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Tobacco Harm Reduction Update

25, Sep, 2015

FDA contravenes Judge Leon’s 2010 ruling on e-cig marketing claims

FDA tries to decimate 1st Amendment Rights of e-cig companies with another ban on truthful claims about e-cigs (beyond the deeming reg MRTP ban on health claims), challenges Judge Leon’s 2010 ruling that an e-cig is a “tobacco product” unless the manufacturer makes a “therapeutic claim”. Agency proposes reclassifying and regulating any “tobacco product” as a “drug, device or combination product” if the agency believes it is “intended for use in the . . . prevention of disease” or “intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.” Public comment period ends on November 24, 2015.
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-24313.pdf
https://www.federalregister.gov/articles/2015/09/25/2015-24313/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or

Note that FDA’s proposal above follows warning letters FDA sent on 9/8/2010 to five e-cig companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to use their e-cig product) and even posted research studies and news stories violated the FDCA in conflict with Judge Leon’s ruling (since smoking isn’t a disease, and since just one of the dozens of FDA alleged violations could be considered a “therapeutic claim” to treat the disorder of “tobacco dependence”)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm (Johnson Creek)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225177.htm (Gamucci)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225178.htm (E-CigaretteDirect)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225181.htm (Ruyan America)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225187.htm (E-Cig Technology  Inc)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf (Electronic Cigarette Association)

Judge Leon’s 1/14/2010 ruling striking down FDA’s 2009 e-cig ban, and stating FDA can regulate an e-cig as a drug or device only if the manufacturer makes a “therapeutic claim” https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54

More FDA

Mike Siegel: Nominee for FDA Commissioner has massive conflicts of interest and is not an appropriate choice
http://tobaccoanalysis.blogspot.com/2015/09/nominee-for-fda-commissioner-has.html

Medpagetoday lobbies for Califf nomination as FDA Commissioner
http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/53594
http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/53633
http://www.medpagetoday.com/Cardiology/CardioBrief/53622?xid=nl_mpt_DHE_2015-09-19&eun=g220600d0r

FDA issues the “Use of Investigational Tobacco Products Draft Guidance”; sixty day public comment period
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm463951.htm
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM463953.pdf

Obama’s FDA/NIH tout massively funded Tobacco Regulatory Science Program (TRSP), which funds activist researchers to demonize and misrepresent risks and benefits of nicotine, vapor products, OTP, flavorings, advertising, etc., and to promote FDA’s abstinence-only anti-harm-reduction prohibitionist tobacco regulatory agenda
https://prevention.nih.gov/tobacco-regulatory-science-program

List of FDA/NIH Tobacco Regulatory Science Program grants reveals dozens of activist researchers who have made false and misleading fear mongering claims about vaping
https://prevention.nih.gov/tobacco-regulatory-science-program/research-portfolio

FDA touts its funded activist researcher Stephen Higgins, who inhumanely advocates making cigarettes even more harmful by mandating nicotine reductions, which prompts smokers to smoke even more cigarettes and to inhale deeper and longer
http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/ucm446726.htm

FDA touts its funded activist researcher Suchitra Krishnan-Sarin, who falsely insinuates flavorings make e-cigs addict children (despite no evidence e-cigs have ever created daily dependence in any nonsmoker), falsely claims FDA banned all flavorings except  menthol in “regular” tobacco products (as the TCA only banned flavorings in cigarettes, and only banned about 1% of flavored cigarettes since menthol was exempted).
http://www.fda.gov/TobaccoProducts/PublicHealthScienceResearch/ucm446720.htm

FDA promotes abstinence-only policies, misrepresents risks and benefits of different tobacco products to US Military
http://blogs.fda.gov/fdavoice/index.php/2015/09/fda-and-the-department-of-defense-a-joint-force-to-reduce-tobacco-use-in-the-military-2/

Big Pharma financed CTFK criticizes FDA for not imposing deeming regulation (that would ban >99.9% of all nicotine vapor products now on the market), deceitfully claims FDA’s proposal would protect kids
http://www.tobaccofreekids.org/press_releases/post/2015_09_22_fda

DHHS

After aggressive lobbying by Big Pharma, US Preventive Services Task Force falsely claims “current evidence is insufficient to recommend electronic nicotine delivery systems (ENDS) for tobacco cessation in adults, including pregnant women,” urges doctors to advise all adults to “stop using tobacco, and provide behavioral interventions and FDA approved pharmacotherapy for cessation to adults who use tobacco.”
http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions1
http://annals.org/article.aspx?articleid=2443060
http://www.eurekalert.org/pub_releases/2015-09/acop-tfr091515.php

Lazy stupid news media tout biased task force’s propaganda on smoking cessation
http://time.com/4043177/quit-smoking/
http://www.reuters.com/article/2015/09/21/us-health-smoking-e-cigarettes-idUSKCN0RL2BX20150921

AVA – US Government task force to smokers: Quit or Die
http://vaping.info/news/2015/u-s-government-task-force-to-smokers-quit-or-die

Guy Bentley: Government task force issues useless advice on e-cigarettes
http://dailycaller.com/2015/09/22/government-task-force-issues-useless-advice-on-e-cigarettes/

US SG

US SG Vivek Murthy pushes abstinence-only policies and propaganda, falsely claims tobacco use is a disease, applauds intolerant vaping and tobacco usage bans
http://www.chargerbulletin.com/2015/09/23/the-ongoing-battle-against-tobacco/

THR advocacy

Former US Surgeon General Richard Carmona: E-cigarette hysteria is hazardous to your health
http://nypost.com/2015/09/22/e-cigarette-hysteria-is-hazardous-to-your-health/

Lynn Kozlowski: Vaping as a ‘gateway’ to smoking is still more hype than hazard
https://theconversation.com/vaping-as-a-gateway-to-smoking-is-still-more-hype-than-hazard-47399

John Boley: Smoke and mirrors in the debate over e-cigarettes
http://asia.nikkei.com/Viewpoints/Perspectives/Smoke-and-mirrors-in-the-debate-over-e-cigarettes

US Tobacco Legislation

Pending Federal Legislation on Tobacco Issues
http://www.cspnet.com/category-news/tobacco/articles/pending-federal-legislation-tobacco-issues

MSA

Fitch amends MSA payment spreadsheet for 2015, reports a .36% increase in payments from 2014
http://www.businesswire.com/news/home/20150921006421/en/Amended-Fitch-Completes-U.S.-Tobacco-ABS-Portfolio#.VgWSptLBzGd

Legacy changes name (but still pushes abstinence-only, and still refuses to tell the truth about the dramatically different risks of different tobacco/nicotine products;
http://www.prnewswire.com/news-releases/siegelgale-unveils-new-name-and-brand-identity-for-tobacco-control-non-profit-truth-initiative-300148088.html

THR Business

BAT buys Polish vapor product company CHIC Group, announces “technology sharing” deal with RAI for vapor products
http://www.bat.com/group/sites/UK__9D9KCY.nsf/vwPagesWebLive/DOA2LBUA?opendocument
http://www.reynoldsamerican.com/files/doc_news/2015/2015-07-RJRT-signs-vapor-tech-term-sheet-with-BAT.pdf
http://www.journalnow.com/business/business_news/local/deals-gives-british-american-tobacco-access-to-reynold-s-e/article_986f7d73-b51e-505a-a6e4-9a2849112084.html
http://www.reuters.com/article/2015/09/22/bat-ma-idUSL4N11S2KY20150922
http://www.cityam.com/224917/british-american-tobacco-turns-e-cigarettes-stay-ahead

E-cig volume increases 10% in food/drug/convenience stores, but $ sales decline 7.6% http://www.cspnet.com/category-news/tobacco/articles/nielsen-tobacco-roundup-august

OC Register – The vape debate: Is it good or bad for Orange County to be the ‘Silicon Valley’ of vaping? (author highlights OC’s several hundred vape shops, but repeats many false fear mongering claims about vaping)
http://www.ocregister.com/articles/vaping-682490-industry-liquid.html

Fed Ex to stop tobacco deliveries
http://thecigarauthority.com/fedex-to-ban-shipments-of-tobacco/
http://thecigarauthority.com/could-this-be-the-end-of-mail-order-a-david-garofalo-editorial/

Taxation

This small vape shop could be the first victim of DC’s new tobacco tax
http://dailycaller.com/2015/09/21/this-small-vape-shop-could-be-the-first-victim-of-dcs-new-tobacco-tax/

Mike Siegel: DC’s electronic cigarette tax is an insane policy that will help renormalize smoking
http://tobaccoanalysis.blogspot.com/2015/09/dcs-electronic-cigarette-tax-is-insane.html

Howard University’s Carla Williams heaps praise on DC Council for declaring a no smoking week despite Council’s new 67% e-cig tax to discourage smokers from quitting
https://www.washingtonpost.com/blogs/all-opinions-are-local/wp/2015/09/24/d-c-calls-it-quits/

Chicago Mayor Rahm Emanuel proposes $1.25 tax on e-liquid bottles and $.25/ml tax on the e-liquid (i.e. $8.75 tax for a 30ml bottle of e-liquid)
http://www.chicagotribune.com/news/local/politics/ct-chicago-electronic-cigarette-tax-met-0917-20150917-story.html

AVA: Chicago Vape Tax is About Cigarette Tax Dollars, Not Health
http://vaping.info/news/2015/chicago-vaping-tax-is-about-cigarette-tax-dollars-not-health

55% electronic cigarette tax vexes vapers (Matanuska, Alaska)
http://www.alaskapublic.org/2015/09/22/e-cig-tax-vexes-vapers/

Alabama Gov signs budget, which increases cigarette tax by $.25/pack
http://wkrg.com/2015/09/17/gov-bentley-passes-alabama-budget-with-cigarette-tax-money-from-education-reserves/

‘Vaping the Coast’ draws e-cigarette industry attention as legislative battle looms in Montgomery (AL)
http://www.al.com/news/mobile/index.ssf/2015/07/vaping_the_coast_draws_e-cigar.html

Cigarette Litigation

In the US, one state is ground zero for cigarette suits
http://www.cbsnews.com/news/in-the-u-s-one-state-is-ground-zero-for-tobacco-suits/

Frivolous CA Prop 65 Litigation

Proposed Prop 65 class action law suits filed against e-cig companies
http://topclassactions.com/lawsuit-settlements/lawsuit-news/149299-blu-e-cigarettes-face-proposed-class-action-suit-formaldehyde-ingredients/
http://www.bigclassaction.com/lawsuit/e-cigarette-maker-rj-reynolds-vapors-consumer-fraud.php

Left wing US PIRG touts and repeats CEH fear mongering about e-cigs
http://www.uspirg.org/blogs/blog/usp/next-battle-e-cigarettes

Flavoring Sales Regulation

Berkeley (CA) City Council bans sales of flavored tobacco and e-cig products within 600 feet of any school
http://www.berkeleydailyplanet.com/issue/2015-09-11/article/43700?headline=Berkeley-City-Council-Restricts-Tobacco-Sales---Scott-Morris-BCN-

More Advertising Regulation

Irish Advertising Standards Authority protects cigarettes by banning e-cig companies from truthfully claiming e-cigs are less harmful than cigarettes, Irish Cancer Society applauds cigarette protecting regulation
http://www.independent.ie/irish-news/health/crackdown-on-ads-for-ecigarettes-aimed-at-under18s-31536868.html
http://www.herald.ie/news/ecigarettes-must-not-be-marketed-to-under18s-under-new-ad-guidelines-31536563.html

Australian e-cig prohibitionists lobby to further protect cigarettes by also banning e-cig advertisements
http://www.abc.net.au/news/2015-09-23/e-cigarettes-ban-sought-doctors-heart-asthma-foundation/6796642

E-cig sales ban to minors

MA’s e-cig sales ban to minors, other regulations, take effect this week
http://www.fairfieldcitizenonline.com/news/article/New-regulations-on-sale-of-e-cigarettes-kick-in-6517560.php

Smoking ban

Intolerant Zimbabwe Ministry of Health imposes $500 fine or six months in prison for smoking in public, says policy intended to comply with WHO policy
http://www.zimeye.com/6-months-in-prison-for-public-smoking-zim-new-laws/

Vaping Bans

CASAA urges Tacoma-Pierce County (WA) vapers to oppose proposed vaping ban
http://blog.casaa.org/2015/09/tacoma-pierce-co-wa-local-alert-share.html

Many Tacoma-Pierce County (WA) vapers criticize vaping ban proposal at Health Dept public hearing that just one Health Dept Board member attended, public comments accepted until October 20
http://www.thenewstribune.com/news/local/article36432348.html
http://www.thenewstribune.com/news/local/crime/article35914647.html

Ramsey County (MN) commissioners vote to ban vaping everywhere smoking is banned,
State funded Clearway Minnesota praises vaping ban that protects cigarettes.
http://minnesota.cbslocal.com/2015/09/22/ramsey-county-to-vote-on-e-cigarette-ban/
http://www.prnewswire.com/news-releases/ramsey-county-protects-clean-air-by-restricting-e-cigarettes-and-secondhand-smoke-exposure-300147340.html

Santa Clarita (CA) City Council bans vaping by redefining it as smoking
http://www.hometownstation.com/santa-clarita-latest-news/e-cigarette-regulation-approved-by-santa-clarita-city-council-160625

EU TPD

Clive Bates: Tobacco Products Directive – what’s next and what can be done?
http://www.clivebates.com/?p=3324

Public Health England

PHE/UK study finds smokers who used premium vaporizers and e-liquid daily were more likely to quit smoking that smokers who didn’t vape, and nondaily cigalike users.
http://ntr.oxfordjournals.org/content/17/10/1187.full

AVA: UK Public Health Orgs Push Back Against False Vaping Claims
http://vaping.info/news/2015/uk-public-health-orgs-push-back-against-false-vaping-claims

Dick Puddlecote: Honesty and consistency in short supply at the BMJ
http://dickpuddlecote.blogspot.co.uk/2015/09/honesty-and-consistency-in-short-supply.html

Article in the Guardian hypes false and defamatory allegations by intolerant e-cig opponents against Public Health England’s comprehensive scientific report on e-cigs
http://www.theguardian.com/society/2015/sep/19/vaping-benefits-hyped-by-smoking-lobby-claim-acadamics

Lizzy Buchan: Time to address e-cigarette confusion (further exaggerates deceitful lie by McKee/Capewell, falsely claims e-cig company paid for Public Health England’s report)
http://www.scotsman.com/news/lizzy-buchan-time-to-address-e-cigarette-confusion-1-3893020

WHO

WHO 2015 European health report falsely claims “tobacco use” is one of three major risk factors for premature mortality (it’s daily cigarette smoking) to deceive public; says 30% of Europeans use tobacco (but doesn’t report cigarette smoking rate)
http://www.euro.who.int/__data/assets/pdf_file/0008/284750/EHR_High_EN_WEB.pdf?ua=1

WHO claims European Health Ministers pledge to support WHO’s intolerant campaign for tobacco free society (instead of reducing cigarette smoking)
http://www.euro.who.int/en/media-centre/sections/press-releases/2015/09/who-european-region-member-states-commit-to-denormalizing-tobacco

Vaping Research

International survey finds 86% of 5,000 vapers (who smoked cigarettes regularly when they began vaping) had completely quit smoking, while another 8% had reduced their cigarette consumption by at least half (since they began vaping).
http://www.drugmisuseresearch.org/
https://www.youtube.com/watch?t=117&v=Z3vCBwjC3RA

Mike Siegel: Important new study documents that dual use is not a negative consequence of e-cigarette use, but a positive one
http://tobaccoanalysis.blogspot.com/2015/09/important-new-study-documents-that-dual.html

Teen surveys in Great Britain find “past month use” of e-cigs increased from 0.9% in 2013 to 1.7% in 2014, but remained <0.2% among nonsmokers
http://www.sciencedirect.com/science/article/pii/S0033350615002693

Konstantinos Farsalinos responds to false and misleading fear mongering propaganda in BMJ by those who vehemently oppose smokers quitting smoking by switching to vaping
http://www.bmj.com/content/351/bmj.h4863/rr-13

Nicotine and Tobacco Research devotes special issue to e-cigarettes; while many/most published studies were funded by Obama’s DHHS, journal charges $39 per article
http://www.eurekalert.org/pub_releases/2015-09/oupu-esi091615.php
http://ntr.oxfordjournals.org/content/current

E-cig Safety

UK National Poison Information Service received 241 telephone calls about e-cigarettes in 2014/15, seven cases of moderate toxicity and one case of severe toxicity reported; but news media misrepresents findings to sensationalize, confuse and scare.
http://www.npis.org/NPISAnnualReport2014-15.pdf
http://www.thesundaytimes.co.uk/sto/news/uk_news/Health/article1609589.ece

Smoking Research

Study finds teens with a smoker parent are twice as likely to smoke cigarettes than teens with a never smoker parent, three times more likely to have ever smoked, consistent with other studies finding parental smoking is attributable for far more youth smoking than cigarette advertisements, sponsorships, promotions, flavorings, movies showing actors smoking, and everything else tobacco controllers claim causes smoking, all combined
http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2015.302775
http://consumer.healthday.com/kids-health-information-23/adolescents-and-teen-health-news-719/teens-copy-parents-smoking-study-703411.html
http://www.reuters.com/article/2015/09/22/us-health-teens-smoking-idUSKCN0RM2BI20150922
http://www.universityherald.com/articles/23773/20150918/teens-are-more-likely-to-smoke-if-their-parents-do.htm

Review of 54 studies in 20 countries abroad finds 84% of people in drug and alcohol treatment programs were cigarette smokers, compared to 31% of the population; but study’s author advocates ineffective treatment for tobacco users and WHO’s intolerant abstinence-only anti-harm-reduction prohibitionist MPOWER policy agenda
http://www.eurekalert.org/pub_releases/2015-09/uoc--atw091815.php
http://www.forbes.com/sites/cjarlotta/2015/09/22/alcohol-drug-addicts-far-more-likely-to-smoke-tobacco/

Survey finds majority of world’s smokers (primarily those from countries that follow WHO policies and guidelines) have no desire to quit smoking (perhaps due to WHO’s false and misleading fear mongering claims and prohibition policies for e-cigs and snus)
http://www.cdc.gov/pcd/issues/2015/15_0146.htm
http://www.bloomberg.com/news/articles/2015-09-17/most-of-the-world-s-smokers-have-no-plans-to-quit

Florida survey finds record low teen cigarette smoking rates (i.e. 2% of middle school students, and 6.9% of high school students) as vaping increases; but Florida Health Dept. press release absurdly claims “This alarming increase in e-cigarette use among teens has the potential to normalize smoking again” and falsely insinuates (despite no evidence) that e-cigs are addicting youth.
http://www.floridahealth.gov/newsroom/2015/09/092215-fyts-data-release.html
http://www.floridahealth.gov/statistics-and-data/survey-data/fl-youth-tobacco-survey/_documents/2015-state/index.html
http://www.miaminewtimes.com/news/florida-teens-are-smoking-at-a-record-low-but-love-to-vape-7925077

NYC cigarette smoking rate dropped to record low 13.9% in 2014 as vaping keeps skyrocketing, but e-cig opposing NYC Health Dept congratulates itself for the decline
http://www.capitalnewyork.com/article/city-hall/2015/09/8576947/nyc-smoking-rate-drops-lowest-record

Reduced exposure cigarette?

22nd Century touts more harmful “low nicotine” cigarette as “reduced exposure product,” says it intends to submit MRTP application to FDA
http://www.businesswire.com/news/home/20150924005743/en/22nd-Century-Presents-Potential-Reduced-Exposure-Tobacco#.VgR3ndLBzGd

Chantix/Champix Hazards

Australian mother (whose son committed suicide after taking Champix) gathers almost 50,000 signatures on petition urging Australian Health Ministry to require drug warning
http://www.brisbanetimes.com.au/queensland/mum-lobbies-for-antismoking-drug-warning-20150921-gjr5jo.html

JAMA’s e-cig gateway fraud

UK expert reaction to new study on e-cigarette use in US adolescents
http://www.sciencemediacentre.org/expert-reaction-to-new-study-on-e-cigarette-use-in-us-adolescents/

JAMA’s false and deceitful e-cig gateway claim repeated by duped news media http://triblive.com/news/healthnews/9063936-74/vape-cigarette-cigarettes#axzz3mHt6mSzi
http://theweek.com/articles/577779/end-smoking
http://www.reporterherald.com/opinion/editorial/ci_28820477/editorial-troubling-trends-teen-smoking

NEJM’s fraudulent e-cig formaldehyde study

Konstantinos Farsalinos: Creating a problem results in reward of millions: follow-up of the NEJM study on e-cigarette formaldehyde
http://www.ecigarette-research.org/research/index.php/whats-new/whatsnew-2015/231-form4

Critics demand retractions in Portland State University e-cigarette findings
http://www.oregonlive.com/health/index.ssf/2015/09/critics_demand_retractions_in.html

More junk science, propaganda and lies

Mike Siegel: Physicians continue to make unsupported claims about e-cigarettes
http://tobaccoanalysis.blogspot.com/2015/09/physicians-continue-to-make-unsupported.html

US Rep Frank Pallone (D-NJ), ranking member of US House Health Subcommittee, absurdly insists that e-cigs are as harmful as cigarettes (in article about airline vaping)
http://nj1015.com/e-cigarettes-still-not-banned-on-airlines/
Send e-mail about this to  kevin.mcardle@townsquaremedia.com

Pediatrician Ilana Schmidt repeats AAP’s six year old lie that e-cigs are gateways to cigarette smoking
http://www.gazettenet.com/home/18719546-95/dr-ilana-schmitt-vaping-is-proven-path-to-tobacco-addiction

Kentucky and KU funded Audrey Darville protect cigarettes by making false and misleading fear mongering claims about far less hazardous vaping and nicotine
http://www.kentucky.com/2015/09/20/4046428/tobacco-industry-once-again-targets.html

Mike Siegel: Electronic Cigarettes are Not Renormalizing Smoking, Anti-Tobacco Groups Are
http://tobaccoanalysis.blogspot.com/2015/09/in-my-view-electronic-cigarettes-are.html

Satyen Singh further exaggerates fales fear mongering claims about vaping
http://www.northjersey.com/counties/guest-editorial-listing-the-advantages-of-e-smoking-1.1415729

Study finds mice who that vaped nicotine had more “head dips” and “rearing activity” than mice who vaped no nicotine; researchers conclude that mice who vape nicotine may experience behavioral changes.
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0137953

Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218