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Stonewall and the FDA

Discussion in 'Smokeless tobacco' started by TWISTED VICTOR, Oct 1, 2010.

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    TWISTED VICTOR Vaping Master ECF Veteran

    Sep 14, 2009
    The edge of Mayhem
    Copied from Randall at SnusOn:

    Firm to be case for lower-risk tobacco
    Will FDA allow products to be marketed as safer

    Updated: Tuesday, 28 Sep 2010, 1:32 PM EDT
    Published : Tuesday, 28 Sep 2010, 1:32 PM EDT

    RICHMOND, Va. (AP) - Tobacco maker Star Scientific Inc. hopes there's fire where there's no smoke.

    The small Virginia company has made itself the test case for a big issue: whether the Food and Drug Administration will allow certain tobacco products -- particularly the company's tobacco lozenges that dissolve in the user's mouth -- to be marketed as less harmful than cigarettes.

    The application to market the product as safer also highlights a philosophical debate over how best to control tobacco. One camp says there's no safe way to use tobacco and pushes for people to quit above all else. Others embrace the idea that lower-risk alternatives like smokeless tobacco or electronic cigarettes can improve public health, if they mean fewer people smoke.

    How the FDA handles the products is being closely watched by both the public health community and bigger tobacco companies, which are looking for new products to sell as they face declining cigarette demand due to tax increases, health concerns, smoking bans and social stigma.

    A law enacted last year gives the FDA authority to evaluate tobacco products for their health risks and lets the agency approve ones that could be marketed as safer than what's currently for sale.

    So far only Star Scientific has applied for approval to market what the agency calls "modified-risk" products. The company says the small, flavored tablets that dissolve in the user's mouth contain "below detectable levels" of certain cancer-causing chemicals found in tobacco and its smoke. It wants to sell them to smokers as "a useful alternative -- with greatly reduced toxin levels."

    "Why shouldn't tobacco users ... have an opportunity to know this and make an informed decision? That's why we took the risk, that's why we spent the money," Paul Perito, president of Star Scientific, said in an interview with The Associated Press.

    The company, formerly known as Star Tobacco and Pharmaceuticals, has sold varieties of the dissolvable tobacco under the Ariva and Stonewall brands since 2001. Its sales have grown about 47 percent since 2007, but it still remains a tiny player in the industry.

    The tablets contain tobacco's most addictive component, nicotine. Star Scientific says its method of tobacco cultivation and preparation creates tobacco leaves with low levels of some carcinogens.

    While the FDA's Center for Tobacco Products has not yet ironed out its guidelines for approval of such products, draft guidelines suggest it could take nearly a year to review an application.

    Tobacco companies want to market more smokeless tobacco and other cigarette alternatives to make up for falling cigarette sales. Some have introduced snus -- small pouches like tea bags that users stick between the cheek and gum -- and dissolving tobacco -- finely milled tobacco shaped into orbs, sticks and strips. But they can't explicitly market them as less risky than cigarettes.

    But a report from the Royal College of Physicians, a U.K. medical group, titled "Harm Reduction in Nicotine Addiction," -- along with other scientific studies -- suggests that when compared with cigarettes, some smokeless tobacco products are about 90 percent less harmful.

    Meanwhile, GlaxoSmithKline, which makes nicotine replacement therapy products like Nicorette gum and NicoDerm patch, has urged the FDA to take dissolvable tobacco off the market until companies can demonstrate that selling them is appropriate for the protection of public health.

    The question remains whether smokers, which total about 46 million in the U.S., are really willing to switch, even if it means saving their lives.

    Max Levin, a 29-year-old longtime cigarette smoker from St. Louis, is skeptical.

    "For me, the lighting of the cigarette is too convenient, and I wouldn't care to trade it just because I could do (smokeless tobacco) anywhere," said Levin, who has tried snus a few times. "When I do decide to quit, it's not like I'm going to quit cigarettes and switch over to another tobacco product."

    The powerful combination of addiction and the rituals of smoking are difficult to overcome, said Richard Brown, a Brown University professor whose research focuses on smoking behavior and nicotine addiction at Brown University.

    "It's a poor substitute. They know it won't do the same thing," he said.

    But tobacco company research shows that many smokers transition to smokeless products in about a year and a half once they begin to notice the benefits of going smoke-free, said David Sweanor, a Canadian law professor and tobacco expert who consults with companies and others on industry issues.

    "People can change what they do when they have sufficient motivation," Sweanor said.

    Several studies say that pushing alternatives such as smokeless products with lower levels of carcinogens could reduce the number of smokers by between 1 and 3 percent over five years.

    Matthew Myers, president of the Campaign for Tobacco-Free Kids, said the FDA can now keep tobacco companies accountable for health claims and ​
  2. Guttermouth

    Guttermouth Ultra Member Verified Member ECF Veteran

    Jul 15, 2010
    aaah... it's always good to see big pharma tell our government agencies what to do.:facepalm:
  3. hittman

    hittman ECF Guru Verified Member ECF Veteran

    Supporting member
    I was wondering what was going on with stonewalls not being readily available. I didn't even think you could buy them online any longer until stubby posted a link the other day.
  4. Stubby

    Stubby Ultra Member ECF Veteran

    Apr 22, 2009
    Madison, WI USA
    The interesting point on this is that if Stonewalls and Ariva don't get classified as a reduced risk tobacco product and the company allowed to market it as a less harmful alternative to cigarettes, what would. It would basically mean the whole classification process is bogus. You can bet there will be a bunch of interested parties trying to kill this.

    TWISTED VICTOR Vaping Master ECF Veteran

    Sep 14, 2009
    The edge of Mayhem
    We have the legit FDA policies which exist to protect consumers from bogus or harmful products. That's what it's for. Unfortunately, politics have interfered with its operation and, as with anything politicized, standard operating procedures become fuzzy and vague in their implementation and therefore become "nonstandard modus operandi". The unbiased proof of reduced harm with any smokeless tobacco is well documented, but from the highest levels these things are suppressed and outright lies are told by the FDA, AHA and ACS. Star Scientific has a good case and they have an arsenal of real proof, but if they win it's apt to expose a lot of skeletons in the government and special interest closets. Probably one of the most exciting side-notes to this is that Star knows how the pitbull lawyers will defend the FDA and have likely prepared their case accordingly.
  6. Guttermouth

    Guttermouth Ultra Member Verified Member ECF Veteran

    Jul 15, 2010
  7. Stubby

    Stubby Ultra Member ECF Veteran

    Apr 22, 2009
    Madison, WI USA
    Tobacco Maker Wants FDA Approval On Less Harmful Tobacco - Health News - redOrbit

    So it appears they have developed a moist snuff with the same low TSNA levels of Ariva and Stonewalls. I didn't know that. It's doesn't appear to be available to the public as of yet. Of course the FDA is still a year away from even having the process set up for getting a modified risk product approved.

    Wonder if the new snuff is spitless. I would guess it would be.
  8. firechick

    firechick Ultra Member Verified Member ECF Veteran

    Jun 24, 2009
    Upstate New York
    Any guesses on the WTAs?
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