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Amazon receives FDA warning letter for supplements with undeclared ingredients

fda.gov

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Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#301

Post by serial_dev »

altairprime wrote: post #241
toomuchtodo wrote: post #3

Earlier quoted context omitted.

The FDA likely needs a data team if they don’t have one already to monitor Amazon for ongoing compliance. Similar to the SEC’s data team that monitors capital market data flows for anomalies that would indicate illegal behavior. 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. https://usajobs.github.io/microsite-data-scie…

If Amazon fails to comply with the auditing requirements imposed by law, their entire retail shipping business could be closed by the US federal government. The FDA need only prove that Amazon has a pattern of negligence in their product auditing duties under law, in order to impose severe penalties, up to and including shuttering Amazon FBA. The FDA is not required to perform inventory assessments as a free service…

I assume it's still a move with lots of politicking involved, so they need to stand on solid grounds, proof and all, I don't think they would every take lightly closing down vone of the biggest companies of the country (and the world).

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.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#302

Post by AnthonyMouse »

kayodelycaon wrote: post #285
psychlops wrote: post #258

Earlier quoted context omitted.

"A business should only be permitted to exist if the government allows it." What could go wrong?

That’s a bit of a stretch. You’re not allowed to start a business selling cocaine. 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.

Pharmaceuticals and medical devices have life and death implications. But prohibiting a life-saving product is just as deadly as allowing an unsafe one, and there are existing mechanisms that punish the sellers of dangerous products (it comes out and they lose their customers and get sued).

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.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#303

Post by stefan_ »

dopa42365 wrote: post #36
pbj1968 wrote: post #16

Heard a talk once by someone that managed nutrition for an NFL team. She said periodically clusters of players would pop positive for meth and inevitably it would be some new supplement that was giving them results and they told all their teammates about it. They’d just tell them to quit using it and move on. Interesting story, possibly true.

Any even remotely WADA compliant drug testing uses chromatography, this story is most likely false.

That's the joke, they are non-WADA compliant on purpose - American NFL and other sports leagues are rotten with steroid abuse and more. And the reason the teams run their own "anti-doping" is so they can know about it before, not because they are beacons of purity.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#306

Post by lwhi »

bjt wrote: post #292
lwhi wrote: post #271

Earlier quoted context omitted.

It's the job of a regulatory body to reduce risk. If wrongly prescribed equipment can cause harm, it's very justifiable that a license scheme is put in place.

> It's the job of a regulatory body to reduce risk. 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 tabl…

Kitchen knives have multiple uses and discretion through education is expected as standard.

Viagra and Cialis have a singular use and contraindications aren't likely to be understood through cultural osmosis.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#307

Post by AnthonyMouse »

ben_w wrote: post #297
AnthonyMouse wrote: post #294

Earlier quoted context omitted.

You're assuming that people would disregard the labels. But people with allergies don't disregard the labels, they buy a different product. Most others don't care if it has traces of nuts or not because nuts aren't going to kill them, so those products find a wide market of people who are perfectly safe eating them. California says that everything causes cancer because everything kind of causes cancer and their label…

> But people with allergies don't disregard the labels, they buy a different product. 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…

> 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.

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?

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#308

Post by AnthonyMouse »

Retric wrote: post #299
AnthonyMouse wrote: post #294

Earlier quoted context omitted.

You're assuming that people would disregard the labels. But people with allergies don't disregard the labels, they buy a different product. Most others don't care if it has traces of nuts or not because nuts aren't going to kill them, so those products find a wide market of people who are perfectly safe eating them. California says that everything causes cancer because everything kind of causes cancer and their label…

> You're assuming that people would disregard the labels. 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…

> People do disregard labels including those with allergies.

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.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#309

Post by ben_w »

AnthonyMouse wrote: post #307
ben_w wrote: post #297

Earlier quoted context omitted.

> But people with allergies don't disregard the labels, they buy a different product. 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…

> 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. 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 "co…

> Are you proposing that we ban beef gelatin?

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.

Re: Amazon receives FDA warning letter for supplements with undeclared ingredients

#310

Post by LoganDark »

kayodelycaon wrote: post #245
AnthonyMouse wrote: post #237

Earlier quoted context omitted.

> As a side note, this letter is exactly why I think a regulatory agency like the FDA is absolutely necessary. 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 la…

Having things unnecessarily banned is a trade off of enforcing regulations effectively. 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.

> Someone has to decide what substances safe and prevent them from sold.

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.

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