My assumption is that when the FDA was created there were already a large number of foods and food additives and testing all of those would have been impossible (and would have struck the public as absurd).
You also have to deal with the fact that food processors are fairly powerful and that the number of new foods/additives created a year would swamp the agency and be virtually untestable.
That's a reasonable guess, and on the more benign end of the spectrum for reasons it works the way ths title does. We really just have to guess at intent though, the best we can do is look at their output and see if we're okay with the quality of regulation they put in place.
I mean it appears the explicit answer is due to the 1938 FDC act. Whereby congress explicitly empowered the FDA to enforce the fact that new drugs must be shown safe before selling and advertising can begin. However no such rule was passed for food or supplements as such the regulatory authority in that space is oriented towards preventing "adulterated or misbranded or poisonous or deleterious food, drugs, medications, and liquor"
Having the legislative mandate definitely helps. Interestingly, the Chevron case would have left the FDA well within their rights to decide that a similar rule was important for food and supplements, they chose not to do that.
Our food supply was totally different in 1938, I can understand why the original legislation didn't include this. Processed foods weren't common, seed oils were even less common, and I assume supplements like we gave today didn't exist though I'm less sure about that one.
Well two of the major reasons for the original act were because of highly unsanitary conditions at slaughter houses (Upton Sinclair's The Jungle) and the use of known unsafe preservatives (e.g formaldehyde, spurred on heavily by Harvey Washington Wiley).
While I do think some oversight of food additives is warranted, given the way the FDA currently operates, having them have oversight over them would essentially be tantamount to banning new additives. If the cost was even 1/100th as high as it is to get drug approved it seems likely that there would be no economic payoff worth the hassle.
If I wasn't generally opposed to an ever-growing scope of federal powers, I'd probably support an effective ban or extremely high bar on new additives. If food companies aren't willing to test it they shouldn't bother trying to sell it.
I think you are underestimating the cost of testing a new additive. It's also the case that the risk on additives is not nearly as high as with a drug, which paradoxically both makes the testing less important and also vastly more expensive (since the effect size is smaller). Something like xylitol for instance seems completely safe and we didn't have a huge obvious reason for thinking it was likely to be problematic. In fact previous studies were unable to pick up on the signal of increased stroke risk because they were confounded by the fact that sugar free consumers were vastly more likely to have those anyway.
As an additional point I'll just note that regulating this stuff would then have to deal with the fact that many things (like red meat) are already associated with known health risks. Putting principles aside, even if you want to only ban "additives", you'll start running into issues like we see with nitrates/nitrites, where organic manufacturers add celery juice (extremely high in nitrates), to avoid the label of added nitrates.
The vast majority of the cost to get a new drug approved is a Phase 3 clinical trial, which is all about proving efficacy. Just running phase 1 & 2 trials would be expensive, probably still prohibitively so, but it's no where near the cost of a full drug approval with phase 3 trials.
Yep that's a totally fair point. I was actually just talking to my father-in-law about that earlier today. We were processing a couple roosters and he was mentioning stories from his mother about how bad meat processing plants used to be.
If I wasn't generally opposed to an ever-growing scope of federal powers, I'd probably support an effective ban or extremely high bar on new additives. If food companies aren't willing to test it they shouldn't bother trying to sell it.
Comments
My assumption is that when the FDA was created there were already a large number of foods and food additives and testing all of those would have been impossible (and would have struck the public as absurd).
You also have to deal with the fact that food processors are fairly powerful and that the number of new foods/additives created a year would swamp the agency and be virtually untestable.
That's a reasonable guess, and on the more benign end of the spectrum for reasons it works the way ths title does. We really just have to guess at intent though, the best we can do is look at their output and see if we're okay with the quality of regulation they put in place.
I mean it appears the explicit answer is due to the 1938 FDC act. Whereby congress explicitly empowered the FDA to enforce the fact that new drugs must be shown safe before selling and advertising can begin. However no such rule was passed for food or supplements as such the regulatory authority in that space is oriented towards preventing "adulterated or misbranded or poisonous or deleterious food, drugs, medications, and liquor"
(https://library.weill.cornell.edu/about-us/snake%C2%A0oil%C2...)
Having the legislative mandate definitely helps. Interestingly, the Chevron case would have left the FDA well within their rights to decide that a similar rule was important for food and supplements, they chose not to do that.
Our food supply was totally different in 1938, I can understand why the original legislation didn't include this. Processed foods weren't common, seed oils were even less common, and I assume supplements like we gave today didn't exist though I'm less sure about that one.
Well two of the major reasons for the original act were because of highly unsanitary conditions at slaughter houses (Upton Sinclair's The Jungle) and the use of known unsafe preservatives (e.g formaldehyde, spurred on heavily by Harvey Washington Wiley).
While I do think some oversight of food additives is warranted, given the way the FDA currently operates, having them have oversight over them would essentially be tantamount to banning new additives. If the cost was even 1/100th as high as it is to get drug approved it seems likely that there would be no economic payoff worth the hassle.
I think you are underestimating the cost of testing a new additive. It's also the case that the risk on additives is not nearly as high as with a drug, which paradoxically both makes the testing less important and also vastly more expensive (since the effect size is smaller). Something like xylitol for instance seems completely safe and we didn't have a huge obvious reason for thinking it was likely to be problematic. In fact previous studies were unable to pick up on the signal of increased stroke risk because they were confounded by the fact that sugar free consumers were vastly more likely to have those anyway.
As an additional point I'll just note that regulating this stuff would then have to deal with the fact that many things (like red meat) are already associated with known health risks. Putting principles aside, even if you want to only ban "additives", you'll start running into issues like we see with nitrates/nitrites, where organic manufacturers add celery juice (extremely high in nitrates), to avoid the label of added nitrates.
The vast majority of the cost to get a new drug approved is a Phase 3 clinical trial, which is all about proving efficacy. Just running phase 1 & 2 trials would be expensive, probably still prohibitively so, but it's no where near the cost of a full drug approval with phase 3 trials.
Yep that's a totally fair point. I was actually just talking to my father-in-law about that earlier today. We were processing a couple roosters and he was mentioning stories from his mother about how bad meat processing plants used to be.
If I wasn't generally opposed to an ever-growing scope of federal powers, I'd probably support an effective ban or extremely high bar on new additives. If food companies aren't willing to test it they shouldn't bother trying to sell it.