Thursday, January 31, 2013

THR News of the Day

There have been a couple of interesting developments in the world of tobacco harm reduction, the first being from a company that I have been following since last April:

CLARENCE, N.Y. --(BUSINESS WIRE)-- 22nd Century Group, Inc. (OTCBB: XXII) announced today that its subsidiary, Goodrich Tobacco Company, LLC (Goodrich Tobacco) applied to the Alcohol and Tobacco Tax Trade Bureau of the United States Treasury Department (TTB) for a federal permit to manufacture its own tobacco products. Until now, Goodrich Tobacco has contracted with independent federally licensed tobacco manufacturers to produce its proprietary commercial products, RED SUN®, MAGIC® and SPECTRUM®. Goodrich Tobacco has always supplied its contract manufacturers with its own proprietary tobacco blends.

In parallel with becoming a federally licensed tobacco products manufacturer, Goodrich Tobacco is meeting with the National Association of Attorneys General (NAAG) to become a subsequent participating manufacturer (SPM) to the Tobacco Master Settlement Agreement, commonly referred to as the “MSA.” As an SPM producing its own tobacco products, Goodrich Tobacco will contribute funds in perpetuity to the MSA on every pack of cigarettes it sells and will agree to various restrictions on tobacco marketing practices required by the MSA.

By establishing its own manufacturing facility, Goodrich Tobacco will achieve additional flexibility in production, increased quality control, and a greater capacity for new product development. Besides becoming the manufacturing site for Goodrich Tobacco’s own commercial brands, RED SUN®, MAGIC® and SPECTRUM®, the new facility will also produce X-22, a very low nicotine cigarette currently going through the U.S. Food and Drug Administration (FDA) approval process as a prescription smoking cessation aid, and BRAND A and BRAND B, two potential less harmful cigarettes (as compared to leading brands) in development. Goodrich Tobacco expects to file a modified risk application with the FDA for BRAND A in the second quarter of 2013 and a modified risk application with the FDA for BRAND B in the third quarter of 2013. 22nd Century Group’s April 2012 press release describes the merits of BRAND A and BRAND B, Goodrich Tobacco’s potential modified risk cigarettes in development.

Hopefully the FDA won't stall on approving these applications, as I have been intrigued by the concept of Brand B for some time now. I am also looking forward to the day that I'll be able to actually try it out for myself.

The company’s management is looking forward to Goodrich Tobacco becoming a federally licensed tobacco product manufacturer and working with NAAG to become a member of the MSA. Goodrich Tobacco’s leased manufacturing facility is 6 miles from its headquarters in Clarence, New York. Henry Sicignano III, President of 22nd Century Group and Goodrich Tobacco, stated, “We believe our novel science-based tobacco products will emerge as highly distinctive brands among the sea of conventional cigarettes offered by our larger competitors. Due to 22nd Century’s groundbreaking proprietary technology, no other tobacco company in the world can duplicate our tobacco blends or match the product attributes of our highly differentiated super-premium cigarettes.”
About 22nd Century Group, Inc.

I suspect that  becoming a member of the MSA will speed things along with the FDA approval process. It is all about the money, after all. As a side note, I have to say that it seems somewhat unfair to make an up and coming company (that is offering new and novel products such as Brand A and Brand B) pay what is presumably the same amount into the MSA as the existing majors that are still atoning for the sins of the past. Ah, but the price of doing business means that you have to get through the gatekeeper. For the sake of fairness, hopefully there's a provision in the MSA somewhere that allows for fee adjustments (for both new and existing companies) for products according to their level of risk.

22nd Century is a plant biotechnology company whose proprietary technology allows for the levels of nicotine and other nicotinic alkaloids (e.g., nornicotine, anatabine and anabasine) in the tobacco plant to be decreased or increased through genetic engineering and plant breeding. 22nd Century owns or is the exclusive licensee of 107 issued patents in 78 countries plus an additional 38 pending patent applications. Goodrich Tobacco and Hercules Pharmaceuticals, LLC and are wholly-owned subsidiaries of 22nd Century. Goodrich Tobacco is focused on commercial tobacco products and potential modified risk cigarettes. Hercules is focused on X-22, a prescription smoking cessation aid in development.

There have been a couple of conversations in the blogosphere that I have come across that mention the role of "other" nicotinic alkaloids in tobacco. It's not something that is mentioned or talked about often, as the center of attention (when it comes to the rewards and behavioral aspects associated with smoking) has almost always been on nicotine itself. What a lot of folks (including myself, up until now) don't realize is that these "other" nicotinic alkaloids can act as MAO inhibitors, which have been useful in treating depression and Parkinson's disease. Hence, there are many benefits that could come from varying/raising the levels of not only nicotine, but that of its associated alkaloids, which would presumably result in more of the "good stuff" and less of the "bad stuff" that has given smoking a bad name.

For additional information, please visit: www.xxiicentury.com




22nd Century Group Subsidiary, Goodrich Tobacco, Applies for Federal License to Manufacture Tobacco Products | Business Wire


The other story that caught my attention this morning was this one:

Tubb, a retired brigadier general, served three presidents in various White House capacities, including director of the White House Medical Unit and physician to the president. He retired from the White House in 2009. Tubb has been actively involved in the science and policy development of alternative nicotine products and tobacco harm reduction, BAT said. 



I am delighted to be welcoming such a prominent and well respected expert in the field of tobacco harm reduction to our Board,” said BAT Chairman Richard Burrows. “This appointment further demonstrates our commitment to putting science at the heart of our business.

..Very promising indeed.

Former White House Doctor Joins BAT

6 comments:

  1. I wish I could share your optimism, Jredheadgirl. The anti-tobacco reactionaries use as a main tool of their repression, the persecution of the most visible behavior, that of, anything that resembles smoking. In short, behavior control. In a web interview last summer, while CA prop 29 was in progress, Glantz was quoted (or something like it) saying that when it passes, "...we may see the behavior collapse."
    As to XXII's reduced nicotine tobacco, it has been tried before:
    http://en.wikipedia.org/wiki/Quest_%28cigarette%29
    and given the short shrift by the anti intelligentsia.
    By contrast, high on the anti despicable list, Benowitz, has given his holy 'laus deo' to Century XXII:
    http://www.ucsf.edu/news/2012/07/12242/cigarettes-made-tobacco-less-nicotine-may-help-smokers-quit
    I wouldn't trust these liars and thieves, one bit, Jredheadgirl. Call me paranoid, yet it has all the hallmarks of "Verschönerung":|
    http://www.scrapbookpages.com/CzechRepublic/Theresienstadt/TheresienstadtGhetto/History/RedCrossVisit.html

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    1. I'm not a fan of Benowitz (or of Glantz for that matter), or of the idea of a mandate (which would be a disaster for both public health and freedom of choice) for lowered nicotine. I'm in favor of freedom of choice. If people WANT to quit, then that's their business. If people want to continue on smoking, then it is likewise their/our choice. I am fully aware of the antis out there that would like to FORCE low-nicotine cigarettes on us. I obviously oppose that idea. On the other hand, if their is a small contingent of smokers out there that would prefer the lowered nicotine cigarettes (much as some..ie., but very few, e-cigarette users prefer nicotine-free cartridges), then that's their prerogative.

      My interest in XXII comes from their raised-nicotine cigarette (Brand-B- ie., low tar to nicotine, rather than just low tar/low nicotine), which was something that Dr. Gori (NCI-Tobacco Working Group- http://archive.tobacco.org/news/19410.html) has been a proponent of for years now. The anti-tobacco establishment has been vehemently opposed to this idea. I have been a fan of Dr. Gori's for some time now and he recently appeared (back in September, I believe) at a XXII shareholder meeting in support of Brand B, which is what in turn generated my interest in the first place.

      ..and we all know that the anti-smokers (like the ones mentioned above) are not such big fans of Dr. Gori, nor are they big proponents of harm reduction when it comes to combustible tobacco. Yet, it is what 90+% of us smokers prefer. Harm reduction via a higher nicotine cigarette may well cut the risk for many of us in half...or more...So, you see, it's not so simple.

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  2. Jredheadgirl, the entrenched abolitionists have infiltrated every law-making environ and are, in no way, interested in allowing 'choice'. It is their way or the highway (to hell).
    Granted , Dr Gori, Dr. Rodu, Dr. Phillips, and a few others have spoke out about the excesses the Tobacco Control advocates yet the mainstream media side steps them in favor of pseudo-scientific political correctness.
    Dr. Gori has spoken out about the wrongheadedness of the abolitionists:
    www.youtube.com/watch?v=K9gtMKB6X2o&list=PL7CD40BB9C1C57991
    I wish him luck, but he's up against some really extremist groups that hate Harm Reduction.

    ReplyDelete
  3. "Jredheadgirl, the entrenched abolitionists have infiltrated every law-making environ and are, in no way, interested in allowing 'choice'. It is their way or the highway (to hell)."

    I know.

    "Granted , Dr Gori, Dr. Rodu, Dr. Phillips, and a few others have spoke out about the excesses the Tobacco Control advocates yet the mainstream media side steps them in favor of pseudo-scientific political correctness."

    Again, I understand exactly what you mean. That's why people like me have started our own blogs...in the hopes that someone with a conscience (and w/ the ability and the connections, etc..) will read our side of the story, and thus make a difference in some way.

    The mountain may be high, but that doesn't mean that we should cease to try.

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  4. I didn't say not to try, Jredheadgirl. If I gave that impression with my previous post, I'm sorry. I'm a frequent visitor to your, and many other sites, where the lunatic prohibitionists are exposed as the fools, liars and thieves that they are.
    The willing conspirators, such as the MSM, tax-evading NGOs, and prostituting gov't agencies are a formidable force that have vested their fortunes in no exceptions to their myopic ideology.
    Century XXII may be a step forward YET since the FDA has the power to regulate nicotine in tobacco, it may be a rouse to FORCE the traditional tobacco companies to offer ONLY this genetic low or zero nicotine tobacco in its products!
    That'd suit the prohibitionists just fine although you and I would have no choice.
    Know your enemy and what they'll stoop to do to you. Tobacco Control knows NO limits including subterfuge.

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    Replies
    1. "Century XXII may be a step forward YET since the FDA has the power to regulate nicotine in tobacco, it may be a rouse to FORCE the traditional tobacco companies to offer ONLY this genetic low or zero nicotine tobacco in its products!"

      I see what you're saying. There is obviously a conflict of interest on the FDA tobacco panel, which is why there is currently a lawsuit seeking an injunction to the advisory board:

      "U.S. District Court Judge Richard Leon has allowed a lawsuit seeking an injunction by R.J. Reynolds and Lorillard Tobacco to proceed against the Tobacco Products Scientific Advisory Committee. It alleges a conflict of interest on the scientific panel responsible for regulating tobacco products."

      http://news.heartland.org/newspaper-article/2013/01/03/alleged-conflict-interest-fda-tobacco-panel#.UQrhKdmlw9w.twitter

      I think that they (RJR and Lorillard) have a case. If their is an injunction, then there may be hope for the concept(s) of fairness and honesty in the field of tobacco science. This should be an interesting case to watch.

      I remember...not too long ago..that the FDA tried to ban menthol, even though it was found to be 30% LESS risky than non-menthol tobacco. I haven't heard too much about that proposal in the media since. I suspect that much the same will happen with the idea of a mandate for low/nicotine-free cigarettes. I don't think that the public would go for that, precisely for the reason that the concept of a higher nicotine (with almost no tar) has been proven to be less risky/carcinogenic.

      "Know your enemy and what they'll stoop to do to you."

      What is that supposed to mean exactly?

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