Washington Post - Zeller takes the reins at FDA Monday March 4 2013

[Lilkurty]

http://www.washingtonpost.com/natio...57ddca-81e2-11e2-b99e-6baf4ebe42df_story.html

 

[Lilkurty]

This also posted

Will President Obama let Mitch Zeller do a great job at the FDA? | Center for Tobacco Control Research and Education

 

[Fiamma]

This also posted

Will President Obama let Mitch Zeller do a great job at the FDA? | Center for Tobacco Control Research and Education

OMG it's Stanton Glantz and a love in for Mitch. Imagine that !! //sarcasm off. I note they shut the comments off on this, only 3 zealots allowed to post. Typical Glantz.

 

[Fiamma]

http://www.washingtonpost.com/natio...57ddca-81e2-11e2-b99e-6baf4ebe42df_story.html

Commented 10 chars

 

[Lilkurty]

Editorial
Three years later: an assessment of the implementation of the Family Smoking Prevention and tobacco Control Act
Mitch Zeller




Three years later: an assessment of the implementation of the Family Smoking Prevention and Tobacco Control Act -- Zeller -- Tobacco Control

 

[Lilkurty]

"Zeller will become director of the center next month, as the FDA is preparing to make recommendations on regulating electronic cigarettes, cigars and other tobacco products. The agency is also considering restrictions on menthol cigarettes."


New Head of FDA

 

[Vocalek]

http://www.washingtonpost.com/natio...57ddca-81e2-11e2-b99e-6baf4ebe42df_story.html

It faces pressure from public health advocates and industry officials over the backlog of 3,500 applications that tobacco companies have submitted for new products and changes to existing ones. Regulators have yet to rule on any of them, citing “significant deficiencies” in many applications.

Well, if the FDA looked at an application long enough to determine that there are “significant deficiencies,' instead of going on to the next one, the reviewer should have written a letter to the submitter, citing the deficiencies. Doing nothing is not acceptable.

 

[rothenbj]

Well, if the FDA looked at an application long enough to determine that there are “significant deficiencies,' instead of going on to the next one, the reviewer should have written a letter to the submitter, citing the deficiencies. Doing nothing is not acceptable.

Doing nothing is not acceptable in our eyes, but, I believe, that is the FDA's SOP with dealing anything tobacco related. They're going to make NDAs and ANDAs look like a cake walk by comparison. April approaches very quickly. I hope the industry is poised for a reaction.

 

[Bill Godshall]

With Zeller replacing Deyton, I won't be surprised if April passes without FDA proposing the "deeming" regulation.
It would be nice to know why Deyton resigned (or was told to resign).

One thing is certain, anti tobacco extremists love Mitch Zeller (because he's one of them) and are now urging him to implement tobacco regulations that federal courts are very likely to strike down.

In yesterday's NY Times at
http://www.nytimes.com/2013/03/04/o...-abolition-of-smoking.html?smid=pl-share&_r=0
my old friend and colleague .... Daynard wrote an op/ed advocating two types of cigarette prohibition, (i.e. urging the FDA to mandate nicotine reductions in cigarettes, and urging states to enact laws banning cigarette sales to anyone born after 2000.

The American Bar Association Journal cited Daynard's op/ed at
Want a smoke-free generation? Ban tobacco sales to anyone born this century, law prof says - ABA Journal
to which I posted a comment revealing that such measures would be disasterous for society and would be counterproductive for public health, and pointing out that the best thing FDA could do to reduce cigarette consumption was to begin truthfully informing smokers that e-cigs and other smokefree alternatives are the most effective ways to reduce smoking.


I also posted the following comment on Stan Glantz' blog at
Will President Obama let Mitch Zeller do a great job at the FDA? | Center for Tobacco Control Research and Education

We'll see if he posts it.

Banning menthol cigarettes would create a black market for unregulated and untaxed menthol cigarettes, and would cause losses of more than ten billion of dollars in tax revenue for the federal and state governments, and in MSA payments for states, now used to fund children's healthcare, smoking prevention and cessation programs, and other important public health programs.
But that probably won't occur since the federal courts would likely strike down the regulation after Lorillard and other companies filed suit against the FDA.

Similarly, the federal courts would very likely strike down any regulation by the FDA to ban the use of colors on cigarette packages as a violation of their 1st Amendment Rights. Please note that a federal judge has already ruled that the FSPTCA's requirement for "black and white thombstone ads" violated the companies 1st Amendment Rights, and that Judge Leon has struck down the Obama FDA's color graphic warnings on cigarette packs because they were propaganda instead of accurate and helpful information.

As the one who first pointed out (back in 2004) that cigarette companies would simply switch to color coded cigarette packages if they had to remove the words "lights'", "ultralights" and "milds" from their packages, I'm pleased that Stan and others now recognize that banning those terms did very little (if anything) to reduce cigarette consumption, or to inform smokers that all cigarettes are similarly hazardous.

And as the one who convinced Sen. Mike Enzi to amend the FSPTCA to require color graphic warnings in 2007 (which was staunchly opposed by CTFK, ACS, AHA, ALA who called it a "poison pill" and "Trojan Horse" amendment intended to destroy the bill), I was pleased that this provision in the law has been ruled constitutional, which has been upheld on appeal. But Obama appointees at FDA, egged on by Stan and others, chose to make their color graphic warnings so shocking that Judge Leon struck them down as unconstitutional, and the entire future of color graphic warnings is uncertain.

Finally, Article 5.3 of the FCTC contains many inaccurate statements and is counterproductive for public health. In sharp contrast to its claim that the tobacco industry and public health have irreconcilable differences, for the past decade I've been convincing tobacco companies to develop and target market exponentially less hazardous smokefree tobacco/nicotine products to cigarette smokers to sharply reduce their morbidity and mortality risks. In fact, smokefree alternatives (including moist snuff, e-cigarettes, nicotine gums and lozenges) have already helped more than a million smokers quit smoking and/or sharply reduce cigarette consumption).

The good news for consumer and public health is that e-cigarettes and snuff have higher profit margins than cigarettes, which makes it a win, win for public health and for tobacco companies to transform from cigarette based companies to smokefree tobacco based companies.

The most important thing that Obama's FDA can do to reduce cigarette consumption is to begin truthfully informing smokers that smokefree tobacco/nicotine products are 99% less hazardous alternatives to cigarettes, and that smokers can sharply reduce their morbidity and mortality risks by switching to or substituting smokefree alternatives for cigarettes until they are ready to quit all tobacco/nicotine use.

Public health doesn't win if/when the FDA losses in court.

Bill Godshall

 

[jkos]

Great comment Bill. He will read it but I doubt he will post, maybe I am wrong. Anti tobacco extremist have a closed mind, they will not acknowledge alternatives. They don't care if their policy's work or not. They have an agenda and they are going to stick to it no matter what.

 

[Dusty_D]

There's already a thread about this. Closing this one. Please post any further comments in the original thread: http://www.e-cigarette-forum.com/forum/media-general-news/384472-fda-names-new-head-tobacco-products-center-impact-us.html