FDA hosting Tobacco Product Analysis workshop April 11 & 12, implications for e-cigs if FDA approves "deeming" regulation

[Bill Godshall]

This FDA workshop started this morning, is now on lunch break and will resume at 1PM (in 30 minutes).

While the workshop focusses on cigarettes and smokeless tobacco products (because they are the only tobacco products regulated under Chapter IX of the FSPTCA), e-cigarettes would be subject to similar or the same regulatory measures if/when the FDA proposes and approves a "deeming" regulation for e-cigarettes (as the agency has repeatedly stated its intent to do).

tobacco Product Analysis- A Scientific Workshop
Tobacco Product Analysis- A Scientific Workshop

Meeting agenda
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM299644.pdf

FDA will be providing a free, live webcast of the public workshop. The webcast will begin at 8:30 a.m.(Eastern Standard Time) each day and each webcast will be recorded and will be available shortly after the workshop.

• Day 1 - https://collaboration.fda.gov/ctp_tpa1/
• Day 2 - https://collaboration.fda.gov/ctp_tpa2/

 

[Randyrtx]

Bill, will the "deeming" regulation on E-cigs be subject to public review during development and before going into effect?

 

[Bill Godshall]

Randyrtx inquired:

Bill, will the "deeming" regulation on E-cigs be subject to public review during development and before going into effect?

FDA CTR director Lawrence Deyton told me in January (when I was telling him how the "deeming" regulation would decimate the e-cigarette industry and could result in FDA again banning product sales) that there would be a pulbic comment period if/when the FDA officially proposes the "deeming" regulation for e-cigarettes and/or other currently unregulated tobacco products.

But staff of a Republican Congressman told me that the FDA might try to just announce the issuance of the "deeming" regulation (without having a public comment period).

Please note that the FDA did not propose (nor allow for public comments on) the agency's issuance of the ban on imports of e-cigarettes back in 2008/2009, which was struck down by Judge Leon (and upheld by the federal appeals courts) after SE and NJOY sued the agency.

Although I'd like to believe Dr. Deyton, the agency has made so many false and misleading claims (and continues to do so) about e-cigarettes, about the comparable health risks of different tobacco products and tobacco harm reduction, and about many other tobacco regulations that I don't trust anything FDA says about tobacco products, policies, companies or consumers.

 

[Bill Godshall]

Also, please note that even if the FDA provides a public comment period (if/when the agency officially proposes a "deeming" regulation for e-cigarettes), the FDA has ignored virtually all public comments (submitted during public comment periods for many other tobacco regulations) that aren't consistent with the agency's policies (including policies opposing the use of ANY tobacco product and that falsely claim all tobacco products are as hazardous as cigarettes).

 

[Randyrtx]

I know the outlook isn't optimistic, but at the least it might provide some exposure... I hope.

 

[Bill Godshall]

Although Obama's FDA officials have repeatedly stated the agency's intent to promulgate (which means propose and subsequently approve) a "deeming" regulation to apply Chapter IX of the FSPTCA to e-cigarettes and other currently unregulated tobacco products, please note that the agency told Senate Democrats (who urged the FDA to ban e-cigs in 2008/09, and who have subsequently urged the agency to quickly approve a "deeming" regulation for unregulated tobacco products) that they planned to propose the "deeming" regulation back in October, 2011.

Since six months have passed since then, I can only conclude that the FDA, DHHS and/or the White House have either decided to delay proposing the "deeming" regulation until next year (to not potentially conflict with Obama's reelection campaign) and/or have realised that Chapter IX of the FSPTCA poses enormous challenges and litigation risks for the agency and is a counterproductive regulatory scheme for e-cigarettes, little cigars, large cigars, shisha/hookah, dissolvables and/or other currently unregulated products.

I also conclude that the key reasons the FDA has not proposed a "deeming" regulation for unregulated products include the premium cigar industry's vocal opposition and lobbying of Congress, our efforts to oppose and expose the agency's outrageous attempt to ban e-cigarettes, and the agency's realization that implementing a "deeming" regulation for unregulated tobacco products poses enormous challenges for the agency and is likely to result in potentially successful lawsuits against the agency.

 

[Bill Godshall]

If nothing eles, this workshop is demonstrating that tobacco industry scientists and regulatory staff are far more knowlegable about many different scientific issues involving different tobacco products than anyone at FDA, CDC, CTFK or other anti tobacco extremist groups.

 

[DC2]

If nothing eles, this workshop is demonstrating that tobacco industry scientists and regulatory staff are far more knowlegable about many different scientific issues involving different tobacco products than anyone at FDA, CDC, CTFK or other anti tobacco extremist groups.

Interesting observation... can you expound on that when you have some time?