FDA June 2014 GAO report on FDA Tobacco Product Regulation

[AgentAnia]

I came across this yesterday, from the US General Accountability Office (formerly General Accounting Office, aka "the government's watchdog"). It's a fairly long read, but useful in understanding the Center for tobacco Products and how a huge bureaucracy (FDA) goes about setting up a new division and acquiring (or not) the resources needed to run it.

http://www.gao.gov/assets/670/664279.pdf

I do recommend you slog your way through the entire thing*, w/ special attention to the tables showing how they spend their appropriation.

*OP is not responsible for any damage or injury to eyesight or brain cells or for any mental or emotional distress that may occur as a result of said slogging.

 

[Kent C]

Interesting.... like I knew this but this hits home as to some issues:

As of March 31, 2014, the Food and Drug Administration (FDA) spent about $1.48 billion (79 percent) of the $1.88 billion in total tobacco user fees it collected since fiscal year 2009. FDA spent the majority of tobacco user fees on key activities led by the agency’s Center for Tobacco Products (CTP), which is funded solely by tobacco user fees.

the Tobacco Control Act authorized FDA to assess and collect user fees—the sole source of funding for CTP’s activities— from each tobacco manufacturer and importer subject to FDA’s regulation.

... why they'd favor 'tobacco manufacturers'. They'd have to rewrite regulations to get funding from mom and pops.

 

[AgentAnia]

....the Tobacco Control Act authorized FDA to assess and collect user fees—the sole source of funding for CTP’s activities— from each tobacco manufacturer and importer subject to FDA’s regulation[/I].

... why they'd favor 'tobacco manufacturers'. They'd have to rewrite regulations to get funding from mom and pops.

Seems to me they'd simply move the goalposts and include mom and pops (for instance, those who mix their own eliquid) in the definition of "tobacco manufacturer." Unless, of course, they just go ahead and write the reg so that mom and pops are effectively prohibited from mixing their own eliquid.

At this point I can imagine nothing they couldn't or wouldn't do...

 

[Kent C]

Seems to me they'd simply move the goalposts and include mom and pops (for instance, those who mix their own eliquid) in the definition of "tobacco manufacturer." Unless, of course, they just go ahead and write the reg so that mom and pops are effectively prohibited from mixing their own eliquid.

At this point I can imagine nothing they couldn't or wouldn't do...

Oh that's what they'll do if for some reason the deeming doc doesn't shut down small vendors. All of this may just be a smokescreen (vapor screen? so that it's easier to tax ecigs. You have to turn someone into an ant first, verbally and in media, before it's 'ok' to step on them.

 

[skoony]

if some one finds the cliff notes version of this, please post. my head hurts allready.

regards
mike

 

[AgentAnia]

if some one finds the cliff notes version of this, please post. my head hurts allready.

regards
mike

I feel your pain! Just spent half an hour or so going through the report to try and pull out some key pages, and no. Couldn't do it. The section starting on p. 35 (FDA Encountered Challenges As It Established CTP, Including Setting Review Time Frames), and Appendix 1 (Summary of Center for Tobacco Products Offices and Key Activities) are particularly interesting to us right now, I think.