Now is the Time To Act! I am Serious! **updated**

[Bill Godshall]

The US Senate will consider tobacco legislation shortly, and be broadcast live on C-SPAN 2
Schedule : C-SPAN Video Library | Created by Cable. Offered as a Public Service.

Here are several related articles.
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Opposing view: Not a job for the FDA
Instead of diverting regulators, move people to smokeless products.

By Steve Buyer
USA Today
June 01, 2009
Not a job for the FDA - Opinion - USATODAY.com

This week, the Senate will consider tobacco legislation that would leave millions of smokers with only one option - quit or die.

This abstinence-only approach to smoking cessation is not a sound public health policy. The Waxman-Kennedy bill places new burdens on the overworked and under-resourced Food and Drug Administration (FDA), which has vital obligations to ensure the safety of our food and drugs.

The FDA is already challenged by tainted food and counterfeit and adulterated drugs, while struggling to maintain its gold standard approval process to get life-saving drugs and medical devices to patients. Thousands of food processing facilities remain uninspected, and more than 360,000 unapproved pharmaceuticals enter our nation each day through our international mail facilities.

Tobacco regulation is counter to the FDA's safety mission, leaving a former U.S. health secretary to state that FDA regulation of tobacco would "divert attention from the significant public health matters of the safety of food, drugs, biologics and medical devices."

We can decrease tobacco-related death and disease in our country. But the House-passed bill would decrease smoking among adults by a mere 2% over 10 years, according to the Congressional Budget Office.

Their proposal would freeze the market and block the introduction of tobacco harm-reduction strategies that can, through science and new technologies, reduce tobacco-related illness and death in the U.S. by 50% to 80% within 10 years and more than 90% within 20 years.

Moving people away from toxic smoking products to smokeless products with up to 99% less health risks is a much healthier approach. For the 96% of smokers who fail to quit smoking every year, harm reduction gives them new options to decrease their health risks.

Americans are familiar with harm-reduction policies such as wearing seatbelts and choosing healthy foods. It is pragmatic to enjoin abstinence with a harm-reduction strategy to improve public health. This week, America has a chance to protect our FDA, oppose ineffective government policies, and use sound science to end our nation's tobacco epidemic by supporting an alternative to FDA regulation, one that calls for innovative, pragmatic, and science-based tobacco harm-reduction strategies.

Rep. Steve Buyer is a Republican from Indiana.

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Tobacco Bill Could Snuff Out RJR's Smokeless Strategy
Putting tobacco under the regulatory umbrella of the FDA has divided the industry.

By David Whelan,
Forbes.com
6.01.09
Tobacco Bill Could Snuff Out RJR's Smokeless Strategy - Forbes.com

For anyone considering putting a menthol cigarette in their mouth during a long conference call, Reynolds now offers the perfect product. Snus, which means snuff in Swedish, is a flavored mini-teabag of pasteurized tobacco, sold chilled in tins.

After test runs in Columbus, Ohio, and Portland, Ore., three years ago, RJR now sells the import in 100,000 locations nationwide. A tin of 15 costs $4.50.

But this kind of innovation may be the last of its kind after this year’s big tobacco bill, sponsored by Sen. Edward Kennedy, turns into law. The bill, which would put tobacco under the regulatory umbrella of the Food & Drug Administration (FDA), is expected to easily pass through the Senate on Tuesday or Wednesday, after getting cleared by the House in April, and then quickly get a presidential signature.

The bill has divided the industry. Altria, which makes market-leading Marlboro cigarettes, helped write the bill, which critics say will institutionalize its market share. The No. 2 tobacco maker, Reynolds American, which makes Camels, has been waging a lonely battle against it.

Kennedy’s bill would allow the FDA to play gatekeeper to tobacco products like Snus and newer smokeless tobacco lozenges and sticks. The legislation also contains language preventing tobacco companies from saying that smokeless tobacco is less hazardous than cigarettes. Supporters argue that the FDA will finally be able to study cigarette ingredients. And by toughening regulations, it could in the long run reduce smoking rates.

Reynolds won’t disclose sales, yet it did recently invest in a new Snus factory. Analysts say Camel Snus looks like a surprise hit in an innovation-challenged industry. Snus users tend to be quitters or banned-at-work smokers who need a fix, but don't like wearing patches or chewing GlaxoSmithKline's Nicorette. The spit-free Snus product is aimed at people on the coasts who wouldn't ever be caught dipping Copenhagen or Skoal.

"We do believe it's a viable product offering or we wouldn't have gone nationwide with it," says Reynolds' David Howard.

A new hit product would be a boon for Reynolds, which has seen its cigarette market share fall. Last year Camel sales dropped 4% to 23 billion cigarettes. Company revenue fell for the first time since 2003.

Undiversified tobacco companies stand to lose if there were a mass migration to smokeless products like Snus. Another loser would be the Feds, who now collect $1 a pack in taxes on cigarettes.

Hostility toward Reynolds’ smokeless strategy came out during the Kennedy tobacco bill’s mark-up session last week. "The best marketers, and particularly the people who make Camels, they really do stay a step ahead of the sheriff," said Ohio Sen. Sherrod Brown. Brown considers Snus and another new Camel invention, dissolvable nicotine mints called Orbs, as transparent attempts to market tobacco to children.

What's ironic is that the product works much like a nicotine replacement for quitters. A 2007 Lancet study of 280,000 Swedes from 1978 to 2004 found no increased incidence of oral or lung cancer among Snus users, but a "tentative" risk of increased pancreatic cancer. Sweden has the lowest lung cancer rates in Europe, since so many adults there opt to Snus instead of smoke. A study in the medical journal Harm Reduction last year found that Snus is a "pathway from smoking, not a gateway to smoking." No surprise there, since it does taste like a soggy cigarette.

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Controversy Swirls Around E-Cigarettes

By Lauren Etter
The Wall Street Journal
June 2, 2009
Controversy Swirls Around E-Cigarettes - WSJ.com

Federal regulators and antismoking groups are taking steps that could snuff out electronic cigarettes, the smokeless nicotine products embraced by a growing number of people trying to kick the habit or avoid bans on smoking in public.

Electronic cigarettes typically consist of a metal tube containing an atomizer, a battery and a cartridge filled with liquid nicotine. When a user sucks on an e-cigarette, a light-emitting diode causes the tip to glow and the atomizer turns the liquid nicotine into a vapor -- thus it is called vaping instead of smoking. The vapor can be inhaled and then exhaled, creating a cloud that resembles cigarette smoke but dissipates more quickly and doesn't have the lingering odor.

The American Lung Association, along with the American Cancer Society Cancer Action Network, the American Heart Association and the Campaign for Tobacco-Free Kids, recently called for e-cigarettes to be removed from the market. The groups say e-cigarettes have yet to be proven safe and that kids may be attracted to the products, some of which come in flavors like chocolate and strawberry. "Nobody knows what the consumers are actually inhaling," says Erika Sward, director of national advocacy at the American Lung Association.

But e-cigarette companies say their product is a better alternative to cigarettes because there is no smoke or combustion involved. "Anybody who doesn't think this product without any smoke attached to it is orders of magnitude less harmful than cigarettes just has no concept of basic science," says Jack Leadbeater, president and chief executive of Scottsdale, Ariz.-based Sottera Inc., which sells the Njoy brand of electronic cigarettes.

There are three large U.S. companies and dozens of smaller ones selling electronic cigarettes, most of which are made in China. Sales of the products, which barely registered in the U.S. just two years ago, have more than doubled over the past 12 months to an estimated $100 million, according to the Washington-based Electronic Cigarette Association, an industry association formed this spring.

A startup kit, which typically includes the e-cigarette device, a set of nicotine cartridges and batteries, costs between $60 and $120. Companies say that using e-cigarettes is cheaper than regular cigarettes in the long run on a cost-per-puff basis.

Regulators have acted quickly to quell the rising popularity of e-cigarettes, saying e-cigarettes are drug devices that need regulatory approval before being legally sold and marketed in the U.S. The Food and Drug Administration says that as of March 1 it "has refused 17 shipments of various brands of these 'electronic' cigarettes, cigars, and pipes, and their components." The agency added that it will continue to evaluate the products on a case-by-case basis "to determine the appropriate action to take."

The FDA has the power to regulate smoking-cessation products but not tobacco. It says it has examined electronic cigarettes and determined that they meet the "definition of both a drug and device under the Federal Food, Drug, and Cosmetic Act," according to legal filings. Drugs and delivery devices must receive FDA approval before being marketed.

Some e-cigarette companies have sued the FDA in federal court, saying the agency has no jurisdiction over the products because they are an alternative to smoking, not a drug device aimed at helping people quit.

"If everybody in the U.S. were to switch to the electronic cigarette tomorrow, you will have removed secondhand smoke, you will have removed combustion products" from the market, says Walt Linscott, lead counsel for Smoking Everywhere Inc., an e-cigarette company in Sunrise, Fla.

Still, some smokers swear by e-cigarettes as a tool for quitting. "I'm a nervous wreck" over a possible halt to e-cigarette sales, says Carolyn Smeaton, 48 years old, of Fall River, Mass. Ms. Smeaton used to smoke three packs of cigarettes a day and now mainly uses e-cigarettes, which she says have helped her get rid of her smoker's cough.

Although not all companies clearly label their ingredients, e-cigarettes typically include water, nicotine, scents or flavorings and propylene glycol, a common ingredient used in hand sanitizers. Nicotine, while addictive, is generally thought to be non-carcinogenic, but it has been linked to high blood pressure.

Electronic cigarettes have become increasingly popular in the U.S. as more states and localities ban indoor smoking and boost taxes on cigarettes. Users have had varied experiences vaping in public, ranging from indifference to odd glances.

On a recent day, Shai Shloush, 25, from Knoxville, Tenn., huddled in the back of a movie theater to watch the new Star Trek movie. He powered up his e-cigarette and puffed away. "I was covering the LED part so people wouldn't notice," said Mr. Shloush, a former smoker. "Every once in a while I'd be really sneaky about letting out the smoke."

[motorcity57]

took me 3 hours to read, jesus. i see no way to stop this from passing and being signed into law. if the tobacco companies with all of their power & money could not stop it, i don't see how we as consumers can.
i think we as e-cigarette users must distance ourselves from the tobacco industry, science has proven that cigarette smoking can and probably will kill you and others.
i have seen very little about the effects of e-cig's, probably because it is such a new technology, who knows 10 or 20 years from now after more research it might be found to be more harmful than regular tobacco cigarettes.
i am using the e-cig as a way to get off analogs. by slowly reducing the nicotine levels of the juice i hope to get to zero nicotine and then , hopefully give up the e-cig as well. i'm sure i can find something better to spend my money on.

[ladyraj]

Originally Posted by motorcity57

took me 3 hours to read, jesus. i see no way to stop this from passing and being signed into law. if the tobacco companies with all of their power & money could not stop it, i don't see how we as consumers can.
i think we as e-cigarette users must distance ourselves from the tobacco industry, science has proven that cigarette smoking can and probably will kill you and others.
i have seen very little about the effects of e-cig's, probably because it is such a new technology, who knows 10 or 20 years from now after more research it might be found to be more harmful than regular tobacco cigarettes.
i am using the e-cig as a way to get off analogs. by slowly reducing the nicotine levels of the juice i hope to get to zero nicotine and then , hopefully give up the e-cig as well. i'm sure i can find something better to spend my money on.

Unfortunately, you may be right that we can't prevent this bill but we could fast-track FDA approval for harm reduction reasons via Mr Godshall's help and contacts. He helped fast-track the availability of NRT with-out a prescription using the same methodology. Hopefully, other people will be able to benefit from the e-cig as a means of reducing harm from cigarettes and ultimately to quit if they so desire. Governmental policy changes with the tide. The anti-smoking groups have made such a good case for the taboo of tobacco the groups have inadvertantly also paved the way for harm reduction. An error they are striving to fix, but we won't let them because you can't have it both ways, either tobacco is the deadliest drug addiction requiring suitable intervention to reduce harm, or it is simply...not.

[TropicalBob]

The anti's have such a simple answer to toss in your face: Quit or die. And smokers have a plethora of FDA-approved methods to quit, they will rush to inform you. Harm reduction is not part of their deal. No use of tobacco or any tobacco derivative product is. So, to them, it is very simple. They will have it both ways. And good luck stopping them.

Everything I've used to stay off cigarettes -- completely -- since July 17, 2007, is at stake here. Snus, dissolvables, nasal snuff and the e-products.

The problem for me is I can avoid relapse only by using these products. I'm a complete failure using Big Pharmaceutical's products. And passage of this bill, with subsequent Presidential approval, marks the beginning of the end of easy availability of all my less harmful alternatives.

[nitewriter]

TB, I've heard you preach the benefits of the many nicotine alternative you've used. You're so good at stating the facts and how these alternatives have helped you. You're also our resident journalist.

Have you combined the 2 on any articles on e-cigs? I've seen you quoted, but not an entire article. It seems you would be a great one to spread the word and I just wondered if you have and I missed it?

Sorry for going off topic.

[Bill Godshall]

Jack Calfee at AEI is a tobacco harm reduction advocate who posted this today.

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I Guess They’re Just Not Dangerous Enough . . .

By John E. Calfee
American Enterprise Institute
June 2, 2009, 11:01 am
I Guess They?re Just Not Dangerous Enough . . . The Enterprise Blog

Both the New York Times and the Wall Street Journal carried front-page stories today (in the Journal, atop the Marketplace section rather than p. A1) on “e-cigarettes,” something most of us never heard of until the past few weeks or not until today. Most e-cigarettes come from China. They have been around for a couple of years but only recently reached the $100 million mark in annual sales. In a sense, e-cigarettes are the latest chapter in the continuing debate over smokeless tobacco, which deliver nicotine from tobacco but eliminate the smoke, which is the source of practically all the harms from cigarette smoking. E-cigarettes are the ultimate smokeless product because they don’t actually involve tobacco at all. They typically contain nicotine, water, some flavorings and scents, and propylene glycol (which the Times explains is common in hand sanitizers)—plus a battery and a miniature atomizer so that when the user takes a puff, he or she receives a nicotine-laced flavored mist.

The leading public health antismoking organizations like the American Cancer Society, American Heart Association, and the Campaign for Tobacco-Free Kids (supported by litigation-induced taxes on smokers) are furious about these unregulated products. They want proof of safety and efficacy, and they want the Food and Drug Administration to force e-cigarettes off the market. That is exactly what the FDA is prepared to do, on the grounds that e-cigarettes are obviously designed to help smokers quit, which is a recognized medical use and therefore renders these products subject to FDA rules about the testing and approval of new drugs.

It is hard to believe that e-cigarettes pose even a tiny percentage of the risks of smoking. Remember, there is no smoke, and the dangers of nicotine itself resemble those of caffeine. The antismoking groups are intent upon perpetuating their reckless gamble that smokers can be induced to quit and that in the meantime, virtually harmless substitutes should be kept off the market unless they go through rigorous FDA testing with all its expense and narrow focus on how products are used.

All of which leads to the totally weird observation that e-cigarettes would be free of all this controversy if only they were more dangerous (by putting real smoke in the lungs, for example) and if they didn’t seem to help people quit smoking cigarettes. In today’s strange public health regulatory environment, cigarettes are OK and smokeless substitutes are not.

And now, what about FDA regulation of tobacco products? Well, that’s another story for another time (really soon).

[nitewriter]

This guy is almost as well informed as you Bill.

This is one of the best articles in our defense I've read.

[ladyraj]

Originally Posted by TropicalBob

The anti's have such a simple answer to toss in your face: Quit or die. And smokers have a plethora of FDA-approved methods to quit, they will rush to inform you. Harm reduction is not part of their deal. No use of tobacco or any tobacco derivative product is. So, to them, it is very simple. They will have it both ways. And good luck stopping them.

Everything I've used to stay off cigarettes -- completely -- since July 17, 2007, is at stake here. Snus, dissolvables, nasal snuff and the e-products.

The problem for me is I can avoid relapse only by using these products. I'm a complete failure using Big Pharmaceutical's products. And passage of this bill, with subsequent Presidential approval, marks the beginning of the end of easy availability of all my less harmful alternatives.

As you can see from the slow response from our legislators and organizations such as the FDA, that all of this banning fostered by the anti-smoking groups takes time to pass, much longer to enact, and even longer still to address small sellers. The e-cig is not on the FDA bill and I'm hoping that it will remain that way because if it is addressed seperately, that takes longer still and suppliers can fly under the radar. I suspect your other products will be grandfathered in because of the similarity to products already on the market.

I do know that if the worst case scenario occurs and all of your options are taken away you have one heck of a class action suit and can be a shoe in for protection under the ADA with disability claims. I'm awaiting the outcome from this action to recommend to all in my purview to file disability claims... mass filings. These issues are what are giving the legislature pause...it's a can of worms, and they know it. But this gives cold comfort to someone who is facing relapse.

[ladyraj]

Hey Mr Bill, I like this find...thanks!

[Ivisi]

Originally Posted by Bill Godshall

Jack Calfee at AEI is a tobacco harm reduction advocate who posted this today.

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I Guess They’re Just Not Dangerous Enough . . .

By John E. Calfee
American Enterprise Institute
June 2, 2009, 11:01 am
I Guess They?re Just Not Dangerous Enough . . . The Enterprise Blog

..snip..

It is hard to believe that e-cigarettes pose even a tiny percentage of the risks of smoking. Remember, there is no smoke, and the dangers of nicotine itself resemble those of caffeine.

...snip...

That, I think, is the first time I've seen someone in the public eye equate straight nicotine use with caffeine. I don't know why e-cig advocates don't point this out more often.

Tobacco and nicotine are treated as the same thing, and they're not. Nicotine, in and of itself, poses nearly the same threat to the human body (in the doses delivered by cigarettes, e-cigs, patches, gums, etc... when used properly) as that of caffeine. It's the contents of cigarette smoke that is the killer to smokers. Take away the smoke, take away a lot of the dying.

I would wager a bet that a vast majority of anti-tobacco people would be hard pressed to stop caffeine cold turkey. But they get to use their drug everyday. Why can't we choose to use ours in a manner that is safer for everyone involved?

Ivisi