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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

#311

Post by Veserv »

AnthonyMouse wrote: post #237
kayodelycaon wrote: post #2

I’m glad the conclusion says the products lists are not the only ones to which this letter applies. Otherwise Amazon could just remove the products mentioned and make the FDA play wack-a-mole. 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.

> 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…

The problem is that the risk-benefit tradeoff is not accurately labeled and presented.

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.

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

#313

Post by Animats »

AnthonyMouse wrote: post #261
cool_dude85 wrote: post #249

Earlier quoted context omitted.

>And the latter is really what you want, because otherwise Amazon has to play whack-a-mole as the perpetrators just create new accounts 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 li…

> 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? 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 the…

> Because they, not Amazon, are the business actually selling the stuff. Amazon is a payment processor and a warehouse provider.

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...

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

#314

Post by __MatrixMan__ »

tadfisher wrote: post #273
__MatrixMan__ wrote: post #81

Earlier quoted context omitted.

There are a lot of undesirable side effects with that solution. You shouldn't have to be tech savvy enough to host a shopping experience that's competitive with Amazon in order to sell things online. You ought to be able to focus solely on your product and if it's a good one you ought to be able to compete with Amazon Basics on a level playing field--even if it's a field served by Amazon metal. I think we need more s…

Can Amazon even run FBA without comingling? This is the root of the problem; tracing an individual item back to the seller is apparently not possible, so seller reputation doesn't really exist. So either it's not a big enough problem for Amazon to kill comingling, or it's not profitable to do so at Amazon's scale.

I'm pretty sure that if we manage to coordinate an existential threat to Amazon, Amazon will respond by finding a way to do it profitably. The problem is that we're not threatening enough because we're uncoordinated.

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

#315

Post by dreamcompiler »

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).

That would work. Viagra is a blood-pressure lowering drug (that was its original purpose). If you take it with other BP-lowering drugs like nitroglycerin etc, you could pass out or even die.

So some degree of oversight by a medical professional is warranted.

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

#316

Post by AnthonyMouse »

ben_w wrote: post #309
AnthonyMouse wrote: post #307

Earlier quoted context omitted.

> 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 hidd…

> 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.

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

#317

Post by blagie »

1905 wrote: post #234
blagie wrote: post #158

Earlier quoted context omitted.

Here's my list of things I won't buy on Amazon.com: - Anything which goes in or on my body (foods, medicines, etc.). - Anything which is easily knocked off (SD cards, memory, SSDs, etc.) - Bed sheets (oddly enough, you'll often get lies on materials and fabric) - Thing I need reliably / reliably on-time (I cancelled Prime after several shipping issues) Since I cancelled Prime, things added to this list include: - Mos…

> - Bed sheets (oddly enough, you'll often get lies on materials and fabric) It makes you wonder about all those masks people were buying online and wearing 14+ hours a day

I don't wonder. Fakes and knock-offs were rampant on Amazon -- for a long time, more common than genuine product. People tested them. That's especially true for brand names like 3M.

I only bought through trusted supply chains. My masks were made in South Korea, and I bought directly from the manufacturer's US-based distributor.

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

#318

Post by rchaud »

AnthonyMouse wrote: post #237
kayodelycaon wrote: post #2

I’m glad the conclusion says the products lists are not the only ones to which this letter applies. Otherwise Amazon could just remove the products mentioned and make the FDA play wack-a-mole. 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.

> 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…

> 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".

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

#319

Post by altairprime »

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…

I definitely don’t have a well-formed opinion on how likely such an outcome is, but I absolutely believe that discussing that outcome as a serious concern is necessary discussion to have.

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

#320

Post by msla »

ben_w wrote: post #300
RobotToaster wrote: post #257

Earlier quoted context omitted.

> Someone has to decide what substances safe and prevent them from sold. Why? If someone buys deadly nightshade, and gets deadly nightshade, why should the government care?

My mum was a big believer in homeopathy and Bach flower remedies. 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 s…

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.
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