4 ms·

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 medic

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.

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.