4 ms·

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

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/
  - deleted 3y ago
    [deleted]
  - bumby 3y ago
    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 https://www.nejm.org/doi/full/10.1056/NEJMsa1504267
    - hammock 3y ago
      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.
      - bumby 3y ago
        >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.
callalex 3y ago
Innocent until proven guilty only applies to individual people, not corporate entities.
- dragonwriter 3y ago
  Incorrect, innocent until proven guilty applies generally (but, as “guilty” applies specifically to criminal law, only there, but to juridical persons as well as natural ones; but the concept is not far removed from that of due process, which applies even outside of criminal law.)
  - dctoedt 3y ago
    > the concept is not far removed from that of due process, which applies even outside of criminal law Spot on. How much process is "due" is largely a function of the potential downside consequences of a mistake by the authorities. Examples (from U.S. law): • A police officer can briefly stop you on the street to ask a question such as "did you see what happened?" pretty much at will. • To detain you or search your person or property, the officer (with some exceptions) needs probable cause, in most cases confirmed by a neutral, independent judicial authority (that's the warrant requirement). • To imprison you or fine you, the government must affirmatively establish your guilt beyond a reasonable doubt, to a neutral jury of your peers, using evidence that meets established legal standards of reliability. • In all civil cases, a claimant seeking damages must put on admissible evidence affirmatively showing facts that legally entitle the claimant to the requested relief. • In certain grave civil matters, such as claims of fraud, the claimant must prove the claim by clear and convincing evidence, the highest standard of proof in civil law. (The usual standard in civil cases is "preponderance of the evidence," i.e., more likely than not.) • In some cases, the testimony of witnesses "having an interest" (e.g., an agenda to advance, an axe to grind, a score to settle) must be supported by corroborating evidence because the law recognizes that such witnesses can sometimes be, ahem, unreliable. Usual caution to readers: IAAL but not your lawyer.
kayodelycaon 3y ago
Frankly, it is absolutely ludicrous to limit the FDA to telling Amazon to remove a product by name and then having to do that again each time someone resells the same product under a different name. In this case the FDA is saying everything that includes regulated medications in non-regulated products must be addressed. Seems reasonable to me. If a company completely ignores regulation, the FDA should have to power to enforce its own regulations.

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/
- deleted 3y ago
  [deleted]
- bumby 3y ago
  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 https://www.nejm.org/doi/full/10.1056/NEJMsa1504267
  - hammock 3y ago
    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.
    - bumby 3y ago
      >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.

callalex 3y ago

Innocent until proven guilty only applies to individual people, not corporate entities.

dragonwriter 3y ago
Incorrect, innocent until proven guilty applies generally (but, as “guilty” applies specifically to criminal law, only there, but to juridical persons as well as natural ones; but the concept is not far removed from that of due process, which applies even outside of criminal law.)
- dctoedt 3y ago
  > the concept is not far removed from that of due process, which applies even outside of criminal law Spot on. How much process is "due" is largely a function of the potential downside consequences of a mistake by the authorities. Examples (from U.S. law): • A police officer can briefly stop you on the street to ask a question such as "did you see what happened?" pretty much at will. • To detain you or search your person or property, the officer (with some exceptions) needs probable cause, in most cases confirmed by a neutral, independent judicial authority (that's the warrant requirement). • To imprison you or fine you, the government must affirmatively establish your guilt beyond a reasonable doubt, to a neutral jury of your peers, using evidence that meets established legal standards of reliability. • In all civil cases, a claimant seeking damages must put on admissible evidence affirmatively showing facts that legally entitle the claimant to the requested relief. • In certain grave civil matters, such as claims of fraud, the claimant must prove the claim by clear and convincing evidence, the highest standard of proof in civil law. (The usual standard in civil cases is "preponderance of the evidence," i.e., more likely than not.) • In some cases, the testimony of witnesses "having an interest" (e.g., an agenda to advance, an axe to grind, a score to settle) must be supported by corroborating evidence because the law recognizes that such witnesses can sometimes be, ahem, unreliable. Usual caution to readers: IAAL but not your lawyer.

kayodelycaon 3y ago

Frankly, it is absolutely ludicrous to limit the FDA to telling Amazon to remove a product by name and then having to do that again each time someone resells the same product under a different name. In this case the FDA is saying everything that includes regulated medications in non-regulated products must be addressed. Seems reasonable to me. If a company completely ignores regulation, the FDA should have to power to enforce its own regulations.