and drying alone isn't likely enough heat to inactivate them. Starting with just pasteurized milk wouldn't be good enough, but UHT milk would be. The UHT process goes well above the time/temp to inactivate the spores. Also, testing alone for spores doesn't guarantee they aren't there, it just guarantees they aren't in the test that you performed. So from my perspective, I think all the raw materials going in (If they aren't already) must go through some sort spore killing heat step and remain in a clean through packaging.
My hope is they bring in experts to look at the entire supply chain going into the formula and update requirements for each ingredient and the final mix. I'm certainly not that expert, but I know enough to see what is likely the problem.

 

[Person_Man]

It seems that the issue here is a lack of testing for pathogens at any point in the supply chain. And they obviously don’t keep file samples at the milk stages either, or the parent lots could have been tested once the contamination was found in the formula. While it may not be possible to determine the root cause (source) in this case, it is most certainly possible to implement testing and/or sample retention to help prevent future recurrences. That the FDA did not require additional testing is not right (although not surprising in the current environment).

They do test for pathogens in the supply chain, but a negative test only proves the portion tested is negative. Beyond testing, the procedures in place need to prove that the botulism spores are inactivated. Testing is only one validation. This is the part that may need to be revised. Also sample retention for all lots is standard across the industry for everything.

 

[LordEOD]

This isn't going to move any needles for the admin or MAGA world in general.

The baby was born, that's all that matters - everything else? C'est la vie

 

[wastrel]

Well, I mean, RFK doesn't believe bacteria cause illness, so this result is no surprise. If babies get botulism, they should just crawl it off.

Pretty sure his solution will have something to do with Mother's Milk (or "hire a wet nurse"). It's his female corollary to sperm count for males.

 

[FSTargetDrone]

What an embarrassment. Clearly, the answer is to further gut all these regulatory agencies. Can't have them investigating and coming up with no answers... may as well just not investigate to get no answers and save those taxpayer dollars (for slush funds and ballrooms and Arcs and other miscellaneous grifting).

/s - well, except for the grift part. Sigh.

Embarrassment is for teenagers. This is criminal as far as I’m concerned.

 

[graylshaped]

FWIW, my background is in canning and food processing and know a bunch about botulism. It sounds like the companies were probably doing everything they're supposed to, but the regulations need updating. Botulism spores are extremely hardy and drying alone isn't likely enough heat to inactivate them. Starting with just pasteurized milk wouldn't be good enough, but UHT milk would be. The UHT process goes well above the time/temp to inactivate the spores. Also, testing alone for spores doesn't guarantee they aren't there, it just guarantees they aren't in the test that you performed. So from my perspective, I think all the raw materials going in (If they aren't already) must go through some sort spore killing heat step and remain in a clean through packaging.
My hope is they bring in experts to look at the entire supply chain going into the formula and update requirements for each ingredient and the final mix. I'm certainly not that expert, but I know enough to see what is likely the problem.

Prior articles laid out the companies hiding behind testing for botulism not being a required test--so they hadn't done any.

 

[Mechjaz]

FWIW, my background is in canning and food processing and know a bunch about botulism. It sounds like the companies were probably doing everything they're supposed to, but the regulations need updating. Botulism spores are extremely hardy and drying alone isn't likely enough heat to inactivate them. Starting with just pasteurized milk wouldn't be good enough, but UHT milk would be. The UHT process goes well above the time/temp to inactivate the spores. Also, testing alone for spores doesn't guarantee they aren't there, it just guarantees they aren't in the test that you performed. So from my perspective, I think all the raw materials going in (If they aren't already) must go through some sort spore killing heat step and remain in a clean through packaging.
My hope is they bring in experts to look at the entire supply chain going into the formula and update requirements for each ingredient and the final mix. I'm certainly not that expert, but I know enough to see what is likely the problem.

I think expertise has been "outlawed" by executive order. And even if it hasn't, the current administration has no qualms about illegally abdicating any responsibilities or duties and telling the parents of sick or dying kids they should have been stronger babies, better parents, or that that should really just get over it.

 

[rwxatc]

[insert agency name here] still doesn’t know cause—or how to prevent it​

This will be an increasingly frequent theme in all government agencies.

 

[rwxatc]

I think expertise has been "outlawed" by executive order. And even if it hasn't, the current administration has no qualms about illegally abdicating any responsibilities or duties and telling the parents of sick or dying kids they should have been stronger babies, better parents, or that that should really just get over it.

when greed and sociopathy meet eugenics, things like this happen.

 

[Wandering Monk]

Conclusion: All three missed something but aren't willing to look closely at their processes, much less improve them. They'd rather point fingers. Hold all three equally responsible.

If it really was introduced in the last step of the process, then there really isn’t anything that the milk provider did wrong or could do to prevent it.

I think the lawyer has the right idea: go after ByHeart. The buck stops there. If they believe that their supplier provided milk contaminated with botulism, then ByHeart can go after their supplier to recoup some of their losses, but it doesn’t let ByHeart off the hook.

 

[Person_Man]

If it really was introduced in the last step of the process, then there really isn’t anything that the milk provider did wrong or could do to prevent it.

I think the lawyer has the right idea: go after ByHeart. The buck stops there. If they believe that their supplier provided milk contaminated with botulism, then ByHeart can go after their supplier to recoup some of their losses, but it doesn’t let ByHeart off the hook.

This is the way it works. The company I work for won't buy from suppliers that don't have a certain amount of insurance to cover catastrophic things like this that everyone hopes never happens (There are numerous other requirements they must meet as well). If something like this were to happen to us, we'd get sued even if we can conclusively prove it was further up the supply chain. Then we go after whatever supplier is responsible - the insurance makes sure they can cover whatever it is. After the dust settles, the supplier responsible better have a comprehensive corrective action if they even still exist.

 

[Person_Man]

Prior articles laid out the companies hiding behind testing for botulism not being a required test--so they hadn't done any.

Typically botulism spore testing isn't needed because adult digestive systems aren't a suitable environment to grow and produce toxin. Infants on the other hand are, so any food going to infants should require botulism testing.
This may be something where ingredient suppliers that aren't testing for botulism specify their product is not for infants or something along those lines.

 

[Mechjaz]

This is the way it works. The company I work for won't buy from suppliers that don't have a certain amount of insurance to cover catastrophic things like this that everyone hopes never happens (There are numerous other requirements they must meet as well). If something like this were to happen to us, we'd get sued even if we can conclusively prove it was further up the supply chain. Then we go after whatever supplier is responsible - the insurance makes sure they can cover whatever it is. After the dust settles, the supplier responsible better have a comprehensive corrective action if they even still exist.

I was cynical in my last response but I should have taken a moment to thank you for bringing your knowledge to bear on this matter. People like you sharing their expertise and insight are a huge component of Ars' draw for me.

 

[Dean C. Rowan]

FWIW, this isn't the first time FDA has corresponded with ByHeart. In August 2023 the agency sent a "warning letter" to the company following an inspection. The letter reports, "During our inspection at the (b)(4) facility, FDA investigators found significant violations of Title 21, Code of Federal Regulations, Part 106 (21 C.F.R. Part 106), Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications ('the Infant Formula Rule')." It goes on to chide ByHeart for failing to "establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment, as required by 21 C.F.R. § 106.55(a)." Botulism was not the adulterating pathogen at the time; the formula tested positive for Cronobacter sakazakii.

 

[TimeToTilt]

FWIW, my background is in canning and food processing and know a bunch about botulism. It sounds like the companies were probably doing everything they're supposed to, but the regulations need updating. Botulism spores are extremely hardy and drying alone isn't likely enough heat to inactivate them. Starting with just pasteurized milk wouldn't be good enough, but UHT milk would be. The UHT process goes well above the time/temp to inactivate the spores. Also, testing alone for spores doesn't guarantee they aren't there, it just guarantees they aren't in the test that you performed. So from my perspective, I think all the raw materials going in (If they aren't already) must go through some sort spore killing heat step and remain in a clean through packaging.
My hope is they bring in experts to look at the entire supply chain going into the formula and update requirements for each ingredient and the final mix. I'm certainly not that expert, but I know enough to see what is likely the problem.

Also I don't think most people realize how toxic botulism is. Like the lethal dose is so low that failing to detect it in a sample from a large vat of something wouldn't really mean much I don't think.

 

[RZetopan]

Well, I mean, RFK doesn't believe bacteria cause illness, so this result is no surprise. If babies get botulism, they should just crawl it off.

They obviously need to be fed roadkill and bathed in sewer water to boost their immune system. Maybe exposure to the measles or the polio virus will help. /S

 

[+Griz]

I'm not sure I like the word "devastating" in "the devastating outbreak of botulism in babies" in that as far as I can see no babies died - and as I understand it botulism doesn't typically have major damaging sequelae for survivors (and none seem to be mentioned in the links I have seen).

the cost of having your baby in NICU on a respirator for weeks is absolutely devastating

 

[gefitz]

They obviously need to be fed roadkill and bathed in sewer water to boost their immune system. Maybe exposure to the measles or the polio virus will help. /S

Why the "/s" ????

 

[schalli110]

[insert agency name here] still doesn’t know cause—or how to prevent it​

This will be an increasingly frequent theme in all government agencies.

I disagree.
Soon there just won't be any agencies left at all..

 

[sir1963nz]

Cure
Have they tried:
Thoughts and Prayers / Exorcisms
Bleach
UV rectal thermometers
Blaming LGBTQ+ / Drag Queens
Blaming immigrants
Just seeing which live and claim the others were woke.

 

[sir1963nz]

the cost of having your baby in NICU on a respirator for weeks is absolutely devastating

Free in civilised countries.

 

[balthazarr]

I'm not sure I like the word "devastating" in "the devastating outbreak of botulism in babies" in that as far as I can see no babies died - and as I understand it botulism doesn't typically have major damaging sequelae for survivors (and none seem to be mentioned in the links I have seen).

That's not intended to be an argument for carelessness with infant formula - just an argument for precision with words.

WTF is wrong with you? Serious question.

The babies didn't die, and probably, maybe, won't have long term effects, so everything is a-okay?

Apart from the devastating costs - this is the USA after all - there's the devastating psychological impact of, oh, I don't know, nearly having your baby die from its food.

JFC.

 

[chateauarusi]

I came down to make sarcastic references to the babies clearly being deficient in crossfit exercise and raw beef, but I see I've been beaten to the punchline many times over. Gotta be quick with this crowd.

(Also, how bleak are things that morbid humor is a common coping mechanism to deal with the malicious incompetence of American leadership.)

 

[Zeppos]

What an embarrassment. Clearly, the answer is to further gut all these regulatory agencies. Can't have them investigating and coming up with no answers... may as well just not investigate to get no answers and save those taxpayer dollars (for slush funds and ballrooms and Arcs and other miscellaneous grifting).

/s - well, except for the grift part. Sigh.

Indeed. These companies are spending all effort to cover ... to find the issue and tackle it ASAP. FDA is just slowing them down with paperwork! Shit happens, give those poor companies some slack!

Maga rationalisations... It is an art.

 

[balthazarr]

Indeed. These companies are spending all effort to cover ... to find the issue and tackle it ASAP. FDA is just slowing them down with paperwork! Shit happens, give those poor companies some slack!

Maga rationalisations... It is an art.

Won't someone please think of the children corporations?

 

[bebu]

"—or how to prevent it"​

Easy. Do what large number of PRC parents who preferred their offspring to consume as little melamine as possible – yep looks like you have arrived at the same dismal point just from the other side — buy your formula from nations who take care not to poison or otherwise harm their most valuable asset viz their children.

The quantity of formula purchased by PRC parents from AU and NZ manufacturers was prodigious. Definitely on every pre-covid PRC tourist's shopping list.

Your kids, your their funeral. Unfortunately.

 

[bebu]

Pretty sure his solution will have something to do with Mother's Milk (or "hire a wet nurse"). It's his female corollary to sperm count for males.

"Breast is best" is still best practice but biology and modern life usually mean that substitution or augmentation with formula is necessary — wet nurses not being in great abundance in developed nations but I suppose the administration is working on that.

 

[billev2k]

the cost of having your baby in NICU on a respirator for weeks is absolutely devastating

Yes. But isn’t that a consequence of our “health care” system, more than of botulism per se?

 

[courtneych]

Cure
Have they tried:
Thoughts and Prayers / Exorcisms
Bleach
UV rectal thermometers
Blaming LGBTQ+ / Drag Queens
Blaming immigrants
Just seeing which live and claim the others were woke.

You left out ivermectin.