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Bill Godshall Update 2015-11-03

Tobacco Harm Reduction Update - November 3rd, 2015


FDA Deeming Regulation / Ban

Somebody at FDA or White House leaked Final Rule for FDA Deeming Regulation to TVECA, which posted excerpts on its website at http://www.tveca.com/

Leaked FDA Draft Guidance for PMTAs for Electronic Nicotine Delivery Systems at
http://tveca.com/tveca_docs/industry_guide_draft_tveca.pdf and
http://www.scribd.com/doc/287324076/Leaked-FDA-Industry-Guidance-for-E-Cigarette-E-Liquid-PMTAs-Legitimacy-Not-Confirmed
delineates how/why Deeming Regulation would:
- change the term E-Cigarettes to Electronic Nicotine Delivery Systems (ENDS),
- cost >$20 million to submit each ENDS PMTA (that FDA would actually accept for review) even though FDA estimated it would cost just $333,554 per PMTA,
- ban the sale of >99.9% of nicotine vapor products to adults,
- put >99% of estimated 10,000 vapor companies (incl. all vape shops) out of business,
- put 50,000+ vaping industry employees out of work,
- create a monopoly or oligopoly of just one or several legal (i.e. FDA approved) ENDS manufacturers and products (with large tobacco companies the most likely winners),
- create a multibillion dollar black market for totally unregulated vapor products, and
- force millions of vapers to go back to smoking cigarettes, switch to an FDA approved ENDS, or buy totally unregulated vapor products from newly created black markets,
- protect cigarettes and threaten the lives of millions of vapers and smokers.

Note that comments submitted to FDA in August 2014 by Bill Godshall and Smokefree Pennsylvania delineated these disastrous ramifications of the proposed Deeming Reg/Ban
http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-80846

Leaked FDA Deeming Regulation Table of Contents confirms that large/premium cigars will be deeming under Chapter IX rules (along with all other OTP and nicotine vapor products), which could ban many/most large/premium cigars from being sold in the US
http://tveca.com/tveca_docs/drp_redacted.pdf

E-cig firms steel for legal battle
http://thehill.com/regulation/258465-e-cig-firms-steel-for-legal-battle

Vapers jam White House phone lines after CASAA Call to Action urges vapers to urge White House to oppose FDA’s cigarette protecting deeming regulation that bans >99.9% of nicotine vapor products now on market, and urges vapers to contact US Representative urging support for HR 2058 (that would keep all e-cig now on market legal in future)
http://blog.casaa.org/2015/10/national-call-to-action-tell-white.html

White Cloud vapor electronic cigarettes to host webinar on FDA deeming regulation featuring Jeff Steir on Wednesday November 4 at 2PM EST
http://webinar.whitecloudelectroniccigarettes.com/regulations/

Carl Phillips: Remember, what FDA wants to do to ecigs, they have already done to smokeless tobacco
http://antithrlies.com/2015/11/02/remember-what-the-us-government-wants-to-do-to-ecigs-they-have-already-done-to-smokeless-tobacco/#more-2491

11 US Senate Democrats urge White House to quickly review and approve FDA deeming regulation (that protects cigarettes by banning >99.9% of nicotine vapor products), and to reject moving grandfather date from February 15, 2007 (to ensure e-cigs are banned).
http://www.durbin.senate.gov/newsroom/press-releases/senators-press-omb-to-quickly-review-rule-finally-regulating-e-cigarettes-and-other-unregulated-tobacco-products
http://www.merkley.senate.gov/news/press-releases/senators-press-omb-to-quickly-review-rule-finally-regulating-e-cigarettes-and-other-unregulated-tobacco-products

Fanatical US Senators Jeff Merkley (D-OR), Ed Markey (D-MA), Richard Blumenthal (D-CT), Elizabeth Warren urge FDA to impose deeming reg to ban e-cigs, grossly misrepresent facts and evidence on vaping and nicotine, conflate lifesaving e-cigs with deadly cigarettes, falsely accuse tobacco companies of target marketing e-cigs to youth.
http://www.c-span.org/video/?c4557627/ignorance

Mike Siegel: Democratic Senators urge OMB to decimate electronic cigarette industry
http://tobaccoanalysis.blogspot.com/2015/10/democratic-senators-urge-omb-to.html

In letter to NY Times criticizing Joe Nocera’s column, CTFK’s Matt Myers makes false claims about vaping’s many health benefits and negligible risks, and about FDA’s deeming regulation (that would ban >99.9% of nicotine vapor products and would put about 99.9% of the 10,000 vapor product manufacturers out of business)
http://www.nytimes.com/2015/10/24/opinion/the-uncertainties-about-e-cigarettes.html

Clive Bates: 10 ways to improve Matt Myers’ letter to the New York Times
http://www.clivebates.com/?p=3379

Joe Nocera signs off as NY Times op/ed columnist advocating e-cigarettes for smokers
http://www.nytimes.com/2015/11/03/opinion/and-thats-my-opinion.html

THR Research and Surveillance

CDC reports 2014 NHIS found:
- 12.6% of US adults (i.e. 30 million) ever used a vapor product,
- 3.7% of US adults (i.e. 9 million) currently vaped (i.e. every day or some days),
- cigarette smokers were 40 times more likely than never smokers to currently vape (15.9% vs 0.4%),
- recent former smokers were 55 times more likely than never smokers to currently vape (22.0% vs 0.4%),
- long-term former smokers were 6 times more likely than never smokers to currently vape (2.3% vs 0.4%), and
- 87.5% of never smokers who ever vaped did NOT currently vape (.028/.032 = 87.5%).
http://www.cdc.gov/nchs/data/databriefs/db217.pdf

Responding to CDC 2014 NHIS data on e-cigarette use by adults, AVA’s Greg Conley calls CDC findings “great news for public health”, but CTFK’s Matt Myers and ALA’s Erika Sward grossly misrepresent CDC data and other evidence to lobby for e-cig ban.
http://www.npr.org/sections/health-shots/2015/10/28/452277042/most-e-cigarette-users-are-current-and-ex-smokers-not-newbies
http://consumer.healthday.com/public-health-information-30/centers-for-disease-control-news-120/e-cigarette-use-highest-among-young-adults-u-s-report-finds-704655.html
http://www.wsj.com/articles/e-cigarettes-appeal-to-smokers-who-are-trying-to-quit-study-says-1446004860
http://www.latimes.com/science/sciencenow/la-sci-sn-electronic-cigarette-use-among-adults-20151027-story.html

CDC says e-cigs help you quit smoking
http://www.thedailybeast.com/articles/2015/11/02/cdc-says-e-cigs-help-you-quit-smoking.html

Jacob Sullum: New CDC data suggest e-cigarettes are helping smokers quit:
The same survey finds that never-smokers rarely become regular vapers.
https://reason.com/blog/2015/11/02/new-cdc-data-suggest-e-cigarettes-are-he

Mike Siegel: New CDC data suggest that e-cigarettes are strongly associated with quit attempts
http://tobaccoanalysis.blogspot.com/2015/10/new-cdc-data-suggest-that-electronic.html

New Delnevo et al study of 2014 NIHS finds recently quit smokers more than four times more likely that daily smokers to vape daily, conculdes “Extremely low e-cigarette use among never-smokers and longer term former smokers suggest that e-cigarettes neither promote widespread initiation nor relapse among adults.”
http://ntr.oxfordjournals.org/content/early/2015/11/02/ntr.ntv237.abstract

Brad Rodu: How many Americans smoke – 2014
http://rodutobaccotruth.blogspot.com/2015/10/how-many-americans-smoke-2014.html

US poll finds (among ever e-cig users) the “primary reason for trying e-cigarettes” were “Method of quitting smoking” (27%), “Curiosity” (24%), “Replacement for tobacco product” (15%), “Healthier alternative to tobacco products” (11%). Finds 40% of e-cig users have health concerns about products (due to DHHS’ War on Vaping). So NPR headlines deceptive finding that 57% of Americans agree with “Do you believe e-cigarettes should be regulated by the FDA like tobacco products?” as question failed to disclose that FDA’s regulation would ban >99% of e-cigs.
http://truvenhealth.com/Portals/0/PULSE-Surveys/NPRPulseeCigsOct2015.pdf
http://www.npr.org/sections/health-shots/2015/10/27/452244929/poll-most-americans-support-fda-regulation-of-e-cigarettes

State Surveillance

Arizona survey finds adult smoking rate lowest ever at 15.3% in 2014.
http://azdailysun.com/news/state-and-regional/percentage-of-adult-arizonans-who-smoke-dips-to-percent/article_5cca2bea-29d8-569e-869e-ec71bc0e72f6.html

2015 YRBS finds record low 12% cigarette smoking rate among North Dakota high school students, 22% used a vapor product (but survey didn’t ask what was vaped), so State employee Jeanne Prom repeats false fear mongering claims about vaping.
http://bismarcktribune.com/news/local/education/e-cigarettes-more-popular-than-tobacco-among-teens-survey-finds/article_513c5759-69a0-5f26-8452-d296bca6b03f.html

Other FDA

FDA takes enforcement action against 8 tobacco retailers by initiating first ever No- Tobacco-Sale Orders (NTSO) for violating the TCA 5 times in 36 months.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm470073.htm
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm232109.htm

FDA issues guidance “National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions--Small Entity Compliance Guide.”
http://www.gpo.gov/fdsys/pkg/FR-2015-10-26/html/2015-27111.htm

US DOT

US DOT sends Final Rule to ban vaping on airlines to White House OMB/OIRA for review (DOT proposed regulation in 2011 to apply smoking ban to smokefree e-cigs)
http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201504&RIN=2105-AE06

US DOT issues interim final banning battery powered e-cigs in checked aircraft baggage, and banning recharging of devices and/or batteries on board aircraft: 30 day public comment period.
http://phmsa.dot.gov/portal/site/PHMSA/menuitem.6f23687cf7b00b0f22e4c6962d9c8789/?vgnextoid=a74862c24f590510VgnVCM100000d2c97898RCRD&vgnextchannel=26a1d95c4d037110VgnVCM1000009ed07898RCRD&vgnextfmt=print
http://phmsa.dot.gov/staticfiles/PHMSA/DownloadableFiles/Files/PHMSA_151013_001_F.pdf
http://www.travelpulse.com/news/impacting-travel/new-law-bans-electronic-cigarettes-in-checked-luggage.html
http://www.nbcnews.com/business/travel/feds-ban-e-cigarettes-checked-airline-bags-citing-fire-threat-n451816

US Rep. Eleanor Holmes Norton (D-DC) introduces bill (HR 3840) to ban vaping on airlines, referred to Committee on Transportation and Infrastructure
http://thomas.loc.gov/cgi-bin/bdquery/z?d114:HN03840:@@@L&summ2=m&
http://gpo.gov/fdsys/pkg/BILLS-114hr3840ih/pdf/BILLS-114hr3840ih.pdf
http://www.gpo.gov/fdsys/pkg/CREC-2015-10-27/pdf/CREC-2015-10-27-pt1-PgE1546-3.pdf#page=1

THR Advocacy

120 health professionals and French vapor trade associations Fivapes and Aiduce urge French government to promote e-cig use to reduce cigarette smoking
http://www.lexpress.fr/actualite/societe/sante/l-appel-de-120-medecins-en-faveur-de-la-cigarette-electronique_1730255.html

Jan Verleur: Embrace, don’t ban, E-cigarettes to help prevent forest fires
http://www.washingtonexaminer.com/embrace-dont-ban-e-cigarettes-to-help-prevent-forest-fires/article/2574967?custom_click=rss

THR Business

Altria reports 1% volume decline for overall US cigarette market during 3Q15, and a 0.1% increase for Altria; reports 0.5% volume decline for overall US cigarette market during first three quarters of 2015, and a 0.5% increase for Altria; reports 0.9% volume increase for USSTC and PM USA smokeless tobacco volume in 3Q15, and a 2% volume increase for first three quarters.
http://www.altria.com/Media/Press-Releases/Pages/PressReleaseDetails.aspx?reqID=2104002

Reynolds reports 4.4% increase in smokeless tobacco volume in 3Q15, cigarette volume changes uncertain due to recent brand sales/purchase by Reynolds, Lorillard, Imperial.
http://www.reynoldsamerican.com/files/doc_news/2015/2015-28-RAI-strong-key-brand-perf-drives-higher-3Q15.pdf

BAT reports 1.8% cigarette volume decline for first 3 quarters of 2015, and 0.4% volume increase for 3Q15
http://www.bat.com/group/sites/uk__9d9kcy.nsf/vwPagesWebLive/DO72TJQU/$FILE/medMDA3QABS.pdf?openelement

Imperial Tobacco issues annual report ending in September, cigarette volume changes from 2014 uncertain due to Imperial’s recent purchase of several brands from Reynolds
http://www.imperial-tobacco.com/files/financial/results/pr2015/pr_2015_press_release.pdf

E-cigarettes stub out the tobacco industry’s success
http://www.worldfinance.com/markets/e-cigarettes-stub-out-the-tobacco-industrys-success

Convenience store survey finds disappointment with vapor product sales (as sales continue growing at vape shops)
http://www.cspnet.com/category-news/tobacco/articles/what-s-wrong-cigalikes-vapor

Litigation

Washington AG Robert Ferguson sues e-liquid company, settles with two others, for claiming products are organic
http://www.atg.wa.gov/news/news-releases/ag-ferguson-cracks-down-deceptive-labeling-organic-e-cigarette-liquids
http://www.thelambertfirm.com/blog/washingtons-ag-takes-action-against-e-cigarette-manufacturers-using-deceptive-advertising/
http://www.dailysunnews.com/news/2015/oct/29/e-cigarette-lawsuits-filed-states-ag/

BAT’s Nicovations sues Australia’s Therapeutic Goods Administration for refusing to allow Voke nicotine inhaler be classified as a health product, and for refusing to even review their application
http://www.theaustralian.com.au/national-affairs/health/bat-moves-from-packaging-to-sue-tga-on-nicotine-inhalers/story-fn59nokw-1227590164902?sv=29e410c01f93f1446af2661b11b605f9&nk=9e70ff317e920fa90e108234fce5bac2-1446485391

Quebec Court of Appeals orders Rothmans, Benson & Hedges and Imperial Tobacco to make security deposit of nearly $1 billion in class-action lawsuits representing about 2 million Quebec smokers
http://montrealgazette.com/news/tobacco-firms-must-pay-almost-1b-in-security-appeals-court-rules
http://www.wsj.com/articles/canada-court-orders-tobacco-companies-to-set-aside-nearly-c-1-billion-1446001179?alg=y

Taxation

Alberta (Canada) government proposes increasing cigarette tax by C$ 5 (US$ 3.80) per carton in 2015 budget
http://www.finance.alberta.ca/publications/tax_rebates/tobacco/overview.html
http://globalnews.ca/video/2302771/alberta-budget-ndp-announces-tax-increase-to-tobacco-and-alcohol

Vapor Product Bans

Malaysian government rejects ban on e-cigarettes
http://www.bangkokpost.com/news/asia/749304/malaysian-government-rejects-ban-on-e-cigarettes

Vaping association to cooperate with Malaysian government
http://www.nst.com.my/news/2015/10/vaping-association-cooperate-government

Macau Health Bureau defends proposed ban on e-cigarette sales (falsely claims e-cigs are as harmful as cigarettes, and that smokers don’t want less harmful alternatives)
http://macaubusinessdaily.com/Society/Health-Bureau-defends-proposed%C2%A0ban%C2%A0-e-cigarette-sales

Retail Restrictions

Chicago’s law banning sale of flavored tobacco products near schools hurts retailers as many adult tobacco customers now shop at other stores
http://www.dnainfo.com/chicago/20151030/wicker-park/7-eleven-challenges-citys-ban-on-selling-flavored-tobacco-near-schools

Sales to minors ban

PA Senate approves bill (SB 751) to ban sales of e-cigarettes to minors, redefines all e-cigarettes as tobacco products (including those that don’t contain or use nicotine); referred to House Judiciary Cmte. http://www.legis.state.pa.us/cfdocs/billInfo/billInfo.cfm?sYear=2015&sInd=0&body=S&type=B&bn=0751

Vaping ban

Ohio County (WV) Health Board considers banning vaping where smoking is banned, expanding smoking ban (but not in casino where most exposures occur)
http://www.wtrf.com/story/30387175/ohio-county-board-of-health-discuss-expanding-smoking-regulations

E-cigarette Safety

Florida man burned by exploding e-cigarette, hospitalized
http://www.wtsp.com/story/news/local/2015/10/27/e-cigarette-explosion-hospitalizes-collier-man/74666086/

More Junk Science, Lobbying, Propaganda and Lies

To lobby for Deeming Reg/Ban, FDA survey in JAMA finds most tobacco and vapor products are flavored (a fact long known by tobacco and vapor product experts), but authors falsely insinuate flavors encourage youth to begin using OTP and vapor products (by touting teen use data but excluding adult use and product flavoring data); survey finds teens cite many different reasons for using vapor products, with 79% of past-30-day e-cig users citing “might be less harmful to me than cigarettes,” 78% citing “might be less harmful to people around me than cigarettes”, 59% citing “help people to quit smoking cigarettes,” and 54% citing it “doesn’t bother non tobacco users”.
http://jama.jamanetwork.com/article.aspx?articleid=2464690
http://www.webmd.com/smoking-cessation/news/20151026/kids-drawn-to-gateway-flavored-tobacco-products-fda-finds
http://www.latimes.com/science/sciencenow/la-sci-sn-first-time-tobacco-flavorings-20151026-story.html
http://www.reuters.com/article/2015/10/27/us-health-teens-smoking-idUSKCN0SL2B220151027

MedPage Today grossly misrepresents CDC 2014 NHIS adult vaping findings with demonizing headline “Vaping: Mainly a Youth Thing”
http://www.medpagetoday.com/PrimaryCare/Smoking/54345?xid=nl_mpt_DHE_2015-10-29&eun=g220600d0r

Mike Siegel – CDC irresponsibly lies to public: Tells ¼ pack per day smokers that they might as well smoke 2 packs a day
http://tobaccoanalysis.blogspot.com/2015/11/cdc-irresponsibly-lies-to-public-tells.html

Deseret News article demonizes lifesaving vapor products and nicotine, touts false fear mongering claims by CDC’s Brian King, Utah DOH’s Brittany Karzan and many other abstinence-only anti-nicotine extremists, promotes FDA deeming regulation (that would ban the sale of >99.9% of nicotine vapor products to adults),
http://www.deseretnews.com/article/print/865640325/The-safety-or-danger-of-e-cigarettes-is-as-cloudy-as-the-vapor-they-produce.html

CDC touts Big Pharma financed ALA data delineating state specific Medicaid coverage requirements and limitations for FDA approved drugs and counseling to treat tobacco dependence, opines that taxpayers should spend even more money subsidizing these less-than-effective (but expensive) drugs and services; press release claims (but cites no evidence) that doing so would increase number of Medicaid recipients who quit smoking.
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6442a3.htm?s_cid=mm6442a3_e

http://www.cdc.gov/media/mmwrnews/2015/1029.html

Big Pharma financed American Academy of Pediatrics (that has urged FDA to ban e-cigs since 2009) falsely touts cigarette protecting deeming reg/ban, vapor product taxes, advertising and flavoring bans as child protection measures; wisely advocates minimum age law of 21 for cigarette sales (but also for lifesaving vapor products)
http://www.aappublications.org/news/2015/10/22/Tobacco
http://pediatrics.aappublications.org/content/early/2015/10/21/peds.2015-3109.full.pdf%20html
http://www.eurekalert.org/pub_releases/2015-10/aaop-aao_1101615.php
https://www.bostonglobe.com/news/nation/2015/10/25/doctors-call-for-tough-restrictions-cigarettes/y64oooArfS8BTUuQdecigO/story.html
http://www.cbsnews.com/news/pediatricians-urge-stronger-regulation-of-tobacco-e-cigarettes/

CA Health Dept to waste more tax dollars to lie about and demonize lifesaving e-cigs, CASAA’s Julie Woessner tells truth about e-cigs and CA Health Dept false claims
http://www.foodworldnews.com/articles/48900/20151101/e-cigarettes-a-health-threat-according-to-ca-department-of-health.htm

Legacy’s Dave Dobbins lies about and demonizes low risk smokeless tobacco products, suggests NFL should ban adult use.
http://truthinitiative.org/news/10-point-stance-does-nfl-have-dipping-problem

Legacy deceitfully promotes intolerantly banning all tobacco and vapor product use at university campuses by deceptively referring to them as “smokefree” policies.
http://truthinitiative.org/news/truth-wants-make-your-epic-creative-and-inspiring-smoke-free-campus-event-reality

CTFK’s Matt Myer totally distorts CDC 2014 NHIS data (finding that many smokers have switched to vaping) to lobby for FDA deeming regulation (that would ban e-cigs)
http://www.tobaccofreekids.org/press_releases/post/2015_10_28_e-cigarettes

THR prohibitionists and propagandists Tomar/Fox/Connolly lie about vaping, urge dentists to discourage smokers from switching
http://jada.ada.org/article/S0002-8177(15)00713-8/pdf

Mike Siegel: Alaska state health director lies about risks of smoking, surpassing the modern day tobacco industry in dishonesty
http://tobaccoanalysis.blogspot.com/2015/11/alaska-state-health-director-lies-about.html

Milwaukee Journal Sentinel’s Raquel Rutledge sensationalizes false and unconfirmed allegations that vaping caused lung diseases
http://www.knoxnews.com/news/nation-and-world/e-cig-industry-test-fails-to-detect-harmful-levels-of-diacetyl-university-testing-shows
http://www.jsonline.com/watchdog/watchdogreports/cases-tie-e-cigarettes-to-lung-injuries-pneumonia-b99606028z1-338598861.html

Big Pharma financed Wisconsin ALA’s Linda Witucki deceitfully claims smokers switching to far less harmful vapor products harms public health
http://www.jsonline.com/news/opinion/increased-use-of-e-cigarettes-threatens-public-health-advances-b99602371z1-336447051.html

Tobacco prohibitionist Fr. Michael Crosby makes false fear mongering claims about lifesaving e-cigarettes, falsely accuses Reynolds of hiding information from public
http://www.jsonline.com/watchdog/watchdogreports/faith-based-shareholder-groups-confront-e-cigarette-companies-b99606264z1-338599271.html

Study author absurdly claims cigarettes are less harmful than smokeless tobacco or OTP, falsely claims nicotine is more harmful than smoking, urges higher taxes on OTP
https://www.informs.org/About-INFORMS/News-Room/Press-Releases/Cigarette-Taxes
http://phys.org/news/2015-10-cigarette-taxes-shifts-consumers-dangerous.html

Survey finds positive association between e-cig use and alcohol use, but author insinuates (without any evidence) e-cigs cause increased alcohol consumption
http://www.eurekalert.org/pub_releases/2015-10/e-ect102815.php
http://www.dailymail.co.uk/health/article-3295049/E-cigarette-users-significantly-likely-problem-drinkers-Devices-encourage-excess-alcohol-consumption-study-claims.html

Per study above, note that another recent survey found that cigarette smoking, but not e-cig use, was positively associated with teen alcohol consumption.
[Link is now dead]

Study finds youth smoking rates declined somewhat more rapidly in states that implemented laws banning e-cig sales to minors before 2014 than in states that didn’t;
(Note that this totally unrelated coincidence has been falsely touted as a cause and effect)
http://www.sciencedirect.com/science/article/pii/S0167629615001150
http://dailycaller.com/2015/10/28/study-laws-banning-e-cigarettes-increase-teen-smoking/