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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

#381

Post by AnthonyMouse »

pfisherman wrote: post #374
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…

Sorry, I do not quite follow. FDA regulates the marketing of drugs, biologics, medical devices, etc. They do not regulate the practice of medicine. Your doctor can prescribe whatever they want “off label”. 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…

> Your doctor can prescribe whatever they want “off label”.

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.

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

#382

Post by AnthonyMouse »

Animats wrote: post #313
AnthonyMouse wrote: post #261

Earlier quoted context omitted.

> 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...

Policy arguments don't depend on what the law is in a particular jurisdiction. Laws are often malleable enough that if you can convince the judge of what should happen, they can reach the corresponding outcome. When that isn't the case, the legislature can change the law. In either event the first step is to figure out how things ought to work and making them work that way comes after.

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

#383

Post by charleslmunger »

cheald wrote: post #298
dahart wrote: post #41

Earlier quoted context omitted.

If we’re going to have an honest conversation, Sildenafil does have some serious potential side effects and contraindications. Googling “why does viagra require a prescription?” I get an answer attributed to Healthline: “due to these severe (but rare) side-effects, Viagra requires a prescription”. At least acknowledge that, it is a good reason. A doc visit does take time but it neither takes 2 hours nor costs $100 fo…

Aspirin has "severe (but rare) side effects", too. Many of the OTC pharmaceuticals we take have potentially nasty side effects. The only 100% safe stuff is homeopathic, and that's because it's not actually chemically active. I'd be a lot more convinced by the argument if it weren't widely OTC in most of the rest of the world. Interestingly, there do seem to be long-term side effects of sildenafil/tadalafil - though t…

As for that "100% safe" homeopathic stuff... https://www.fda.gov/news-events/press-announcements/fda-conf...

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

#384

Post by AnthonyMouse »

verall wrote: post #239
AnthonyMouse wrote: post #227

Earlier quoted context omitted.

For products like this what you need is some entity in the destination jurisdiction responsible for asserting regulatory compliance. That doesn't necessarily have to be Amazon -- it wouldn't be Visa, for example -- as long as there is some domestic manufacturer or domestic importer the FDA can go after instead. And the latter is really what you want, because otherwise Amazon has to play whack-a-mole as the perpetrato…

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'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.

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

#385

Post by Retric »

AnthonyMouse wrote: post #308
Retric wrote: post #299

Earlier quoted context omitted.

> 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 signifi…

> “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.

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

#386

Post by lotsofpulp »

kayodelycaon wrote: post #224
thfuran wrote: post #204

Earlier quoted context omitted.

It seems like a bizarre gap between food and drugs that shouldn't exist. If it's meant to be eaten, the FDA should definitely be regulating it thoroughly.

The FDA still requires supplements to follow safety standards and be properly labeled, but you do not need approval to make them.

Requiring someone to follow safety standards but never spot checking them to ensure they are might as well be not having any safety standards.

See

https://inspection.canada.ca/food-safety-for-industry/food-c...

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

#387

Post by pfisherman »

AnthonyMouse wrote: post #381
pfisherman wrote: post #374

Earlier quoted context omitted.

Sorry, I do not quite follow. FDA regulates the marketing of drugs, biologics, medical devices, etc. They do not regulate the practice of medicine. Your doctor can prescribe whatever they want “off label”. 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…

> Your doctor can prescribe whatever they want “off label”. 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.

> They can prescribe a drug which is not FDA approved, can they?

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...

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

#388

Post by hattmall »

LeifCarrotson wrote: post #346
galangalalgol wrote: post #175

Earlier quoted context omitted.

The FCC should be going after them too. A lot of the wireless stuff they sell isn't registered.

Yes, the FCC should be going after Amazon as well. I have more experience with that as an electrical engineer who's just getting into FDA-adjacent work. 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…

Customs is only barely about checking for prohibited items. It's primarily about collecting the proper revenue for goods. The US isn't very protectionist so customs is extremely loose. In Mexico they are far more concerned about collecting revenue from customers of US businesses so the customs is more thorough. Based on my experience importing there's about a 2-3% chance any sort of inspection is done at all and that's generally just cursory to compare with the stated manifest classification. Not a search for contraband.

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

#389

Post by giarc »

blagie wrote: post #218
giarc wrote: post #199

Earlier quoted context omitted.

Hate to break it to you, but Aliexpress is likely less reliable than Amazon (or have the exact same products). eBay is likely the same and Walmart allows 3rd party sellers so it's pretty much the same as Amazon unless you source the products curated by Walmart.

I think you misread my comment. I'll go to Aliexpress and eBay first for: "kids toys, cables, generic keyboards, battery chargers, basic tools, and basic clothing." I have the exact same list for them as for Amazon. I'll go there first for those products since Aliexpress has much better prices than Amazon. eBay has better seller reviews. I certainly wouldn't buy food or medicine from them, though, or even bedsheets o…

Yes you are correct. I thought you meant you now go to Ali/eBay/walmart.com as first choice for any purchase. My mistake.

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

#390

Post by AnthonyMouse »

diob wrote: post #274
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?

I mean, can't you take this to the extreme and see why it is a bad point of view. Anything is sell-able as long as we slap a warning label on it. That seems like a recipe for disaster, right? We sold a highly radioactive substance to Jim, and endanger more than Jim. 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. O…

> We sold a highly radioactive substance to Jim, and endanger more than Jim.

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.

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