As a side note, this letter is exactly why I think a regulatory agency like the FDA is absolutely necessary. This stuff can kill people and it is impossible for the average person to protect themselves.
My two cents: good market to be looking for good data folks who might want a (potentially remote) federal agency data job with shakiness in tech.
If it ever happened, I can already see the endless coverage by Sean Hannity and similar about how it's governmental overreach that risks destroying an important US company with X thousands employees...
However, I don't think it will ever happen, in the end it's one of the richest men, Jeff Bezos behind Amazon with significant influence on news reporting, who seems to be on good terms with both the Republicans and Democrats, and the regulatory agencies in the US just didn't show a pattern of going too hard against US companies.
When that happens, what would it take to convince you that the reason for the FDA’s decision is Amazon’s compliance with the law, rather than Jeff Bezos’s influence over the government and news media?
Sure; if the only piece of information under consideration is "the FDA did not shut Amazon down," Occam's Razor says that we should expect that to be because Amazon did not do anything that would lead to them being shut down.
But if we get to bring in all the information we have about what Amazon did do, much of which certainly appears to be conduct that would lead to some kind of regulatory penalty...well, then, it seems like it might be reasonable to consider alternative explanations for the outcome.
It also means that if things do get to such a point, then the action will come down swift and heavy in a manner generally agreeable to the majority of the commons.
Not in this universe. The more likely outcome is that Amazon shuts down the FDA.
It doesn't really hurt the Amazons, they're just distributors. Doesn't really even hurt me. If RTP is a part of my software product I should be under a microscope. It's going to be small people who try to market supplements who will get trounced now. Because every report will, by law, have to include the source of the product. And that source company or individual is in for a long year. Even shutting down won't end their legal obligations in a lot of cases.
On the other hand, that was, in part, the original point of the FDA. To stamp out the snake oil salesmen. So, yeah. I guess they're just carrying out that mandate in new and updated ways.
I'll omit brand names here, but I can tell you some sketchy stuff happens in supplement manufacturing all the time. During the ~6 years I worked there, only one letter came from the FDA after a whistleblower at a competitor's company came forward. The FDA sent a warning letter out to several of the large competitors in the industry to "don't do it or else" and never followed up again. The company that got in trouble got a few hundred thousand dollar fine for using mislabeled and toxic ingredients. They had one follow up inspection about 6 months after the warning and that was the end of it. For comparison that company was making ~$600M a year at the time of the fine and is now making $1B+. We carried on and never heard from the FDA again despite being equally guilty in our own company.
The guilt is what eventually led me away from the cash cow, where I went on an 18 month sabbatical to get away from any corporate greed for a little bit. I legitimately had nightmares that I would be complicity guilty of several crimes if I stayed there long enough.
I promise you, there is no oversight in supplements. There are a handful of posted guidelines. If a whistleblower comes forward the FDA might react to that single case, but they are so understaffed; the team that manages nutriceuticals is marked in the "tens" of people, not the thousands dedicated to proper medical equipment and medicines.
The FDA did try regulating supplements. They were legally prohibited from doing much.
You can thank Senator Orrin Hatch (who was the longest-serving Republican senator in history until recently) for preventing the FDA from regulating supplements back in 1994. [1] [2]
[1] https://www.youtube.com/watch?v=WIT5_SMIaHE&t=6m46s (watch a few minutes of it from here)
Edit: Posted it here for those interested: https://news.ycombinator.com/item?id=38797162
[2] https://www.congress.gov/bill/103rd-congress/senate-bill/784
See
https://inspection.canada.ca/food-safety-for-industry/food-c...
I don't think it's an undue burden that if you're going to sell things people are ingesting, you have to know and communicate where they came from.
And I feel like small people that try to market supplements won't be especially damaged by this. It feels like as much as anything this would "hurt" small people that try to start a supplement manufacturing cottage-venture on a shoe string, over which I don't expect to lose any sleep.
I'm doing my first FDA-monitored automation project at a local brewery, and am quickly becoming familiar with the abundant controls that the FDA puts on domestic producers.
But the FDA is an American organization. Amazon or Ebay or Aliexpress or whoever may be just distributors, but they're international distributors. They're fully-automated self-service distributors for manufacturers in China and Russia and Indonesia and India who aren't subject to FDA jurisdiction, who sometimes aren't subject to any oversight at all.
The only entity that the FDA can go after here is Amazon, so this should hurt Amazon.
But the FCC's position is that if I as an electrical engineer want to sell my neighbor here in the US some custom PCB with an antenna, I need to go through testing that costs many thousands of dollars.
If an EE in Shenzhen wants to sell my neighbor the same PCB over Alibaba, Aliexpress, Banggood, Wish, Temu, Shein, Gearbest, or whatever new discount importer is hot I can't keep up anymore, or Ebay/Amazon/Target/Walmart.com, they're just going to create a listing and import it. The FCC simply cannot keep up.
What I don't understand is how they're getting through Customs and Border Patrol. If I want to ship a spare off-the-shelf PLC digital input card for a machine to one of my customers who has a satellite facility in Mexico, there's a 50% chance it gets held up for a month or more. Meanwhile these big distributors have no issues with air-freight shipments of a GPS jammer or raw testosterone direct to American doorsteps in 3 days.
Edit: it seems obvious to me that the CBP should be partially responsible verifying that stuff going through customs subject to FCC or FDA jurisdiction complies with FCC or FDA regulations, or at least to forward the question to the appropriate agency.
Everyone pays. Amazon for their part. The producer for their part. Anyone that is provably in between is held accountable as well. Usually it's the producer that gets hit the hardest. Not disagreeing with that. That's what should happen. Just listing another in a litany of reasons that it's far worse for the producer/manufacturer than for the distributor. Think about it, your grocer rarely suffers the same consequences that a poultry producer does in the event of a poultry recall for instance.
This isn't what anybody objects to about the FDA. "You have to list what's in the product" is a simple rule that every knows, is easy to comply with, and doesn't require any government interaction even in the case of a suspected violation because the FDA can just buy the product to test it and compare the lab results to the label.
What people object to is when someone wants to sell an accurately labeled product with a risk-benefit trade off, the customer knows what the product is and is exercising informed consent, and the government says they can't have it anyway.
The FDA's regulatory purview is to limit the collateral damage (negative externalities) of even accurately labeled products.
Informed consent from the customer is one side of the equation. Unfortunately they cannot consent to conditions like "Don't burden the hospital system if you take the wrong dosage".
By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year.
The government should generally be concerned with preventing deception and coercion and pricing externalities, because otherwise people have the incentive to do them and they would be prolific.
Things nature punishes directly don't need the state to deter them. They happen by accident rather than by motive and we choose purposely to spread the cost of this across the population as a form of insurance and a cost of living in a free society, sometimes even when the misfortune is a result of their own stupidity. Other times we send them a bill for costs.
It's almost like there's a balance of harms to be evaluated.
I'd bet the cheap availability of paracetamol etc. saves more hospital visits than it causes, but I don't have the data to hand.
Which is a highly context-specific evaluation, so is it better decided by the person with the most knowledge of their own circumstances, or across the board with no context at all?
It depends on the context.
In many, many contexts, people are explicitly not the people with the most knowledge about their circumstances. When I'm crossing a pedestrian foot-bridge, I have much less knowledge about whether this particular bridge is safe or not than the people who built it and the regulators who regulated it. The same is true when I drive my car, take medication, eat food, etc. etc. etc. I make risk decisions every day, but those decisions occur within a societal context, and part of that context is a general regulatory framework.
We are not all experts in everything. Which is why we (The People) gather together and delegate that responsibility in general to bodies of experts who try to make context-aware determinations about what in general should be allowed, what shouldn't be, and what should be left up to the end-user. It's a vast spectrum, and people often disagree about what goes where - this is fine! But if you want to get rid of the spectrum and have everything decided by people who should have "the most knowledge of their own circumstances", then it sounds like you're in favour of people dying and then blaming them for it.
Which is why we communicate. If the bridge has loose stones, you put up a sign that says the bridge is hazardous and has loose stones and provide a map with an alternate route. Now the person who comes up to the bridge knows that a professional evaluation designated the bridge as hazardous and why.
Most of the time that means you'll want to go around. But if the bridge is only two feet off the ground and you can see your lost dog on the other side, you might reasonably be willing to exercise careful footing and risk twisting your ankle to get to your dog.
Whereas if it's a hundred feet off the ground, you can try to get your dog later. But you might still cross if was something more serious, like you're in the woods alone and injured, you have to get across to call for help before you bleed to death and the alternate route is several hours longer.
It's a lot easier to get general information to the person in the situation than the other way around.
> But if you want to get rid of the spectrum and have everything decided by people who should have "the most knowledge of their own circumstances", then it sounds like you're in favour of people dying and then blaming them for it.
If a person in a situation makes a judgement call and they're wrong, they could die. If a legislator makes a judgement call for everyone all at once, people will die because different people will be on different sides of the trade off, possibly more of them than would otherwise if they'd each been able to make their own decision in context, and certainly some of them who would have lived if they'd been able to choose for themselves and choose differently.
It sounds like you want to trade the lives of people who choose well for the lives of people who choose wrong without even knowing which number is bigger. Or considering that the number of people who choose well could be increased in various ways other than coercion.
This is quaint, but not actually the problem. The problem is that every bridge manufacturer will cut corners on materials and design (because it's cheaper) meaning that there will be zero safe bridges. The bridge manufacturer's incentives do not line up with its users.
When I walk up to a safe-looking bridge, how am I supposed to know it's been made with insufficient rebar or dodgy concrete until it's collapsed on top of me? A sign?
> If a person in a situation makes a judgement call and they're wrong, they could die. If a legislator makes a judgement call for everyone all at once, people will die because different people will be on different sides of the trade off, possibly more of them than would otherwise if they'd each been able to make their own decision in context, and certainly some of them who would have lived if they'd been able to choose for themselves and choose differently.
Like I said, it's a balance of harms. There's both appropriate and inappropriate places for government intervention, and we're already legally not prevented (encouraged, even) from engaging in a bunch of very dangerous activities.
But the assertion that legislative intervention will always result in more deaths than letting people "decide for themselves" seems highly dogmatic and unsupported.
> It sounds like you want to trade the lives of people who choose well for the lives of people who choose wrong without even knowing which number is bigger.
We know which number is bigger. Go look at non-natural death rates in much countries with much smaller governments / regulatory frameworks.
Generally speaking, each person is best aware of their own context and can choose best for themselves how to take care of themselves and those in their family.
I'm not arguing against regulatory oversight of the free market - the FDA should exist. But there's a lot of talk about "harm reduction" and even "nudging" or "shaping" of society that I think needs to go away. I'm fine with billboards being banned (along with corporate lobbyism); but don't tell me I can't buy something because some other people could hurt themselves with it if they use it in the wrong way.
Yes, and I don't trust that the government can generate a one size fits all model that universally reduces harm. They're just not capable of it, and yet they comfortably assert their authority as if they are, and so they act without actually taking any measure of the impact of their own actions.
It's the problem with any agency. Sometimes the best answer is actually "do nothing" or most likely "regulate elsewhere through different authority."
So, I don't think the FDA paying an oversized amount of attention to one retail segment is going to do anything meaningful in the long term and we shouldn't have to pay for their amateur expeditionary efforts here, both in terms of funding the agency, and in allowing them to control markets on their own without any request or complaint process driving their actions.
Advertising laws in the US mean manufacturers can and should do everything in their power to obscure and mislead about the tradeoff. A person purchasing a unverified product should have tremendous misgivings. They should only purchase it in spite of tremendous misgivings. Anything less is not informed consent; it is deception masquerading as informed consent.
Until you fix that you get companies downplaying risks and overstating potential benefits. Fix that and informed consent becomes a real possibility and a much more attractive proposition.
Which is why I think the model for such things should just be "informed consent." It's a concept that already exists in the medical practice with a well-defined procedure. Someone who your state medical board has deemed competent and responsible has to explain in painfully explicit detail all the tradeoffs and answer any and all questions. If you still want to do it you sign some forms and go on with your day.
Someone has to decide what substances safe and prevent them from sold.
The FDA could do better but you’ll never fix that problem unless you don’t allow the FDA to enforce regulations.
No they don't. If a product has a label that says "this product is considered unsafe by the Food and Drug Administration" and explains why and you buy it anyway, you got what you paid for.
See California and cancer.
Why would this happen for things which aren't currently banned? An abundance of caution - better to claim it's potentially unsafe than pay the claims later. Or economics - why pay more for a safe sweetener when you can use the cheap and cheerful one and just label it unsafe.
California says that everything causes cancer because everything kind of causes cancer and their labeling rules are stupid. If the label was only on products with a significant risk of causing cancer from ordinary use, it would be rare and people wouldn't ignore it. In other words, if it was only on the products that would otherwise be banned.
This would only be a problem if you would otherwise have banned lots of things people would still want to buy given a free and informed choice, in which case actually banning them is even worse.
We didn't ban cigarettes, we informed people of the risk:
https://www.lung.org/research/trends-in-lung-disease/tobacco...
And that's one of the most addictive products known. Around the same percentage of adults smoke cigarettes and use illegal drugs. So what good is the ban?
I have a nut-allergic friend who has given up on reading the labels and relies on his own common sense, because the labels are on everything now. (Worse, if you look at what's happened with sesame, manufacturers now deliberately incorporate sesame into their recipes so that they can put the warning labels on, because that's cheaper than the risk of selling a product that doesn't contain sesame).
> If the label was only on products with a significant risk of causing cancer from ordinary use, it would be rare and people wouldn't ignore it. In other words, if it was only on the products that would otherwise be banned.
How do you imagine that this might be accomplished? If manufacturers have the choice of a) go through an approvals process b) put a warning label on their product, they're going to pick b, every time.
> We didn't ban cigarettes, we informed people of the risk:
And the result is that smoking has fallen a lot more slowly than predicted and millions of people have died.
There is a difference between containing nuts and being processed on equipment that also processed nuts. The difference matters more for some people than others.
> Worse, if you look at what's happened with sesame, manufacturers now deliberately incorporate sesame into their recipes so that they can put the warning labels on, because that's cheaper than the risk of selling a product that doesn't contain sesame
This is what happens when you have bad rules.
They have a machine which has processed nuts in the past, it isn't cost effective to remove every trace of nuts from it, so they accurately labeled their product as one processed on equipment that has processed nuts. Maybe the trace amounts aren't enough to matter, but the consequences can be dire so they're cautious. Isn't this supposed to be about safety?
They only added nuts to the product after you prohibited them from being conservative. And they're being atypically conservative because the "dangerous" label isn't applicable to most of their customers who they then don't have to worry about being deterred.
> How do you imagine that this might be accomplished? If manufacturers have the choice of a) go through an approvals process b) put a warning label on their product, they're going to pick b, every time.
Why is the company even involved in the process? They produce a new product and it initially gets a label that says it hasn't been tested, which will rightfully deter customers when most existing products don't have that label. The government performs its testing to check if it's harmful, prioritizing based on which new products are expected to be popular, and once published their results go on the label one way or the other.
If the company wants to get rid of the untested label or not have it present at release they can pay for expedited evaluation and go to the front of the line, but all popular products get tested relatively quickly and so untested products are suspect, and products evaluated as unsafe then have to be labeled as unsafe.
> And the result is that smoking has fallen a lot more slowly than predicted and millions of people have died.
As compared to the times when we've prohibited other substances and people all stopped using them immediately?
This a fundamental point of misunderstanding. The government in case of the FDA doesn't test products. They just review the documentation that manufacturers submit. In case of medical devices which are similar to an existing approved medical device (a 410k) for instance the FDA charges $21,760 for this review ($5,440 if you are a small business) and under law has to have the review complete within 90 days.
To compare: performing just one of the required tests such as biocompatibility often costs more.
The FDA also doesn't write labels for you. That is entirely your responsibility as a manufacturer and frankly impossible without having complete insight into manufacturing and design.
Safety should be about safe outcomes, not about maximising the number of warnings.
> They only added nuts to the product after you prohibited them from being conservative. And they're being atypically conservative because the "dangerous" label isn't applicable to most of their customers who they then don't have to worry about being deterred.
There's nothing atypical about it. They're finding the cheapest way to avoid liability and they genuinely don't care whether that means "being conservative" or poisoning their customers, and it's not going to result in good outcomes for the customers.
> Why is the company even involved in the process? They produce a new product and it initially gets a label that says it hasn't been tested, which will rightfully deter customers when most existing products don't have that label. The government performs its testing to check if it's harmful, prioritizing based on which new products are expected to be popular, and once published their results go on the label one way or the other.
Presumably you're going to campaign for the massive increase in taxation that would be necessary to enable the government to do testing comparable to what's currently done in any remotely reasonable timeframe? (And some kinds of testing simply can't be done fast - if you want to test for negative after-effects that may take years to show up, there's no way to make that not take years).
> As compared to the times when we've prohibited other substances and people all stopped using them immediately?
As opposed to market consensus on what was expected. And yeah, frankly, banning substances generally does reduce consumption; not to zero, but to significantly less than without the ban.
And sometimes you get people like me, who eat yoghurt without checking the ingredients because you shouldn't need to, only to then find out that for some crazy reason American food companies put beef gelatine into theirs.
For me vegetarian is a choice rather than mandatory, but if you rely on "common sense" people will die, and have died. It's happened with surprise nuts, despite that one being well known.
They made a product and told you what was in it. You're not required to read the ingredients first but you have the opportunity to. Are you proposing that we ban beef gelatin?
> if you rely on "common sense" people will die, and have died. It's happened with surprise nuts, despite that one being well known.
But what are you even suggesting here? That you can't make a product with nuts if someone might not expect it, even if you labeled it?
Although I would in general, that wasn't the point being made in that comment. The point was: nobody expects surprises.
People mostly don't read lists to confirm the absence of things they think would be crazy to find.
Like boiled cow bone and skin derivatives in yoghurt.
> But what are you even suggesting here?
The specific thing that I actually said, with no extra hidden implications between the lines: common sense gets people killed.
That isn't a policy proposal.
If you're in a cornfield next to a farm road that only sees one truck every six months, common sense says you're not at a busy intersection, but if you step into the road without looking and there is a truck, that's not the truck's fault. You can be cautious all the time or you can take a risk once in a while; it's your choice because it's your life.
It's also not clear how it applies to the topic. If you went to the store and asked for some MDMA and they gave you some MDMA, you are not going to be surprised that the contents is MDMA. That's not why it's banned.
Yogurt is already made out of bovine bodily fluids. Why is it so shocking and disgusting for another bovine product to be used in it as well?
If you really don't get why the addition of bones turns "normal" into "horror story", I don't know what to add.
If the reasons are specifically ethical in nature (i.e. not limited to environmental or health reasons etc. but based on a concern for the possibility that animals have a rich inner experience and have the moral standing of humans), then it's definitely ghoulish for all the same reasons treating humans as livestock is ghoulish.
When I was a kid, I simply didn't think about it. I also simply didn't think about how some people ate species that I considered pets.
People do disregard labels including those with allergies.
> If the label was only on products with a significant risk of causing cancer from ordinary use, it would be rare and people wouldn't ignore it. In other words, if it was only on the products that would otherwise be banned.
Ahh, but the risks are high enough that companies will still put that label on everything unless companies where required to only put such a label on products with significant risk which then gets back to regulators.
Exception that proves the rule.
The purpose of the law is to protect people who act within reason. If you have an allergy and don't read the label, that's on you, not the company or the government.
> Ahh, but the risks are such companies will still put that label on everything unless companies where required to only put such a label on products with significant risk which then gets back to regulators.
The entire point is that "regulators say you have to label this" and "regulators say you cannot buy this even with informed consent" are two different things.
They are the same issue, because labels get applied even when not needed which destroys informed consent.
Allergies cover a huge range of sensitivities. People with quite severe allergies can consume small quantities and not notice when someone else with the exact same allergies just in a more severe form would die from consuming it. Thus ‘may contain nuts’ isn’t informed consent what’s needed is a sliding scale of risks not CYA language on basically every package.
However, allergies aren’t universally harmful. There’s no compelling reason to allow food products with high levels of heavy metals.
This is just flat out wrong, and pretty gross.
The purpose of the law is to protect people. Not white people, not land-owning people, not smart people, not literate people, not able-bodied people, not "reasonable" people. People. Full stop.
Assuming people are reasonable is a recipe for disaster, and ablest. Perhaps one day someone you know will get dementia, or have a stroke, or get macular degeneration, or any of the number of ailments that can relieve you of your ability to read and comprehend long texts, lists, and warnings, then maybe you will understand how ridiculous this view is.
To further this point with anecdotes, both my mother and my grandmother had dementia.
Gran started a pot of water boiling, left the room, forgot about it, and thought the subsequent smoke alarm was her neighbours'. Mum stopped being able to count past four, and lost general concept of things existing on the left side of objects from her PoV[0].
When my mum noticed my gran had forgotten to renew her road tax (and noticed this six months after it had expired), she hid the car keys until gran forgot she had a car. When my mum got dementia herself, a similar thing happened.
[0] https://en.wikipedia.org/wiki/Hemispatial_neglect which is distinct from https://en.wikipedia.org/wiki/Homonymous_hemianopsia — eating dinner, thinking she'd finished, but left half of her plate was full of food she couldn't see until we rotated it 180°, sketching my face and missing my right (her left), that thing with the clock: https://en.wikipedia.org/wiki/File:AllochiriaClock.png
If you have a mental illness you can go to the store and buy rat poison and eat it. The law doesn't address this by prohibiting rodenticides. If you think you can fly and jump off the roof of a parking structure, the government can't disable gravity.
Acting within reason in that context is getting treatment, which is a whole different set of laws.
>If you think you can fly and jump off the roof of a parking structure, the government can't disable gravity
The law can make it so you have guardrail on your roof if it is publicly accessible. The law can also make you put up suicide guards if it's really a problem, all of my favorite bridge have them now.
> The law doesn't address this by prohibiting rodenticides.
Rat poison has actually been getting more scrutiny lately, the traditional pellet form was banned this year in favor of bricks in the US, and non-professional exterminators are limited to buying it a pound at a time. Also, rats are a real pressing problem that is being handled with rat poison. Without it, we go back to food security problems related to controlling pest populations. The same can't be said in reverse, we don't have a real, pressing problem with an overabundance of safety.
I'm saying that people can make mistakes and incur the consequences of those mistakes. The only way to prevent this is to remove all choice.
This has nothing to do with whether you have some kind of disability. Have someone read it to you, use a magnifying glass, look it up on the internet with a screen reader, buy it from a store you trust not to carry controversial products, do as you like.
> The law can make it so you have guardrail on your roof if it is publicly accessible. The law can also make you put up suicide guards if it's really a problem, all of my favorite bridge have them now.
Guardrails are for preventing accidents, not purposeful action. You can't convert the entire world into a padded room. Suicide guards are a political maneuver meant to demonstrate something being done when politicians don't want to address underlying causes, not any kind of solution when there are an unending number of other bridges or tall buildings etc.
Their purpose is to prevent enough people from jumping off the same bridge for a newspaper to put a morbid number in a headline, when they should be addressing why those people wanted to jump.
> Rat poison has actually been getting more scrutiny lately, the traditional pellet form was banned this year in favor of bricks in the US, and non-professional exterminators are limited to buying it a pound at a time.
Excellent example of regulation created by the need of legislators to be seen doing something even when nothing needs doing.
Poisons aren't rare. You can also buy a bottle of methanol, or various cleaning solvents, petroleum products, coolants etc. Many over the counter drugs are fatal in high doses.
Someone could drown, in water. Which is also fatal if you drink too much. Or too little.
Danger is everywhere and it's fine.
> The same can't be said in reverse, we don't have a real, pressing problem with an overabundance of safety.
That's exactly what we have. Safety measures with body counts. Mandating inaction in cases of uncertainty is a harm in every case where something is better than nothing.
If you walk up to a food truck you shouldn’t need to worry about long term mercury exposure from a single lunch. But the same is true if you happen to eat the same item from the same truck for 30 years.
The maximum allowable exposure from food is very different between those two cases. But the second case isn’t unreasonable so that’s what the standard should be set for.
"Anyone could have" is closer.
From what little of various laws I've looked at (with the huge caveat that I'm not a lawyer), I think they are written to assume the general public doesn't know what's going on most of the time.
I just looked at the back of the chocolate wrapper I just ate and it "may contain nuts, eggs and peanuts." None of those things are ingredients and the warning is just there to prevent a law suit. My friend who has a severe allergy to eggs and nuts would eat it - otherwise he'd have a very bland diet indeed.
Plenty of substances are risky, but can be worth the risk. For example, psychedelics, for the wrong person or in the wrong situation, can cause psychotic episodes or lasting trauma, but psychedelic therapy has already been legalized in at least 1 US state, because it can also be extremely helpful.
I'm still not able to buy it and take it home (at least legally), but in my honest opinion, I should be.
Why?
If someone buys deadly nightshade, and gets deadly nightshade, why should the government care?
The homeopathic sodium chloride and silicon dioxide sugar tablets probably didn't hurt me, but given how dumb Bach flower remedies are it's entirely possible she randomly and unwittingly dosed me with a small quantity of ground up something in the Solanaceae family.
Governments care because well meaning hippy parents who don't know any better feeding snake oil to their kids gets headlines in newspapers.
In practice parents and the government agree most of the time because it's established science that no one contests, and cases where the government got it wrong are a large class of exceptions. Then people see the government forcing its rules even when they're in the wrong and lose faith in the whole system, including the general consensus. Then you get more counter-culture types fooling around with weird plants.
Whereas in the absence of coercion, the people who are right when the government is wrong are able to openly prove it without being punished, which allows the government to improve its recommendations more rapidly, which reduces how often their recommendations are wrong and thereby the number of people disregarding them wholesale after watching them be incompetent pigheaded bullies.
Or corporal punishment, where scientific consensus since 1990s is that it is harmful. The countries which have banned it since did so ahead of change in public opinion.
There are times when the government is wrong, but it is by far more right than wrong. Thanks to government intervention we saw childhood mortality drop from the high levels in previous centuries, and letting parents just do their thing would eliminate much of that progress.
Keep in mind: This whole "debate" is about parents doing insane crap, like homeopathy and "natural remedies" for which there is no positive evidence, not debatable stuff where there's honest evidence for multiple positions. Parents failing to provide proper medical treatment for their kids is abuse, just as it would be if your boss somehow forced you to drink bleach. And, yes, some of the "natural remedies" are bleach:
https://en.wikipedia.org/wiki/Miracle_Mineral_Supplement
> Miracle Mineral Supplement, often referred to as Miracle Mineral Solution, Master Mineral Solution, MMS or the CD protocol,[1] is a branded name for an aqueous solution of chlorine dioxide, an industrial bleaching agent, that has been falsely promoted as a cure for illnesses including HIV, cancer and the common cold.
Consequences are often far beyond the individual, and I think folks believe they're too smart to get caught in the fallout of someone else's decisions. Oops, Karen from HR brought in deadly nightshade muffins to share ("small amounts are said to be good for the liver, I heard it on my favorite podcast!").
There's a middle ground here, where if it's dangerous enough, we don't allow it to be sold. It's not one way or the other. That's dangerous thinking in and of itself.
Gasoline + air is a high explosive. Most fluids at a hardware store are poisonous and some of them taste sweet. The MSDS for the things under your sink will tell you all the ways they can destroy you.
You can have hydrofluoric acid send to your front door. It can kill someone if you spill it on them, but it also has legitimate uses and is such a simple compound that there is no point in prohibiting it because anyone can make it themselves.
Dangerous things are widely available and everywhere and it's rarely a problem.
> Oops, Karen from HR brought in deadly nightshade muffins to share ("small amounts are said to be good for the liver, I heard it on my favorite podcast!").
https://www.amazon.com/Belladonna-Seeds-Atropa-belladonna-Fl...
> There's a middle ground here, where if it's dangerous enough, we don't allow it to be sold.
Many of the things all around us are even more dangerous than the things that have been banned.
If you ask someone to choose a central example of things they think should be banned, they'll often start with military explosives like C-4. Military explosives are designed to be stable. You have to use a blasting cap to set them off because the last thing you want is unintentional detonation.
If you fill your house with propane or natural gas, the slightest spark from anything will vaporize the entire building and everyone inside. Natural gas is dramatically more dangerous than C-4.
But C-4 is scarier because Hollywood shows it being used in a different context, and that's how politics decides what's banned.
And once you get into the banning things business (because you have to ban C-4, don't you?), people relentlessly want to add more things to the list. Which doesn't happen in any more principled a way.
Most would assume a supplement is safe. If it isn't, we shouldn't be allowing advertisers to lie. Everything you mentioned is upfront about purpose, it doesn't mislead people to use it in a dangerous way.
I'd be okay with the FDA allowing dangerous things to be sold, so long as the product explicitly said it was dangerous and not to be used in anything other than the proper way.
That's an odd take.
Where do these uncorruptible angels live ? Who are they? Who put them there?
Because we all know you are not corruptible, its always the other guy, right?
What about by rights , by the way ?
What could go wrong?
You’re not allow to start an airline without adhering to regulations.
You’re not allow to sell certain unapproved pharmaceuticals or medical devices.
This is a relatively narrow scope.
This comes from a facet of human psychology: If you do something and people die then you're a murderer, but if you do nothing and people die you're allowed to shrug and go home. This may be a reasonable heuristic when deciding whether you should do something but it isn't when deciding whether to prevent someone else from doing something.
Certainly if an elemental analysis is required to ensure that the heavy metal content is lower than 1 ppb, it means something like a comprehensive SEM-EDX is required for every single batch. This should be required to avoid things like not noticing the enormous addition of lead chromate into turmeric, but it does require caring a bit about quality, and caring about quality in this way won't occur in a free market economy without some checks.
The examples of this are everywhere, even in things as basic as water. If you ever want to worry yourself, learn a bit about characterization techniques for determining the amount of heavy metals or organic molecules ("forever chemicals") are in water to ppt levels. It's astounding how much different techniques will provide wildly different answers, and it's unclear which method to believe.
When you look closely enough, it can get pretty scary how little we know about what is in our products.
Dude what? Government around the world are constantly catching corporations for lying on their product lists.
As for controlled substances, on this topic is a completely fine line which I’d probably tend to agree is not treaded properly. There are risk trade offs to allowing open markets on classes of drugs.
With that said, the massive propaganda campaigns corporations get up to completely subvert that risk, and 100% leaves consumers uninformed even with the proper information at their fingertips: as a major example, the opioid crisis, leaded fuels, leaded paints, carcinogenic materials handling. I mean, the list really goes on and on.
The issue with the FDA has time and time and time again been demonstrated to be how toothless it is. Corporations constantly ignore regulation for billions in profits, only to receive a sternly worded letter and MAYBE a 0.01% of profits fine.
In my mind, the question is whether the massive regulatory burdens which protect incumbents and inhibit liberty are worth it. This is not an all-or-nothing question, and might be answered field-by-field, but regulators have not covered themselves in glory.
Btw how is a government responsible for Theranos? There was never a product there, just promises burning VC money. Wirecard is more a failure of trusted independent auditors (one of the big 4) that failed to do a proper international audit.
https://theconversation.com/how-theranos-faulty-blood-tests-...
https://www.sec.gov/litigation/litreleases/lr-24069
Wirecard was actually a much worse regulatory failure in that the regulator attempted to prosecute the reporters which revealed the affair. Not only did the regulator fail to uncover either side of Wirecard's illegal behaviour, they went after the people who did.
https://www.ft.com/content/4ebd9032-d3d1-4a9e-976c-d1235448e...
Obviously you have to interact with the government if they catch you lying. You're not intended to lie.
The point is that you can have a labeling requirement and businesses can comply with it without having to make regulatory filings or prohibiting products.
> There are risk trade offs to allowing open markets on classes of drugs.
Which is why you have labeling requirements. This is cocaine, it's highly addictive, you probably want to try ibuprofen first.
So for example, manufacturers cannot market erbitux as a cure for migraine headaches because no sponsor has submitted an application to FDA with compelling evidence that it is safe and effective for that particular indication. However, your doctor can still prescribe it for migraines if they so choose. Whether your insurance will pay for it is a different story.
They can prescribe a drug which is not FDA approved, can they?
You also have the question of which drugs need a prescription or are considered a controlled substance, which is certainly government regulation regardless of whether or not the regulatory agency is the FDA.
Yes they can. They can give you whatever medical advice or prescribe whatever regimen they want. They could tell you to drink bleach and the FDA would be powerless to do anything about it.
I think the strongest argument for you would be a drug approved in another country; but not in the US. Your doctor can still prescribe it; and under the right conditions that prescription can allow you to obtain the drug in a foreign country and bring it back to the US.
https://www.fda.gov/consumers/consumer-updates/5-tips-travel...
Saying that, the search returns hundreds of other supplements in the same category, with similar nonsensical names. They are certainly attempting to play wack-a-mole.
However, I am curious to see how Amazon handles the other drugs. Seems like pausing the sale of the entire category is the right call
E.g. these or similar tainted supplements could be listed under "Health, Household, and Body Care" (a very broad category that already has products like "stripfast5000 Fire Bullet Capsules with K-CYTRO for Women and Men" listed under it), etc.
I'm not sure the regulation here is great. As with Rx-only contraception, these regulations force patients to spend money and discuss their intimate life with a doctor for no real reason, which many people find difficult. And it's not like you undergo thorough screening to get Viagra anyway. A doctor is not gonna say "no".
The problem with bodies such as the FDA is that once they address grave risks, they seldom reach this point of "OK, we fixed the problem of arsenic in patent medicine, so let's scale back for now." Instead, the bureaucracies only grow. Today, far too many drugs are Rx-only and stay this way for too long. The need for prescriptions for equipment such as eyeglasses or contact lenses is hard to justify too.
If wrongly prescribed equipment can cause harm, it's very justifiable that a license scheme is put in place.
Sure, and the parent comment's point was that there's a line where further risk reduction doesn't make sense anymore. The agency doesn't have the right incentives to stop at that line.
Plenty of very significant risks aren't regulated to the degree that Viagra and Cialis are. You don't need a note from a doctor or a govt-issued permit to buy kitchen knives or a table saw or a Bic lighter, for example.
Viagra and Cialis have a singular use and contraindications aren't likely to be understood through cultural osmosis.
Given the bipartisan war on drugs, I think we are a long ways off.
* Checking the published label of items for illicit content
* Checking the contents of one bottle for undeclared ingredients
* Checking the contents of all bottles for undeclared ingredients
* Checking the contents of all pills in all bottles for undeclared ingredients
...etc. I guess what I'm wondering is, what course of action do you think is reasonable for Amazon to take here? It's easy to say "don't allow this to happen"; I'm curious about what that actually translates to in practice.
It translates into "don't allow this to happen," because any other standard can and will be gamed. So for instance testing a bottle or two at random would work fine if Amazon really does test a random and representative sample of what's being sold, and to me that's a reasonable level of diligence to expect. But if Amazon Testing emails the supplier: "Please send over a batch of X MAX SUPER ENERGY so we can test if for these substances which we hope we won't find, and make absolutely sure what you send is the same thing you're selling!" -- then that will work somewhat less well. There are endless ways for Amazon and sellers to wink and nod and skirt the intent of the rules, if Amazon is just checking a box for the FDA, and doesn't actually care.
The way to get Amazon to care is to hold it responsible for the outcome. Of course there will be sellers that find a way to skirt whatever process Amazon puts in place, but that needs to be Amazon's problem. Amazon can survive taking its lumps when it messes up.
No argument that that's burdensome and makes it more expensive to run an online marketplace; of course it is. But what's the alternative? Pure buyer beware doesn't work when I can't physically inspect what I'm buying and there's often no way to know much of anything about the seller. Hassle-free returns are nice when you're only out money, but undisclosed drugs in supplements can be genuinely dangerous. A refund isn't going to fix things in the really bad cases.
This is how liability has worked in the American and British legal systems for at least three centuries: when there's been harm done, the person harmed can recover the full value of the damage from any party that helped cause the harm. Plaintiffs don't need to worry about who was most at fault; that's for the defendant to work out with the other parties afterwards. Similarly the FDA can't and shouldn't need to start a separate regulatory action for every seller on Amazon's platform. It's totally appropriate for them to lean on the large domestic company with the fixed address and known officers, and rely on Amazon to enforce compliance with the law down at the seller level.
Businesses that sell supplements should create trusted relationships with their suppliers to not break the rules and to limit their own liability.
The only reason you'd need to go after Amazon is if they're selling products dropshipped from another country, which they could avoid by simply requiring sellers of products meant for human consumption to have a domestic presence. They wouldn't even have to ship from here, just have somebody here who gets arrested if they break the law.
From what I can tell, Amazon does not present itself as a farmer's or flea market, yet it tries to limit its liability by pretending it does. To the average consumer things purchased from it come "from amazon", as compared to ebay which makes it much more obvious you are purchasing from a particular person or shop.
Amazon really tries to have its cake and eat it too here, and it sort of blows my mind that consumer product safety regulators haven't clamped down on this.
It's really one thing to have basically anything available on ebay/aliexpress/others (consumer trust is much lower) and another to be a huge retailer (just like walmart) and yet to be able to sell whatever unsafe stuff you want (unlike walmart).
Amazon will send you another one, possibly from a different seller. That's... weird. It's like they inverted the model where the wholesaler sells to the retailer who sells to the customer. Instead the retailer sells to the customer through the wholesaler, combining different kinds of products into a warehouse instead of splitting up a warehouse with large quantities of the same product into smaller retailers.
But you still want to put things like this on the "retailer" because they're the one who knows anything about the product. It's the same reason you don't put it on eBay or UPS or a self-storage place. And the same reason you don't need to -- you want to shut down or punish the retailer selling the fraudulent product, not all the other retailers or the surrounding infrastructure providers.
Walmart is not a 'marketplace', yet they could easily give you a replacement product from a different 'wholesaler', just like Amazon can give you a replacement from a different 'retailer'. There is no material difference here. Amazon owns everything about the interaction, they have just creatively outsourced creating product listings and a bunch of product risk.
How can they just create a new account to sell supplements without thorough testing, vetting, control processes, etc. by Amazon, the business actually selling the stuff? If Amazon doesn't have such controls in place to stop people from "just creating new accounts" then hold Amazon liable.
Because they, not Amazon, are the business actually selling the stuff. Amazon is a payment processor and a warehouse provider.
You go after the person who knew they were breaking the law, not their landlord or their bank or the dealership where they bought their car by accusing them of not thoroughly investigating their customers. Criminal investigations are the role of law enforcement, not private businesses.
That is legally questionable. When Amazon was losing on that issue in Pennsylvania higher courts, they settled to avoid having an on the record decision that Amazon was liable.[1]
[1] https://www.villanovalawreview.com/post/890-oberdorf-v-amazo...
https://www.quality-supplements.org
Although, I have no clue if USP simply rubber stamps it once time, or if they do continuous testing of the products. If I were to bet, I would say they probably do not test often enough after initial certification.
I think the policy mechanism here should be liability:
* If I buy a counterfeit memory card on Amazon, and it loses my photos, Amazon should be liable for the cost and effort of those photos. If I am poisoned with bad medicine, Amazon should be liable for the damages.
* If I spend money on 400TC cotton sheets, and get 300TC cotton/poly blend ones.
* If I write a book, and Amazon sells pirated copies, I should receive damages.
* If a bad medical product injures me, or doesn't have the intended effect, Amazon is liable (with standard astronomical damages)
Critically:
* It should be easy to extract those damages (Amazon can't tie me up in court or arbitration), and when this happens at scale, this should be class action or federal / state enforcement.
* Damages should include reasonable costs of enforcement. They should also be set at a minimum at treble damages, since not all instances will be caught / enforced.
At that point, the actuaries can do their thing on reasonable level of effort Amazon should put in. That may be shutting down all fulfilment-by-Amazon, co-mingling, and marketplace sellers, very different fee structures, inspections / enforcement, or something else. I don't know.
I actually think the most likely outcome is a verified supply chain, where Nestle (or any other manufacturer) sends to Amazon and Amazon to me with no middlemen. Vendors in compatible enforcement regimes with appropriate treaties (e.g. US and EU) are allowed in, so long as they have everything in order (corporate registration, etc.) and are selling under their own name. Vendors where the long arm of my local justice system doesn't quite reach aren't allowed in, at least directly, unless Amazon does a lot more scrutiny to the level to the point where I have similar guarantees about product safety, quality, environmental impact, labor laws, IP, etc.
I would not set a similar bar for eBay or Aliexpress, which claim to be marketplaces and not stores. However, when I buy from Amazon, Walmart, Target, etc., I believe that I am buying from a store (even if the fine print says otherwise). I'd want a very clear distinction between the two. Part of the way Amazon got itself into deep trouble is by trying to mix the two up. If I'm shopping at a flea market, it's caveat emptor, and those can be fun for some things. If I'm shopping at a store, I expect a certain level of trust.
What is clear, though, is that Amazon isn't self-policing, and we need regulatory enforcement.
Verification only needs to be good enough to stop low effort fraud. This is entirely doable.
They also need to ensure the product you buy comes directly from the seller you bought from.
They need to prevent counterfeits from random sellers getting added to inventory of legitimate companies.
Separating inventory by seller is 100% doable. My company manages it. It just costs more.
How much cocaine goes via Amazon?
Or ephedrine, or ecstasy... Etc
https://www.nsf.org/consumer-resources/articles/supplement-v...
Amazon.com does have their own certification program for dietary supplements, but it seems like the rules aren't consistently enforced.
https://blog.ansi.org/anab/requirements-sell-dietary-supplem...
But it seems perfectly reasonable that law enforcement should have to play whack a mole. That's kind and of how it works with innocent until proven guilty. I'm not a fan of the whole "you enforce it for us or we come after you" approach. In reality what it means is that gate keepers like Amazon have to put in place policies that are much more strict than the actual rules in order to avoid even a chance of getting hit. Agencies like the FDA know this and use it as a way to put in place de facto policies that are much stricter than they could legislate.
I’m willing to be that there are far more than 25,000 ER visits a year due to OTC drugs.
Sometimes the risks are labeled. Other times they aren’t. And still other times people just didn’t follow the labeled directions.
You can’t assume that every supplement ER visit was because of off-label ingredients or what FDA is saying here. That’s too far of a leap.
I already acknowledged this in the previous post.
However, if you look at the rates of tainted supplements it probably isn’t a leap to assume a fair number can be attributed to unlisted ingredients. Some studies show contamination rates of nearly 60%. Again, I think the mitigation should be proportional to the risk. We might be about to debate what the acceptable threshold is (and I think most would agree it’s lower than the current data suggests) but I don’t think accuracy in labels is too big of an ask.
And what % of "contamination" is dangerous ingredients (when directions are followed) vs harmless? You can’t assume that every contaminated supplement is dangerous. Fraudulent, maybe. Mislabeled, yes.
A good example of where we threw out the upfront controls was COVID relief money, and that was a disaster in terms of fraud. (Admittedly a purely government program, but the same principle applies.)
In this case the FDA is saying everything that includes regulated medications in non-regulated products must be addressed.
Seems reasonable to me. If a company completely ignores regulation, the FDA should have to power to enforce its own regulations.
Spot on. How much process is "due" is largely a function of the potential downside consequences of a mistake by the authorities.
Examples (from U.S. law):
• A police officer can briefly stop you on the street to ask a question such as "did you see what happened?" pretty much at will.
• To detain you or search your person or property, the officer (with some exceptions) needs probable cause, in most cases confirmed by a neutral, independent judicial authority (that's the warrant requirement).
• To imprison you or fine you, the government must affirmatively establish your guilt beyond a reasonable doubt, to a neutral jury of your peers, using evidence that meets established legal standards of reliability.
• In all civil cases, a claimant seeking damages must put on admissible evidence affirmatively showing facts that legally entitle the claimant to the requested relief.
• In certain grave civil matters, such as claims of fraud, the claimant must prove the claim by clear and convincing evidence, the highest standard of proof in civil law. (The usual standard in civil cases is "preponderance of the evidence," i.e., more likely than not.)
• In some cases, the testimony of witnesses "having an interest" (e.g., an agenda to advance, an axe to grind, a score to settle) must be supported by corroborating evidence because the law recognizes that such witnesses can sometimes be, ahem, unreliable.
Usual caution to readers: IAAL but not your lawyer.
If you understand how tough it is in one case, think how many trails yearly never get done because of the FDA.
The amount of benefit vs. the amount of deaths caused by the FDA being slow likely means many more are deaths at the hands of the FDA than you expect.
Cracking down on supplements that people take voluntary hardly seems like something I’m pleased they meddle with too.
I am very happy they crack down on supplements, a kind of product that is filled with fraud and that I lack the resources to make informed purchases on. I would also be just as happy if they started cross-approving drugs with the EU and Australia. They are neither angels nor the devil.
Though I do think Amazon should have a share of the blame. Buyer and seller are both wrong here.
The mislabeling is certainly a problem, but really these drugs (sildenafil and tadalafil) should be over-the-counter and cheaply available on Amazon as generics. That they are not is a failure of the same FDA. They have a great safety profile and limited contraindications, comparable to many other OTC drugs.