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Bill Godshall Update 2016-08-04

Tobacco Harm Reduction Update - August 4th, 2016

Bill Godshall Tobacco Harm Reduction Update 2016-08-04, featuring:
A Billion Lives, FDA Deeming Regulation, ACTION ALERT for all vape shops and other vapor product manufacturers in US, Helpful FDA Documents on
Substantial Equivalence, FDA Deeming Regulation Litigation, Deeming Rule on Cigars, More FDA CTP, CPSC, More THR Prohibition, Vapor Legalization, THR Advocacy and Education, THR Business, Smoking Cessation Drug Licensing Agreements, Abusing MSA Funds, Indiana E-liquid Monopoly Law, Taxation, Vaping Bans, Minimum Age Laws, Litigation, Plain Packaging, Advertising Bans, Conferences, Research, Junk Science - Propaganda - Lies.

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A Billion Lives

A Billion Lives North American Premiere August 6, 2016 at Pabst Theater in Milwaukee

Heartland Daily Podcast – Aaron Biebert: E-cigarettes and A Billion Lives

FDA Deeming Regulation

FDA Deeming Rule takes effect August 8, 2016 (next Monday), key provisions include:
- bans sales of all deemed products that aren’t on the market on August 8, 2016,
- bans manufacturers/retailers from making truthful health claims about deemed products,
- bans free sampling of all deemed products to adults,
- bans sales of deemed products to anyone under 18, and
- requires photo ID of consumers appearing under 27 who tries purchase products



ACTION ALERT for all US vape businesses

- alert for all vape shops and other vapor product manufacturers in USA

To protect your currently manufactured vapor products from being banned by the FDA after August 8, 2016 (next Monday), and to keep your products on the market after August 8, 2018 (if HR 2058 and/or Cole-Bishop amendment to the House Appropriations bill get enacted), you MUST thoroughly document that each of your manufactured vapor products (that you want to continue manufacturing) is on the market on August 8, 2016.

All vapor manufacturers are strongly urged to document (e.g. video record and detail all ingredients, supplies, packaging and labeling) the manufacturing process for each product (including e-liquids, building coils, assembling components, packaging, labeling) to protect your manufactured products from being banned by FDA (as the agency is likely to declare that many/most vapor products on the market after August 8, 2016 were NOT on the market on August 8, 2016), and in preparation for future Substantial Equivalence (SE) reports (if HR 2058 and/or Cole-Bishop amendment are enacted into law).



Helpful FDA Documents on Substantial Equivalence

FDA Guidance: Establishing that a Tobacco Product was Commercially Marketed as of February 15, 2007 (and August 8, 2016 for newly deemed products)
Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions
2013-2015 Substantial Equivalence Marketing Orders (i.e. approved by FDA)

Tobacco deeming regs go into effect Aug 8: What retailers need to know about compliance

Jared Meyer: FDA cannot distinguish between eggplants and tobacco - in yet another power grab, it’s claiming authority to crack down on e-cigs

Mike Siegel: FDA’s convoluted response to a simple question shows how arbitrary, capricious, and inane the Deeming Regulations are (Godshall comments)

Jacob Sullum: The FDA’s incomprehensible answer to a crucial question about its e-cigarette regulations

Jeff Stier: Checks and Balances are Critical to Public Health (cites Sen. Ron Johnson’s inquiry about FDA’s vapor deeming ban)

New FDA tobacco regulations stir help, harm debate

Mike Siegel – FDA Tobacco Center Director to Ex-smoking Vapers: You Don’t Exist

US Rep. Tom Cole interviewed by SFATA’s Cap O’Rourke on HR 2058, the Cole-Bishop amendment, small business, vapor advocacy and more

HR 2058 now has 71 cosponsors, including two Democrats

White Cloud: The FDA vs The Vaping Industry Parts 1 and 2

FDA Deeming Regulation Litigation

Docket for Nicopure Labs v FDA et al: Five parties have filed motions for leave to appear as amicus curiae in support of plaintiffs.

Nicopure v FDA: SFATA’s amicus curiae brief in support of plaintiffs

CTFK files unopposed motion to submit amicus brief supporting FDA deeming ban

Right to be Smoke-Free Coalition and E-Vapor Industry Trade Associations file Motion for Summary Judgment in Lawsuit Challenging FDA’s Deeming Regulation and Tobacco Control Act

Right to be Smoke-Free Coalition v FDA: Memorandum of Points and Authorities in Support of Plaintiff Trade Associations’ Motion for Summary Judgment

Not Blowing Smoke (interview with Nicopure Labs’ Jeff Stamler and White Cloud’s Steve Miller about FDA vapor deeming ban)

Altria claims FDA has decided to NOT enforce the Deeming Regulation’s ban on “mild” brand descriptor for Black and Mild cigars (after Altria sued FDA citing 1st Amendment)

Deeming Rule on Cigars

New rules could leave cigar industry in ashes

FDA cigar rules could snuff out Central Florida cigar makers

4 Cigar Concerns Post Deeming


FDA issues Not Substantially Equivalent Order on Maverick Menthol Product

FDA: “Not Substantially Equivalent” Determinations Summary

Mike Siegel: FDA claims it is protecting public health by keeping slightly altered cigarettes off the market

FDA proposes "Guidance for Tobacco Retailers on Tobacco Retailer Training Programs" for public comment until August 31, 2016

FDA announces four Tobacco Regulatory Science (i.e. propaganda) Fellows

NIH funded Univ. of Michigan authors write “Tobacco Regulation and Cost-Benefit Analysis: How Should We Value Foregone Consumer Surplus?”


SFATA Reveals Child-Resistant Packaging Rules Change by CPSC

US government agency suddenly requires child-proofing immediately

E-cigarette makers contending with New CPSC and FDA Regulations

More THR Prohibition

Hong Kong public health official determined to protect cigarettes by banning all vapor products (HK banned the sale of nicotine e-cigs in 2008), falsely claims products are marketed to youth and falsely claims products are harming vapers.

Malaysian Health Ministry keeps protecting cigarettes by lobbying to ban vapor

Oman bans sale of chewing tobacco, but not far more harmful cigarettes

Singapore protects cigarettes by banning smokeless tobacco, e-cigarettes and other low risk smokefree alternatives.

Vapor Legalization

New Zealand Health Ministry proposes legalizing the sale of nicotine vapor products to adults, public consultation until September 12, 2016

Proposal to legalise the sale of nicotine e-cigarettes announced

New Zealand to make nicotine e-cigarettes legal

A starter pack on e-cigarettes: what you should know

While the US gets more strict on vaping, New Zealand moves to relax its laws

Australian Therapeutic Goods Administration issues Proposed amendments to Poisons Standard, including one to exempt most nicotine e-liquid products (i.e. <3.5% nicotine) from Schedule 7 (a Dangerous Poison: which now bans the sale of all nicotine vapor products), Public Consultation closes September 1, 2016.

Australian TGA: General process for amending the Poisons Standard: Nicotine

THR Advocacy and Education

Clive Bates: “Disinformation from anti-vaping activists more harmful than from tobacco industry”

NCI survey finds >37.5% of Americans inaccurately believe lifesaving vapor products are just as or more harmful than smoking cigarettes, just 5.3% accurately believe vaping is much less harmful than smoking cigarettes (due to massive War on Vaping by Obama’s DHHS and Big Pharma shills since 2009)

In April 2009, Rita Chappelle announced FDA’s ongoing policy to deceive Americans to inaccurately believe lifesaving e-cigarettes are just as harmful as cigarette smoking:
"We don’t want the public to perceive them as a safer alternative to cigarettes.”

Mike Siegel: Hiding the truth from the public: American Lung Association is undermining the public’s knowledge of the hazards of smoking

What medical ‘experts’ hide: Nicotine does NOT cause cancer

Smoking rate hits low in England (drops from 17.8% in 2014 to 16.9% in 2015)

THR Business

Reynolds American reports 3.9% overall US cigarette industry volume decline in 2Q16 (and a 1.7% decline when adjusted for wholesale inventory changes), 24.6% RJ Reynolds cigarette volume increase (due largely to 2015 purchase of Newport), 3.2% overall US smokeless tobacco industry volume increase, .7% American Snuff volume decline, Vuse is leading selling cigalike with 29% of e-cig market in “traditional retail channels”.

Altria reports 5.0% cigarette volume decline in 2Q16, 4.3% smokeless tobacco volume increase, 7.5% cigar volume increase, plans to submit MRTP to FDA for a new heat-not-burn product by end of 2016.

Vector reports 4.2% cigarette volume decline in 1st half of 2016 (US)

British American Tobacco (BAT) reports 3.4% cigarette volume increase for 1st half of 2016, estimates entire cigarette industry volume will decline by 2.5% during 2016.

Japan Tobacco International reports 2.2% cigarette volume increase in 2Q16

CLSA reports estimate Reynolds lost $520M, Altria lost $421M on e-cigarettes from 2013-2105

Nerudia licensed by MHRA to manufacture drugs (UK)

BAT advocates global standards for vapor products, falsely claims doing so would benefit small vapor companies

SFATA appoints three new board members

New Jersey Vapor Rights Coalition launches new website

Smoking Cessation Drug Licensing Agreements

Report Buyer issues/sells “Global Smoking Cessation Partnering 2010-2016” report (which reveals why Big Pharma declared War on Vaping in many/most countries)

Abusing MSA Funds

Philadelphia (PA) Health Dept abuses PA settlement funds on ads advocating an unconstitutional tobacco advertising ban, falsely accuses tobacco companies of target marketing to youth (a violation of the 1998 MSA and the 2009 TCA), inaccurately claims tobacco advertising has increased, advocates retail tobacco sales bans.
Philadelphia Health Dept Director Thomas Farley (who banned vaping in NYC workplaces in 2014 by repeating lies about vaping) accuses tobacco companies of target marketing to youth (but provides no evidence, fails to inform PA AG, NAAG or FDA):
"They are not just selling them. They are marketing them, and marketing them to our children," said city Health Commissioner Thomas Farley. "I think that people should be quite unhappy and even outraged about the amount of marketing of this killer product in low-income neighborhoods by companies who want nothing more than to make a profit off people getting sick."

Indiana E-liquid Monopoly Law

Up in Smoke: Legislation vaporizes Indiana e-cig shops


Commonwealth Foundation: Taxes threaten Chris’s life (PA’s 40% vapor tax)

Commonwealth Foundation: Why Dori is fighting back against government overreach

Commonwealth Foundation: Overtaxing can change lives for the worse (PA vapor tax)

Smokers, retailers burn as Pennsylvania cigarette tax rises

Merchants: Pa. cigarette tax will kill out-of-state business (PA/NJ/NY)

Scranton Times-Tribune editorial: Fair taxation just so much cigar smoke

Mark Hughes: A tale of two tobacco taxes (MO)

New lawsuits aim to throw out proposed tobacco tax hike (MO)

Vaping Bans

East Peoria is first downstate community to ban vaping in public (IL)

Minimum Age Laws

Tasmania decides to not increase minimum age for tobacco sales

Legacy lies initiative deceitfully conflates lifesaving vapor products and very low risk smokeless tobacco with exponentially more harmful cigarettes to advocate minimum age 21 laws for the sale of all vapor and tobacco products (to further deceive the public to believe vaping and smokeless tobacco use are just as harmful as cigarette smoking)

DHHS funded vapor prohibitionist OSU’s Micah Berman and vapor prohibitionist Rob Crane falsely claim raising minimum age to 21 for tobacco sales is most effective way to reduce cigarette smoking, deceptively conflate deadly cigarette smoking with use of low risk smokeless tobacco, fail to admit law would also apply to lifesaving vapor products.


Philip Morris USA settles class action lawsuit (alleging PM USA violated Arkansas Deceptive Trade Practices Act) for $45 million three days before trial set to begin.

Las Vegas man files lawsuit after over exploding e-cigarette battery

Stan Glantz touts frivolous class-action lawsuit (purportedly filed by injured movie goers) against MPAA seeking to mandate R ratings for movies with cigarette smoking

Plain Packaging

Health Canada weighs plain packaging, size restrictions for cigarettes

Cancer Council Australia’s Kylie Lindorff tells Canadains Australia’s plain packaging law reduced the number of smokers by 108,000 (yet vaping has helped millions quit smoking, but are banned in Australia and, in Canada as well according to Health Canada)

Advertising Bans

FDA/NIH funded Stan Glantz advocates enactment and aggressive enforcement of advertising bans in foreign countries that violate the 1st Amendment of US Constitution


Tobacco/vapor prohibitionists to discuss so-called “end game” strategies to ban tobacco and vapor products and industries worldwide (creating new huge black markets) at Royal Society of Medicine in London, September 16, 2016

ECIG Europe: Vapor Industry Conference London, October 12/13, 2016

FDLI Introduction to Tobacco Law and Regulation in Washington DC, October 26, 2016

FDLI Tobacco Conference: Tobacco and Nicotine Policies and Products at a Regulatory and Legislative Crossroads in Washington DC, October 27, 2016


Brad Rodu: Smoking and using e-cigarettes? Moffitt Cancer Center wants you to be “Forever Free”

Koby Michaels – Vaping is cool, smoking is not: Could rise of teen e-cig use have an upside?

Junk science, propaganda and lies

Another junk vapor study burns e-liquid to create dry puffing that humans cannot inhale to confuse, scare and lobby for FDA’s vapor ban; CA funded Berkeley Labs deceptive press release creates fearmongering headlines and news articles without any fact checking or comments by objective experts

Washington Post article grossly misrepresents findings of Berkeley Labs junk vapor study, falsely claims federal health officials consider propylene glycol and glycerin “probable carcinogens”

Bradley Fikes and Kaleigh Rogers also tout inapplicable (for humans) findings of Berkeley Labs “dry puff” vapor study

Vapor prohibitionist John Banzhaff (who used to oppose cigarette smoking) touts bogus Berkeley Labs ‘dry puff’ study to push lawsuits against vapor companies and vaping bans

Paul Barnes / Facts Do Matter: Outpourings of Hot Air (delineates how and why Berkeley Labs dry puff study is dishonest junk science).

Anyway . . . . . called halt study (exposes false and misleading claims by anti vaping Berkeley Labs dry puff study); authors: German
(translated into English)

TheWeek article repeats false fear mongering claims about vaping by DHHS funded Stan Glantz and Robert Teran to confuse, scare and discourage smokers from switching

DHHS funded activists bait teens with deceptive straw man questions about e-cigarette risks, falsely assume all e-cig products contain nicotine, falsely claim flavored e-cigs are more harmful than non-flavored e-cigs.

JAMA entitles article “Adults Join Kids in e-Cigarette Use” to deceive readers to inaccurately believe vapor products have been primarily marketed to and used by youth

New Mexico Health Department’s Dan Green deceitfully conflates lifesaving vapor products with highly addictive and deadly cigarettes, claims sharp decline in NM youth smoking (to 11.4% in 2015) was “offset” by increased vaping

Harvard Medical School issues more false and misleading anti vaping propaganda

Inapplicable cell study by FDA/NCI Benowitz, Jaspers et al confuses and scares readers about vaping, authors falsely claim “the effects of e-cigarettes on human health and how they compare with those induced by cigarette smoking is largely unknown”.

FDA/NCI funded Stan Glantz falsely claims 2013/14 study was just published, grossly misrepresents its findings to confuse, scare and lobby for vaping bans and FDA’s ban

Mike Siegel: Study demonstrates low health risks associated “secondhand vapor” from e-cigarettes

Miami Herald article demonizes vaping and nicotine, fails to acknowledge 2015 MTF survey found teen e-cig use declined, and <20% of teen vapers reported vaping nicotine

Big Pharma funded Population Reference Bureau report deceitfully conflates low risk smokeless tobacco and e-cigarettes with deadly cigarettes, falsely claims “e-cigarettes may normalize smoking and serve as a gateway to the use of traditional cigarettes, especially among youth”, advocates >75% tax on all tobacco products, banning all tobacco advertising, sponsorships and promotions (which violates the US Constitution).

Big Pharma funded AHA publishes junk rat study by UCSF vaping prohibitionist Stan Glantz et al demonizing 2nd hand pot smoke, fail to acknowledge that vaping or ingesting pot pose no smoke inhalation risks for users or the public.

UCLA Cardiologist Ravi Dave falsely claims e-cigarette advertising “renormalized smoking” when opposing CA ballot initiative that would allow marijuana advertising


- Bill Godshall
Godshall THR update 2016-08-04