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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

#411

Post by verall »

AnthonyMouse wrote: post #384
verall wrote: post #239

Earlier quoted context omitted.

Every brick and mortar store has to assert the safety and legality of everything they sell or else risk serious liability. 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 particu…

Amazon is kind of a third thing though. They're a warehouse in addition to a marketplace like eBay. If you buy a thing from an auction site and it's defective, the site might be able to get you a refund (or not, if you didn't pay through them), but they can't get you a replacement product unless the seller has one. The site has none to send you. Amazon will send you another one, possibly from a different seller. That…

It's not.

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.

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

#412

Post by trogdor »

serial_dev wrote: post #301
altairprime wrote: post #241

Earlier quoted context omitted.

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 thous…

Let’s assume that the FDA doesn’t shut Amazon down.

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?

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

#413

Post by danaris »

trogdor wrote: post #412
serial_dev wrote: post #301

Earlier quoted context omitted.

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 thous…

Let’s assume that the FDA doesn’t shut Amazon down. 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?

Well, how much information about Amazon's behavior prior to this are you allowing us to take into account in that determination?

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.

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

#414

Post by trogdor »

danaris wrote: post #413
trogdor wrote: post #412

Earlier quoted context omitted.

Let’s assume that the FDA doesn’t shut Amazon down. 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?

Well, how much information about Amazon's behavior prior to this are you allowing us to take into account in that determination? 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…

It’s usually a good idea to be open to alternative explanations, but that wasn’t my question.

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

#415

Post by bilbo0s »

tacheiordache wrote: post #40
toomuchtodo wrote: post #34

Earlier quoted context omitted.

I am not unsympathetic to the disparity you mention, but am advocating that distributor gorillas (like Amazon, but others as well) need strong controls (both regulatory and technical) due to their incentives to not be compliant and the potential negative outcomes (illness, perhaps death even, depending on material and consumer) from non compliance.

Absolutely. And Amazon should also pay for it!

Not how it works.

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.

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

#416

Post by djur »

ben_w wrote: post #404
djur wrote: post #353

Earlier quoted context omitted.

> Like boiled cow bone and skin derivatives in yoghurt. 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?

When you were an infant, did you drink just your mother's milk, or was it thickened with extract of her bones? If you really don't get why the addition of bones turns "normal" into "horror story", I don't know what to add.

I eat stuff with bones in it all the time, as do most humans. I was a vegetarian for years and the inclusion of gelatin in foods where it isn't immediately obvious was certainly annoying. As was the inclusion of non-vegetarian products in cheese, beer, and sugar. Doesn't change the fact that gelatin isn't generally considered a ghoulish or unusual ingredient -- little kids get served big bowls of it! If you have a special diet you need to read labels. That's what they're for.

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

#417

Post by ben_w »

djur wrote: post #416
ben_w wrote: post #404

Earlier quoted context omitted.

When you were an infant, did you drink just your mother's milk, or was it thickened with extract of her bones? If you really don't get why the addition of bones turns "normal" into "horror story", I don't know what to add.

I eat stuff with bones in it all the time, as do most humans. I was a vegetarian for years and the inclusion of gelatin in foods where it isn't immediately obvious was certainly annoying. As was the inclusion of non-vegetarian products in cheese, beer, and sugar. Doesn't change the fact that gelatin isn't generally considered a ghoulish or unusual ingredient -- little kids get served big bowls of it! If you have a sp…

There are many possible reasons for being vegetarian or vegan.

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.

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

#418

Post by msla »

AnthonyMouse wrote: post #396
msla wrote: post #320

Earlier quoted context omitted.

And this is something the "Freedom!"-yelpers don't mention: Yes, adults can be "Free!" to do crappy and dangerous things to themselves, but when it's parents poisoning children, you have to be pretty damned sociopathic to only consider how the rights of the parents are being infringed by regulation. I honestly think some people consider children to be property.

This is assuming the parents are rubes and the government is competent, ignoring the cases when it's the other way around. 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 w…

> This is assuming the parents are rubes and the government is competent, ignoring the cases when it's the other way around.

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.

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

#419

Post by YumanLi »

jacurtis wrote: post #100
bilbo0s wrote: post #17

Earlier quoted context omitted.

If you've ever been with a startup that needed a 510k, you'd know that the FDA regularly monitors everyone for compliance. At least in my narrow domain of medical imaging and treatment planning devices they do. I'd be surprised if they didn't have similar mechanisms in place in every area of their 'jurisdiction'. It doesn't really hurt the Amazons, they're just distributors. Doesn't really even hurt me. If RTP is a p…

As someone who worked at a startup that grew to a significant size in the "Nutraceuticals" industry (the fancy name for supplements), I can tell you that the FDA has nearly zero regulation or monitoring of supplements. 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 whistle…

This is scary to read. I have never been a fan of unnecessarily swallowing medications and will much rather get my nutrients from my food instead

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

#420

Post by everforward »

lokar wrote: post #15
bpodgursky wrote: post #12

Earlier quoted context omitted.

Can we have an honest conversation about whether there's any good reason for Viagra to require a prescription? The barrier right now is that you have to waste 2 hours and $100 to tell a doctor that you have ED. What's the point? It's not stopping anyone except people too poor or busy to jump through the hoops.

A middle ground is to let a pharmacist dispense it after going over side effects, instructions, interactions and existing conditions (without a Rx).

The pharmacist probably doesn't have a medical history. You could have a copy sent to them from your doc.

At that point we're approaching the same level of hassle as just getting a prescription, though.

My proposal would be to create a new type of rx: a "standing rx". Some form of probably-digital rx that your doctor gives you that allows you to buy unlimited quantities of the named drug until the doctor revokes it, and it's easily transfer-able between pharmacies. Digital mostly to provide a means of revoking it that doesn't involve calling the doctor every time you try to buy it, though I'm open to counter-arguments about being vulnerable to hacking.

Then you only have to go through the hassle once, and it's honestly probably easier to have your doctor check the interactions than it is to do yourself. They have nifty tools to do that kind of stuff.

I do still wonder whether it should just be OTC, though. On one hand, the interactions are easy to understand. On the other hand, I routinely see people not read or intentionally ignore the instructions on stuff like tylenol (oh it says 2? I'll take 4, because my headache is bad). The common "do we give adults agency or try to protect them from themselves?" issue.

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