Godshall goes to the White House and Congress urging them to not let FDA give the e-cig industry to Big Tobacco

[NorthOfAtlanta]

The three folks I met with at OMB didn't appear interested in
meeting me, and looked like they couldn't wait until the meeting
was over. It was the strangest meeting I've ever had.

In sharp contrast, the Congressional staff all appeared very
interested in what I had to say.

Simple, one groups boss can't be re-elected and Bill doesn't represent anyone who can donate to a library. The other group needs votes next November and can't afford not talking to and listening to someone who represents several million vocal, voting constituents.

 

[squee]

Actually, it wouldn't be a bad idea to write to the President, who was a smoker up until a very short time ago. I'm sure you remember that - every right wing website loved that photo of him with a cigarette - and every right wing radio show and fox news was constantly telling everyone just how terrible President Obama was for not quitting those evil, evil cigarettes. If anyone would understand the difficulty in quitting and would appreciate an easier, safer alternative - it just might be him.

 

[patkin]

^While I hope this thread doesn't deteriorate into a political debate deviating from the OP's intention, I feel I must point out to you that ALL politicians appeal to their base to get elected regardless of their personal opinions. As for Obama's, think about it: The areas with the most aggressive banning of ecigs are those with the thickest and most militant left-wing concentrations.

 

[Apptiger]

New Federal Regulations (including FDA e-cig regs) cannot be officially proposed without OMB's blessing.

The FDA deeming and other e-cig regsa are now at the 4th step of the 9 step regulatory rulemaking process (see map below)

The Reg Map: Informal Rulemaking
http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

At least a half dozen opponents of FDA e-cig regs have or will be meeting with OMB to express their concerns.

Since OMB has scheduled two of these meetings the first week of January, FDA won't be proposing the regs this month (missing yet another announced date for proposing the regs).

We'll see how serious they are about doing it wrong by the length of time they leave for Public comments. Think they have to leave it for a minimum of 60 days but can leave it open longer if they choose. Believe 6 months is more the standard for big changes that may impact commerce. Followed by a rewrite and 6 more months of public comment.
I am not optimistic but thinking once we see the rule all comments should be copied to the White House. While the White House is not up for re-election, its friends are.

 

[NorthOfAtlanta]

Actually, it wouldn't be a bad idea to write to the President, who was a smoker up until a very short time ago. I'm sure you remember that - every right wing website loved that photo of him with a cigarette - and every right wing radio show and fox news was constantly telling everyone just how terrible President Obama was for not quitting those evil, evil cigarettes. If anyone would understand the difficulty in quitting and would appreciate an easier, safer alternative - it just might be him.

Typical far left or right comment, doesn't understand small amount of sarcasm and that the statement was as true 8 years ago as it is now.

 

[rothenbj]

For those who like a little music with their poetry: https://www.youtube.com/watch?v=ja0_m-4NAec

Brings back memories. In the late 70s when I was teaching Senior HS English, the curriculum specified a Rock Poetry unit for the last 6 weeks of the year (when the short-timers did not have their brains engaged very deeply). One of the kids selected the Rock Opera, Tommy as his project. That was my introduction to The Who.

Boy you were a late bloomer. Happy Jack came out in the late 60s. I even remember that and that's impressive for that era.

 

[ennagizer]

A heartfelt thank you for all that you do, Bill.

 

[bikerbeagle]

Adding my thanks to you, Bill, for all you do on our behalf ...but, like others, I can't help but think that - whatever they plan to do - minds have already been made up to do it.

 

[Luisa]

Yesterday, I drove to DC and met with key staff at the White House
Office of Management and Budget (OMB), US House Energy & Commerce
Committee, and Subcommittee Chairs Joe Pitts and Tim Murphy urging
all of them to stop/prevent the FDA from giving the entire e-cig
industry to Big Tobacco.

The White House OMB is currently reviewing the potentially
forthcoming FDA regs, while the House E&C Committee and
Subcommittees have Congressional oversight over FDA, CDC
and the rest of DHHS.

I showed all of them 4 different cigalikes, 4 different mods/APVs
and a 10ml bottle of e-liquid, and pointed out that the APVs and
e-liquid are far superior to cigalikes for smoking cessation
and for reducing cigarette consumption, and that FDA regs would
ban all or virtually all e-liquid products (and perhaps APVs as well).

The three folks I met with at OMB didn't appear interested in
meeting me, and looked like they couldn't wait until the meeting
was over. It was the strangest meeting I've ever had.

After nearly a half hour, one of them told me I had several
minutes remaining. Two minutes later he abruptly ended
the meeting, then all three got up and left the room. At least
they shook my hand when I offered it and thanked them (as
they began walking down the hall).

In sharp contrast, the Congressional staff all appeared very
interested in what I had to say. I urged them to hold a public
hearing and invite e-cig consumers, me and other objective and
knowledgeable folks to testify about e-cigs and the impact of FDA
regulations, to renew their investigation of illegal CDC funding
for state/local lobbying by e-cig opponents, and to introduce
legislation I drafted two years ago that would require FDA to
conduct and publish a comprehensive disease risk assessment and
comparison of different types of tobacco products (including
vapor products) before the agency could impose the deeming regulation.

A potential silver lining of today's announcement by Philip Morris
International (in support of the FDA deeming and other e-cig regs)
is that it verifies what I said yesterday, and what I've been
saying about FDA e-cig regs for the past several years.

Thank you,Bill. Now is the time for all of us to contact our Rep and our Senators. This is NOT THE TIME TO SIT BACK and think someone else will do it for us. We are all responsible for attempting to stop these upcoming regs.

 

[soba1]

Thank you very much for your efforts

 

[MD_Boater]

Yes. Thank you VERY much!

 

[Elnroth]

A big thank you to Bill.

 

[Bill Godshall]

Below is the 2 page outline I wrote for my meeting with OMB.

My activism to reduce smoking / dislcosure.

Cig smoking >99%, OTP <1% of tobacco disease, death & healthcare costs

Nicotine similar to caffeine

Scientific and empirical evidence indicates e-cigarettes:

- are 99% (+/-1%) less hazardous than cigarettes,

- emit similar trace levels of constituents as FDA approved nicotine inhalers, posing no risks to nonusers,

- haven’t created nicotine dependence in any nonsmoker (youth or adult), teen and adult smokers >20 times more likely than nonsmokers to report past-30-day e-cig use.

- haven’t preceded cigarette smoking in any daily smoker (youth or adult),

- are consumed almost exclusively (i.e. 99%) by smokers and former smokers who quit by switching to e-cigs,

- have helped several million smokers quit and/or sharply reduce cigarette consumption,

- have replaced (reduced consumption of) nearly 1 Billion packs of cigarettes in the US in the past five years,

- are gateways away from (not towards) cigarette smoking, and are rapidly driving down cigarette consumption,

- are more effective than for FDA approved nicotine gums, lozenges, patches and inhalers (5% success rate) for smoking cessation and reducing cigarette consumption, and

- pose fewer risks than FDA approved Verenicline (Champix).

States can ban e-cig sales to minors faster than FDA, 26 states already have, but Big Pharma funded CTFK, ACS, AHA, ALA oppose them


Impact of Deeming and other e-cig regs

- Prohibition clauses Chapter IX (905, 910 grandfather dates SE, New Product Applications, accessories and components, 911 ban truthful claims

- If FDA exempts e-cigs from bans, deeming reg would give e-cig industry to Big Tobacco (5,000 to a dozen products, 500 to half dozen companies)

- Altria lobbying for FDA regs to protect its cigarette, cigar and e-cig brands

- FDA regs would ban most effective e-cigs (AVP/mods e-juice, flavorings)

- FDA regs would create black markets (2009 FDA ban, Canada, Australia),

- FDA e-cig marketing regs (incl. behind the counter) benefit Big Tobacco

- Cigars, pipe tobacco also less hazardous than cigarettes

Since 1986, DHHS policy on smokeless (no safe alternative to cigarettes)

Big Pharma funded CTFK, ACS, AHA, ALA, AMA, AAP, Pinney, etc.

Since 2009, FDA has claimed:
- agency doesn’t want people to perceive e-cigs as less hazardous than cigs,
- e-cigs are target marketed to youth and may be gateways to cigarettes,
- e-cigs contain carcinogens and toxic chemical DEG, and
- no evidence e-cigs help smokers quit

SE/NJOY lawsuit and FDA’s response made e-cigs partisan political issue (State AG lawsuits, state bills to ban e-cigs, state/local bills to ban e-cig use)
No corrections about e-cigs by FDA after SE/NJOY won lawsuit

FDA actions on Section 918, MRTP, dissolvables (lack of transparancy),
Petitions to the White House
Mitch Zeller (history at FDA and as GSK lobbyist, claims about THR)

False claims by CDC’s Tom Frieden and Tim McAfee (addicting kids, gateway to cigs)

 

[Luisa]

Below is the 2 page outline I wrote for my meeting with OMB.

I hope they really listen.

 

[xyanide]

Thanks so much for your support to our cause.

 

[AegisPrime]

What I love about Bill is that he's completely against smoking but 100% behind vapers - he totally gets it and it's so important to have people like him and Clive Bates on our side - no one can point a finger at either of them and say they're advocates of Big Tobacco - they just want smokers to have every opportunity to transition to something healthier not only for them but for all those around them.

Bill: I smoked for 15 years and have tried to quit several times, the longest period was for a couple of months - e-cigs had me off the analogs in less than a week, and in two weeks I don't have any urge to go back to them. Thank you for continuing to make the case for this powerful tool for harm reduction!

 

[Vicky]

Thank you Bill!

 

[Luisa]

Thank you,Bill. Now is the time for all of us to contact our Rep and our Senators. This is NOT THE TIME TO SIT BACK and think someone else will do it for us. We are all responsible for attempting to stop these upcoming regs.

Please keep this thread going!

 

[Lisa Belle]

Thank You Bill Godshall for all that you do in the face of so much corruption you are courageous.

 

[Anjaffm]

wow thank you Bill!