Next FDA TPSAC meeting

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Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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FDA's David Ashley just told the TPSAC, that since FDA intends to propose/approve a deeming regulation to apply Chapter IX of the FSPTCA to currently unregulated tobacco products (including some dissolvables), TPSAC should consider both regulated and unregulated dissolvables) in its study.

While I similarly urged TPSAC to consider both regulated and unregulated dissolvables in their report, the reason I urged them to do so was because the law requires it (not because the FDA plans to propose/approve a deeming regulation).

This is critically important, as FDA's Ashley is telling the TPSAC to write its report (which is due March 23) under the assumption that FDA will approve a new deeming regulation sometime in the future.

At the beginning to TPSAC meeting on Wednesday, FDA's Caryn Cohen also stated that the FDA intends to propose/approve the deeming regulation.

Yesterday, after the TPSAC meeting, I told Ashley and Deyton that virtually all e-cigarettes and some dissolvable tobacco products would be banned if the FDA approved this deeming regulation (after Deyton asked one of the vapers who testified why he was concerned that dissolvables or e-cigarettes might be banned, implying that the FDA had no intention of banning the products).

After I told them the deeming regulation would effectively ban e-cigarettes and some dissolvables, Deyton played dumb and asked me how passing this deeming regulation would ban these products, and I told him that for starters, Section 910 would ban all e-cigarette products not on the market prior to Feb 15, 2007 (which includes virtually all e-cigarette products currently on the market).

Then Deyton responded by saying that the way the process works is that the FDA proposes regulations and that anyone can submit their concerns to the FDA during the written comment period, and that the FDA would take those comments under consideration.

Then I told Deyton that the FDA has totally ignored all of dozen or more comments I've submitted (and posted on FDA dockets) during the past 30 months (since the TPC was created by enactment of the FSPTCA).

That was pretty much the end of our conversation.
 
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Bill Godshall

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The TPSAC is now discussing what evidence to actually consider in its report, and just as I pointed out yesterday during the public comment period, the TPSAC is ignoring all of the 100 pages of written comments I submitted (and that CASAA and others submitted) as well as the oral comments made by 15 tobacco harm reduction advocates at yesterday's public comment period.
 

Lisa Belle

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thank you.
I will keep trying. A college education would have helped. :facepalm:
 

wfx

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Bill Godshall

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FDA TPSAC Meeting on Dissolvable Tobacco Products

January 19, 2012

Statement
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
smokefree@compuserve.com

Hi,

I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania. Since 1990, we’ve advocated local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, increase cigarette tax rates, and in 2007 I convinced Senator Mike Enzi to amend the FSPTCA to require picture warnings on cigarette packs.

For disclosure, neither Smokefree Pennsylvania nor I have ever received any funding from any tobacco, drug or electronic cigarette company.

I urge TPSAC members to carefully review the 100 pages of comments I submitted evaluating hundreds of studies and other evidence finding that smokefree tobacco products are about 99% less hazardous than cigarettes, and that several million smokers in US have already quit smoking cigarettes by switching to smokefree alternatives, far more than in Sweden.

Since >99% of tobacco attributable deaths in the US are caused by inhaling tobacco smoke, it is vitally important that TPSAC’s report on dissolvables acknowledge the exponential differences of risk between cigarettes and smokefree tobacco products.

Smokers have a human right to be truthfully informed that smokefree tobacco products are far less hazardous alternatives to cigarettes. Consistently, health agencies have an ethical duty to truthfully inform smokers that smokefree tobacco products are far less hazardous alternatives to cigarettes.

Since several million smokers in the US have already switched to smokefree tobacco alternatives, it is mathematically impossible for smokefree tobacco products to increase tobacco attributable mortality even if every American begins using dissolvables or other smokefree tobacco products.

Dissolvable tobacco products are target marketed to smokers as cigarette alternatives. Most new users of smokefree tobacco products are adult smokers, and most smokefree products pose no health risks to nonsmokers.

On a scale of mortality risk from 1 to 100 where NRT products are 1 and cigarettes are 100, all smokefree tobacco products sold in the US and Sweden appear to be below 2. Smokefree tobacco products and NRT products have very similar health/safety risk/benefit profiles.
Unfortunately, the FDA has falsely stated “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."

In 2009 the FDA misrepresented its own laboratory test findings on e-cigarettes to scare the public and falsely claimed the products were target marketed to youth. Those and other false and misleading claims are still on FDA’s website.

In preparing for meetings in July and this week, the FDA instructed TPSAC to focus its report on nonexistent, miniscule and hypothetical risks of dissolvables, but not to consider the health benefits that occur every time a smoker consumes a dissolvable tobacco product instead of a cigarette.

It was wrong for cigarette companies to mislead the public about the risks of cigarettes for decades. But it is far worse when public health agencies misrepresent the comparable health risks of cigarettes and noncombustible tobacco products.

Human rights, ethics, science and public health must no be compromised by abstinence-only policies and anti-tobacco propaganda.

Thank you
 

CJsKee

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Carl Phillips posted his presentation on his blog:

Today I departed from my usual practice of fiercely avoiding any "science by committee" setting or engaging with government overlord-types, and gave some testimony at the Center for Tobacco Products TPSAC meeting. Greg Conley and Bill Godshall talked me into make the trip as an advisor to the tobacco harm reduction advocacy group CASAA. It was worth it -- there were several great presentations by harm reduction advocates in the "citizen comments" that our public mastersservants grudgingly allow because they have to. Greg recruited several people who had quit smoking by switching to low-risk products, and there were great THR presentations also by Greg, Bill, Elaine Keller, Jeff Stier, Gil Ross, and others. I was pretty pleased with mine too, given that I wrote it while sitting through the talks earlier in the day (something to do during the tedious and pointless presentations by the well-paid consultants and others who were invited to speak by the hosts).
EP-ology by Carl V. Phillips: My testimony at today's FDA tobacco center meeting
 
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