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.
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.
This isn't just in the US. In Australia there are have been limits on how much baby formula you can buy per day for years because Chinese parents do not trust domestic powdered milk and so there's an underground market for shipping baby formula from other countries to China at extortionate prices.
My impression is that they trust anything that is not from mainland China will be better than what they can get domestically.
> ...so there's an underground market for shipping baby formula from other countries to China at extortionate prices.
I have long suspected years ago that in the US mysterious, sporadic local news reports of a Wal-Mart, CVS, Target, or similar store getting wiped out of all baby formula or all of a certain brand/SKU were simply rings of people scooping it up for this arbitrage over eBay, similar resale/auction sites or even WeChat. It doesn't seem systematic, and was very arbitrary which towns/cities they hit and when, but I've always wondered what the real story was.
And since real reform would likely require regime change, activists outraged over the latest problem (train derailment, buildings not meeting earthquake code due to fraud, etc) go to jail for disrupting social harmony.
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.
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.
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
Temple Grandin is extremely influential in some spaces. I think she has probably designed like half the beef processing plants in the US.
She wrote up a set of safety guidelines for the beef industry and McDonald's adopted her recommendations. You couldn't sell beef to McDonald's without following her guideline.
McDonald's buys so much beef, this became the de facto industry standard.
You can't put a gun to someone's head and force them to love you. You can't get blood from a turnip. And draconian measures generally fail to get real results.
Carrots and stick sometimes work. But "the beatings shall continue until morale improves" is generally counterproductive. It doesn't supply the necessary competence for setting a higher standard and usually actively disincentivizes trying to solve the problem.
"You can't put a gun to someone's head and force them to love you. You can't get blood from a turnip. And draconian measures generally fail to get real results."
I might be willing to stipulate the above. However there is a different mechanism at work when actors in the system have skin in the game.
And so, I will see your Temple Grandin (who I admire) and raise you a Nassim Nicholas Taleb.
Specifically: these producers need to be feeding their own children and raising their own families with these very same products.
Ironically, wealthy-global-north consumers (like foodco CEOs) are almost certainly not consumers of infant formula[1] (or lunchables or scent sprays or Monster drinks) so it is difficult to establish "skin in the game".
... and therein lies a tremendous amount of information. It should give consumers pause to learn that these products are not used - and likely disdained - by the stakeholders that produce them.[2][3]
[3] “I don’t think my kids have ever eaten a Lunchable,” she told me. “They know they exist and that Grandpa Bob invented them. But we eat very healthfully.”
I’m actually ok with beatings figuratively (or literally) if someone sells me poison to give to my baby.
It’s really that simple. We know how to make baby formula safely. We have known how to do that for a long time. It’s clearly profitable enough that companies are willing to do it.
But if you cut corners to boost profits and you end up poisoning babies you should be punished. There’s no need to tie yourself into knots reasoning that it’s actually not possible to enforce safe production of baby formula.
Which is why it's a saying about how it doesn't work: it starts from a faulty premise, that people know how to the job properly and aren't out of malicious intent.
When in reality, the worker who's not maintaining the machine properly, isn't doing so because he was never instructed in it's operation, his supervisor who's "been doing this job for years, never had a problem with this", the manager of the department loves how many run hours they're getting from that machine and "it hasn't killed anyone" is said when the dangers of not cleaning it are mentioned in meetings, and after all they don't want to look bad to the executives who are saying serious things like "the economy is tightening, we need to find savings!" a lot.
In that chain, pick out who is directly responsible for the situation? Better: pick out who can be told to fix this problem, and they'll actually know how to do it? Pick out who you kill as a lesson to the others that will actually be learned?
Suppose you kill all of them: great, so what are you now doing to make sure the next group actually do their jobs properly?
Why not target the individual with the most influence in the organization, the highest C-level executive responsible for overseeing the operation? The threat of punishment for oversight failures on high level executives will naturally result in strict company cultures of safety and caution since the most powerful person faces real risk.
Temple Grandin supplied a superior solution. A very influential company adopted it because it works better. They voted with their dollars. No one was told "You will go to jail."
She provided a better method. Market forces took care of the rest.
A gun to someone's head doesn't magically make them capable of coming up with better solutions.
What does the market having a standard higher than the legal minimum have to do the law enforcing a minimum?
In your example, for instance, even if the law said Ronald McDonald would face the firing squad if their beef didn’t meet the legal minimum standard it wouldn’t matter because they are already exceeding it. The stick is not causing the carrot any trouble.
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.
> Today pfizer is one of the most trusted companies and many people will be mad at you if you criticize pfizer in any way.
I don't buy that for a second. I see plenty of criticism of pfizer, for both what they've done before the pandemic and what they've done after it. This includes criticism from what many would consider "left-wing" sources. Whoever told you that they were beyond criticism lied to you, and you may want to reconsider trusting them in the future.
I was listening to a podcast recently where a left-wing host had a right-wing guest. The guest said it was strange that in the right there are so many subgroups that are all infighting and disparate, but the left sees them as a monolithic whole. And the host said that they was very funny, because his impression is that broadly opposite: the left is fractured and the right, despite the cliques and subgroups, generally sticks together. Which is what has been phrased as "the right falls in line, the left falls in love".
So it seems that everyone (or at least many) have an inherent bias to view the "other" as much less nuanced then they are themselves. The thought that a left-winger might oppose Pfizer in some ways while supporting the vaccine[1] is as unexpected as a left-winger opposing Obama's drone policies to someone who doesn't see the detail of the other side.
And the same goes in reverse, I hasten to add. And the same goes for every other A Vs B situation: the other side are all humans too and humans are complicated.
I don't think many on the left would be surprised that there are factions within the right, There is a view that the right won't hold themselves accountable though which I don't think is unfair.
The right can't view the left as entirely monolithic either. They get a lot of mileage out of phrases like "The left eats their own" and "Democratic civil war" which, again, not unfair.
I think it's just easier to demonize a caricature so that's what ends up in heavily repeated talking points which then get regurgitated even when they're demonstrably false or ridiculous.
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.
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 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”.
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.
That would simply ensure that class actions almost completely cease to exist. And poor people (by which I mean anybody with less means than your average mega-corp) don’t have access to civil remedies in the US.
They would sure decrease in frequency (which is the whole point), but they would not disappear: if the legal case is good, the law companies would still take them on contingency. If the law company thinks their case is so weak that they might end up paying the defendant’a cost, good.
If the chance of winning at trial is, say, 75%, It’s extremely likely the suit will be backed by investors, since if you back hundreds of suits, the impact of being unlucky goes away.
There are many hedge funds, public equity firms etc. with easily as many resources as an average mega-corp.
In addition to what alistairSH said, the US already has remedies for lawyer fees. If the judge feels your lawsuit is frivolous, they can award “fees” in addition to damages to the other party.
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.
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.
I get that formula is better, and should be the #1 choice but in a formula shortage/emergency situation would most babies be seriously harmed by using goat milk instead?
I suspect the end result would be similar to why me and my two siblings had to be put on formula - malnutrition. Goat milk simply is not going to have all the elements that a human baby needs, so I'd consider it somewhere closer to "last resort" rather than "oh well, not enough formula, let's grab goat milk". Doable, but only because it's emergency.
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 wanting to breastfeed is also a good reason. First, breastfeeding and/or pumping is a lot of work. Second, it can be painful for a number of reasons (latching, chafing, engorgement). Third, women have jobs and the US has horrendous parental leave policies. It can be nearly impossible to breastfeed/pump AND do your job. Fourth, it isn’t your kid so it isn’t your choice how to feed them. If you want to breastfeed your kids that is fine. Many women do hybrid. Some don’t do any breast milk.
You have provided no good reasons to think your position on this is correct and you have said a number of other things which are just reprehensible. I am only responding because I hope you will see this.
The WHO has weighed in on this topic, and their recommendations are well known. "Breast is best" is not just a trite cliché, but supported by science and worldwide medical authorities. I'll leave the research to you.
“Breast is best” does not mean or suggest “you shouldn’t have kids if you don’t want to breastfeed” for the simple reason that the second best option can also be a good one. Put differently, breast is best doesn’t imply that formula is bad. Your reasoning is atrocious and simply isn’t justified by anything the WHO could cite in support of “breast is best”.
Problems are not a lack of desire. I didn't address "can't" for exactly that reason: if you tried and it didn't work out, then of course it's a valid reason to feed formula.
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.
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.
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.
What are the minimum USD capital and operating costs of a non-accredited lab that is as automated as possible, and does absolutely nothing but test random batch samples of formula 24x7x365?
Crowdsource/co-op the funding of such a lab, those who fund it get the results first, and choose their own private, independent decisions based upon those results. Route around the damage caused by lobbying and regulatory capture, and own up to self-policing of quality instead of relying upon accreditation and the agency problem of running a for-profit QA lab constantly bidding upon contracts.
If you were going this path, I'd say you're not thinking big enough. In rice packaging for example, literally every single grain is inspected: there's an automated imaging system which analyses the grains as they are fired through the air by air pressure, and a deflector system which emits a puff of air to kick rejected grains into the discard pile - literally grain by grain.
We should be trying to do this for everything, but formula in particular: ideally tin-by-tin we would be testing samples and barcoding the accreditation data onto them. That's the challenge here.
That's awesome, I love hearing about applied technology like that, thank you! I wonder what they do with the discard pile?
Contaminated soil, use of pesticides containing dangerous metals, and leaching from manufacturing equipment and packaging are the main sources of heavy metals in baby formula. We should be testing those aspects like soil down to the per square meter samples, production line sampling, and packaging sampling, all as an integral part of the supply chain quality assurance process. The better testing methodologies for heavy metals in food are atomic absorption spectrophotometry (AAS), inductively coupled plasma-optical emission spectroscopy (ICP-OES), or inductively coupled plasma-mass spectrometry (ICP-MS).
Unfortunately, I don't know enough about the operational details to understand whether those methodologies can be packaged into a reliable, accurate, precise miniaturized form factor aimed specifically at testing formula to simplify the sampling aspects. I imagine sampling contamination might be a big issue with a miniaturized tester, along with an entire host of other challenges. There might even be limits of physics I'm unaware of that entirely prohibit miniaturization; the test equipment I'm aware of are benchtop at best in size, not handheld with maybe a smartphone front-end (to leave a screen out of the BOM).
I wonder if gamma rays could help this. It kills germs without affecting the nutrition of the food (as opposed to heat, which often does break down nutrients).
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.
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.
And why is the FDA preventing imports? From the article, because the dairy industry convinced the previous POTUS to do so. It’s not like the FDA just decided out of thin air to ban Canadian formula - the decision was made higher up.
Which isn’t to say the current POTUS shouldn’t tell them to relax that rule. They should. I’m objecting to laying so much blame on the FDA - our federal agencies are acting on laws and policies enacted by our politicians.
That was a terrible thing for Trump to do but now we have a different POTUS who is (supposedly) not beholden to the dairy industry, yet it's not been changed.
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.
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?
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.
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.
Thiel is unconvincing. The guy studied law and philosophy and is now a financier. He has no understanding at all about supply chains because he never encountered any and should not be let near them.
this is where our ideology conflicts with our needs. I'm a libertarian in many ways, but I'm not religious in adherence to the ideology, and see the need for the FDA and EPA. I'm also in favor of keeping their roles confined and reasonable. The voices of the extremes are too loud these days.
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.
> 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.
Until Covid hit I had a friend who would go stores in the USA, Buy baby formula at retail price and re-sell it on WeChat to wealthier people in China who she'd mail it to. She actually made a decent margin, because they really don't trust the manufactures there.
I'm surprised it was worth shipping. I do understand, though--I have relatives over there and the majority of our baggage is always various things they have requested, mostly because they don't trust the local products.
I was as well. I don't know what the "Chinese Fedex" rate's were but maybe it's because most of the volume they move is from China -> US and the return trips are empty.
Post office in the village my parents live is also post office for major Chinese immigrant community.
This resulted in small post office pushing two or more 2TEU containers every day filled majorly with powdered milk, sent as normal international post package to China.
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?
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.
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.
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.
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.
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.
> 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.
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.
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.
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.
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.
> 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.
The availability of landlines to remote locations is in large part due to government subsidies. There are programs at both the state and the federal level to help offset the costs of providing services in areas that wouldn't otherwise be as profitable or indeed bring in any profit at all. If the government hadn't been helping to ease the burden on telecoms for providing those services we wouldn't see nearly as much copper being strung/buried/maintained in rural or difficult to reach locations.
As for police, I think most everyone agrees that it's not an ideal situation to have areas too dangerous for police to effectively respond, but at a certain point it becomes a matter of safety. Private companies also won't deliver services in extremely dangerous neighborhoods and have a long history of using "discretion on whether to provide service" based on much less.
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.
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.
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.
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.
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.
"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.
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.
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.
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.
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.
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.
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"
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.
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.
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.
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.
My partner could literally not produce enough breast milk. She breastfed day and night, pumped constantly, took supplements, whatever it took. It just wasn't enough. I'm glad I'm not in the market for formula now; it seems like a terrible situation.
Was in same situation a dozen years ago. But we needed speciality formula. We learned the local shipping schedules for stores and would be there waiting as they rolling product off the truck.
Was scary. When second child was same. Decided to adopt after that.
Abbot did some evil stuff last October. Nestle is just an on-topic citation. If 20 years of seeing, first-hand, across different industries, how much "professionals" will sweep under the rug to keep the paychecks coming in is a "high horse," I choose to remain mounted.
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.
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.