FDA as useless as ever...Reply
This essay claims to explain what's going on right now with the US baby formula shortages: https://mattstoller.substack.com/p/big-bottle-the-baby-formu...
Some things are obviously overstated or cited for propaganda value. For example with our ability to detect elements in parts per billion or less, it matters very much how much arsenic etc. is in them, I doubt it makes any sense to reduce those to 1 part per trillion or less.
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.Reply
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.Reply
> 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.Reply
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?Reply
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.Reply
Republican who opposes funding the FDA complains they can’t do their job quickly enough.Reply
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.Reply
First item for preventing cronobacter infections:
Breastfeeding. This is one of the best things that can do for the infant's health, and benefits include preventing many kinds of infections. Reports Cronobacter infections among infants who were fed only breast milk and no formula or other foods are rare.
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.Reply
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.Reply
Here's a copy of the referenced redacted complaint:Reply
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"Reply
There was no match between strains in the lab, dead infant #1, & dead infant #2
So, they shut down the lab for nothing, rather than merely taking corrective action.
This is beyond crazy and it is not good science.Reply
"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.Reply
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.Reply
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.Reply
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.Reply
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.Reply
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.Reply
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.Reply
and people wonder where conspiracy theories come from...
please stop being horrible people and own up to mistakes, we all make them.Reply