FDA Another enemy: Tobacco Control Legal Consortium

[Gato del Jugo]

tobacco Control Legal Consortium Supports Deeming Regulation Changes that Would Take Almost All Electronic Cigarettes Off the Market


The tobacco Control Legal Consortium (TCLC) is urging the public to write to the FDA and encourage the agency to strengthen the proposed deeming regulations on electronic cigarettes. In a set of talking points provided by the TCLC, the Consortium attacks the 24-month grace period for the submission of substantial equivalence or new product applications by electronic cigarette products, calling for the removal of this grace period:

"The FDA proposal would significantly delay the implementation of premarket review for newly covered products. Most egregiously, the proposal creates a twenty-four month provisional period for the submission of tobacco product marketing applications. Applications received during the provisional period enable the continued marketing of the product until the FDA acts on the application which may be well beyond the twenty-four month period. A similar loophole was established during the passage of the Act to apply to cigarettes and smokeless products. The FDA received 3,517 applications but three years later has only issued an order removing four products from the market. After the withdrawal of 117 applications, the tobacco companies are still able to market the unapproved products represented by the 3,396 outstanding applications."

[MORE...]

http://tobaccoanalysis.blogspot.com/2014/05/tobacco-control-legal-consortium.html



Who are they..?

Tobacco Control Legal Consortium | Public Health Law Center


Check out that list of major funders, partners & affiliated organizations...

 

[DeeLeeKay]

Basically, ANTZ!

 

[JackInCali]

Wow, the FDA only removed four products? I really hope that is the same with this regulation lol

 

[iowajosh]

Wow, comments under the first link are toxic enough.

 

[NorthOfAtlanta]

Check out that list of major funders, partners & affiliated organizations...

A who's who list of the BP/FDA cartel.

 

[Kent C]

Regarding who's who. These people, depending on their decisions, have the potential of saving lives along the lines of 5 star Generals and other noted leaders of the Allies in WWII. And they can eradicate more lives than the infamous leaders of the Third Reich. We should know who they are.

FDA Center for Tobacco Products

Executive Biographies

Mitch Zeller, J.D. Director, Center for Tobacco Products

Richard J. Turman, MPP Deputy Director, Center for Tobacco Products

David L. Ashley, PhD Director, Office of Science

Janelle R. Barth, MS, MBA Acting Associate Director, Office of Management

Beverly Chernaik, JD Director, Office of Regulations

Kathleen Crosby Director, Office of Health Communication and Education

Ann Simoneau, JD, MBA Director, Office of Compliance and Enforcement

 

[Katya]

Not an M.D. in sight...

And in related news:

Americans feel the burn as FDA waits to approve new sunscreen ingredients | The Rundown | PBS NewsHour

Skincare product manufacturers and cancer-research advocates have recently teamed up to pressure the FDA to approve new sunblock ingredients. FDA commissioner Margaret Hamburg said sunscreen was “one of the highest priorities” in a 2013 Capitol Hill hearing.

Wendy Selig, president of the Melonoma Research Alliance, told the Washington Post that the hold-up isn’t fair to American consumers.

“We’re basically saying that the American people should make do with what was the most innovative science from 10 to 12 years ago,” she said. “Ask someone if they want to buy automobile technology from 12 years ago, or computer technology from 12 years ago.”

 

[DrMA]

Basically, ANTZ!

Worse than ANTZ. Theses are the ANTZ's inside counsel. They're the ones who advise the ANTZ how to operate above and outside the law, indeed how to become The Law.

 

[Gato del Jugo]

A who's who list of the BP/FDA cartel.

Isn't it wild & bizarre that the names on that list would be against something that threatens to all but eradicate combustible tobacco use in this country??


Goes to show where their true motives lie...

 

[Kent C]

Not an M.D. in sight...

And in related news:

Americans feel the burn as FDA waits to approve new sunscreen ingredients | The Rundown | PBS NewsHour

That's because last year it was found!! ....

Sunscreen Could Be Giving You Skin Cancer

Wendy must have just got the word on that.

Oh and saturated fats, eggs cause cholesterol? Junk science strikes again. Who knows, maybe smoking is good for you

 

[Gato del Jugo]

Wow, comments under the first link are toxic enough.

There are some pretty upset vapers out there, to put it mildly -- and rightfully so..


I can't speak for everybody, but when I post at ECF, I use my nice-boy words..
Outside of ECF? Perhaps a different story...

 

[Kent C]

Isn't it wild & bizarre that the names on that list would be against something that threatens to all but eradicate combustible tobacco use in this country??

Goes to show where their true motives lie...

And they could set an example for other countries as well. Imagine the lives saved.... well despite what Roly says about that

 

[Jman8]

The 'talking points' linked from OP, and not worthy of relinking, are weak and pathetic.

No rationale for why, other than 'the kids' and it is idiots like this that just gave coolness factor to minors to make sure you get the good stuff after the rule is in effect.

Nothing from them that is 'reasonable regulations.' And the only ones that come close, are the ones FDA already has addressed.

The fact that the current regulations do 'significantly delay' things from ANTZ perspective means 2 things to me. First ANTZ stinks. Just plain stinks, but mostly mean they stink at advocacy. Second, pro-vapers need to argue better (which ought to be easy) that the delay must be longer. Change of grandfather date does this, and they know that, but are becoming irrelevant on this battle.

Changing the grandfather date is a reasonable regulation. Doesn't give any vaping vendor a 'get out of restrictions free' card, and thus FDA deeming regulations are in effect, plus provides equal playing field to other existing tobacco products. Plus saves FDA from lots and potentially insurmountable amounts of data research, tracking and determination. The delay already keeps them on the market, and ANTZ is, to some degree, conceding that (while hoping their position, not based on science or reasoning, but on appeal to emotion --think of the kids-- will make sense to some). Changing the grandfather date goes into effect the same day as final rule which bans sales to minors, so hard to take ANTZ position seriously, as FDA tackled their biggest superficial problem head on. Hard to argue that products will be banned to minors, while magically being advertised to them.

Good to see ANTZ overplaying their (pathetic) hand. Will make our work that much easier.

 

[DC2]

Does anyone have the skillz to put these folks in Nazi uniforms?
Because I feel one of my "you are all murderers" rants coming on and I like the visual connotations.

Beverly is kinda cute though, so maybe we can skip her?

Regarding who's who. These people, depending on their decisions, have the potential of saving lives along the lines of 5 star Generals and other noted leaders of the Allies in WWII. And they can eradicate more lives than the infamous leaders of the Third Reich. We should know who they are.

FDA Center for Tobacco Products

Executive Biographies

Mitch Zeller, J.D. Director, Center for Tobacco Products

Richard J. Turman, MPP Deputy Director, Center for Tobacco Products

David L. Ashley, PhD Director, Office of Science

Janelle R. Barth, MS, MBA Acting Associate Director, Office of Management

Beverly Chernaik, JD Director, Office of Regulations

Kathleen Crosby Director, Office of Health Communication and Education

Ann Simoneau, JD, MBA Director, Office of Compliance and Enforcement

 

[Kent C]

Does anyone have the skillz to put these folks in Nazi uniforms?
Because I feel one of my "you are all murderers" rants coming on and I like the visual connotations.

Beverly is kinda cute though, so maybe we can skip her?

Not great but...

 

[badwolf91]

awesome Kent

too bad ecf doesn't have its own mainstream media channel, we would be able to blow the fools away

 

[Katya]

Not great but...

 

[Jman8]

Wow, Mitch Zeller finally has man hands

 

[Gato del Jugo]

There's a few people over at the ProVape sub-forum who are pretty good with graphic design...

 

[sonicdsl]

I think the point is made