Both Tyler and Chowdhury look like they have some degree of expertise in this area. It would be cool if they were posting here, but that doesn't seem to be the case and it might be unwise for them to do so. They'd have to be very discreet.
FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)
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It's almost clichéd that Congress passes ambiguous laws that are then 'interpreted' by the agencies that are affected. EPA is a good example. There have been several incidences of Congressmen and/or Senators - some of which introduced the bills - saying that the actions that the agencies have taken 'were no part of the intent or wording of the law as passed'. (paraphrasing of course).
Gee, to borrow a phrase, it's almost like the wild, wild west.
More like Brokeback mountain when it comes to certain congress critters and the agencies.
I'm not going to argue with that point as you stated it.
However it may also be relevant to note that a clearly illegal regulation would not have the "force and effect of law," in the sense that the agency would probably have to back down because it might even get scolded by a federal judge.
Go back to my hypothetical - proposed rule becomes final. Now FDA publishes in the FReg that 21 is the age for vaping products. Next, it shuts down a B&M for selling a drip tip to a 20 year old. The FReg clearly does not have the "force and effect of law" as it were, in the sense that the FDA would be very stupid not to back down in that situation.
That's a silly hypothetical, but it raises the larger issue of situations in which regulations may be regarded as unjustified with a prior valid exercise of APA rulemaking or inherent statutory authority.
And that larger problem may be relevant in the situation of the health effects test. You pointed to my ex. of smokeless tobacco, and the general absurdity of regulating vaping like tobacco cigarettes. This not-so-niggling objection - namely that a reg. (something in the FReg) is outside the scope of valid rulemaking and the inherent powers under enabling statutes - is in fact a situation in which the regulation doesn't really have the "force and effect" of law. Even though the intervention of a Fedl court would be (as you correctly point out) be requried to stop the FDA from acting illegally in that particular way (say, by denying an application).
I know that seemed like a "shaggy dog story" LOL but you guys get where I'm going
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I know that seemed like a "shaggy dog story" LOL but you guys get where I'm going
Not really. Although I don't get most of your references. What bdhawk says is true - only congress and courts, even if the fda is 'scolded' by a judge, that's still courts.
It appears your 'hypothetical' has nothing to do with anything other than your mental .........ions. So there's a law that you can't spit on the sidewalk. It's not enforceable.. is that what you're saying. If so, so what? (that's rhetorical).
I know that seemed like a "shaggy dog story" LOL but you guys get where I'm going
Theoretically, I think I see the point you're trying to make. But I don't see any practical impact until the regs are finalized and issued. Until then, how could anyone begin to argue (as in litigate) that they go beyond the scope of the enabling statute?
Now, if what you mean is that you've read the statute and proposed regs and think the proposed regs go beyond the scope of the statute, I suppose that could be addressed in your comments to the FDA (using the rhetorical "you").
Right - this is our problem: we have no idea how they plan to define the health effects balancing test required by the FSPTCA's phrase "appropriate to public health" in the context of vaping. To make matters worse, as far as I know, they've never reviewed - let alone receieved - an application for a tobacco cigarette under the "new" (not SE) pathway. Or any tobacco product, for that matter.
(Which makes sense to me: after all, if every tobacco product is as dangerous as tobacco cigarettes, by definition any new tobacco product has a net negative effect on public health, and must therefore necessarily be a loser under the "appropriateness" standard of rerview!).
The best information we have so far is within the SE rubric. While I loathe Glantz, he does have some rather interesting blog posts on the subject ...
http:// tobacco.ucsf .edu/fda-removes-first-4-tobacco-products-market-3513-go
(Useful for some good general links on SE)
www. tobacco.ucsf .edu/public-comment-fdas-process-documenting-substantial-equivalence-need-high-standards-evidence-and-rea
(Mainly interesting for the image of an SE application)
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Frankly I can't find any useful guidance at all on their site about either the SE or the new products pathway, so it must be in the freg. Although some fiddling here might help: FReg search (I've never had occasion to use this.)
BTW not to pimp, I just posted this on another thread about population studies and various devices, in case it matters (I think it might turn out to be quite relevant to the new products pathway).
(And yes, I read a lot of Glantz. In some ways, he's more interesting than our friends like Siegel, C.V. Phillips, Rodu, etc. That doesn't mean I enjoy reading him
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You may be sorry you asked, they are not brief or written in plain english.....
Demonstrating Substantial Equivalence for Tobacco Products
Modified Risk Tobacco Product Applications
You may be sorry you asked, they are not brief or written in plain english.....
Demonstrating Substantial Equivalence for Tobacco Products
Modified Risk Tobacco Product Applications
Ah thanks!
Those weren't exactly what I was looking for, however, they lead me to this (the new products draft guidance): www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM273425.pdfTo get MRTP (modified risk) you still have to come in under one of the three pathways - the two SE pathways (neither of which are relevant of couse), and the new pathway.
https://www.google.com/#q="Draft+Gu...+Review+of+New+Tobacco+Products"+site:fda.gov
also has smoe more interesting stuff.
Adapt what is useful, reject what is useless, and add what is specifically your own.
Taxes are being proposed at the state and local level right now, this thread and a few others are more concerned with if there will be anything left to tax once the FDA get through passing regulations.
The FDA does not have the power to tax, therefore there should not be any mention of taxes that would be expected in their proposed regulations.
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