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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 an

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.

toomuchtodo 3y ago
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-science/ https://usajobs.github.io/microsite-data-science/
- bilbo0s 3y ago
  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 part of my software product I should be under a microscope. It's going to be small people who try to market supplements who will get trounced now. Because every report will, by law, have to include the source of the product. And that source company or individual is in for a long year. Even shutting down won't end their legal obligations in a lot of cases. On the other hand, that was, in part, the original point of the FDA. To stamp out the snake oil salesmen. So, yeah. I guess they're just carrying out that mandate in new and updated ways.
  - toomuchtodo 3y ago
    I am not unsympathetic to the disparity you mention, but am advocating that distributor gorillas (like Amazon, but others as well) need strong controls (both regulatory and technical) due to their incentives to not be compliant and the potential negative outcomes (illness, perhaps death even, depending on material and consumer) from non compliance.
    - tacheiordache 3y ago
      Absolutely. And Amazon should also pay for it!
      - bilbo0s 3y ago
        Not how it works. Everyone pays. Amazon for their part. The producer for their part. Anyone that is provably in between is held accountable as well. Usually it's the producer that gets hit the hardest. Not disagreeing with that. That's what should happen. Just listing another in a litany of reasons that it's far worse for the producer/manufacturer than for the distributor. Think about it, your grocer rarely suffers the same consequences that a poultry producer does in the event of a poultry recall for instance.
  - LeifCarrotson 3y ago
    > 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-service distributors for manufacturers in China and Russia and Indonesia and India who aren't subject to FDA jurisdiction, who sometimes aren't subject to any oversight at all. The only entity that the FDA can go after here is Amazon, so this should hurt Amazon.
    - galangalalgol 3y ago
      The FCC should be going after them too. A lot of the wireless stuff they sell isn't registered.
      - LeifCarrotson 3y ago
        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.
  - pfisherman 3y ago
    They do not for supplements. Supplements fall under the office of the Director, which is not funded by PDUFA / MDUFA. Supplements are basically the Wild West.
  - jacurtis 3y ago
    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 whistleblower at a competitor's company came forward. The FDA sent a warning letter out to several of the large competitors in the industry to "don't do it or else" and never followed up again. The company that got in trouble got a few hundred thousand dollar fine for using mislabeled and toxic ingredients. They had one follow up inspection about 6 months after the warning and that was the end of it. For comparison that company was making ~$600M a year at the time of the fine and is now making $1B+. We carried on and never heard from the FDA again despite being equally guilty in our own company. The guilt is what eventually led me away from the cash cow, where I went on an 18 month sabbatical to get away from any corporate greed for a little bit. I legitimately had nightmares that I would be complicity guilty of several crimes if I stayed there long enough. I promise you, there is no oversight in supplements. There are a handful of posted guidelines. If a whistleblower comes forward the FDA might react to that single case, but they are so understaffed; the team that manages nutriceuticals is marked in the "tens" of people, not the thousands dedicated to proper medical equipment and medicines.
    - thfuran 3y ago
      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.
      - kayodelycaon 3y ago
        The FDA still requires supplements to follow safety standards and be properly labeled, but you do not need approval to make them.
        deleted 3y ago
        [deleted]
  - BobaFloutist 3y ago
    > Because every report will, by law, have to include the source of the product. I don't think it's an undue burden that if you're going to sell things people are ingesting, you have to know and communicate where they came from. And I feel like small people that try to market supplements won't be especially damaged by this. It feels like as much as anything this would "hurt" small people that try to start a supplement manufacturing cottage-venture on a shoe string, over which I don't expect to lose any sleep.
- altairprime 3y ago
  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.
  - serial_dev 3y ago
    I assume it's still a move with lots of politicking involved, so they need to stand on solid grounds, proof and all, I don't think they would every take lightly closing down vone of the biggest companies of the country (and the world). If it ever happened, I can already see the endless coverage by Sean Hannity and similar about how it's governmental overreach that risks destroying an important US company with X thousands employees... However, I don't think it will ever happen, in the end it's one of the richest men, Jeff Bezos behind Amazon with significant influence on news reporting, who seems to be on good terms with both the Republicans and Democrats, and the regulatory agencies in the US just didn't show a pattern of going too hard against US companies.
    - altairprime 3y ago
      I definitely don’t have a well-formed opinion on how likely such an outcome is, but I absolutely believe that discussing that outcome as a serious concern is necessary discussion to have.
    - Dalewyn 3y ago
      It's a good thing that regulatory actions are slow going and difficult to prove under the law, otherwise the commons would be subject to powertripping leaders above clouds far more than they are already. It also means that if things do get to such a point, then the action will come down swift and heavy in a manner generally agreeable to the majority of the commons.
    - trogdor 3y ago
fallingknife 3y ago
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 reality what it means is that gate keepers like Amazon have to put in place policies that are much more strict than the actual rules in order to avoid even a chance of getting hit. Agencies like the FDA know this and use it as a way to put in place de facto policies that are much stricter than they could legislate.
- werico 3y ago
  I totally get where you're coming from, but the problem with enforcement-by-whack-a-mole is that some crimes are very cheap and easy to carry out and very difficult to detect and prosecute. The asymmetry means criminals are incentivized to commit those crimes, and can even become fantastically wealthy by doing so. If there isn't an offsetting risk for them (or control), then they're going to do it. Some of those crimes can ruin victims' lives, and in some cases (like this) people can die. We simply can't afford to use no other enforcement strategies. A good example of where we threw out the upfront controls was COVID relief money, and that was a disaster in terms of fraud. (Admittedly a purely government program, but the same principle applies.)
- bumby 3y ago
  I think it's a distinction in risk philosophy. The whack-a-mole approach is "continue until we find you unsafe" while the other approach is "don't start until you prove you're safe". I think both approaches can be reasonable depending on the level of risk. When it comes to supplements tainted with unlisted ingredients that can have harmful or deadly effects for consumers, I personally think the latter is the better approach.
  - fallingknife 3y ago
    But the risk level is very low. The stats I see show less than 20 hospitalizations and 2 deaths per year due to bad supplements. https://time.com/5602125/dietary-supplements-kids/ https://time.com/5602125/dietary-supplements-kids/
1920musicman 3y ago
I searched for all products mentioned in the letter - they are all gone. Amazon is quick to react to such public letters to pretend that they are a responsible company. Saying that, the search returns hundreds of other supplements in the same category, with similar nonsensical names. They are certainly attempting to play wack-a-mole.
- ssgodderidge 3y ago
  I think the speed to remove the noted items isn’t suspect; it’s what I would expect a responsible company to do in this scenario. However, I am curious to see how Amazon handles the other drugs. Seems like pausing the sale of the entire category is the right call
  - 1920musicman 3y ago
    The category these supplements were listed under is "Sports Nutrition Endurance & Energy Products" with some legitimate products listed under it. I doubt Amazon would delist the entire category. But also, something tells me that sellers would just list products under a different category without any meaningful consequences. E.g. these or similar tainted supplements could be listed under "Health, Household, and Body Care" (a very broad category that already has products like "stripfast5000 Fire Bullet Capsules with K-CYTRO for Women and Men" listed under it), etc.
  - treprinum 3y ago
    Amazon bans all sellers that ever attempt to sell/list anything Amazon bans even if the ban was not made public (unless they pay their "consultants" closely connected to managers to unban them of course).
stickfigure 3y ago
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. I guess what I'm wondering is, what course of action do you think is reasonable for Amazon to take here? It's easy to say "don't allow this to happen"; I'm curious about what that actually translates to in practice.
- Baldbvrhunter 3y ago
  It is an interesting question. How much cocaine goes via Amazon? Or ephedrine, or ecstasy... Etc
- giarc 3y ago
  GNC (and likely other online supplement stores) have an online presence and likely has some QA for the products they sell. Amazon just insists on having 1,000,000+ listings for supplements rather than a more curated list. Perhaps some categories shouldn't have endless list of products.
  - lotsofpulp 3y ago
    The only QA in the "supplement" and "vitamin" business I know of is USP: https://www.quality-supplements.org https://www.quality-supplements.org Although, I have no clue if USP simply rubber stamps it once time, or if they do continuous testing of the products. If I were to bet, I would say they probably do not test often enough after initial certification.
- verall 3y ago
  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.
nradov 3y ago
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-vitamin-certification https://www.nsf.org/consumer-resources/articles/supplement-v... https://www.nsfsport.com/ https://www.nsfsport.com/ 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-supplements-amazon/ https://blog.ansi.org/anab/requirements-sell-dietary-supplem...
loeg 3y ago
> 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 mislabeling is certainly a problem, but really these drugs (sildenafil and tadalafil) should be over-the-counter and cheaply available on Amazon as generics. That they are not is a failure of the same FDA. They have a great safety profile and limited contraindications, comparable to many other OTC drugs.
AnthonyMouse 3y ago
> 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.
- wredue 3y ago
  >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.
  - nickff 3y ago
    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.
ineedaj0b 3y ago
I don’t want to sound like a nut job, but please look into how much the FDA hampers drug trails. If you understand how tough it is in one case, think how many trails yearly never get done because of the FDA. The amount of benefit vs. the amount of deaths caused by the FDA being slow likely means many more are deaths at the hands of the FDA than you expect. Cracking down on supplements that people take voluntary hardly seems like something I’m pleased they meddle with too.
- neaden 3y ago
  You're only taking them voluntarily if they are what they say they are, if as in this case they aren't you aren't meaningfully taking them voluntarily.
  - Tao3300 3y ago
    Buying shady penis pills on the Internet is a voluntary risk. Play stupid games, win stupid heart attacks and priapisms. Though I do think Amazon should have a share of the blame. Buyer and seller are both wrong here.
- hibikir 3y ago
  It's possible, and even a good idea, to say that the FDA massively overregulates drug trials, while at the same time also say that the current supplement market is almost just as massively underregulated, and would be far healthier with more oversight. Organizations, just like people, can do good and bad things at the same time. I am very happy they crack down on supplements, a kind of product that is filled with fraud and that I lack the resources to make informed purchases on. I would also be just as happy if they started cross-approving drugs with the EU and Australia. They are neither angels nor the devil.
pardoned_turkey 3y ago
Well, on the flip side: the whole reason these are sold is that the FDA is preventing the substance from being sold OTC. This is not an example of a manufacturer putting something unwanted in the product. It's all just a wink-wink-nudge-nudge kind of a deal with willing buyers. It creates some risk of accidents, but I doubt there were any. I'm not sure the regulation here is great. As with Rx-only contraception, these regulations force patients to spend money and discuss their intimate life with a doctor for no real reason, which many people find difficult. And it's not like you undergo thorough screening to get Viagra anyway. A doctor is not gonna say "no". The problem with bodies such as the FDA is that once they address grave risks, they seldom reach this point of "OK, we fixed the problem of arsenic in patent medicine, so let's scale back for now." Instead, the bureaucracies only grow. Today, far too many drugs are Rx-only and stay this way for too long. The need for prescriptions for equipment such as eyeglasses or contact lenses is hard to justify too.
- lwhi 3y ago
  It's the job of a regulatory body to reduce risk. If wrongly prescribed equipment can cause harm, it's very justifiable that a license scheme is put in place.
  - bjt 3y ago
    > It's the job of a regulatory body to reduce risk. Sure, and the parent comment's point was that there's a line where further risk reduction doesn't make sense anymore. The agency doesn't have the right incentives to stop at that line. Plenty of very significant risks aren't regulated to the degree that Viagra and Cialis are. You don't need a note from a doctor or a govt-issued permit to buy kitchen knives or a table saw or a Bic lighter, for example.
    - lwhi 3y ago
      Kitchen knives have multiple uses and discretion through education is expected as standard. Viagra and Cialis have a singular use and contraindications aren't likely to be understood through cultural osmosis.
adolph 3y ago
A regulatory agency was fine for a world with a finite number of trusted vendors working operating in the the agency jurisdiction. Reliable consumer owned/operated molecular characterization is needed for a future that moves faster and farther than an agency or regulation.

toomuchtodo 3y ago

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-science/ https://usajobs.github.io/microsite-data-science/

bilbo0s 3y ago
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 part of my software product I should be under a microscope. It's going to be small people who try to market supplements who will get trounced now. Because every report will, by law, have to include the source of the product. And that source company or individual is in for a long year. Even shutting down won't end their legal obligations in a lot of cases. On the other hand, that was, in part, the original point of the FDA. To stamp out the snake oil salesmen. So, yeah. I guess they're just carrying out that mandate in new and updated ways.
- toomuchtodo 3y ago
  I am not unsympathetic to the disparity you mention, but am advocating that distributor gorillas (like Amazon, but others as well) need strong controls (both regulatory and technical) due to their incentives to not be compliant and the potential negative outcomes (illness, perhaps death even, depending on material and consumer) from non compliance.
  - tacheiordache 3y ago
    Absolutely. And Amazon should also pay for it!
    - bilbo0s 3y ago
      Not how it works. Everyone pays. Amazon for their part. The producer for their part. Anyone that is provably in between is held accountable as well. Usually it's the producer that gets hit the hardest. Not disagreeing with that. That's what should happen. Just listing another in a litany of reasons that it's far worse for the producer/manufacturer than for the distributor. Think about it, your grocer rarely suffers the same consequences that a poultry producer does in the event of a poultry recall for instance.
- LeifCarrotson 3y ago
  > 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-service distributors for manufacturers in China and Russia and Indonesia and India who aren't subject to FDA jurisdiction, who sometimes aren't subject to any oversight at all. The only entity that the FDA can go after here is Amazon, so this should hurt Amazon.
  - galangalalgol 3y ago
    The FCC should be going after them too. A lot of the wireless stuff they sell isn't registered.
    - LeifCarrotson 3y ago
      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.
- pfisherman 3y ago
  They do not for supplements. Supplements fall under the office of the Director, which is not funded by PDUFA / MDUFA. Supplements are basically the Wild West.
- jacurtis 3y ago
  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 whistleblower at a competitor's company came forward. The FDA sent a warning letter out to several of the large competitors in the industry to "don't do it or else" and never followed up again. The company that got in trouble got a few hundred thousand dollar fine for using mislabeled and toxic ingredients. They had one follow up inspection about 6 months after the warning and that was the end of it. For comparison that company was making ~$600M a year at the time of the fine and is now making $1B+. We carried on and never heard from the FDA again despite being equally guilty in our own company. The guilt is what eventually led me away from the cash cow, where I went on an 18 month sabbatical to get away from any corporate greed for a little bit. I legitimately had nightmares that I would be complicity guilty of several crimes if I stayed there long enough. I promise you, there is no oversight in supplements. There are a handful of posted guidelines. If a whistleblower comes forward the FDA might react to that single case, but they are so understaffed; the team that manages nutriceuticals is marked in the "tens" of people, not the thousands dedicated to proper medical equipment and medicines.
  - thfuran 3y ago
    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.
    - kayodelycaon 3y ago
      The FDA still requires supplements to follow safety standards and be properly labeled, but you do not need approval to make them.
      - deleted 3y ago
        [deleted]
- BobaFloutist 3y ago
  > Because every report will, by law, have to include the source of the product. I don't think it's an undue burden that if you're going to sell things people are ingesting, you have to know and communicate where they came from. And I feel like small people that try to market supplements won't be especially damaged by this. It feels like as much as anything this would "hurt" small people that try to start a supplement manufacturing cottage-venture on a shoe string, over which I don't expect to lose any sleep.
altairprime 3y ago
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.
- serial_dev 3y ago
  I assume it's still a move with lots of politicking involved, so they need to stand on solid grounds, proof and all, I don't think they would every take lightly closing down vone of the biggest companies of the country (and the world). If it ever happened, I can already see the endless coverage by Sean Hannity and similar about how it's governmental overreach that risks destroying an important US company with X thousands employees... However, I don't think it will ever happen, in the end it's one of the richest men, Jeff Bezos behind Amazon with significant influence on news reporting, who seems to be on good terms with both the Republicans and Democrats, and the regulatory agencies in the US just didn't show a pattern of going too hard against US companies.
  - altairprime 3y ago
    I definitely don’t have a well-formed opinion on how likely such an outcome is, but I absolutely believe that discussing that outcome as a serious concern is necessary discussion to have.
  - Dalewyn 3y ago
    It's a good thing that regulatory actions are slow going and difficult to prove under the law, otherwise the commons would be subject to powertripping leaders above clouds far more than they are already. It also means that if things do get to such a point, then the action will come down swift and heavy in a manner generally agreeable to the majority of the commons.
  - trogdor 3y ago

fallingknife 3y ago

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 reality what it means is that gate keepers like Amazon have to put in place policies that are much more strict than the actual rules in order to avoid even a chance of getting hit. Agencies like the FDA know this and use it as a way to put in place de facto policies that are much stricter than they could legislate.

werico 3y ago
I totally get where you're coming from, but the problem with enforcement-by-whack-a-mole is that some crimes are very cheap and easy to carry out and very difficult to detect and prosecute. The asymmetry means criminals are incentivized to commit those crimes, and can even become fantastically wealthy by doing so. If there isn't an offsetting risk for them (or control), then they're going to do it. Some of those crimes can ruin victims' lives, and in some cases (like this) people can die. We simply can't afford to use no other enforcement strategies. A good example of where we threw out the upfront controls was COVID relief money, and that was a disaster in terms of fraud. (Admittedly a purely government program, but the same principle applies.)
bumby 3y ago
I think it's a distinction in risk philosophy. The whack-a-mole approach is "continue until we find you unsafe" while the other approach is "don't start until you prove you're safe". I think both approaches can be reasonable depending on the level of risk. When it comes to supplements tainted with unlisted ingredients that can have harmful or deadly effects for consumers, I personally think the latter is the better approach.
- fallingknife 3y ago
  But the risk level is very low. The stats I see show less than 20 hospitalizations and 2 deaths per year due to bad supplements. https://time.com/5602125/dietary-supplements-kids/ https://time.com/5602125/dietary-supplements-kids/

1920musicman 3y ago

I searched for all products mentioned in the letter - they are all gone. Amazon is quick to react to such public letters to pretend that they are a responsible company. Saying that, the search returns hundreds of other supplements in the same category, with similar nonsensical names. They are certainly attempting to play wack-a-mole.

ssgodderidge 3y ago
I think the speed to remove the noted items isn’t suspect; it’s what I would expect a responsible company to do in this scenario. However, I am curious to see how Amazon handles the other drugs. Seems like pausing the sale of the entire category is the right call
- 1920musicman 3y ago
  The category these supplements were listed under is "Sports Nutrition Endurance & Energy Products" with some legitimate products listed under it. I doubt Amazon would delist the entire category. But also, something tells me that sellers would just list products under a different category without any meaningful consequences. E.g. these or similar tainted supplements could be listed under "Health, Household, and Body Care" (a very broad category that already has products like "stripfast5000 Fire Bullet Capsules with K-CYTRO for Women and Men" listed under it), etc.
- treprinum 3y ago
  Amazon bans all sellers that ever attempt to sell/list anything Amazon bans even if the ban was not made public (unless they pay their "consultants" closely connected to managers to unban them of course).

stickfigure 3y ago

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. I guess what I'm wondering is, what course of action do you think is reasonable for Amazon to take here? It's easy to say "don't allow this to happen"; I'm curious about what that actually translates to in practice.

Baldbvrhunter 3y ago
It is an interesting question. How much cocaine goes via Amazon? Or ephedrine, or ecstasy... Etc
giarc 3y ago
GNC (and likely other online supplement stores) have an online presence and likely has some QA for the products they sell. Amazon just insists on having 1,000,000+ listings for supplements rather than a more curated list. Perhaps some categories shouldn't have endless list of products.
- lotsofpulp 3y ago
  The only QA in the "supplement" and "vitamin" business I know of is USP: https://www.quality-supplements.org https://www.quality-supplements.org Although, I have no clue if USP simply rubber stamps it once time, or if they do continuous testing of the products. If I were to bet, I would say they probably do not test often enough after initial certification.
verall 3y ago
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.

nradov 3y ago

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-vitamin-certification https://www.nsf.org/consumer-resources/articles/supplement-v... https://www.nsfsport.com/ https://www.nsfsport.com/ 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-supplements-amazon/ https://blog.ansi.org/anab/requirements-sell-dietary-supplem...

loeg 3y ago

> 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 mislabeling is certainly a problem, but really these drugs (sildenafil and tadalafil) should be over-the-counter and cheaply available on Amazon as generics. That they are not is a failure of the same FDA. They have a great safety profile and limited contraindications, comparable to many other OTC drugs.

AnthonyMouse 3y ago

> 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.

wredue 3y ago
>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.
- nickff 3y ago
  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.

ineedaj0b 3y ago

I don’t want to sound like a nut job, but please look into how much the FDA hampers drug trails. If you understand how tough it is in one case, think how many trails yearly never get done because of the FDA. The amount of benefit vs. the amount of deaths caused by the FDA being slow likely means many more are deaths at the hands of the FDA than you expect. Cracking down on supplements that people take voluntary hardly seems like something I’m pleased they meddle with too.

neaden 3y ago
You're only taking them voluntarily if they are what they say they are, if as in this case they aren't you aren't meaningfully taking them voluntarily.
- Tao3300 3y ago
  Buying shady penis pills on the Internet is a voluntary risk. Play stupid games, win stupid heart attacks and priapisms. Though I do think Amazon should have a share of the blame. Buyer and seller are both wrong here.
hibikir 3y ago
It's possible, and even a good idea, to say that the FDA massively overregulates drug trials, while at the same time also say that the current supplement market is almost just as massively underregulated, and would be far healthier with more oversight. Organizations, just like people, can do good and bad things at the same time. I am very happy they crack down on supplements, a kind of product that is filled with fraud and that I lack the resources to make informed purchases on. I would also be just as happy if they started cross-approving drugs with the EU and Australia. They are neither angels nor the devil.

pardoned_turkey 3y ago

Well, on the flip side: the whole reason these are sold is that the FDA is preventing the substance from being sold OTC. This is not an example of a manufacturer putting something unwanted in the product. It's all just a wink-wink-nudge-nudge kind of a deal with willing buyers. It creates some risk of accidents, but I doubt there were any. I'm not sure the regulation here is great. As with Rx-only contraception, these regulations force patients to spend money and discuss their intimate life with a doctor for no real reason, which many people find difficult. And it's not like you undergo thorough screening to get Viagra anyway. A doctor is not gonna say "no". The problem with bodies such as the FDA is that once they address grave risks, they seldom reach this point of "OK, we fixed the problem of arsenic in patent medicine, so let's scale back for now." Instead, the bureaucracies only grow. Today, far too many drugs are Rx-only and stay this way for too long. The need for prescriptions for equipment such as eyeglasses or contact lenses is hard to justify too.

lwhi 3y ago
It's the job of a regulatory body to reduce risk. If wrongly prescribed equipment can cause harm, it's very justifiable that a license scheme is put in place.
- bjt 3y ago
  > It's the job of a regulatory body to reduce risk. Sure, and the parent comment's point was that there's a line where further risk reduction doesn't make sense anymore. The agency doesn't have the right incentives to stop at that line. Plenty of very significant risks aren't regulated to the degree that Viagra and Cialis are. You don't need a note from a doctor or a govt-issued permit to buy kitchen knives or a table saw or a Bic lighter, for example.
  - lwhi 3y ago
    Kitchen knives have multiple uses and discretion through education is expected as standard. Viagra and Cialis have a singular use and contraindications aren't likely to be understood through cultural osmosis.

adolph 3y ago

A regulatory agency was fine for a world with a finite number of trusted vendors working operating in the the agency jurisdiction. Reliable consumer owned/operated molecular characterization is needed for a future that moves faster and farther than an agency or regulation.