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


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.


If you make the punishment for passing hazardous product high enough you could make a dent. Send the C-suite to jail if they cut enough corners that infants die -- you'll probably see a lot of improvements very quickly. Money fines won't be enough and are a complete waste of time and human life.

It still won't be perfect, but we can't let the perfect be the enemy of the good.


China executed people for this years ago and I think public trust in the product has yet to recover


I've read elsewhere in expat forums that PRC citizen parents with infants visiting the US will load up big parts of their luggage allowance on the return trip with formula. Costco is their favorite store to use. They similarly trust the US-branded formula sold from Costco in the PRC. The general supply chain QA and integrity US citizens take for granted domestically cannot be overstated as an important differentiator until you've traveled extensively around the world. US and EU supply chain integrity problems are nothing compared to many parts of the world.


Probably because it’s like playing whack a mole, executing a few scapegoats isn’t going to fix the lack of regulatory oversight


he didn’t say execute them prison time is a much more effective incentive for cases resulting in death


There's that bumper sticker: "I'll believe corporations are people when Texas executes one".

I mean, I know that the lawyers and finance people would create such convoluted ownership structures that forcing a company out of existence and liquidating its assets would be meaningless, but apart from that detail, it has a certain appeal in the way many ideas that fit on a bumper sticker do.


It's very rare for a corporate executive to even be charged let alone be convicted.


Which is why corporations get away with murdering, poisoning, and polluting. Lack of accountability combined with the incentive of obscene profits pretty much makes it impossible for anything to change. Throw in outright bribery and regulatory capture and it doesn't look like anything will improve any time soon. I doubt I'll see it happening in my lifetime, and it's sad that not even the ongoing poisoning of babies for profit is enough to force the needed changes.

I'll give congress some credit for being vocal about the problem at least. In a congressional report last year about the dangerous levels of heavy metals in baby foods they repeatedly concluded that the FDA's polices were "designed to be protective of baby food manufacturers" and they recommended more regulation, but still, I haven't seen any action that would address the underlying issues that allow a regulatory body to prioritize the profits of industry over the health and safety of the population.

If you're curious, that report can be read here:

There was also a follow up report on the issue you can read here:


You often don't get to be a c-executive without having a major appetite for risk-taking.

Short of shooting both the c-suite, and their families, I don't think this will align their interests with those of the public as well as you hope.


You would be surprised at how many people are on board with that level of punishment in the USA.


you'll probably see a lot of improvements very quickly

More likely: people stop making baby formula entirely and women have no choice but to breastfeed, which is a problem if baby is lactose intolerant, among other things.


Even if we buy your premise that actually putting teeth behind food safety regulations would cause a capital strike, that just provides opportunity for others to step in and fill the gap. Like your post alludes to there is a large and stable demand for safe formula. The problem is right now one company owns a majority of the market share thanks to the poor way the existing govt reimbursement program is structured


Lactose-intolerant to mother’s breast milk? Had to look up, apparently it is a thing. Thank you mother nature…


someone says that after every scandal, and I’m open to it morally, but from an “actually improving compliance” standpoint: Is there any evidence it’s true?


I'm not sure we've tried it or anything like it in the US. Intrinsic in this idea is the requirement that we actually enforce the rules, so when folks dismiss it as ineffective because it won't be enforced, I think they're missing the point.

I'd bet on improvement if we enforced the law and actually sent people to jail.


It’s a nice idea but nah.

In pharmaceuticals, a executive needs to sign off, under penalties of imprisonment, if prices reported to the US government are incorrect.

Fraud still happens and nobody goes to jail because hell , people don’t jail for more severe crimes so no court would impose the punishment.


The largest fine in history was levied on pfizer. They paid a "criminal" fine. Nobody went to jail.

Today pfizer is one of the most trusted companies and many people will be mad at you if you criticize pfizer in any way.


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.

Here's a suggestion: companies are allowed to use in-house testing, but as soon as defective/substandard products are found in the market, the company loses its in-house testing license and must have its products validated by external agencies. Only after X number of years/batches/volume of fault-free product can a company request to reinstate its in-house testing license.

And those external agencies may charge whatever they want, of course. And if a competitor finds a fault in an agency's testing procedures, they win said agency's existing contracts.

That model creates all the adversarial business relations that small-government aficionados seem to salivate over, I think.


uh no. I'm a food engineer for one of the largest manufacturers in America and there isn't any pressure from corporate to just pass lines that might be dangerous.

the problem is in testing and just how statistically unfeasible it is. case in point, we had a line that passed every QA test but we would still get back 1 product every now and then from a customer with spoilage. we'd test thousands of samples each year and they're all fine but still something was the problem. on top of that, we had "nearly identical" lines that never had any problem.

luckily we found the problem in the line and how to push the failures alway the way down to zero for little cost instead of corporate wanting to pay $10 million to fix it.

so no, corporate isn't some boogy man.


SRE folks really should be speaking with engineers like you.

I'd love to spend a few months crawling in and around the QA problems your industry faces in production, and how your industry tackles it. There are many echoes of only-happens-at-scale and statistical quality control that software folks think are the first time anyone has ever solved, but are really process engineering problems old hands in industries like yours have long since codified into practices.

This is part of the reason I like going on factory tours and see "How It's Made". The US lost a hell of a lot more than the ability to make goods when we shipped off our manufacturing infrastructure. We lost the capacity to cross-fertilize between industries and create compounding innovation effects.

If you can share as many interesting stories of production line QA as hits your whimsy in as much detail as you care to share, it would be greatly appreciated.


This assumes you even try. The US allows for relatively large amount of some heavy metals in baby formula and as a result parents have to be especially careful about certain brands with high heavy metal content.


I finished the formula years recently. I had never heard of this. I'm assuming I fed my kids some heavy metal. Do you have a source for this?


I tried to find my source but I’m no longer able to successfully google it. I do remember the worst offenders were big box chain fake-organic brands like “Earth’s Best”.


Making babies listen to heavy metal, on the other hand...



Got me through the late nights with two kids


What should be done is change laws around class action lawsuits so lawyers representing the public are incentivized to get higher payouts instead of settling early and taking a huge cut. That would solve a lot more problems without requiring an expanded role for a regulatory agency that is subject to regulatory capture.


While I'm not opposed to changes to laws surrounding class action lawsuits, it seems inadvisable for a society's plan A to require waiting for babies to get poisoned or starve to death before it can take action.

Of course you could argue that the threat of meaningful class action is a check against it happening in the first place, but profits from illegal activities are quarterly and the punishment will be a decade away. If anything is consistent in the US, its that we can't rely on enough executives to act morally or with long-term interests in mind when their compensation hinges on them not doing so.


A big problem is that many of the big class actions are on shaky ground and it’s actually advantageous to settle rather than go through the motions and lose. After all, the company is offering you $100M not because they’re wrong, but just to get you to go away. Why not take it rather than risk losing it all?

Not all class actions are like that, but a lot are.


The United States desperately needs loser pays[1] to make it worthwhile to fight frivolous lawsuits, particularly class actions.



In civil suits US courts really, really want you to settle early.


Note that the strains found at the plant do not match anything that was found infecting babies. The probable consumer injury here is zero.


Yeah; there should be a floor on settlements of statutory fines + 1.5x damages being paid out to each member of the class, with money set asside assuming 100% claim rate.

Excess money would go to a relevant non-profit of a judge's choosing.


In most class action lawsuits, the actual damages are a total guess and almost impossible to quantify in any legally consistent manner. Pick a number.


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.


I'm no expert on infant nutrition but why wouldn't cow milk and/or goat milk be an acceptable substitute? They're both safe for humans to consume, they're widely available at fairly low cost. They provide enough nutrition to get large animals growing.

It may not be scientifically 100% "perfect" but why wouldn't it be "close enough"?


Goat's milk was the historical alternative, since it's a close match. We don't have a lot of goats, nor a lot milking of them. But my wife's grandfather was in fact fed on goat's milk when he was young.

Cow's milk is absolutely inappropriate [1]: it has way too much protein for babies and the wrong nutritional profile - even when they start being able to drink it you have to be careful about how much since they're not great at digesting it yet. It's missing all sorts of things - i.e. not enough iron.



Look up history of alternatives to breastfeeding. Cow/goat milk has been used as portion of various recipes, and I think cow milk is one of usual inputs in formula making, but it's not enough on its own and could get contaminated etc.

Not to mention other mammals have different micro and macro element needs than humans.

But formula is effectively a safer and more filling endpoint of improvements that started with animal milk and some other foods.


> 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.


Those are pretty naive and shortsighted views. Some women simply can’t breastfeed, and don’t discover that until the baby is born. Milk doesn’t always come in, feeding can be painful, etc.

Some babies are orphans. You gonna pump a corpse? Or force the child on some other new mother?


"> Not all mothers can or want to breast feed.

Those that don't want to should probably reconsider having kids."

How well does that work for their first baby if it's some unanticipated problem the mother has??

Modern civilization starting with agriculture is also a repudiation of the "survival of the fittest" philosophy you're pushing.


> Those that don't want to should probably reconsider having kids.

Buddy I got some news for you r.e. the availability of that option


You realize not all women *can* breastfeed? And they don't always know it when they decide to have a kid.

And some babies need the special formulas. And some non-babies need the special formulas.


When I say mothers are not always available that was a polite way of saying mothers sometimes die during childbirth. A gross number in America but childbirth is dangerous even in the best circumstances. It is a leading cause of death among young women in the US.



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)


I never understand how people in large companies would be motivated do anything immoral or against the law. If you are an individual entrepreneur and stand to gain something from it, sure. But if you are just a cog in the machine, you just work strictly to contract and regulation, and don't go out of your way to do something illegal just to help the company. That would not just be against my self interest, but in fact against my whole professional ethos.

It is really surprizing that stakeholders manage to create that kind of pressure in corporations. Maybe what is needed are much stonger labour laws, so that if you actually stand up to your boss, they cannot just fire you the next day.


In large companies it's much easier.

As an individual entrepreneur, you're the sole decision maker and responsible for everything.

In a large company, you can always blame someone else, your boss, your employee, the HR guidelines, the unclear safety guidelines, the shareholders, boss implied you should ignore the law, ... there's often conflicting formal (e.g. "compliance training") and informal (e.g. promotion/commission) incentives as well.


If you are just a cog in the machine, it's more likely that you need to protect the status quo in order to insure your own daily employment.

Since you would be subject to much more distress upon loss of your job than those higher up the food chain.


I generally agree, but there have also been many incidents of bacterial contamination from unprocessed foods like lettuce.


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.


Yeah when it works as intended sure, but as far as I'm concerned, the FDA is another incompetent government organization motivated by playing politics. FWIW I do NOT want them gutted or neutered financially, but there's obviously some serious flaws in how they do things and I think that starts with holding people at the top of the organization accountable.


How Bad Government Policy is Fueling the Infant Formula Shortage


Not only is this pretty thin and not really recognizing the main issues aren’t government-created, it’s a libertarian rag trying to blame the government when private industry on their own puts out contaminated formula. If this isn’t exactly the kind of problem that shows why a pure libertarian position can go wrong, I don’t know what is.


> not really recognizing the main issues aren't government-created

Quote from the article:

"Bad U.S. policy surely didn't cause the infant formula crisis, but it just as surely made the situation worse than it needed to be."

Much of the article seems to be making the argument that the FDA is preventing importation of formula from other nations during the crisis because the FDA hasn't done all its bureaucratic work wrt certification of those sources. This seems a relevant point to raise when we're talking about food shortages for infants.


On the other hand, the FDA continues to block the import of European manufactured formula.


They also blocked the use of Thalidomide [0], which was available over the counter in Europe. They get a lot of credit for doing that, in my opinion.

The important question is why are they blocking European formula? Is there a nutrition deficit? Are there contaminants or is it adulterated? A failure to follow Good Manufacturing Processes? [1] Or is it just that approval is still in process?




The Thalidomide scandal occurred over 50 years ago--the FDA of that era is certainly not the same FDA of the modern era. Other federal agencies like the FAA have, in that time period, transformed from world leaders in advocation for safety to shells of their former selves peddling corporate interests.


Someone has to do the blocking - reliable domestic food supply is a matter of national security.


Right but we're here because the domestic food supply is... Unreliable at the moment for baby formula. So we can't import European formula because we need to protect the domestic food supply for national security? Wtf?


If you open the market, you’ll get Americans products to be inspected by the EU, which is better at its job than the FDA.


Yes but apparently previous blockings were done by issues like minor labelling issues. Which of course have to be followed, but put a sticker on the bottle instead of block the import.


I bought all my baby formula imported from Austria. Fuck that shit, don’t trust American companies. And with all this news, glad I made that decision.

Highly unfortunate that their are families in the “greatest country in the world” who now have to literally scavenge for formula.


Huh? They’ve already issued multiple recalls for European formula too.

How smug are you now?


There are many brands available in Europe that are not available here because the FDA drags it feet or otherwise prevents them selling here.


Absolutely but how hard is it to regulate an industry in a culture that prides itself on minimal government oversight?




Counter example: Underwriters Lab.


UL is not a consumer protection agency, but is one of several companies approved to perform safety testing by federal agencies. They do important work.


> UL is not a consumer protection agency

I feel the most protected as a consumer when I don't get shocked plugging something in.


Could you elaborate on this?


Whether the FDA has contributed to a net saving or net loss of life is a very debatable question.


It is amazing how despite regularly checking, 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?


Well, if it helps, 4chan has been talking about this for at least a month, complete with maps of various food production facilities that have suffered fires or otherwise suddenly gone out of commission.


On ZeroHedge for a while too :V


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.


I saw articles about that on several months ago. Maybe the way they filter your feed?


I'm certain there's some PR crap going on, but a shortage was building even before the recall (mid-feb).

From (referenced from, 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.


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.


tons of people on twitter blaming biden for it


Presidential blamers are always going to blame the one from the other side of the spectrum.


Those people (and bots) will blame everything on Biden regardless of veracity.


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.


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


Here's a copy of the referenced redacted complaint:


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.


This essay claims to explain what's going on right now with the US baby formula shortages:

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.


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.


> 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).


"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.


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.


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.


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.


> 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.


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


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.


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.


>The postal service has to deliver to everyone. Not just people living in high density areas.

Well unless they decide not to.


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.


How do you run a consumer protection agency when shareholder value is the #1 concern? Genuinely curious.


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.


Wasn’t Project Warp Speed a Republican idea?



Project Warp Speed was originally proposed by non-political civil servants and then approved by the Republican administration. It was one of several proposals to deal with the pandemic. Most of the others (such as a plan to provide masks for all Americans) were rejected, for better or worse.

IMHO, the civil servants that do the work of government don't get enough credit. Without them, our elected officials wouldn't have options.


I mean plenty of proposals are made, but ignored. A Republican administration gave it the go ahead.

A wildly successful FDA + private company partnership which directly contradicts OPs comment that “republicans hate the FDA”


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.


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.


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.


My wife pumped milk for a baby whose teen Mom had run away. The grandmother of the baby paid my wife for it, too.


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.


Also tricky - asking your donor to be tested for diseases which can be passed via breast milk. Such as AIDS...


I can't know whether the medical situation allows this, but Human milk banks exist and provide service, e.g.:


You can buy a goat in milk for $500 or so.


Goat milk was the traditional* answer for intolerance to human milk. Infants typically don't do well with cow's milk.

Goat and sheep cheeses are viable options for some adults who don't tolerate cheese from cow's milk.

* as in "the go to answer before we had commercial baby formula."


Goat milk is probably the plan. I know I was a bit dramatic, my son won’t starve. I can’t support a goat where I live, but I’m close enough to places I can buy goat milk that I can make it work.