FDA FDA deeming regulation proposals

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Kent C

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Thanks for the research Kent. I might be missing something or failed to take my meds. That OIRA Prompt Letters page shows the last letter sent almost 10 years ago! And the rest of them are even older.

So noted here as well. I'm guessing them to be samples of prompts, but the other question on 'returns' etc. was more closer to 'trying's' question, where they appear to be required to post publically.
 
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Jman8

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Question: if, for some obscure, miraculous reason the FDA would deem vaping non-tobacco (yea, dream on!), would that override state laws calling it tobacco?

That's a good question. I would think not, but it could make court challenges a bit easier if not all are on the same page.

Some states making *other stuff* legal hasn't changed other states/feds opinions on that. I would think it would be entirely up to the state at the time. Would be nice if it were up to the people of the state, but pretty sure anti influence is what will be the driving factor.
 

clnire

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That's a good question. I would think not, but it could make court challenges a bit easier if not all are on the same page.

Some states making *other stuff* legal hasn't changed other states/feds opinions on that. I would think it would be entirely up to the state at the time. Would be nice if it were up to the people of the state, but pretty sure anti influence is what will be the driving factor.
All very true. Thank you. :)
 
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DavidOck

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That's a good question. I would think not, but it could make court challenges a bit easier if not all are on the same page.

Some states making *other stuff* legal hasn't changed other states/feds opinions on that. I would think it would be entirely up to the state at the time. Would be nice if it were up to the people of the state, but pretty sure anti influence is what will be the driving factor.

I tend to agree with that, Jman8. But if the Feds were to decriminalize the other stuff, it would ease the change State by State. A similar effect could well occur with our good stuff :)
 

bigdancehawk

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Question: if, for some obscure, miraculous reason the FDA would deem vaping non-tobacco (yea, dream on!), would that override state laws calling it tobacco?
At this point that's a hard question to answer. Under the Supremacy Clause, the courts have ruled that if Congress intended to give a federal agency complete regulatory control over a particular thing or activity, then state laws or regulation which are materially different from the federal regulations are unconstitutional and void.

For example, state regulations setting safety standards for nuclear power plants are void because Congress gave the Nuclear Regulatory Commission comprehensive control over those particular standards. OTOH, the SCOTUS has held that Arizona could use state licensing provisions to sanction employers for hiring unauthorized workers because it wasn't inconsistent with the federal government's power to regulate immigration. Same thing goes for the federal wiretap statute. The courts have held that the states can impose more stringent requirements. For example, the federal law does not prohibit me from recording our phone conversations without your consent, but some state laws do.

Preemption comes up all the time in product liability cases when plaintiffs argue for more rigorous safety measures or warnings than those required by federal regulations.

But you're right: given the federal enabling statute's definition of a tobacco product to include anything derived from the tobacco plant, I think it's extremely unlikely that the FDA will say that products containing nicotine aren't tobacco products. Of course, the statute was never intended to cover e-cigarettes. It was designed to make it virtually impossible to introduce new combustible and smokeless tobacco products. It's obvious that a new statute needs to be written and passed which is specifically tailored to address e-cigarettes.
 

bigdancehawk

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Thanks for the research Kent. I might be missing something or failed to take my meds. That OIRA Prompt Letters page shows the last letter sent almost 10 years ago! And the rest of them are even older.

HA!

feel the Bern! /joke
IMO, something has been going on behind closed doors for quite some time. How can the OMB/OIRA go 10 years without issuing a prompt letter? Before 2005 they were issuing them on a fairly regular basis and now they've stopped. It's impossible for me to believe that for the past 10 years all of the proposed regulations have been flawless under the applicable guidelines.
 

SeniorBoy

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IMO, something has been going on behind closed doors for quite some time. How can the OMB/OIRA go 10 years without issuing a prompt letter? Before 2005 they were issuing them on a fairly regular basis and now they've stopped. It's impossible for me to believe that for the past 10 years all of the proposed regulations have been flawless under the applicable guidelines.

Great minds think alike, some say! DITTO! :)

Learn more about "letters" and how are tax dollars are spent via an agency shrouded in secrecy.
 
why would USA regulation affect the global market? Co you mean, in the sense that others will likely follow suit? I'm not entirely sure how true that is,I mean look at .......... It's surely not gonna help.
but was far as directly affecting the market, it's my understanding that most American made products stay in America,I didn't think we did much export in this area?

This just occurred to me as well. Can't FDA deeming regs simply be sidestepped by manufacturing offshore? In the same way, can't American vapers, residing in the US, just buy ecigs and eliquid from international sellers? This may have been brought up before, but is there anything in the deeming regs that specifically prohibits buying products online from overseas and having them shipped to a residence in the USA? If not, then there are no real restrictions for the consumer, just a change in the method of ordering the product. Thoughts?
 
OK, fair enough. I was just thinking, if I'm a consumer, residing in the USA and I order a 30ml bottle of eliquid, a 5 pack box of coils and two Li batteries, from a website of a retailer, located overseas and they send me that package, what is it in the deeming regs that specifically disallows for that?
 

Jminton1985

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OK, fair enough. I was just thinking, if I'm a consumer, residing in the USA and I order a 30ml bottle of eliquid, a 5 pack box of coils and two Li batteries, from a website of a retailer, located overseas and they send me that package, what is it in the deeming regs that specifically disallows for that?

I was wondering the same thing. It might become a customs violation, if the new reqs hold.
 
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SilverBear

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Posted elsewhere... but it appears CC processors are now closing services
to online vaping sites:

(quote)

Folks you had better get orders in fast from the looks of this !!

Hello friends.....I hope all is well. Things are not so well for MyVapeJuice.....my
credit card processor has just terminated my contract today...nice warning
hey...and without credit card processing I am done. So I am fighting but today
may be MyVapeJuices last day. They did this because now I am considered a
Tobacco manufacturer per the FDA and MC and VISA have strick rules about not
allowing tobacco sales online ever. So the battle begins and so far they have the
upper hand....but they have not won the war

(end quote)
 
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