Earlier quoted context omitted.
It's better than that. According to Wikipedia > Chalk is typically almost pure calcite, CaCO3, with just 2% to 4% of other minerals The supplement I just looked up uses Calcium Carbonate. That could just be purified chalk and be in compliance with the FDA. In fact, it probably is just that.
Animals eat naturally-occurring chalk (and other substances) to regulate key minerals. It's called geophagia.
Amazon receives FDA warning letter for supplements with undeclared ingredients
201–210 of 433 posts
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#202Earlier quoted context omitted.
Reviews are transferable? I was wondering because many reviews I have seen don't seem to be for the product I am looking at at all.
Amazon tracks the "wrong item was sent" returns to find such items. They outsourced the checking to the customers, but they're eating the cost of processing the returns/shipping. Maybe that is cheaper in the long run?
You misunderstand. It's the correct item. The old product page was rebuilt for the new product. Users aren't confused or expecting the original product.
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#203I've had so many issues with Amazon counterfeits lately. Most recently, it turned out that my Coravin cartridges were fake. I've returned to buying direct from the manufacturer for many branded consumables (such as fish oils).
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#204Earlier quoted context omitted.
If you've ever been with a startup that needed a 510k, you'd know that the FDA regularly monitors everyone for compliance. At least in my narrow domain of medical imaging and treatment planning devices they do. I'd be surprised if they didn't have similar mechanisms in place in every area of their 'jurisdiction'. It doesn't really hurt the Amazons, they're just distributors. Doesn't really even hurt me. If RTP is a p…
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.
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#205Looks like a lot of uninformed opinions in here. As someone who has made a career consulting for supplement companies selling on Amazon, this does not surprise me. When Amazon first instituted testing requirements for supplements (something that already exists under federal law) they required all sellers to provide testing for all of their products. Failure to do so resulted in removal of your products from the marke…
This is a really high quality comment you've written here, thank you for posting your perspective.
For those of us who don't know about testing, can you explain COA/GMP and how robust the testing process is?
The reason I ask I'm a little concerned about Amazon's incentives not being aligned with consumers priority for high quality and safe product and is letting suppliers choose which product(s) to submit for testing rather than doing periodic random testing which I fear is too much to hope/ask for...
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#206Earlier quoted context omitted.
It's better than that. According to Wikipedia > Chalk is typically almost pure calcite, CaCO3, with just 2% to 4% of other minerals The supplement I just looked up uses Calcium Carbonate. That could just be purified chalk and be in compliance with the FDA. In fact, it probably is just that.
Animals eat naturally-occurring chalk (and other substances) to regulate key minerals. It's called geophagia.
> geophagia
Animals are eating the world
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#207Earlier quoted context omitted.
That article is just a subset of the overall data because it only focuses on those under the age of 25. [1] suggests there are almost 25,000 ER visits and over 2,100 hospitalizations per year due to supplements (although adverse reactions don't necessarily mean tainted or poorly controlled dosage). [1] https://www.nejm.org/doi/full/10.1056/NEJMsa1504267
How many of those are due to unknown, unlabeled risks? I’m willing to be that there are far more than 25,000 ER visits a year due to OTC drugs. Sometimes the risks are labeled. Other times they aren’t. And still other times people just didn’t follow the labeled directions. You can’t assume that every supplement ER visit was because of off-label ingredients or what FDA is saying here. That’s too far of a leap.
>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 about to debate what the acceptable threshold is (and I think most would agree it’s lower than the current data suggests) but I don’t think accuracy in labels is too big of an ask.
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#208I’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.…
Whatever level is needed, so that if I'm buying a product made be Nestle, I know that it was made by Nestle.
I think the policy mechanism here should be liability:
* If I buy a counterfeit memory card on Amazon, and it loses my photos, Amazon should be liable for the cost and effort of those photos. If I am poisoned with bad medicine, Amazon should be liable for the damages.
* If I spend money on 400TC cotton sheets, and get 300TC cotton/poly blend ones.
* If I write a book, and Amazon sells pirated copies, I should receive damages.
* If a bad medical product injures me, or doesn't have the intended effect, Amazon is liable (with standard astronomical damages)
Critically:
* It should be easy to extract those damages (Amazon can't tie me up in court or arbitration), and when this happens at scale, this should be class action or federal / state enforcement.
* Damages should include reasonable costs of enforcement. They should also be set at a minimum at treble damages, since not all instances will be caught / enforced.
At that point, the actuaries can do their thing on reasonable level of effort Amazon should put in. That may be shutting down all fulfilment-by-Amazon, co-mingling, and marketplace sellers, very different fee structures, inspections / enforcement, or something else. I don't know.
I actually think the most likely outcome is a verified supply chain, where Nestle (or any other manufacturer) sends to Amazon and Amazon to me with no middlemen. Vendors in compatible enforcement regimes with appropriate treaties (e.g. US and EU) are allowed in, so long as they have everything in order (corporate registration, etc.) and are selling under their own name. Vendors where the long arm of my local justice system doesn't quite reach aren't allowed in, at least directly, unless Amazon does a lot more scrutiny to the level to the point where I have similar guarantees about product safety, quality, environmental impact, labor laws, IP, etc.
I would not set a similar bar for eBay or Aliexpress, which claim to be marketplaces and not stores. However, when I buy from Amazon, Walmart, Target, etc., I believe that I am buying from a store (even if the fine print says otherwise). I'd want a very clear distinction between the two. Part of the way Amazon got itself into deep trouble is by trying to mix the two up. If I'm shopping at a flea market, it's caveat emptor, and those can be fun for some things. If I'm shopping at a store, I expect a certain level of trust.
What is clear, though, is that Amazon isn't self-policing, and we need regulatory enforcement.
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#209Earlier 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…
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.
From much experience, AliExpress customer service is 100x better than Amazon. Very prompt refunds and dispute resolutions.
Re: Amazon receives FDA warning letter for supplements with undeclared ingredients
#210I’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 does some good work, but they have no authority to specifically approve or certify most types of nutritional supplements. If you want to know what you're actually getting and avoid contamination, then only buy supplements when have been certified by the NSF.
https://www.nsf.org/consumer-resources/articles/supplement-v...
Amazon.com does have their own certification program for dietary supplements, but it seems like the rules aren't consistently enforced.
https://blog.ansi.org/anab/requirements-sell-dietary-supplem...