FDA requests public comments regarding 3rd party governance of scientific studies by tobacco companies

[Bill Godshall]

Following up on its statement at the March 19^th workshop on Third Party Governance of Industry-Sponsored MRTP Research, the FDA announced the opening of a docket (FDA-2013-N-0305) to take comments from the public until September 30, 2013 on nine specified questions:
http://www.ofr.gov/(X(1)S(r4thdrmaoxl13ygrgxgbcimi))/OFRUpload/OFRData/2013-07576_PI.pdf

 

[Fiamma]

I cannot find anything related to this on the page reached via the link in the PDF.

 

[mischi3vous]

Actually it looks like the FDA is asking about a third party to govern stuff related to tobacco research and NRT, not sure if this would be beneficial to the vaping community or not (can't imagine it would hurt). I'm sure that with the health benefits a lot of us have experienced from vaping as opposed to smoking it would have to be a contender.

 

[Bill Godshall]

This could be extremely important for the vaping community if the FDA ultimately approves it's not-yet-proposed "deeming" regulation, all research conducted by all e-cigarette companies (to apply for MRTP, for a New Tobacco Product, and perhaps even for "substantial equivalence") could/would be overseen (called third party governance) by a largely hostile group of abstinence only prohibitionists (who claim to be public health researchers), including many who urged FDA to ban e-cigs, many who campaigned to ban many universities from accepting any research funding from a tobacco company, and many whose goal is to eliminate all tobacco products, companies and users.

Public comments aren't due until Sept. 30 and a lot of things may happen by then (e.g. the FDA may propose its deeming regulation and additional regs for vapor products), which would make it clear why we need to oppose third party governance proposals for MRTP research funded by companies that plan to submit applications for MRTP, New Products and/or other things.