White House OMB rejects FDA's draft regs for e-cigs as too restrictive, tells agency to draft/submit a new proposal

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Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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Several reliable sources in DC have confirmed that the White House Office of Management and Budget (OMB) has rejected the draft e-cig regulations FDA submitted to the agency back in October because they were too restrictive (just as I've been saying since 2011).

While there haven't been any news stories exposing this huge victory for vapers and the e-cig industry (and the White House OMB isn't likely to acknowledge this to any news reporter, as doing so would reveal a split within the Obama Administration), this would explain why the FDA deeming and other e-cig regulation still haven't been proposed (i.e. published in the Federal Register) despite past assertions that the e-cig regs would be proposed in October, then in December, and then again in January.

A news story several days ago exposed our campaign urging the White House OMB reject the FDA's e-cig regs
(including meetings with 35 different companies/organizations/groups) is at
E-cig industry on tenterhooks ahead of U.S. regulation | Reuters

I suspect it would take the FDA another several-to-six-months (and perhaps longer) to draft and submit another e-cig regulatory proposal, which buys us some very important additional time to expose the facts about e-cigs, expose and criticize the false and misleading claims by e-cig prohibitionists, and further expose and oppose the lethal (for vapers and smokers) ramifications of Chapter IX tobacco regulations if/when they are applied to e-cigs.

Don't know how many different sets of regs the FDA has drafted for e-cigs since 2011, but they've missed a half dozen dates they previously claimed the e-cig regs would be proposed (the first was in October, 2011).

So while this is a huge temporary victory for vapers and the e-cig industry, we must now step up our efforts to defeat the next FDA e-cig regulatory proposal before the agency mobilizes another PR and lobbying campaign (as occurred from Sept-December) for its next e-cig regulatory proposal.


If you haven't already done so, please contact your members of Congress urging them to oppose FDA e-cig ban/reg per my alert at
Action Alert: Urge Congress to prevent FDA from banning e-cigarettes again and to stop FDA from giving the e-cig industry to Big tobacco
http://www.e-cigarette-forum.com/fo...op-fda-giving-e-cig-industry-big-tobacco.html


This setback for FDA also should help us focus our efforts on defeating the many awful state/local bills we now face (as 49 State legislatures are currently in session, and many will end their legislative sessions in March, April and May).

Thanks to everyone who met with the White House OMB.
 
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I wonder if the rejection has spurred on all the additional flurry of regulations that we're seeing proposed across the country?

I've seen numerous stories in which anti-vaping politicians have basically said just that. Something akin to: "We have to act now to protect minors and/or the public because Feds haven't."

We're damned if the FDA doesn't, and we're damned if it does.
 
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I wonder if the rejection has spurred on all the additional flurry of regulations that we're seeing proposed across the country?

I've seen numerous stories in which anti-vaping politicians have basically said just that. Something akin to: "We have to act now to protect minors and/or the public - because the Feds haven't."

I'm no psychologist nor a mind-reader ... but I just haven't gotten the sense that these politicians care too much about the underlying reasons for the FDA's failure to publish regs. (Conflicts w/i the Obama admin. might be interesting fodder for a story in POLITICO or The Hill - but as far as the locals are concerned, that may just be irrelevant DC gossip.)

You might say that we're damned if the FDA doesn't publish reg.s, and we're damned if it does.

The same thing is going on at the local level, vis-a-vis the states. For ex., when bills get tabled in the legislature, then co. and city pols jump right into the fray. It's the proverbial hydra-headed monster. We could fight in bigger cities like Cleveland, Columbus, Cincinnati, Des Moines, Portland OR etc. (I haven't done the research, those are just ex.s. Maybe some of those places already have indoor clean air acts which have been extended to cover vaping.)

But we just don't have the same number of "boots on the ground" to oppose the local legislation in smaller jurisdictions. State and local health officials, tobacco control/cessation "experts," ACS/ALA/etc. rep.s all get involved when it goes local. I've seen that reported repeatedly. I also wonder whether some of them may even actively lobby behind the scenes to initiate ord.s (but I have no evidence yet). Although they definitely do write some of the most shamelessly horrid articles in the local press. "Your tax dollars at work."
 

Alexander Mundy

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I saw that Reuters piece that Bill referenced the other day and I did like this part:

"Mitch Zeller, head of the FDA's tobacco division, said in an interview that there is a "continuum of risk" among nicotine products currently on the market, with cigarettes on one end and medicinal nicotine on the other. He declined to say where on the spectrum he expects e-cigarettes to fall or what is contained in the FDA's proposals. In general, he said, people smoke for the nicotine and die from the tar.

"I'm not saying nicotine is benign, but when compared to the risk associated with regular tobacco, it pales," he said."

Course he could just be pacifying there since he put pharma's stuff on the good end and didn't say where vaping lies.

E-cig industry on tenterhooks ahead of U.S. regulation | Reuters
 
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Nermal

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And then he went on to say they're releasing zero nicotine cigarettes.

You're kidding, Uma? Please tell me you're kidding. They're only going to keep the dangerous part of burning tobacco? I bet you could roll and smoke spinach leaves and find more dangerous tars than anything in our liquids.
 

dr g

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Bill, question. What do you think of the industry numbers published in that article? It claims cigalike manufcturers account for 80% of the market. But I can personally say that none of the many vapers I know of use cigalikes on an ongoing basis. They might get that first sale, but if a person continues vaping, I would guess only a minority use cigalikes permanently. It also claims internet sales only account for 25% of the industry.

IMO if those numbers are not correct then they cannot be allowed to stand. Numbers like that would make it easier to ban internet sales and impose other regulation on manufacturers, etc. by making control seem easier and more directed at big business (Especially big tobacco) than if it is more small-business based as I believe.
 
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aikanae1

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I wondered where they got those numbers too. My guess is those numbers were supplied by industry (BT and BP) which have a habit of not counting anyone else but themselves. There are too many areas of the country without access to a b&m nearby. I read an article that Fast Tech is number 2 in sales and a lot of that business is vaping. I highly doubt their figures.
 
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