Hacker News Board Hacker News, browsed like a classic message board
Live data from Hacker News

Amazon receives FDA warning letter for supplements with undeclared ingredients

fda.gov

Post reply on HN
Print view View original

231–240 of 433 posts

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

#231

Post by JumpCrisscross »

sdbrown wrote: post #223
JumpCrisscross wrote: post #211

Earlier quoted context omitted.

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 tw…

NTI drugs, a/k/a critical dose drugs, can avoid titration requirements through dilution. It’s harder to fuck up a 500 mL difference than a 1 mL difference. Again, this is why most OTC versions of prescription drugs are different in only one way: concentration.

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

#232

Post by gruez »

asveikau wrote: post #226
gruez wrote: post #222

Earlier quoted context omitted.

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.

>I disagree with this. A comment like this can provide some amusement and joy

Maybe you still get a chuckle, but after the same tired strawmans get posted over and over again it gets annoying, similar to all the low effort comments on reddit like "username checks out", "RIP my inbox", "came here to say this", or any number of the common copypastas.

>as well as legitimate criticism of people who unironically hold similar beliefs to the one parodied.

Strawmans are not "legitimate criticism".

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

#233

Post by dataflow »

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.

> 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 did try regulating supplements. They were legally prohibited from doing much.

You can thank Senator Orrin Hatch (who was the longest-serving Republican senator in history until recently) for preventing the FDA from regulating supplements back in 1994. [1] [2]

[1] https://www.youtube.com/watch?v=WIT5_SMIaHE&t=6m46s (watch a few minutes of it from here)

Edit: Posted it here for those interested: https://news.ycombinator.com/item?id=38797162

[2] https://www.congress.gov/bill/103rd-congress/senate-bill/784

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

#234

Post by 1905 »

blagie wrote: post #158
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.

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)

It makes you wonder about all those masks people were buying online and wearing 14+ hours a day

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

#235

Post by zopa »

stickfigure wrote: post #185
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.

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. But if Amazon Testing emails the supplier: "Please send over a batch of X MAX SUPER ENERGY so we can test if for these substances which we hope we won't find, and make absolutely sure what you send is the same thing you're selling!" -- then that will work somewhat less well. There are endless ways for Amazon and sellers to wink and nod and skirt the intent of the rules, if Amazon is just checking a box for the FDA, and doesn't actually care.

The way to get Amazon to care is to hold it responsible for the outcome. Of course there will be sellers that find a way to skirt whatever process Amazon puts in place, but that needs to be Amazon's problem. Amazon can survive taking its lumps when it messes up.

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

#236

Post by 1905 »

blagie wrote: post #218
giarc wrote: post #199

Earlier quoted context omitted.

Hate to break it to you, but Aliexpress is likely less reliable than Amazon (or have the exact same products). eBay is likely the same and Walmart allows 3rd party sellers so it's pretty much the same as Amazon unless you source the products curated by Walmart.

I think you misread my comment. I'll go to Aliexpress and eBay first for: "kids toys, cables, generic keyboards, battery chargers, basic tools, and basic clothing." I have the exact same list for them as for Amazon. I'll go there first for those products since Aliexpress has much better prices than Amazon. eBay has better seller reviews. I certainly wouldn't buy food or medicine from them, though, or even bedsheets o…

> I'll go to Aliexpress and eBay first for: "kids toys, cables, generic keyboards, battery chargers, basic tools, and basic clothing."

I do too. I don't use Amazon Prime and can usually find the same products for cheaper on ebay with free shipping. The competition among other sellers is greater on ebay so the price will often be lower. It is difficult to do returns though

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

#237

Post by AnthonyMouse »

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.

> 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 lab results to the label.

What people object to is when someone wants to sell an 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.

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

#238

Post by kayodelycaon »

stickfigure wrote: post #185
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.

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.…

They don’t need to inspect individual products, but they should be able to verify anyone selling supplements is who they say they are.

Verification only needs to be good enough to stop low effort fraud. This is entirely doable.

They also need to ensure the product you buy comes directly from the seller you bought from.

They need to prevent counterfeits from random sellers getting added to inventory of legitimate companies.

Separating inventory by seller is 100% doable. My company manages it. It just costs more.

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

#239

Post by verall »

AnthonyMouse wrote: post #227
verall wrote: post #196

Earlier quoted context omitted.

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 perpetrato…

Every brick and mortar store has to assert the safety and legality of everything they sell or else risk serious liability.

From what I can tell, Amazon does not present itself as a farmer's or flea market, yet it tries to limit its liability by pretending it does. To the average consumer things purchased from it come "from amazon", as compared to ebay which makes it much more obvious you are purchasing from a particular person or shop.

Amazon really tries to have its cake and eat it too here, and it sort of blows my mind that consumer product safety regulators haven't clamped down on this.

It's really one thing to have basically anything available on ebay/aliexpress/others (consumer trust is much lower) and another to be a huge retailer (just like walmart) and yet to be able to sell whatever unsafe stuff you want (unlike walmart).

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

#240

Post by wredue »

AnthonyMouse wrote: post #237
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.

> 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…

>doesn’t require any government interaction

Dude what? Government around the world are constantly catching corporations for lying on their product lists.

As for controlled substances, on this topic is a completely fine line which I’d probably tend to agree is not treaded properly. There are risk trade offs to allowing open markets on classes of drugs.

With that said, the massive propaganda campaigns corporations get up to completely subvert that risk, and 100% leaves consumers uninformed even with the proper information at their fingertips: as a major example, the opioid crisis, leaded fuels, leaded paints, carcinogenic materials handling. I mean, the list really goes on and on.

The issue with the FDA has time and time and time again been demonstrated to be how toothless it is. Corporations constantly ignore regulation for billions in profits, only to receive a sternly worded letter and MAYBE a 0.01% of profits fine.

Post reply on HN