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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

#81

Post by __MatrixMan__ »

dawnerd wrote: post #57
noodlesUK wrote: post #26

I think with the state of things, Amazon should be completely banned from selling anything that might be construed a supplement. They have such lax controls that your protein powder or vitamin pills might contain pretty much anything. Even reputable brands bought from their brand storefront might be counterfeit [1]. You’d be shocked at the number of things that are counterfeit. A friend of mine recently bought a nich…

The solution is to stop allowing third party sellers. The idea that any random person can get an Amazon seller account and scam their way into being approved for certain categories and just send in anything as long as it has a label is insane (it’s incredibly easy to forge the invoices they request). There’s zero control at Amazon, they frequently put returned products back into new inventory as well which makes buyi…

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 separation between the part of Amazon that handles clicking "buy" and printing shipping labels, and the part that comes up with things for sale. So much separation, in fact, that the former considers the latter to be no more trustworthy than any other company or individual.

Seller reputation should be important, and the medium for determining if a seller is trustworthy should be free from conflicts of interest.

If the user facing part was adequately adversarial about the cardboard facing part it would result in a UI which had no reason to encourage the user to trust the contents of the cardboard, and instead simply presented facts that enable the user to apply their own scrutiny.

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

#82

Post by JumpCrisscross »

dahart wrote: post #74
JumpCrisscross wrote: post #50

Earlier quoted context omitted.

> maybe the minor hurdle of having to require a doc to check on the potential for side-effects really is justified? Viagra is trivially available on the black market because many people don’t want to put up with that B.S. Antibiotics have a public interest in being gatekept; they harm everyone if abused. A similar argument can be made for addictive substances. Merely-harmful drugs, on the other hand, can be disclaime…

Everything is available on the black market, that doesn’t mean regulations are BS, it means people are willing to risk breaking the law to avoid being tracked. The demand for Viagra might have more to do with being embarassed about ED or other fears than with concern about the difficulty of getting it legally. (As another commenter pointed out, the bar is extremely low when using online remote clinics.) What does “me…

> What does “merely-harmful” mean?

Drugs that really only harm the person who takes them if abused. Alternatively, drugs which are unproblematically sold over the counter the world over.

> Everything is available on the black market

Available versus commonly procured.

> that doesn’t mean regulations are BS, it means people are willing to risk breaking the law to avoid being tracked

It means they’re willing to break regulations to get it. We can’t impute motivation.

> how will people know when and how to avoid fatal doses

Same way they do for e.g. Tylenol.

> Why do you assume it might be either effective or safe if diluted?

I don’t. Dilution is a common (and obvious) pharmaceutical tool for increasing the distance between the therapeutic and harmful dose.

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

#83

Post by pfisherman »

bilbo0s wrote: post #17
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 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…

They do not for supplements. Supplements fall under the office of the Director, which is not funded by PDUFA / MDUFA. Supplements are basically the Wild West.

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

#84

Post by werico »

fallingknife wrote: post #27
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'm certainly in favor of these regulations that require supplements and food products to accurately list ingredients. I'm also in favor of the FDA coming down hard on violators. But it seems perfectly reasonable that law enforcement should have to play whack a mole. That's kind and of how it works with innocent until proven guilty. I'm not a fan of the whole "you enforce it for us or we come after you" approach. In…

I totally get where you're coming from, but the problem with enforcement-by-whack-a-mole is that some crimes are very cheap and easy to carry out and very difficult to detect and prosecute. The asymmetry means criminals are incentivized to commit those crimes, and can even become fantastically wealthy by doing so. If there isn't an offsetting risk for them (or control), then they're going to do it. Some of those crimes can ruin victims' lives, and in some cases (like this) people can die. We simply can't afford to use no other enforcement strategies.

A good example of where we threw out the upfront controls was COVID relief money, and that was a disaster in terms of fraud. (Admittedly a purely government program, but the same principle applies.)

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

#85

Post by toast0 »

gehwartzen wrote: post #51
notyourwork wrote: post #35

Earlier quoted context omitted.

I wonder the same thing. It seems like something that at Amazon scale we pick on but at physical store scale we discard as not possible.

I haven't hear about these problems at Walmart and would think the scale of stuff sold is comparable. I think the main problem, as others have mentioned, is that Amazon commingles products from various suppliers (so everything that comes in from a manufacturer or a true vetted wholesaler + 1000's of "flip stuff from china" garage operations get mixed up at Amazon warehouses before being sold).

Walmart is known for having a very tight control over their suppy chains. IMHO, mostly for cost control, but quality control and authenticity are useful side effects.

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

#86

Post by TaylorSwift »

Most supplements are garbage. Since they don't actually work, most people would never know if you replaced their magnesium or calcium supplement with chalk. Some supplements do work, but since they're not regulated, they're drowned out by nonsense and noise. OK, so you don't want to be a rube?...you do your research and then piece of shit fitness influencers tell you "ohh...that vitamin you bought form Walgreens or Costco didn't work?...of course not, you need to buy mine...it's CHELATED!!!!! thus is more BIOAVAILBLE...or some other random scientific work which is either incorrectly used or outright fraudulent.

Half of my family spends a huge fortune on supplements, most of which are placebos. If you're young, you may not understand, but for us over 40, life starts to suck, physically. When you're young, your body is very fault-tolerant...have 6 beers and a cheeseburger for supper every day for a week?...nothing a few tums can't fix. Now that I'm over 40, I do everything right (daily exercise, eat healthy, get sleep, etc) and still feel like shit most of the day....same with most my age...thus we're desperate for anything that will make us feel better and not have any side effects that make things worse.

Supplements are the dream and an age-old scam. Maybe punishing big retailers who tolerate fraud will not only reduce false claims, but make the public more aware that so called health experts online are ignorant, scammers, or both.

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

#87

Post by pfisherman »

I had the opportunity to get a peek at the FDA database of adulterated supplements and by far the most common type of adulteration was people spiking with viagra. I asked why and was told:

“Man has been searching for an aphrodisiac for thousands of years and we finally found it. Of course they are going to put it in everything!”

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

#88

Post by asquabventured »

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.

I had the similar experience back in 2018... Led to temporary hair loss (I remember my hair falling out in tufts) from what I believe was counterfeit hair gel (it smelled different from same product I've used for years). Stopped using the product from Amazon and only ever order from reputable sites like Sephora and Nordstrom now.

Amazon has lost all of my business for consumable goods. It's not worth the convenience to risk my own or my families health. Fuck 'em.

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

#89

Post by bumby »

fallingknife wrote: post #27
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'm certainly in favor of these regulations that require supplements and food products to accurately list ingredients. I'm also in favor of the FDA coming down hard on violators. But it seems perfectly reasonable that law enforcement should have to play whack a mole. That's kind and of how it works with innocent until proven guilty. I'm not a fan of the whole "you enforce it for us or we come after you" approach. In…

I think it's a distinction in risk philosophy. The whack-a-mole approach is "continue until we find you unsafe" while the other approach is "don't start until you prove you're safe". I think both approaches can be reasonable depending on the level of risk. When it comes to supplements tainted with unlisted ingredients that can have harmful or deadly effects for consumers, I personally think the latter is the better approach.

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

#90

Post by ta988 »

TaylorSwift wrote: post #86

Most supplements are garbage. Since they don't actually work, most people would never know if you replaced their magnesium or calcium supplement with chalk. Some supplements do work, but since they're not regulated, they're drowned out by nonsense and noise. OK, so you don't want to be a rube?...you do your research and then piece of shit fitness influencers tell you "ohh...that vitamin you bought form Walgreens or C…

If you replace the Calcium with chalk you would still have a source of calcium so it wouldn't be that bad :D
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