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Bill Godshall Update 2016-05-13

Tobacco Harm Reduction Update - May 13th, 2016

Lawsuit vs FDA Cigarette Protection, Public Health vs FDA Cigarette Protection, More On FDA Deeming Reg / Ban, FDA Flip Flops On PMTA Cost And Submission Estimates For Political Purposes, DHHS And Allies Demonize Vaping, DHHS Deceives Public On E-Liquid Poisoning, More FDA and DHHS, Taxation, Cigarette Litigation, Tobacco Divestment, Flavored Tobacco / Vapor Sales Ban, Vaping / Smoking Ban, Vaping Allowed, Minimum Age, Funding Abstinence-Only Anti-Tobacco / Vaping Propaganda, UK / EU TPD, France, Hungary, India, South Korea, Australia, Malaysia, Vapor Research, A Billion Lives.

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Lawsuit challenges FDA’s cigarette protecting vapor ban

Nicopure Labs files lawsuit challenging FDA’s vapor deeming ban (press release)

Nicopure Labs complaint againt FDA’s Vapor deeming ban (filed in DC Circuit Court)

Nicopure Labs Introductory Overview of the FDA Deeming Regulation

Company files first lawsuit against the FDA’s e-cigarette rule

Mike Siegel: First lawsuit challenging FDA Deeming Regulations

Smoke and Fire: FDA’s e-cig rules spark a battle

Daniel Crane-Hirsch to represent FDA and other defendants in Nicopure Labs lawsuit

Public Health vs FDA Cigarette Protection

- Public health activists and many others criticize FDA’s cigarette protecting vapor ban

Mike Siegel: FDA Draft Guidance confirms that Deeming Regulations will decimate the e-cigarette industry

Brad Rodu: US Policymakers Ignore Royal College of Physicians’ Smoke-Free Tobacco Report – Again

AVA’s Greg Conley interviewed on CNN on Deeming Final Rule

Melissa Vonder Haar: Blog: Did Mitch Zeller just show his true colors?
FDA’s Mitch Zeller calls five million vapers “hypothetical individuals” and says their claims of quitting smoking are “anecdotal reports” to defend FDA’s cigarette protecting ban on lifesaving vapor products: “But we can’t make policy at a national and population level on the basis of hypothetical individuals or anecdotal reports of benefit.”

Jacob Sullum: The FDA’s deadly censorship of lifesaving e-cigarette information

Jonathan Adler: Why the FDA’s new e-cigarette regulations are a gift to Big Tobacco and could actually harm public health

Snuffed Out: How not to regulate e-cigarettes

Kaleigh Rogers: Five ways the FDA’s new regulations will transform the vaping industry

Cigarette companies like FDA Deeming Ban so much, they raise cigarette prices by $.07/pack (Altria announces price hike, and other cigarette companies follow suit).

Mike Siegel – FDA Regulations present an imminent threat to the safety of the public: Urgent changes are needed

AVA’s Greg Conley on Texas Public Radio on Deeming Final Rule; FDA attorney Gerrie Voss outrageously claims FDA Deeming Ban will reduce cigarette deaths and falsely claims e-cigarettes kill people; Univ of Texas’ Dr. Laura Tenner grossly misrepresents scientific evidence on vaping to scare.

AVA’s Greg Conley debates FDA/NIH/Legacy funded vapor prohibitionist Stan Glantz on vapor products; Glantz keeps lying to protect cigarettes and demonize vaping

TVECA on FDA’s Final Rule

SFATA Deeming Regulations Analysis

NATO’s Thomas Briant: FDA Deeming Regulation: What’s Next?
Lawsuits, additional regulations and a grandfather-date battle all lie ahead

Jacob Sullum – FDA stubs out an anti smoking aid: Why the government’s punishment of e-cigarettes is counterproductive

Rich Lowry: FDA blowing smoke on e-cigs

Andrew Stuttaford – E-cigarettes and the FDA: First, do no harm

Walter Olson: Winners and losers from the FDA’s vaping and cigar crackdown

Jacob Sullum: FDA imposes slow-motion ban on e-cigarettes

Walter Olson: FDA’s slow motion ban of e-cigarettes

Rafi Letzter: Here’s how new FDA rules could wipe out e-cigarettes

Melissa Vonder Haar: Grandfather date takes center stage in ‘deeming’ regs

Jacob Grier: The FDA’s new tobacco rules will be terrible for cigar smokers too

Richard Craver: New regulations may turn up the heat on FDA

Richard Craver: Vape shops face uncertain future with new FDA regulations

Kevin Atencio: E-cigarette black market may flip FDA’s new rules

Melissa Vonder Haar: 4 problems for electronic cigarettes post-‘deeming’

Michelle Minton: FDA’s attack on e-cigarettes will cost lives

Eli Lehrer: FDA moves to kill e-cigarettes: Public health and the economy be damned.

R Street calls on Congress to amend FDA rules for e-cigarettes

Jared Meyer: FDA’s new e-cig regs will kill

Mike Siegel: Wall Street Journal interviews Mike Siegal on FDA vapor ban

Mark Dickinson: When two tribes go to war

Sally Satel: What the US should learn from UK’s wisdom on e-cigarettes

FDLI: Slide presentations on the TCA’s outrageously expensive MRTP application (to allow smokeless tobacco companies to truthfully inform smokers or even smokeless tobacco users that smokeless tobacco is far less harmful than cigarettes) by Latham & Watkins’ J. Booneville Haas, PMI’s Moira Gilchrist and THR opponent Eric Lindblom (a former CTFK propagandist and lobbyist, and former FDA CTP policy director)

Aaron Carrol: E-cigarettes are safer, but not exactly safe

Washington Times editorial: A little fire with no smoke: The government gets in the way of smokers trying to quit

Investors Business Daily editorial: The FDA’s new e-cigarette rules hand Big Tobacco a big win

Pittsburgh Tribune Review editorial – The vaping ruling: A valuable smoking-cessation tool could be regulated out of existence

New FDA e-cigarette rules leave local fans, foes sharply divided (WA State)

‘Hundreds out of jobs,’ e-cigarette seller warns after FDA regulations

More on FDA Deeming Reg / Ban

VTA to host Vape & the FDA: Understand it. Manage it. (June 7/8 in Washington, DC)

FDA Deeming Regulation published in May 10 Federal Register

FDA Flip Flops on PMTA Costs

- Prevaricates on Costs and Submission Estimates, for Political Purposes

**FDA Final Deeming Rule now absurdly estimates it will cost a manufacturer just 1,713 hours (ie. less than one FTE working for a year) or just $114,276 to prepare/submit a PMTA for a vapor product, which is 2/3rds fewer hours/dollars than FDA’s estimated 5,000 hours (2.5 FTEs) costing $333,554 in 2014 (after FDA was repeatedly informed by many that the costs of submitting a PMTA are far greater than 5,000 hours and $333,554)
(see page 29091)
**FDA Final Deeming Rule also now estimates 750 PMTAs will be submitted to FDA annually for vapor products (642 ENDS Liquids and 108 ENDS Delivery Systems), 30 times more than FDA’s estimate of 25 PMTAs in 2014; agency attributes exponential change to growing vapor market (which has increased by only about 30% since 2014), but fails to admit their grossly inaccurate flip flopping estimates were purely political.

DHHS And Allies Demonize Vaping

- Obama’s DHHS and anti THR allies demonize vaping to defend FDA’s vapor ban

FDA’s Mitch Zeller continues to obfuscate on his cigarette protecting vapor ban

FDA’s Mitch Zeller claims agency’s cigarette protecting vapor ban is a “balancing act”

FDA Commissioner Robert Califf falsely claims “protecting and promoting the public health” is “where everything must start at FDA” at FDLI conference same day FDA issued its cigarette protecting ban on lifesaving vapor products; falsely claims “we function most effectively when we have access to high quality, reliable evidence” after FDA (since 2009) has ignored, rejected and denied the growing mountain of scientific and empirical evidence (submitted by many groups and individuals at many meetings and on many dockets) finding vapor products are far less harmful than cigarettes, have helped millions quit smoking, and have dramatically improved public health.'s-remarks

US Senator Chuck Schumer (D-NY) applauds FDA’s cigarette protecting vapor ban, grossly exaggerates the declining risks of e-cig battery explosions to confuse and scare

Chuck Schumer wants to get rid of your e-cigarettes

Legacy lies initiative’s Robin Koval criticizes Nicopure Labs lawsuit, outrageously claims FDA’s vapor ban ensures that “smokers have options that help them quit”.

Big Pharma and DHHS funded AHA applauds FDA’s cigarette protecting vapor ban, fails to ethically disclose irreconcilable financial conflicts of interest

Big Pharma funded ALA’s Harold Wimmer keeps praising FDA’s cigarette protecting vapor ban by lying about vapor products to preserve ALA’s funding from Big Pharma, fails to ethically disclose ALA’s irreconcilable financial conflict of interest.

AAFP absurdly claims FDA’s cigarette protecting vapor ban is a big win for patients (it’s a big $$$$ win for Big Medicine by ensuring many more sick and dying smokers)

Big Pharma financed medical groups praise FDA cigarette protecting vapor ban, fail to ethically disclose financial conflicts of interest

NAATPN’s Delmonte Jefferson praises FDA’s cigarette protecting vapor ban, urges FDA to also create a huge black market for untaxed menthol cigarettes

FDA’s first cigarette protecting e-cig prohibitionist Josh Sharfstein (in 2009) praises FDA second cigarette protecting vapor ban

DHHS funded Rand’s William Shadel unsurprisingly endorses FDA’s cigarette protecting sales ban for lifesaving vapor products

Deceitful propaganda by Obama’s DHHS and Big Pharma shills dupes biased and/or naïve news media to support FDA’s cigarette protecting ban on lifesaving vapor products

Bloomberg News editorial calls for further protection of cigarettes by banning e-cig ads

FDLI: FDA Deeming Regulation slide show by vapor prohibitionist TCLC’s Desmond Jenson touts cigarette and NRT protection clauses in TCA as public health protection clauses, cites legal cases relevant to forthcoming Deeming Regulation litigation

Unethical lung cancer research group applauds FDA’s cigarette protecting ban on lifesaving vapor products (which will cause millions of more lung cancers)

Ken Warner hypocritically says FDA was “right” to impose deeming regulation, while criticizing FDA’s rule for banning virtually all vapor products and not considering THR.

Amy Fairchild absurdly claims FDA vapor product ban benefits tobacco harm reduction because one sentence in the rule says FDA believes e-cigs are less harmful than cigarettes

Dr. Brian Secemsky unethically urges doctors to discourage smokers from vaping

DHHS deceives and scares public about e-liquid poisoning

DHHS funded study finds 4,128 calls to PCCs in US for e-liquids in 40 months from 1/1/2012 - 4/30/2015 (i.e. 11 calls/month), reports one death (caused by irresponsible actions of a toddler’s aunt) and 77 cases (i.e. 2% of all calls) of severe complications;
...but authors, Big Pharma financed AAP and others falsely claim study found e-liquid poisonings have sharply increased to confuse, scare and lobby for FDA deeming ban.

Headlines of NY Times, CNN and Healthday falsely claim e-liquid poisonings have sharply increased among children; DHHS funded study author falsely tells AP reporter "This is an epidemic by any definition”, and Big Pharma financed vapor prohibitionist AAP’s Joan Shook absurdly claimed e-liquid poisonings are "a huge public health issue."

But Safe Kids reported more than 2 million calls to PCCs (i.e. 54,717 calls/month) for children ingesting pharmaceutical drugs in a recent 40 month period.

Also, a recent Pediatrics article found 2,594 calls/month to PCCs reporting exposure to detergents by kids under 6 (in 24 months in 2013 and 2014) (62,254/24 = 2,594)

For objective comparison of calls to PCCs for e-cigs compared to other products, see:

ACSH: E-cigarette poison center calls related to kids rise


Former FDA Cmsnr David Kessler admits that FDA, Big Pharma and Big Medicine created deadly opioid addiction epidemic

Former FDA head: Opioid epidemic one of “great mistakes of modern medicine”

DHHS funded anti-THR activists at GSU falsely claim e-cigs don’t help smokers quit (because some smokers who have tried vaping didn’t quit smoking), media repeats lie

Brad Rodu: NIH wastes more tax dollars on misguided smokeless tobacco research

FDA announces New “Reference Cigarette” (called the 1 R6F) to Help Measure Properties of US cigarettes

US DHHS touts abstinence-only anti-tobacco/vaping program targeting LGBT

NPR: Notorius FDA? Feds turn to hip-hop to tamp down teen smoking
(left wing NPR praises FDA’s $128 million abstinence-only program targeting teens)


Big Tobacco backed group submits proposal to raise Missouri’s tobacco tax, which includes additional $.67/pack surcharge on cigarettes sold by smaller cigarette companies

Cigarette Litigation

Smoker’s widower awarded $12M in cancer trial against RJR, with Punitives still to come

Tobacco Divestment

CalPERS chair Fiona Ma irresponsibly says CalPERS should continue losing money by not investing in tobacco industry stocks (CA)

Flavored Tobacco / Vapor Sales Ban

CASAA asks NJ vapers to urge NJ Senators to oppose cigarette protection bill (S 298) that would ban the sale of all flavored vapor products except tobacco, clove and menthol

Vaping/smoking ban

Montgomery County (PA) County Commissioners ban vaping and smoking at county parks (but not far more polluting automobiles or charcoal grills, and not alcohol). Commissioner Dr. Valerie Arkoosh falsely claimed "The science is still uncertain around e-cigarettes," and absurdly claimed park staff cannot tell the difference between vaping and smoking (as another disingenuous excuse to ban lifesaving vapor products).

Vaping Allowed

Nottingham University Hospitals Trust rescinds hospital vaping ban due to PHE report

Vaping now allowed on grounds of Vale of Leven Hospital (UK)

Minimum Age

Illinois Senate defeats bill (SB 3011) that would have increased minimum age for sales of lifesaving vapor products, deadly cigarettes and lower risk OTP

Albany County (NY) increased minimum age for sales of lifesaving vapor products, deadly cigarettes, and less harmful OTP to 21.

Funding Abstinence-Only Anti-Tobacco / Vaping Propaganda

American Cancer Society recruits teens to lobby NC legislators for $17.3 million to dupe teens to believe lifesaving vapor products and low risk OTP are as harmful as cigarettes


UK Prime Minister David Cameron says he’ll investigate EU TPD impact on vaping (video)
Mrs Anne Main (Conservative MP)
“Yesterday Lord Prior spoke up for vaping as a way of getting off cigarettes; so has the Royal College of Physicians. Why are we bringing in the Brussels diktat that says that we must include vaping in the tobacco directive?”
The Prime Minister (David Cameron)
“I am happy to look at this issue closely. It is necessary to differentiate between smoking and vaping, because they have very different health effects. I actually think that that is what is being achieved, but I will look into this carefully and will write to my hon. Friend.”

Christopher Snowdon: EU e-cigarette laws savaged in the House of Lords

UK House of Lords debates EU TPD mandate on vapor products (transcript)
Lord Hunt: "The fact is—I speak as president of the RSPH—that some elements in the public health world were prejudiced from the start against e-cigarettes. That clearly influenced the Department of Health and is the reason why it has taken such a mealy-mouthed approach to e-cigarettes, which is simply not based on evidence at all. It is interesting that, if you look at some of the papers produced by public health bodies, there are some weaselly words around this issue: “We still don’t know and we need to be very careful”.
"They are really trying to find a legitimisation for the initial very negative reaction, which I am afraid has laid the foundations for where we are today, because this is bonkers. It is simply madness. Here we have a product which is clearly of benefit to smokers and there is no evidence whatever that it will be used by non-smokers, which is where all this nonsense has come from. Why would a non-smoker take up these e-cigarettes?”

New EU rules on e-cigarettes and tobacco products: Everything you need to know (UK)

Clive Bates: Professor Glantz brings his anti-vaping crusade to Europe – I review his presentation


1st Vapor Summit in France "Sommet de la Vape" consensus statement says:
- vaping is >95% less harmful than cigarette smoking
- vaping has helped many smokers quit or significantly reduce cigarette consumption
- flavors, nicotine dose and equipment suited to each smoker are key to quitting smoking
- for youth, e-cigarettes appear more of competitor to cigarettes instead of introductory product, with no evidence e-cigarettes are gateways to cigarettes, and
- long term cohort studies of vapers are needed to confirm benefits of vaporizers. (English) (French)


Hungarian law would protect cigarettes by banning vaping in all workplaces


Indian Medical Association protects cigarettes by condemning lifesaving e-cigarettes

Rustam Singh: Here’s Why IMA’s White Paper on e-Cigarettes Seems Misleading & Possibly Flawed (Parts I and II) (India) (Part I) (Part II)

ITC resumes cigarette production in India

South Korea

South Korea announces plan to protect cigarettes by regulating lifesaving e-cigs same as cigarettes on taxation, advertising, sales and warning images.


Colin Mendelsohn: E-cigarettes will save lives and should not be illegal in Australia


Malaysian Organisation of Vape Entities (MOVE): Vaping helps you quit smoking

Vaping laws to govern makers and users proposed

Vapor Research

Melissa Vonder Haar: 4 Takeaways from FDA’s long term PATH nicotine study
- Regular e-cigarette use is very low at 5.5% of adults and 3.1% of youth 12-17
- 42% of vapers are experimenters, vaping less than 3 days in past month,
- 23% of vapers are daily vapers, vaping all 30 days in past month,
- 50% of daily vapers are current smokers, 27% are recent quitters, 14% are long term quitters, 8% are never smokers (but no info if nicotine or something else was vaped)
- Just 14% of 15-17 year old minors who vaped reported buying their own e-cigarettes (as overwhelming majority obtained e-cigs from social sources, not retailers).

Study finds e-cigarettes substantially more likely to encourage smokers to quit than prompt non-smokers to begin vaping

Cigarette smoke but not electronic cigarette aerosol activates a stress response in human coronary artery endothelial cells in culture
“Conclusion: The use of e-cigarettes as a substitute for conventional cigarettes is likely to reduce immediate tobacco-related harm, at least with respect to cardiovascular harms.”

FDLI conference slides available at

FDLI: FDA Deeming Regulation slide presentation by SFATA’s Cynthia Cabrera

FDLI : PAX Labs Gal Cohen’s slides show scientific evidence that vaping helped smokers quit smoking and reduce cigarette consumption, and reduced use of Big Pharma smoking cessation drugs (the real reason FDA is banning them);
Legacy’s Ray Niaura slides show scientific evidence vaping has helped smokers quit and discusses dual use (yet Legacy has lied about e-cigs since 2009 to lobby for both FDA vapor product bans);
Big Pharma/FDA funded AHA’s Aruni Bhatnager slides show e-cigs emit similar levels of constituents as FDA approved nicotine inhalers and exponentially less than cigarettes (yet AHA has lied about vaping since 2009 to lobby for FDA e-cig bans and vaping bans)

DHHS funded study finds little interest in low risk snus among US smokers, but fails to acknowledge that is the result of massively funded anti-snus and anti-smokeless tobacco propaganda by DHHS, dozens of DHHS funding recipients, Big Pharma shills & Legacy

A Billion Lives

A Billion Lives World Premiere in New Zealand;

Paul Henry interviews Aaron Biebert, producer of A Billion Lives

Ryan Jays reviews A Billion Lives

E-cigarettes could be the ‘imperfect’ solution to saving lives

World looks to New Zealand for wisdom on e-cigarettes

New Zealand Health Research Council to fund “high-tech” study on e-cigarettes


- Bill Godshall

Godshall THR update 2016-05-13