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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

#221

Post by bumby »

hammock wrote: post #215
bumby wrote: post #207

Earlier quoted context omitted.

> You can’t assume that every supplement ER visit was because of off-label ingredients I already acknowledged this in the previous post. However, if you look at the rates of tainted supplements it probably isn’t a leap to assume a fair number can be attributed to unlisted ingredients. Some studies show contamination rates of nearly 60%. Again, I think the mitigation should be proportional to the risk. We might be abo…

>Some studies show contamination rates of nearly 60%. And what % of "contamination" is dangerous ingredients (when directions are followed) vs harmless? You can’t assume that every contaminated supplement is dangerous. Fraudulent, maybe. Mislabeled, yes.

Those rates are from prohibited substances. Meaning there is the possibility a strong enough effect to be concerning (otherwise they wouldn't be prohibited as a PED), but you’re correct that dosage matters too. But I already addressed that in the first post. Regardless, there is a truth in labeling standard that many believe should extend to supplements. I’m probably in that camp. If you’re not, I’d be interesting in hearing why.

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

#222

Post by gruez »

asveikau wrote: post #73
techbrovanguard wrote: post #59

Earlier quoted context omitted.

[flagged]

I read it as sarcasm, but I guess you can't tell these days. (Where these days is at least 20 years) You won't buy such a cable twice because it will burn down your house and risk killing you, hence, you're not buying it a second time as a dead person. Obviously no flaws in that logic.

Not the guy you replied to, but I downvoted that comment because I find sarcastic strawmans to be tiring and don't add to discussion.

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

#223

Post by sdbrown »

JumpCrisscross wrote: post #211
sdbrown wrote: post #189

Earlier quoted context omitted.

That doesn't change the difference between effective and toxic doses, it changes the potential scale of off-by-one user error. If 20 milligrams is delivered in 1 tablet, then 3 tablets is the toxic dose. If 20 milligrams is delivered in 5 tablets, then 15 is the toxic dose. A single daily tablet is far superior to multiple daily tablets in terms of patient adherence and hence disease management. Can you name specific…

Idk what to say, this is established medicine [1]. When you have a small TI you dilute to make measurement tolerances wider in absolute terms. This is a motivating factor behind prescription-strength medicine. > Increased pill counts historically reduces patient adherence Of course. There are tradeoffs. You want to know what also increases burden? Requiring a prescription. [1] https://en.m.wikipedia.org/wiki/Therapeu…

I don't see dilution anywhere on that page, and increasing volume of administration at a lower concentration to achieve the same effective dose does not alter the dose itself. You are not interpreting TI correctly.

Edit: further, to your comment about "prescription strength" nomenclature, look at section 14 of the Cialis/tadalafil prescribing information, IIRC, table of clinical studies, where they have the second two outcomes of the clinical studies broken down by dose. Efficacy increases pretty directly with increasing dose, and these are where the observed side effects show up. It seems like patients may well self-escalate. Maybe the OTC countries have public data on this?

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

#224

Post by kayodelycaon »

thfuran wrote: post #204
jacurtis wrote: post #100

Earlier quoted context omitted.

As someone who worked at a startup that grew to a significant size in the "Nutraceuticals" industry (the fancy name for supplements), I can tell you that the FDA has nearly zero regulation or monitoring of supplements. I'll omit brand names here, but I can tell you some sketchy stuff happens in supplement manufacturing all the time. During the ~6 years I worked there, only one letter came from the FDA after a whistle…

It seems like a bizarre gap between food and drugs that shouldn't exist. If it's meant to be eaten, the FDA should definitely be regulating it thoroughly.

The FDA still requires supplements to follow safety standards and be properly labeled, but you do not need approval to make them.

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

#225

Post by lostlogin »

LargeTomato wrote: post #187
lostlogin wrote: post #123

Earlier quoted context omitted.

> 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?

Step 1: Cease and desist letter Step 2: Legal action to pursue a change of policy and damages. Step 3: 2nd legal action if Amazon continues to be out of compliance with the previous ruling. There's a process here and jumping to the very end is not how it works.

This seems entirely appropriate, but skip step 2, then start sanctions or shutdowns if the situation persists.

There is surely a template for this - quite possibly it’s what you detail?

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

#226

Post by asveikau »

gruez wrote: post #222
asveikau wrote: post #73

Earlier quoted context omitted.

I read it as sarcasm, but I guess you can't tell these days. (Where these days is at least 20 years) You won't buy such a cable twice because it will burn down your house and risk killing you, hence, you're not buying it a second time as a dead person. Obviously no flaws in that logic.

Not the guy you replied to, but I downvoted that comment because I find sarcastic strawmans to be tiring and don't add to discussion.

I disagree with this. A comment like this can provide some amusement and joy, as well as legitimate criticism of people who unironically hold similar beliefs to the one parodied.

I know the HN guidelines have had a "no joke" recommendation but it seems rather humorless (obviously) and can deny some form of humanity, the latter of which is rather unreasonable.

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

#227

Post by AnthonyMouse »

verall wrote: post #196
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.…

Supplements should probably not be sold in a marketplace fashion by fly-by-night distributors by a major trusted brand (amazon). Businesses that sell supplements should create trusted relationships with their suppliers to not break the rules and to limit their own liability.

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 perpetrators just create new accounts, whereas the government could charge them with a crime to actually deter them.

The only reason you'd need to go after Amazon is if they're selling products dropshipped from another country, which they could avoid by simply requiring sellers of products meant for human consumption to have a domestic presence. They wouldn't even have to ship from here, just have somebody here who gets arrested if they break the law.

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

#228

Post by kayodelycaon »

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…

Frankly, it is absolutely ludicrous to limit the FDA to telling Amazon to remove a product by name and then having to do that again each time someone resells the same product under a different name.

In this case the FDA is saying everything that includes regulated medications in non-regulated products must be addressed.

Seems reasonable to me. If a company completely ignores regulation, the FDA should have to power to enforce its own regulations.

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

#229

Post by [deleted] »

kayodelycaon wrote: post #224
thfuran wrote: post #204

Earlier quoted context omitted.

It seems like a bizarre gap between food and drugs that shouldn't exist. If it's meant to be eaten, the FDA should definitely be regulating it thoroughly.

The FDA still requires supplements to follow safety standards and be properly labeled, but you do not need approval to make them.

[deleted]

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

#230

Post by neither_color »

floatrock wrote: post #38
gruez wrote: post #14

Earlier quoted context omitted.

I checked a random amazon basics powerstrip and there's an ETL certification mark on them. As much as it's popular to hate on amazon for fakes/subquality products, your particular example is a poor one. https://m.media-amazon.com/images/W/MEDIAX_792452-T2/images/...

EV Chargers then. Search for Level 2 EV Charger. The number of generic chineesium chargers available that will move 40amps of power in your garage without UL or ETL certification is mind-boggingly high. I've seen some advertise "UL Safety Report", which I assume is weasel-words for "We failed UL certification so we can't actually say the magic phrase 'UL Listed'". I've seen some claim to be UL Listed without being ab…

I went down a small rabbit hole of Amazon electrical products once. You truly are better off at the big orange or blue hardware store for anything electric. Might cost a few bucks more but you don't have multiple suppliers referencing the same fake certificates and skimping on wire gauge to save a few cents.
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