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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

#241

Post by altairprime »

toomuchtodo wrote: post #3
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.

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 for Amazon in order to reach that final outcome. This letter is the first, necessary, step towards doing so.

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

#242

Post by siliconc0w »

This is a real risk and why supplementation is probably not a good idea except for like specific conditions as recommended by your doctor (e.g pregnancy). In an unregulated space like this, it's basically impossible to know what you're getting which can range from ineffective to seriously harmful (heavy metals, toxins, or active pharmaceuticals). Better to get micronutrients from bio-available sources and optimize diet, sleep, and exercise.

It's also relatively expensive compared to the usually marginal benefit. Most likely you should sock away that spend into an index so you can afford the more effective and expensive therapies that our healthcare system doesn't give you access to (because it generally won't pay for prevention).

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

#243

Post by jupp0r »

LegitShady wrote: post #71
jupp0r wrote: post #31

Earlier quoted context omitted.

The customer service is pretty amazing compared to most other stores, at least in my opinion. Returns are easy and free, and you get a replacement shipped right away but have weeks to return the item.

returns are not universally free or easy. I bought a power supply for a computer (corsair) and it went on sale a week later. I called to get a price adjustment and amazon told me they don't match even their own prices. So I said I'd return it and order a new one and I was told I'd have to pay return shipping. I don't buy many products on amazon anymore.

I have never had that problem and have probably returned ~100 items over the years. YMMV I guess.

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

#244

Post by nickff »

wredue wrote: post #240
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…

>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…

Governments around the world are terrible at 'catching corporations for lying' in any way. There are manifold examples in every regulatory field, in every country. Examples include Wirecard, Theranos, Volkswagen, Johnson & Johnson talc, etc. In most cases, the regulators are handed the evidence, and take a long time to do anything about it.

In my mind, the question is whether the massive regulatory burdens which protect incumbents and inhibit liberty are worth it. This is not an all-or-nothing question, and might be answered field-by-field, but regulators have not covered themselves in glory.

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

#245

Post by kayodelycaon »

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…

Having things unnecessarily banned is a trade off of enforcing regulations effectively.

Someone has to decide what substances safe and prevent them from sold.

The FDA could do better but you’ll never fix that problem unless you don’t allow the FDA to enforce regulations.

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

#246

Post by FredPret »

infamouscow wrote: post #217
FredPret wrote: post #213

Amazon is a scam site. I will buy my books from Indigo (Canada) from now on. Electronics and related doodads can come from Costco, Bestbuy, Walmart. Maybe it's not as convenient, but you know what you're getting. It's really unfortunate that Audible is in the Amazon family, because I'm not cancelling that any time soon. I know much of the internet runs on AWS, but I'll never really trust that either.

I've purchased quite a few paperbacks and hardcovers from Amazon because the author sidestepped the traditional publishing industry with Kindle Direct Publishing. I've enjoyed a number of book series this way.

That is the one light in the darkness that is amazon.com

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

#247

Post by [deleted] »

nickff wrote: post #244
wredue wrote: post #240

Earlier quoted context omitted.

>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…

Governments around the world are terrible at 'catching corporations for lying' in any way. There are manifold examples in every regulatory field, in every country. Examples include Wirecard, Theranos, Volkswagen, Johnson & Johnson talc, etc. In most cases, the regulators are handed the evidence, and take a long time to do anything about it. In my mind, the question is whether the massive regulatory burdens which prot…

[deleted]

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

#248

Post by AnthonyMouse »

wredue wrote: post #240
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…

>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…

> Government around the world are constantly catching corporations for lying on their product lists.

Obviously you have to interact with the government if they catch you lying. You're not intended to lie.

The point is that you can have a labeling requirement and businesses can comply with it without having to make regulatory filings or prohibiting products.

> There are risk trade offs to allowing open markets on classes of drugs.

Which is why you have labeling requirements. This is cocaine, it's highly addictive, you probably want to try ibuprofen first.

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

#249

Post by cool_dude85 »

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…

>And the latter is really what you want, because otherwise Amazon has to play whack-a-mole as the perpetrators just create new accounts

How can they just create a new account to sell supplements without thorough testing, vetting, control processes, etc. by Amazon, the business actually selling the stuff? If Amazon doesn't have such controls in place to stop people from "just creating new accounts" then hold Amazon liable.

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

#250

Post by AnthonyMouse »

kayodelycaon wrote: post #245
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…

Having things unnecessarily banned is a trade off of enforcing regulations effectively. Someone has to decide what substances safe and prevent them from sold. The FDA could do better but you’ll never fix that problem unless you don’t allow the FDA to enforce regulations.

> Someone has to decide what substances safe and prevent them from sold.

No they don't. If a product has a label that says "this product is considered unsafe by the Food and Drug Administration" and explains why and you buy it anyway, you got what you paid for.

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