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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

#341

Post by Spivak »

Veserv wrote: post #311
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…

The problem is that the risk-benefit tradeoff is not accurately labeled and presented. Advertising laws in the US mean manufacturers can and should do everything in their power to obscure and mislead about the tradeoff. A person purchasing a unverified product should have tremendous misgivings. They should only purchase it in spite of tremendous misgivings . Anything less is not informed consent; it is deception masq…

> Anything less is not informed consent; it is deception masquerading as informed consent.

Which is why I think the model for such things should just be "informed consent." It's a concept that already exists in the medical practice with a well-defined procedure. Someone who your state medical board has deemed competent and responsible has to explain in painfully explicit detail all the tradeoffs and answer any and all questions. If you still want to do it you sign some forms and go on with your day.

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

#342

Post by AnthonyMouse »

growse wrote: post #332
AnthonyMouse wrote: post #325

Earlier quoted context omitted.

> Unfortunately they cannot consent to conditions like "Don't burden the hospital system if you take the wrong dosage". By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. The government should generally be concerned with preventing deception and coercion and pricing externalities, because otherwise people have the incentive to do them and they would be prolific.…

> By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. It's almost like there's a balance of harms to be evaluated. I'd bet the cheap availability of paracetamol etc. saves more hospital visits than it causes, but I don't have the data to hand.

> It's almost like there's a balance of harms to be evaluated.

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?

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

#343

Post by dctoedt »

dragonwriter wrote: post #195
callalex wrote: post #191

Earlier quoted context omitted.

Innocent until proven guilty only applies to individual people, not corporate entities.

Incorrect, innocent until proven guilty applies generally (but, as “guilty” applies specifically to criminal law, only there, but to juridical persons as well as natural ones; but the concept is not far removed from that of due process, which applies even outside of criminal law.)

> the concept is not far removed from that of due process, which applies even outside of criminal law

Spot on. How much process is "due" is largely a function of the potential downside consequences of a mistake by the authorities.

Examples (from U.S. law):

• A police officer can briefly stop you on the street to ask a question such as "did you see what happened?" pretty much at will.

• To detain you or search your person or property, the officer (with some exceptions) needs probable cause, in most cases confirmed by a neutral, independent judicial authority (that's the warrant requirement).

• To imprison you or fine you, the government must affirmatively establish your guilt beyond a reasonable doubt, to a neutral jury of your peers, using evidence that meets established legal standards of reliability.

• In all civil cases, a claimant seeking damages must put on admissible evidence affirmatively showing facts that legally entitle the claimant to the requested relief.

• In certain grave civil matters, such as claims of fraud, the claimant must prove the claim by clear and convincing evidence, the highest standard of proof in civil law. (The usual standard in civil cases is "preponderance of the evidence," i.e., more likely than not.)

• In some cases, the testimony of witnesses "having an interest" (e.g., an agenda to advance, an axe to grind, a score to settle) must be supported by corroborating evidence because the law recognizes that such witnesses can sometimes be, ahem, unreliable.

Usual caution to readers: IAAL but not your lawyer.

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

#344

Post by riversflow »

AnthonyMouse wrote: post #335
riversflow wrote: post #324

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…

I hope your argument isn't that only white people can exercise reason. If you have a mental illness you can go to the store and buy rat poison and eat it. The law doesn't address this by prohibiting rodenticides. If you think you can fly and jump off the roof of a parking structure, the government can't disable gravity. Acting within reason in that context is getting treatment, which is a whole different set of laws.

My argument is that you are picking a specific group and saying the law is only for them.

>If you think you can fly and jump off the roof of a parking structure, the government can't disable gravity

The law can make it so you have guardrail on your roof if it is publicly accessible. The law can also make you put up suicide guards if it's really a problem, all of my favorite bridge have them now.

> The law doesn't address this by prohibiting rodenticides.

Rat poison has actually been getting more scrutiny lately, the traditional pellet form was banned this year in favor of bricks in the US, and non-professional exterminators are limited to buying it a pound at a time. Also, rats are a real pressing problem that is being handled with rat poison. Without it, we go back to food security problems related to controlling pest populations. The same can't be said in reverse, we don't have a real, pressing problem with an overabundance of safety.

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

#345

Post by lumb63 »

lostlogin wrote: post #123
lumb63 wrote: post #65

Earlier quoted context omitted.

Calling for Amazon to be banned from selling supplements is extreme, IMO. But they should be accountable for preventing counterfeit items from being sold or marketed as the items they’re counterfeiting. In cases where the authenticity of the item has not been verified, that should be made clear to the buyer. Absence of such an indicator would mean the product is authentic (consumers should IMO be able to rely on prod…

> Calling for Amazon to be banned from selling supplements is extreme If a physical store near you sold fake everything, including supplements, you’d think it extreme to shut it down?

Wouldn’t it be better for all parties involved to keep it open and implement regulations requiring they be honest about products? The customers could use the marketplace to get the products they actually want, and the business gets to benefit.

Note that idea isn’t mutually incompatible with penalizing the company for all the counterfeit products it sold/marketed.

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

#346

Post by LeifCarrotson »

galangalalgol wrote: post #175
LeifCarrotson wrote: post #61

Earlier quoted context omitted.

> It doesn't really hurt the Amazons, they're just distributors. I'm doing my first FDA-monitored automation project at a local brewery, and am quickly becoming familiar with the abundant controls that the FDA puts on domestic producers. But the FDA is an American organization. Amazon or Ebay or Aliexpress or whoever may be just distributors, but they're international distributors. They're fully-automated self-servic…

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 Alibaba, Aliexpress, Banggood, Wish, Temu, Shein, Gearbest, or whatever new discount importer is hot I can't keep up anymore, or Ebay/Amazon/Target/Walmart.com, they're just going to create a listing and import it. The FCC simply cannot keep up.

What I don't understand is how they're getting through Customs and Border Patrol. If I want to ship a spare off-the-shelf PLC digital input card for a machine to one of my customers who has a satellite facility in Mexico, there's a 50% chance it gets held up for a month or more. Meanwhile these big distributors have no issues with air-freight shipments of a GPS jammer or raw testosterone direct to American doorsteps in 3 days.

Edit: it seems obvious to me that the CBP should be partially responsible verifying that stuff going through customs subject to FCC or FDA jurisdiction complies with FCC or FDA regulations, or at least to forward the question to the appropriate agency.

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

#347

Post by thorncorona »

1920musicman wrote: post #186

Since Amazon removed these products already, here is a link to one of the supplements mentioned in the letter: "X Max Triple Shot Energy Honey" ( https://khan-alasal.com/honey-product/3-triple-shot-honey/ ). The company looks very shady, with no registered address and no contact details. They list dozens of "male energy" supplements that all apparently have been certified by HAACP (Safe Food Alliance, https://safefoo…

They're probably faked certs.

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

#348

Post by paulmd »

AnthonyMouse wrote: post #325
rchaud wrote: post #318

Earlier quoted context omitted.

> accurately labeled product with a risk-benefit trade off, the customer knows what the product is and is exercising informed consent, and the government says they can't have it anyway. The FDA's regulatory purview is to limit the collateral damage (negative externalities) of even accurately labeled products. Informed consent from the customer is one side of the equation. Unfortunately they cannot consent to conditio…

> Unfortunately they cannot consent to conditions like "Don't burden the hospital system if you take the wrong dosage". By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. The government should generally be concerned with preventing deception and coercion and pricing externalities, because otherwise people have the incentive to do them and they would be prolific.…

Paracetamol is one of the most dangerous OTC drugs on the market, with one of the narrowest theraputic ranges and almost certainly would not be approved today. However, as the article mentions the FDA tends to lean strongly towards grandfathering existing things regardless of risk, unless they're "the fun drugs" or pose a manufacturing/diversion risk somehow.

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

#349

Post by AnthonyMouse »

Retric wrote: post #340
AnthonyMouse wrote: post #335

Earlier quoted context omitted.

I hope your argument isn't that only white people can exercise reason. If you have a mental illness you can go to the store and buy rat poison and eat it. The law doesn't address this by prohibiting rodenticides. If you think you can fly and jump off the roof of a parking structure, the government can't disable gravity. Acting within reason in that context is getting treatment, which is a whole different set of laws.

This isn’t about extremely dumb behavior, this is about extreme consequences for reasonable actions. If you walk up to a food truck you shouldn’t need to worry about long term mercury exposure from a single lunch. But the same is true if you happen to eat the same item from the same truck for 30 years. The maximum allowable exposure from food is very different between those two cases. But the second case isn’t unreas…

It seems like the main issue here is that the level of "informed" has to scale with the level of danger and surprise. If the product is bread and "wheat" is listed as an ingredient, someone with a gluten allergy can be reasonably expected to suss this out. If the product is a granola bar and it contains shellfish, maybe this should be separately noted and not just somewhere in the middle of the ingredients list. If the product contains unsafe levels of mercury, the words "This Product Contains Unsafe Levels Of Mercury" better be featured at least as prominently as the name of the product.

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

#350

Post by TimTheTinker »

AnthonyMouse wrote: post #342
growse wrote: post #332

Earlier quoted context omitted.

> By this logic the FDA would have to ban Tylenol and Robitussin. Tens of thousands of ER visits every year. It's almost like there's a balance of harms to be evaluated. I'd bet the cheap availability of paracetamol etc. saves more hospital visits than it causes, but I don't have the data to hand.

> It's almost like there's a balance of harms to be evaluated. 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?

In my opinion, this the best type of argument for a liberal, free society that is possible within a utilitarian moral framework.

Generally speaking, each person is best aware of their own context and can choose best for themselves how to take care of themselves and those in their family.

I'm not arguing against regulatory oversight of the free market - the FDA should exist. But there's a lot of talk about "harm reduction" and even "nudging" or "shaping" of society that I think needs to go away. I'm fine with billboards being banned (along with corporate lobbyism); but don't tell me I can't buy something because some other people could hurt themselves with it if they use it in the wrong way.

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