FDA to send Section 918 report to Congress on Monday (will include e-cigs)

[Bill Godshall]

Excerpt from article in today's Wall St. Journal
Graphic New Antismoking Ads Launched
Graphic New Antismoking Ads Unveiled - WSJ.com

The FDA is also scheduled to update Congress by Monday on its efforts to clamp down on smoking, nearly four years after it assumed regulatory control over tobacco. Next month, the FDA also plans to propose oversight rules for products it doesn't currently regulate, which include cigars, electronic cigarettes and pipe tobacco.

Section 918 of the FSPTCA at
http://www.gpo.gov/fdsys/pkg/PLAW-111publ31/pdf/PLAW-111publ31.pdf
FDA is sending Congress a report on Monday.

‘‘(b) REPORT ON INNOVATIVE PRODUCTS.—
‘‘(1) IN GENERAL.—Not later than 3 years after the date
of enactment of the Family Smoking Prevention and tobacco
Control Act, the Secretary, after consultation with recognized
scientific, medical, and public health experts (including both
Federal agencies and nongovernmental entities, the Institute
of Medicine of the National Academy of Sciences, and the
Society for Research on Nicotine and Tobacco), shall submit
to the Congress a report that examines how best to regulate,
promote, and encourage the development of innovative products
and treatments (including nicotine-based and non-nicotine-
based products and treatments) to better achieve, in a manner
that best protects and promotes the public health—
‘‘(A) total abstinence from tobacco use;
‘‘(B) reductions in consumption of tobacco; and
‘‘(C) reductions in the harm associated with continued
tobacco use.
‘‘(2) RECOMMENDATIONS.—The report under paragraph (1)
shall include the recommendations of the Secretary on how
the Food and Drug Administration should coordinate and facilitate
the exchange of information on such innovative products
and treatments among relevant offices and centers within the
Administration and within the National Institutes of Health,
the Centers for Disease Control and Prevention, and other
relevant agencies.

It will be interesting to see how badly FDA's report to Congress misrepresents the testimony provided at the FDA's Dec. 17th public hearing and the written testimony submitted by 5,300 vapers in January.

 

[junkman]

A but out topic to Mr. Godshall's discussion, but also from the WSJ article:$48 million to run the ads. 207 thousand additional calls. $232 per caller. 20% claimed quit rate per Dr. Friedan at CSC. So now we are at $1160/quitter. Still not bad if the numbers are to be believed.

But that is quite a success rate. I wonder how the measure that and what they consider quitting? For a week? A month? Out long term? My guess at that kind of rate, it isn't people who quit for very long.

 

[Bill Godshall]

FDA's Section 918 report to Congress on Monday is the subject of a April 23rd FDLI conference session

Agenda

Harm Reduction and Innovation: Update on FDA’s Regulation of NRTs and Smoking-Cessation Products

This session follows up on issues raised during FDA’s December public hearing on agency actions related to nicotine replacement therapies (NRTs) and smoking-cessation products, including modified risk tobacco products (MRTPs). Panelists will provide regulatory updates and discuss concerning the implementation of section 918 of the FDCA, including approval mechanisms, additional indications, and extended use of NRTs and related products that deliver nicotine. The panel will also consider the report to Congress (pending its delivery in March 2013) on the development of innovative products and treatments for tobacco dependence.

Jed E. Rose, PhD, Director, Center for Smoking Cessation and Professor, Department of Psychiatry and Behavioral Science, Duke University Medical Center

Jeffrey P. Walker, MD, Vice President and Chief Medical Officer, Altria Client Services

Moderated by Carlos Angulo, Partner, Zuckerman Spaeder LLP

Interesting panel makeup, as e-cigarette consumers and THR advocates accounted for two thirds of the testifiers at FDA's Dec. 17th hearing, and submitted 99% of the written comments to FDA's docket, while drug companies (and their funding recipients) accounted for about one fourth testifiers at the Dec 17th hearing.

 

[Bill Godshall]

Please note that the E-Cigarette Forum urged consumers to send FDA comments on Section 918 of FSPTCA
http://www.e-cigarette-forum.com/fo...-fda-e-cigarettes-your-action-needed-now.html

5,366 comments were submitted to FDA's docket on Section 918, with vast majority (probably >5,300) from vapers delineating their use and effects of tobacco cigarettes, FDA approved drugs, and e-cigarettes; and urging the agency to not impose unwarranted regulations that would ban or otherwise restrict adult smoker's legal access to e-cigarette products.
Regulations.gov

Also please note that the White House still hasn’t responded to January's ECF generated:

Petition to "Prevent the FDA from regulating or banning the sale and use of electronic cigarettes, accessories and associated liquids."
https://petitions.whitehouse.gov/pe...igarettes-accessories-and-associated/RQLBYRsd


Below are webcasts of the FDA's Public Hearing on December 17, 2012

FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence
FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing

FDA 12/17/12 Hearing: 1 of 4 webcast (FDA's Grail Sipes 0:00-0:08, Gregory Conley 0:08-0:15, Lorie McClung 0:15-0:23, Carl Phillips 0:23-0:39, Linc Williams 0:40-1:00, CASAA's Elaine Keller 1:00-1:14, SRNT's Jonathan Foulds 1:14-1:47)
https://collaboration.fda.gov/p98191651/?launcher=false&fcsContent=true&pbMode=normal

FDA 12/17/12 Hearing: 2 of 4 webcase (ATTUD's Michael Steinberg 0.00-0.10, CTFK's Danny McGoldrick 0.11-0.17, ACS' Angela Jones 0.18-0.24, Legacy's David Abrams 0.24-1.10, Smokefree Pennsylvania's Bill Godshall 1:11-1:28, TCLC's Kathleen Dachille 1:28-1:37)
https://collaboration.fda.gov/p95861884/?launcher=false&fcsContent=true&pbMode=normal

FDA 12/17/12 Hearing: 3 of 4 webcast (ACSH's Gil Ross 0:00-0:11, Scott Ballin 0:12-0:22, Altria's James Dillard 0:22-0:37, Johnson & Johnson's James Walmsley 0:38-1:09, GlaxoSmithKline's Howard Marsh 1:09-1:38, What A Smoke's Mark Anton 1:38-1:47)
https://collaboration.fda.gov/p36279658/?launcher=false&fcsContent=true&pbMode=normal

FDA 12/17/12 Hearing: 4 of 4 webcast (Blue Mist Vaping's Robert Jack 0:00-0:08, American E-Liquid Manufacturing Standards Association's Lou Ritter 0:08-0:32, Legacy's David Abrams 0:33-0:36)
https://collaboration.fda.gov/p20988129/?launcher=false&fcsContent=true&pbMode=normal

 

[cashley]

Thank you for the information and links

 

[rockymtnrobin]

FDA's Section 918 report to Congress on Monday is the subject of a April 23rd FDLI conference session

Agenda


Interesting panel makeup, as e-cigarette consumers and THR advocates accounted for two thirds of the testifiers at FDA's Dec. 17th hearing, and submitted 99% of the written comments to FDA's docket, while drug companies (and their funding recipients) accounted for about one fourth testifiers at the Dec 17th hearing.

Bill I was one of the 10,000 Vapers who did follow the December 17, 2012 webcast. Looking at the meeting as it stands today I don't see anyone speaking for US.
Are we being dismissed?

 

[tnt56]

Sorry but I just got a bad gut feeling about all this. Big tobacco has all the money while they tried their best to kill us all.

 

[Fiamma]

Sorry but I just got a bad gut feeling about all this. Big tobacco has all the money while they tried their best to kill us all.

I agree with the bad gut feeling, but would amend it with BT and BP have all the money, while BT did it's best to kill us and BP did it's best to keep us on the merry go round, smoke, NRT's, relapse to smoking, NRT's and round and round. Both need to protect their cash cows, now BT moving into E Cigs and BP continuing to fight for their ineffective 'quitting aids' that only create more smoking during relapse periods, and ultimately protect their smoker's disease profits from the meds required to keep smokers alive in extremis.

 

[mostlyclassics]

Bill, thanks for the summaries and the links. Do you know if there's a printout of all 5,300-odd comments? I'd love to buy copies and snail-mail them to my congresscritter and both senators.

 

[ElectricalSocket]

Here's the way I see BT vs. BP.

BT has a lot to GAIN by supporting and selling e-cigs. They sell an addictive product and if they want to jump on the bandwagon, I don't see them having any issues with e-cigs. Their first goal isn't to kill or harm people, it's to cash in on a highly addictive product. E-cigs still fit the bill.

BP on the other hand....THEY are the ones who benefit from chronic illness. THEY are the ones who want e-cigs to go away. BT sells a harmful product that people choose to start using, BP will sell AIDS infected blood products to innocent hemophiliacs without batting an eye (look up Bayer Aids scandal). I know it's ignorant to generalize, but generally speaking, BP is much worse than BT right now.

 

[Fiamma]

Here's the way I see BT vs. BP.

BT has a lot to GAIN by supporting and selling e-cigs. They sell an addictive product and if they want to jump on the bandwagon, I don't see them having any issues with e-cigs. Their first goal isn't to kill or harm people, it's to cash in on a highly addictive product. E-cigs still fit the bill.

BP on the other hand....THEY are the ones who benefit from chronic illness. THEY are the ones who want e-cigs to go away. BT sells a harmful product that people choose to start using, BP will sell AIDS infected blood products to innocent hemophiliacs without batting an eye (look up Bayer Aids scandal). I know it's ignorant to generalize, but generally speaking, BP is much worse than BT right now.

Yes BT has a lot to gain, HOWEVER, they could enormously gain from just the right kind of regulation. If the FDA follows the Blu formula of small cigarette look a like e cigs BT gains as they are moving into just that size market.

Blu has helped a lot of people quit, but some new vapers move on to something a bit larger and with longer battery life, and some move back to tobacco cigarettes as what they get is not enough to keep them off tobacco.

The FDA could cement that small size and mandate low nicotine prefilled unrefillable cartridges and decimate the market for anything else, which would probably keep more people smoking and the governments collecting sin taxes on tobacco and keep BP happy with their NRT/relapse/big drug sales down the road current model. They continue on down the road, BT selling BOTH and BP not missing a beat or a buck.

I see it as not so much BT vs BP but a bonus for both, IF FDA mandates the small low nic model.

Not every quitter reads ECF, knows what else there is, or takes up vaping for the long term as a hobbyist. We are the minority of e cig users.

 

[DaveP]

Funny, a search for "electronic" only found references to electronic storage and retrieval methods. Nicotine is referred to as a tobacco product and not called out in a separate clause for electronic cigarettes.

 

[Petrodus]

Not every quitter reads ECF, knows what else there is, or takes up vaping for the long term as a hobbyist.
We are the minority of e cig users.

Well said !!

 

[Petrodus]

I would be SHOCKED if the FDA would allow bottled e-liquids with higher nic levels
and the flavor choices we enjoy today.

I suggest those who prefer Blu/NJOY cigalikes with low nic levels
and few choices of flavors ... will not be effected by the FDA regulations.

Those here who argue our favorite vape machines, nic levels, and flavors
help smokers switch to e-smoking and save lives ... Keep in mind ...
The FDA COULDN'T CARE LESS !!

 

[DaveP]

Check out the latest "FDA News Release" from PBusardo. Read the red type on the second page before heating up your credit card!

http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/399542-fda-news-release.html

 

[brooke2775]

not funny, but funny, scared me.

 

[Petrodus]

Check out the latest "FDA News Release" from PBusardo. Read the red type on the second page before heating up your credit card!

http://www.e-cigarette-forum.com/forum/general-e-smoking-discussion/399542-fda-news-release.html

 

[Talyon]

Gotta love April,fools,day eh!

 

[Bill Godshall]

Looks like the FDA missed its Congressionally mandated deadlines today for submitting three reports, apparently including the Section 918 report cited in this thread.

http://www.huffingtonpost.com/huff-wires/20130401/us-fda-nicotine-replacement/?

Meanwhile, the FDA said it is missing a Monday deadline to submit three tobacco-related reports to Congress, which the agency said are nearing completion. It also is missing another deadline to publish a consumer-friendly list of the levels of dangerous chemicals found in cigarettes and other tobacco products, as well as tobacco company testing and reporting requirements for ingredients and additives.

There are no penalties for forgoing the deadlines outlined in the 2009 law that gave the FDA authority to regulate a number of aspects of tobacco marketing and manufacturing

 

[Tintreach]

It sounds like a bit more breathing room until they do submit. Interesting, I heard on the news this morning a blurb about the new CDC campaign. Would be cool if they pulled a study group and handed them a decent mod and a bottle of liquid to start and what would the success rates would be?

I think these forums (and others) are a pretty good testament to how effective vaping is to quitting analogs. However it looks like we don't have any study data to back up the effectiveness of it to offset whatever BS the FDA proposes.