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."
nah with the wackjobs runing this country that would doom the market in this country, we would see a permanent nationwide ban effective that session. hell one of those .......s would wright a bill up right then and there no doubt.
