Next FDA TPSAC meeting

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mwa102464

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Bill I have to ask you this,

You stated in the 3rd to last paragraph of your post this =

" 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. "


My question is, why and how does the FDA instruct the TPSAC to focus on what the FDA say's to focus on ? Instead of focusing on what you would like to focus on ? Am I missing something here ? and why in the heck would they NOT want you to consider the health benefits that occur every time a smoker consumes a dissolvable tobacco product instead of a cigarette.

Edit; Or is this what your stating towards that = Human rights, ethics, science and public health must no be compromised by abstinence-only policies and anti-tobacco propaganda.

I just want to be clear on my understanding of this


Thank You,

MWA
 
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Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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MWA inquired

My question is, why and how does the FDA instruct the TPSAC to focus on what the FDA say's to focus on ?

Please look at the following documents, and you will see that FDA has instructed TPSAC (at meetings last July and last week) to focus its study and forthcoming report on potential product risks, but didn't ask the committee to study or report on the product's benefits every time a smoker substitutes them for a cigarette.

Archived recordings of the TPSAC meeting webcasts are available below.

January 18: https://collaboration.fda.gov/p24943709/
January 19: https://collaboration.fda.gov/p49817128/
January 20: https://collaboration.fda.gov/p36812959/

FDA's Questions to TPSAC for Jan 18-20 meeting
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM288305.pdf

12/20/11 memo from FDA's David Ashley instructing TPSAC to focus on insignificant and hypothetical health/safety risks of dissolvable tobacco products instead of the enormous health benefits the products provide to adult smokers (their target market) who substitute them for cigarettes: "In its review and consideration of recommendations, TPSAC shall address (1) the risks and benefits to the population as a whole including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do no use tobacco product will start using such products."
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM287431.pdf

FDA's Bibliography of 25 articles for TPSAC on dissolvables includes many written by tobacco harm reduction opponents, and just several written by tobacco harm reduction advocates.
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM287443.pdf

FDA agenda for Jan 18-20 meeting
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM287705.pdf

FDA list of 25 articles for TPSAC to consider at Jan. 18-20 meeting
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM287443.pdf

FDA Summary Memorandum to TPSAC for July 21/22, 2011 meeting
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM263290.pdf

FDA suggested studies for TPSAC to consider for its July 21/22, 2011 meeting
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM263324.pdf

FDA Questions for TPSAC to consider at its July 21/22, 2011 meeting
http://www.fda.gov/downloads/Adviso...uctsScientificAdvisoryCommittee/UCM263294.pdf
 

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
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MWA also inquired:

and why in the heck would they NOT want you to consider the health benefits that occur every time a smoker consumes a dissolvable tobacco product instead of a cigarette.

Because the FDA doesn't want smokers (or anyone else) to know that dissolvables and all other smokefree tobacco products improve the health of smokers every time they use a smokefree alternative instead of smoking a cigarette.
 
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