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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

#261

Post by AnthonyMouse »

cool_dude85 wrote: post #249
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…

>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 they bought their car by accusing them of not thoroughly investigating their customers. Criminal investigations are the role of law enforcement, not private businesses.

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

#262

Post by RobotToaster »

blagie wrote: post #158
throw__away7391 wrote: post #5

Nothing bought on Amazon should be consumed or applied topically or otherwise come into prolonged contact with your body. I learned this the hard way a few years back with some counterfeit shampoo that severely burned my scalp after a single use.

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)

Happens with clothes too, had to return several linen shirts for this reason.

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

#263

Post by treprinum »

ssgodderidge wrote: post #197
1920musicman wrote: post #171

Earlier quoted context omitted.

I searched for all products mentioned in the letter - they are all gone. Amazon is quick to react to such public letters to pretend that they are a responsible company. 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.

I think the speed to remove the noted items isn’t suspect; it’s what I would expect a responsible company to do in this scenario. 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

Amazon bans all sellers that ever attempt to sell/list anything Amazon bans even if the ban was not made public (unless they pay their "consultants" closely connected to managers to unban them of course).

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

#264

Post by pardoned_turkey »

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.

Well, on the flip side: the whole reason these are sold is that the FDA is preventing the substance from being sold OTC. This is not an example of a manufacturer putting something unwanted in the product. It's all just a wink-wink-nudge-nudge kind of a deal with willing buyers. It creates some risk of accidents, but I doubt there were any.

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.

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

#265

Post by abracadaniel »

schemescape wrote: post #174
bradfa wrote: post #111

Earlier quoted context omitted.

At least Walmart lets you easily filter search results for only things sold by Walmart itself. That makes it fine by me to be both a seller and marketplace. Amazon does not make such filtering easy at all.

Anecdote: I filtered to “sold by Walmart” (I forget the exact terminology, but customer support confirmed it was not from a marketplace seller), but the item I received had an Amazon return label and was shipped from an Amazon warehouse. That was the last time I bought from Walmart in an attempt to avoid Amazon’s shenanigans.

There is absolutely a tier of marketplace seller that bypasses that filter. I was trying to buy rechargeable batteries just yesterday and noticed this. If you look carefully, they are still listed as sold by a marketplace seller. Very frustrating, as it’s gotten nearly impossible to find a retailer that isn’t secretly selling me crap from the back of someone’s van.

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

#266

Post by Scoundreller »

tonyarkles wrote: post #255
Scoundreller wrote: post #156

Earlier quoted context omitted.

I’d be surprised if the buyers were expecting any different. With the amount of mislabelled product out there in circulation (and presumably a general lack of harm), does it still make sense to require a prescription?

I'm personally pretty torn on that. On the one hand I agree with you, especially from a harm-reduction perspective (e.g. people who are on blood pressure medication ordering "natural" Viagra because Viagra's contra-indicated with the medication they're on, not realizing that they're getting something that could cause a very bad situation). On the other hand, requiring a prescription does mean that a physician can ask…

It’s pretty much just an interaction with “nitrates” which are typically taken by people with pretty serious cardiac issues, and usually educated re: the side effects if taken with viagra or similar compounds (cuz you never know if someone has Viagra in their drawer from another pharmacy or years ago or “natural” Viagra from another source).

The interaction with other blood pressure meds appears additive rather than synergistic and Viagra alone only minimally reduced blood pressure. The cough and cold aisle or a cafe presents more dangers.

https://pubmed.ncbi.nlm.nih.gov/10078539/

At least over the counter Viagra would be properly labelled about these things.

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

#267

Post by dahart »

JumpCrisscross wrote: post #214
dahart wrote: post #198

Earlier quoted context omitted.

> The point is the forced choice is flawed. There wouldn’t be a market for the adulterated stuff if the medicine were OTC. You haven’t convinced me that there’s anything wrong with the regulation. There might be, but again, the existence of a black market is not a valid reason to relax the regulation. The black market exists for guns and heroine and antibiotics and certain types of illegal porn too, not to mention cr…

> wouldn’t argue any of those should be less regulated just because you can buy them on the black market I’d use that as evidence there is demand. Then I’d consider the harm of looser controls. The harm balance for Viagra seems minimal, particularly given so many people take it without bothering with a prescription. If you think Viagra is in the same harm bucket as guns and heroin, then yes, it makes sense to regulat…

Demand is not a valid reason to deregulate, that’s exactly the same argument as the existence of a black market argument. And it doesn’t have to be in a severe harm bucket as heroine to deserve deregulation, it has to be relatively safe, and not have big contraindications with others commonly used medications.

Better reasons to deregulate would be that it’s shown as safe or safer than existing OTC products, that many other countries offer it OTC, or that Viagra provides a compelling health benefit when used safely. The benefit is there for some specific cases, but quite questionable broadly speaking, given that it often gets used casually and to help men who don’t truly need it, to party when they’re drunk or whatever. The safety has been reviewed and deemed worthy of a prescription gate, and it’s not a hard gate to get through at all, the top comment exaggerated it. Maybe it’ll change and get deregulated, but I guess I don’t really even see why deregulating Viagra would be a net positive for anything other than Pfizer’s pocketbook.

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

#268

Post by hibikir »

ineedaj0b wrote: post #256
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.

I don’t want to sound like a nut job, but please look into how much the FDA hampers drug trails. 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 hardl…

It's possible, and even a good idea, to say that the FDA massively overregulates drug trials, while at the same time also say that the current supplement market is almost just as massively underregulated, and would be far healthier with more oversight. Organizations, just like people, can do good and bad things at the same time.

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.

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

#269

Post by Eji1700 »

RobotToaster wrote: post #257
kayodelycaon wrote: post #245

Earlier quoted context omitted.

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. Why? If someone buys deadly nightshade, and gets deadly nightshade, why should the government care?

Basically for the same reasons they don't let you buy other toxins/dangerous materials with almost no alternative use?
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