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Amazon receives FDA warning letter for supplements with undeclared ingredients

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

#401
post #385

Earlier quoted context omitted.

> “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…

So the labeling requirements need a sliding scale. There still isn't anything to ban.

Not just a sliding scale but an accurate sliding scale with inaccurate labeling resulting in a ban.

However, allergies aren’t universally harmful. There’s no compelling reason to allow food products with high levels of heavy metals.

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

#402
post #355

Earlier quoted context omitted.

> Which is a highly context-specific evaluation, so is it better decided by the person with the most knowledge of their own circumstances, or across the board with no context at all? It depends on the context. In many, many contexts, people are explicitly not the people with the most knowledge about their circumstances. When I'm crossing a pedestrian foot-bridge, I have much less knowledge about whether this particul…

> When I'm crossing a pedestrian foot-bridge, I have much less knowledge about whether this particular bridge is safe or not than the people who built it and the regulators who regulated it. Which is why we communicate. If the bridge has loose stones, you put up a sign that says the bridge is hazardous and has loose stones and provide a map with an alternate route. Now the person who comes up to the bridge knows that…

> If the bridge has loose stones, you put up a sign that says the bridge is hazardous and has loose stones and provide a map with an alternate route.

This is quaint, but not actually the problem. The problem is that every bridge manufacturer will cut corners on materials and design (because it's cheaper) meaning that there will be zero safe bridges. The bridge manufacturer's incentives do not line up with its users.

When I walk up to a safe-looking bridge, how am I supposed to know it's been made with insufficient rebar or dodgy concrete until it's collapsed on top of me? A sign?

> If a person in a situation makes a judgement call and they're wrong, they could die. If a legislator makes a judgement call for everyone all at once, people will die because different people will be on different sides of the trade off, possibly more of them than would otherwise if they'd each been able to make their own decision in context, and certainly some of them who would have lived if they'd been able to choose for themselves and choose differently.

Like I said, it's a balance of harms. There's both appropriate and inappropriate places for government intervention, and we're already legally not prevented (encouraged, even) from engaging in a bunch of very dangerous activities.

But the assertion that legislative intervention will always result in more deaths than letting people "decide for themselves" seems highly dogmatic and unsupported.

> It sounds like you want to trade the lives of people who choose well for the lives of people who choose wrong without even knowing which number is bigger.

We know which number is bigger. Go look at non-natural death rates in much countries with much smaller governments / regulatory frameworks.

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

#403
post #399
post #377

Earlier quoted context omitted.

> It's just super ironic the parent post said they avoid counterfeits and knock-offs by shopping on Aliexpress. Aliexpress is basically counterfeit and knock-off central... It doesn't. You read it wrong. Read it again.

Uh... > Here's my list of things I won't buy on Amazon.com > However, [Amazon.com is] no longer my first source. I'll go Aliexpress, eBay, and Walmart first.

You said "the parent post said they avoid counterfeits and knock-offs by shopping on Aliexpress" which I'm afraid is incorrect given that the post in question said "Amazon [is] no longer my first source [for] generic gizmos, [...] I'll go Aliexpress, eBay, and Walmart first" (if I may rearrange for clarity without changing the meaning).

"Generic gizmos" roughly equates to "counterfeits and knock-offs" in my book, and that commenter isn't trying to avoid them when shopping at AliExpress and formerly Amazon. That's separate from the situations where they do want to avoid knock-offs, listed separately from all of this.

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

#404
post #353
post #309

Earlier quoted context omitted.

> 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…

> Like boiled cow bone and skin derivatives in yoghurt. Yogurt is already made out of bovine bodily fluids. Why is it so shocking and disgusting for another bovine product to be used in it as well?

When you were an infant, did you drink just your mother's milk, or was it thickened with extract of her bones?

If you really don't get why the addition of bones turns "normal" into "horror story", I don't know what to add.

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

#405
post #357

Earlier quoted context omitted.

> But people with allergies don't disregard the labels, they buy a different product. I have a nut-allergic friend who has given up on reading the labels and relies on his own common sense, because the labels are on everything now. (Worse, if you look at what's happened with sesame, manufacturers now deliberately incorporate sesame into their recipes so that they can put the warning labels on, because that's cheaper…

> I have a nut-allergic friend who has given up on reading the labels and relies on his own common sense, because the labels are on everything now. There is a difference between containing nuts and being processed on equipment that also processed nuts. The difference matters more for some people than others. > Worse, if you look at what's happened with sesame, manufacturers now deliberately incorporate sesame into th…

> Why is the company even involved in the process? They produce a new product and it initially gets a label that says it hasn't been tested, which will rightfully deter customers when most existing products don't have that label. The government performs its testing to check if it's harmful, prioritizing based on which new products are expected to be popular, and once published their results go on the label one way or the other.

This a fundamental point of misunderstanding. The government in case of the FDA doesn't test products. They just review the documentation that manufacturers submit. In case of medical devices which are similar to an existing approved medical device (a 410k) for instance the FDA charges $21,760 for this review ($5,440 if you are a small business) and under law has to have the review complete within 90 days.

To compare: performing just one of the required tests such as biocompatibility often costs more.

The FDA also doesn't write labels for you. That is entirely your responsibility as a manufacturer and frankly impossible without having complete insight into manufacturing and design.

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

#406

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, thes…

I'd say step 1 would be respecting the bodily autonomy of citizens to put what drugs they want into their own body.

Given the bipartisan war on drugs, I think we are a long ways off.

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

#407
post #399
post #377

Earlier quoted context omitted.

> It's just super ironic the parent post said they avoid counterfeits and knock-offs by shopping on Aliexpress. Aliexpress is basically counterfeit and knock-off central... It doesn't. You read it wrong. Read it again.

Uh... > Here's my list of things I won't buy on Amazon.com > However, [Amazon.com is] no longer my first source. I'll go Aliexpress, eBay, and Walmart first.

Read the full paragraph yet again, carefully and closely:

Most of what I will buy on Amazon are generic gizmos, like kids toys, cables, generic keyboards, battery chargers, basic tools, and basic clothing (kids pyjamas and that sort of thing). However, it's no longer my first source. I'll go Aliexpress, eBay, and Walmart first.

Reading comprehension questions:

* Amazon is a source for the author for what type of products?

* Author prefers Aliexpress and eBay over Amazon. Therefore, what types of products does the author buy there?

* Does preferring those vendors over Amazon mean or imply that the author will buy things he does not buy on Amazon there instead?

I apologize, in advance, by the didactic approach. Some people, especially from some high-context American communication styles, will believe it implies that I'm being patronizing. However, it is not intended to be; I'm from a different culture with different communication styles. I am using it since it is effective for identifying miscommunications and / or explaining misconceptions. Given that this is my third shot now, I thought it made sense to give it a shot, at the risk of offending people across cultural backgrounds.

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

#408
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) Happens with clothes too, had to return several linen shirts for this reason.

I almost never buy fancy clothes with materials like linen. I do buy fancy sheets :)

With work-at-home, most of my work day is spent in fluffy cotton pyjamas in the winter and simple underpants in the summer from basic-but-large companies like Hanes, Fruit-of-the-Loom, and similar. I'll put on a plain cotton t-shirt and a pair of jeans to go out to the store or whatever. If it's cold, I'll toss on a worn-out long-sleeved t-shirt (the good ones see very little use) and/or a jacket of some kind.

I do have fancy clothing for business meetings, as well as for specific types of exercise, but the total number of hours of usage on those is quite low.

Post-covid life is good!

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

#409

Earlier quoted context omitted.

> 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…

> The purpose of the law is to protect people who act within reason. This is just flat out wrong, and pretty gross. The purpose of the law is to protect people . Not white people, not land-owning people, not smart people, not literate people, not able-bodied people, not "reasonable" people. People. Full stop. Assuming people are reasonable is a recipe for disaster, and ablest. Perhaps one day someone you know will ge…

> Perhaps one day someone you know will get dementia

To further this point with anecdotes, both my mother and my grandmother had dementia.

Gran started a pot of water boiling, left the room, forgot about it, and thought the subsequent smoke alarm was her neighbours'. Mum stopped being able to count past four, and lost general concept of things existing on the left side of objects from her PoV[0].

When my mum noticed my gran had forgotten to renew her road tax (and noticed this six months after it had expired), she hid the car keys until gran forgot she had a car. When my mum got dementia herself, a similar thing happened.

[0] https://en.wikipedia.org/wiki/Hemispatial_neglect which is distinct from https://en.wikipedia.org/wiki/Homonymous_hemianopsia — eating dinner, thinking she'd finished, but left half of her plate was full of food she couldn't see until we rotated it 180°, sketching my face and missing my right (her left), that thing with the clock: https://en.wikipedia.org/wiki/File:AllochiriaClock.png

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

#410

Earlier quoted context omitted.

> The purpose of the law is to protect people who act within reason. This is just flat out wrong, and pretty gross. The purpose of the law is to protect people . Not white people, not land-owning people, not smart people, not literate people, not able-bodied people, not "reasonable" people. People. Full stop. Assuming people are reasonable is a recipe for disaster, and ablest. Perhaps one day someone you know will ge…

Do you really have any idea what a body of laws would look like that treated the public as though everyone has "dementia, ... a stroke," and "macular degeneration"?

"Everyone has" goes beyond what the op wrote.

"Anyone could have" is closer.

From what little of various laws I've looked at (with the huge caveat that I'm not a lawyer), I think they are written to assume the general public doesn't know what's going on most of the time.

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