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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

#421

Post by [deleted] »

ben_w wrote: post #417
djur wrote: post #416

Earlier quoted context omitted.

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…

[deleted]

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

#422

Post by stickfigure »

zopa wrote: post #235
stickfigure wrote: post #185

Earlier quoted context omitted.

Genuine question: What level of scrutiny do you think Amazon should provide here? In vaguely increasing level of detail/effort, it could be... * Checking the published label of items for illicit content * Checking the contents of one bottle for undeclared ingredients * Checking the contents of all bottles for undeclared ingredients * Checking the contents of all pills in all bottles for undeclared ingredients ...etc.…

> It's easy to say "don't allow this to happen"; I'm curious about what that actually translates to in practice. It translates into "don't allow this to happen," because any other standard can and will be gamed. So for instance testing a bottle or two at random would work fine if Amazon really does test a random and representative sample of what's being sold, and to me that's a reasonable level of diligence to expect…

Does Amazon test any other product in its marketplace? I mean, other than Amazon-branded products. That seems like an odd expectation. I don't expect Amazon, or Ebay, or Aliexpress, or even Walmart.com to physically test anything. Mostly I expect them to give me quick shipping, cheap prices, and hassle-free returns or refunds if I'm not satisfied.

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

#423

Post by Eddy_Viscosity2 »

altairprime wrote: post #241
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 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…

> their entire retail shipping business could be closed by the US federal government

Not in this universe. The more likely outcome is that Amazon shuts down the FDA.

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

#424

Post by Forgeties79 »

LargeTomato wrote: post #190
Forgeties79 wrote: post #24

Earlier quoted context omitted.

And I imagine a lot of nutritionists on teams kind of know what’s going on, but are disincentivized from looking too closely at it unless it could really hurt somebody. Or rather, it could hurt somebody enough for someone to notice immediately or impact their performance in the short term. This is obviously armchair speculation, but I’ve seen it in other industries, time and time again. Everyone kind of knows, but no…

It's possible the nutritionists are also duped. They know that giving their athletes X mg of Y gives them better performance. They don't know that their particular X supplement is really just sugar pills and meth.

Totally. I highly doubt there’s only one answer here. Though I would expect a nutritionist to know and understand the contents of any supplement they recommend to an athlete.

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

#425

Post by dahart »

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…

That first paper is not showing a positive long-term effect for healthy men, it’s showing some cognitive return to normal for people who have a cognitive impairment, possibly associated with their ED. It’s wrong to jump to the unsupported conclusion that it might help old people in general. On top of that, 17% of the very small sample had to bail out of the study due to excessive side-effects.

It’s not useful to say other things have side effects without actually comparing magnitudes or dosage. Everything can kill you if you ingest too much. The call the FDA made is about the relative severity and danger level, and they allow lots of things OTC that have side effects. Why do you not believe that Viagra is more dangerous than Aspirin, why are you armchair second guessing that call? I’m pretty sure Aspirin is far safer than Viagra when used as directed, and that people sometimes take a lot of it because it’s a pain killer and believed to be quite safe. Two thirds of Aspirin deaths are attributed to taking high doses, where Viagra is rarely if ever taken with higher than prescribed dose because everyone knows that’s pretty dangerous.

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

#426

Post by rsync »

jetanoia wrote: post #272
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…

Agreed with your post – except on the “Kids pajamas” – they should probably be reclassified under the “Anything which goes in or on my body” list you made. Whether it’s undisclosed flame retardants, toxic dyes, or other harmful substances, kids bodies are generally more susceptible to harm via environmental pollutants. Such harms may not be at all obvious in the short term, but could still be very harmful over the lo…

"I wish I knew of a vastly superior option (ie, safer option) for buying kids or baby clothes."

Just buy the long underwear and "base layer" items from either REI or Patagonia.

Very versatile and utilitarian, last forever, and you can buy them directly from the source - either online or at an actual retail store.

We had patagonia base layer onesies and long underwear, etc., that were handed down across three children.

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

#427

Post by throw__away7391 »

enlightenedfool wrote: post #52
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.

Did you take any action at all? Sounds serious enough for legal action.

I put a negative review which was promptly taken down.

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

#428

Post by throw__away7391 »

jejeyyy77 wrote: post #295
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.

what about brand name items?

This was a brand name item which I'd already been using for years.

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

#429

Post by zopa »

stickfigure wrote: post #422
zopa wrote: post #235

Earlier quoted context omitted.

> It's easy to say "don't allow this to happen"; I'm curious about what that actually translates to in practice. It translates into "don't allow this to happen," because any other standard can and will be gamed. So for instance testing a bottle or two at random would work fine if Amazon really does test a random and representative sample of what's being sold, and to me that's a reasonable level of diligence to expect…

Does Amazon test any other product in its marketplace? I mean, other than Amazon-branded products. That seems like an odd expectation. I don't expect Amazon, or Ebay, or Aliexpress, or even Walmart.com to physically test anything. Mostly I expect them to give me quick shipping, cheap prices, and hassle-free returns or refunds if I'm not satisfied.

I hope I wasn't unclear, I'm not stuck on testing per se. I want Amazon to stand behind what's sold on its site. I don't really care what goes into that: if it needs to physically test products to do that, then it should, but if there's a different/better/cheaper way of getting the confidence to take responsibility than that's fine too.

No argument that that's burdensome and makes it more expensive to run an online marketplace; of course it is. But what's the alternative? Pure buyer beware doesn't work when I can't physically inspect what I'm buying and there's often no way to know much of anything about the seller. Hassle-free returns are nice when you're only out money, but undisclosed drugs in supplements can be genuinely dangerous. A refund isn't going to fix things in the really bad cases.

This is how liability has worked in the American and British legal systems for at least three centuries: when there's been harm done, the person harmed can recover the full value of the damage from any party that helped cause the harm. Plaintiffs don't need to worry about who was most at fault; that's for the defendant to work out with the other parties afterwards. Similarly the FDA can't and shouldn't need to start a separate regulatory action for every seller on Amazon's platform. It's totally appropriate for them to lean on the large domestic company with the fixed address and known officers, and rely on Amazon to enforce compliance with the law down at the seller level.

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

#430

Post by diob »

AnthonyMouse wrote: post #390
diob wrote: post #274

Earlier quoted context omitted.

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 su…

I think you missed the point. All of those things are sold to do the purpose they're meant for. Someone isn't telling folks to drink gasoline. Actually someone probably is. . .

Most would assume a supplement is safe. If it isn't, we shouldn't be allowing advertisers to lie. Everything you mentioned is upfront about purpose, it doesn't mislead people to use it in a dangerous way.

I'd be okay with the FDA allowing dangerous things to be sold, so long as the product explicitly said it was dangerous and not to be used in anything other than the proper way.

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