House Panel Approves FDA Tobacco Oversight

[Tallulah]

‘(3) LIMITATION ON POWER GRANTED TO THE FOOD AND DRUG ADMINISTRATION- Because of the importance of a decision of the Secretary to issue a regulation--

‘(A) banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or

‘(B) requiring the reduction of nicotine yields of a tobacco product to zero,the Secretary is prohibited from taking such actions under this Act.

I've said it before on this forum and I'll say it again, THIS is why Philip Morris is supporting this bill. It's also why I think the proposed legislation may be a double-edged sword for us. On the one hand, we may be saved from having nicotine banned outright; on the other, it may be the bloody road on which Big Pharma rides in to slay us.

[dc2k08]

I think joel nitzkin said it best:

Still, some critics say the bill, largely the product of years of negotiation between cigarette giant Phillip Morris and the advocacy group Campaign for Smoke Free Kids, does not go far enough.

"This is a big gift to Phillip Morris and a big scam," said Joel Nitzkin, chairman of the tobacco control task force of the American Association of Public Health Physicians. "Our initial impression was gee, this would be great. But when we read through the entire 160 pages, we were horrified by what we saw."

Nitzkin said, for instance, that the bill has a grandfather clause that protects products currently on the market but creates hurdles for new products such as low-nicotine lozenges that deliver a nicotine dose but are not smoked and therefore pose no risk of lung disease and a much reduced chance of heart disease.

we are a pathetic bunch us nicotine addicts, having to spend time worrying about bull.... like this. actually does make me want to quit nic completely and spend my time taking something useful.

[Sun Vaporer]

But what this legislation is saying in its implication is that nicotine is a drug needing regulation by the Food and Drug Administration. If that's so, what of e-smoking's future and our drug delivery devices for nicotine?

TB is right on point here--as reiterated from the bill ---The literal reading is once again bad news on the door step for us -- Specifically Sec. 918 as set forth here-- is our device in fact going to be considered "An Innovative Product" --See below in relevent part..............
H.R.1256

Family Smoking Prevention and Tobacco Control Act (Introduced in House)

`SEC. 918. DRUG PRODUCTS USED TO TREAT TOBACCO DEPENDENCE.

• `(a) In General- The Secretary shall--

• • `(1) at the request of the applicant, consider designating products for smoking cessation, including nicotine replacement products as fast track research and approval products within the meaning of section 506;

• • `(2) consider approving the extended use of nicotine replacement products (such as nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco dependence; and

• • `(3) review and consider the evidence for additional indications for nicotine replacement products, such as for craving relief or relapse prevention.

• `(b) Report on Innovative Products-

• • `(1) IN GENERAL- Not later than 3 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary, after consultation with recognized scientific, medical, and public health experts (including both Federal agencies and nongovernmental entities, the Institute of Medicine of the National Academy of Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the Congress a report that examines how best to regulate, promote, and encourage the development of innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments) to better achieve, in a manner that best protects and promotes the public health--

• • • `(A) total abstinence from tobacco use;

• • • `(B) reductions in consumption of tobacco; and

• • • `(C) reductions in the harm associated with continued tobacco use.

• • `(2) RECOMMENDATIONS- The report under paragraph (1) shall include the recommendations of the Secretary on how the Food and Drug Administration should coordinate and facilitate the exchange of information on such innovative products and treatments among relevant offices and centers within the Administration and within the National Institutes of Health, the Centers for Disease Control and Prevention, and other relevant agencies.

[Tallulah]

we are a pathetic bunch us nicotine addicts, having to spend time worrying about bull.... like this. actually does make me want to quit nic completely and spend my time taking something useful.

Caffeine to make you work hard, alcohol to get the angst out of your system, like a good little worker bee. Weed is out of the question because it makes you not give a good ....... about the structure of the honeycomb. I honestly don't know where nicotine fits into this picture, except that some .......s won't be happy until they control every aspect of your nasty, short, and brutish life.

[Lithium1330]

I think joel nitzkin said it best:



we are a pathetic bunch us nicotine addicts, having to spend time worrying about bull.... like this. actually does make me want to quit nic completely and spend my time taking something useful.

Yes DC this sucks, lets just grow our own tobacco and vaporize that and send goverments to hell.

We will not have health issues and they will not have big taxe's money.

[Delite]

all of this is ludicrous, why doesn't the FDA test it first instead of straight up baning it?

[jamie]

Regarding the legislation, esp. for letter writers, two documents from AHEAD with proposed modifications (note these are pdf):

---------------------------
June 2008 (Revised January 2009)

MAKING SCIENCE-BASED REDUCED RISK TOBACCO PRODUCTS A PART OF EFFORTS TO REDUCE DISEASE AND DEATH FROM TOBACCO

CONSTRUCTIVE AND RATIONAL MODIFICATIONS TO THE FINDINGS AND SECTION 911 OF HR 1108

http://www.tobaccoatacrossroads.com/...an%202009).pdf

---------------------------
REFORMING NATIONAL TOBACCO POLICY

A Rational Approach For the Comprehensive Reform over the Production, Processing, Manufacturing, Sale, Distribution and Marketing of Tobacco and Tobacco Products

Finding Civil Solutions in an Uncivil Environment

January 2009

http://www.tobaccoatacrossroads.com/...9111thCong.pdf

---------------------------


Here is the status on tobacco issues via search at The Hill:

http://search.thehill.com/search?ie=...G.x=0&btnG.y=0

[Sun Vaporer]

all of this is ludicrous, why doesn't the FDA test it first instead of straight up baning it?

Delight--it is ludicrous--the way the laws are written, the burden of proof falls on the manufacture/maker/distibuters to show by way of application for approval and studies that their product is safe to be approved. So the FDA does not have to do anything but sit their and, absent application and supporting saftey data--it can rear its head anytime it wants and pull the product---Sun

[NumerousOne]

Delight--it is ludicrous--the way the laws are written, the burden of proof falls on the manufacture/maker/distibuters to show by way of application for approval and studies that their product is safe to be approved. So the FDA does not have to do anything but sit their and, absent application and supporting saftey data--it can rear its head anytime it wants and pull the product---Sun

Be the change you expect in the world....

I don't fret at possibilities or look to far into the future, I asked for a safe alternative to smoking have received it and will now support it.

Personally I've registered with govtrack.com and will keep abreast on this and other issues that can affect me.

I am currently writing my local congressmen about my feelings on the situation, will refrain from participating in negative outcome threads in the future, and will continue to propose this as a smoking alternative and possible path to quitting to everybody I know.

I will post my letter when I'm done. I need to get back to work.

God Bless....

[jamie]

Awesome post. Thank you NumerousOne.