Monday, June 10, 2013

Modified Risk Tobacco Company to Hold Meeting With FDA Tobacco Advisory Board

Here is the latest on the fate of Brand A and Brand B, brands that I have expressed interest in on a number of occasions here on this blog:

FDA Meeting

The Center for Tobacco Products of the U.S. Food and Drug Administration (FDA) requested to have a meeting with 22nd Century to discuss the company’s proprietary products. 22nd Century agreed to meet with the FDA on June 17, 2013.

Modified Risk Cigarettes

Goodrich Tobacco has developed two proprietary modified risk cigarettes, referred to as BRAND A and BRAND B, which the company believes are less harmful than conventional cigarettes. The company is in the process of preparing two modified risk applications to be filed with the FDA in accordance with FDA guidelines to seek FDA authorization to market BRAND A and BRAND B as modified risk cigarettes. BRAND A is a very low nicotine (VLN) cigarette containing approximately 95 percent less nicotine than leading brands. BRAND B is a low-tar cigarette with a relatively high nicotine content. The company expects to file one application by the end of 2013 and another in 2014.

For those who may be confused, Goodrich Tobacco is a subsidiary of 22nd Century.

22nd Century has also shipped more than 12 million of its Spectrum cigarettes to the NIH, which are being used solely for research purposes:

SPECTRUM Research Cigarettes
22nd Century expects to ship an additional 5,500,000 SPECTRUM® cigarettes (275,000 packs) in the third quarter of 2013. The SPECTRUM product line consists of a series of cigarette styles that have similar “tar” yield but varying nicotine yields over a 50-fold range – from very low to high – due to different levels of nicotine in the tobacco. Mr. Pandolfino explained, “No other tobacco company anywhere in the world is capable of producing cigarettes with such a wide range of nicotine content.” To date, 22nd Century has delivered approximately 12 million SPECTRUM cigarettes which are used solely for research purposes and distributed under the direction of the U.S. National Institutes of Health.

I suppose that we'll just have to wait and see if the research reveals to us what Dr. Gori has been trying to tell us all along: that less (whole) smoke inhalation may be achieved by manipulating the nicotine content in tobacco.

If is shown that various nicotine levels can assist in meeting the demands and needs of the individual smoker, then it shouldn't matter if one smoker prefers the higher nicotine cigarette whilst the other prefers the lower nicotine cigarette. It should be about choice. If various models result in less inhalation of whole tobacco smoke in aggregate, then the idea of a harm reduction cigarette that is designed for the individual smoker should appear as a no-brainer to harm reduction strategists everywhere.

I imagine, however, that there will be (if there aren't already..surprise, surprise..) various special interests from varying factions of tobacco control that will do everything in their power to attempt (in soundbite fashion, of course) to gloss over any inconvenient truths that may be discovered.  Here's hoping for an independent and watchful eye to oversee the overseers!


  1. It is all very confusing. As I understand it, Tobacco Companies cooperated with the Canadian Gov to grow a tobacco plant variety which produced 'low tar' tobacco. Tobacco Companies then marketed the new cigs as 'lights'. Not long ago, the Zealots in Canada launched a lawsuit against TobComs claiming that 'lights' was misleading, and that using that word suggested that they were not as dangerous - even though TobComs knew that they were just as dangerous. The Zealots claimed that TobComs were therefore responsible for the death of X from lung cancer.
    The TobComs claimed in court that they were 'encouraged' by the Gov and that the Gov should also therefore be 'cited'. The Courts refused to accept that argument stating that the Gov was protected by its 'good intentions' (as a public body). The TobComs therefore face the accusation alone.
    Be that as it may, the problem that 'low risk cigarette' manufacturers face is that, according to the Zealots, along with the Surgeon General, there is no such thing as a 'lower risk cigarette'. The Zealots, via their propaganda, have backed themselves into a corner. The question then comes down to: "Who will decide whether or not the cigs produced by this company are 'safer'"? If it is the Zealots, the company have no chance. If it is proper scientists, then they have a chance.
    Good luck to them....

  2. Junican,

    "If it is the Zealots, the company have no chance. If it is proper scientists, then they have a chance."

    Well, that about sums it up.

    Happy Sunday:-)

  3. Even more interestingly, this same company is marketing red sun cigarettes which genetically enhance levels of nicotine. One look at the website should tell you how they are marketing these cigarettes (to youths). I am a smoker, but when I see shit like this, and when I know that this same company is in bed with the government, it doesn't give me much hope.

    1. I have a few questions:

      1) Are you against the idea of enhancing the nicotine content of cigarettes? If so, why?

      2) If an enhanced nicotine to tar cigarette were to result in the inhalation of less (overall) carcinogens by the smoker, would you still be wary of the idea? Isn't tar the real enemy here?

      3) How are they marketing to youth? The first thing that one is sees upon attempting to enter their website is that you must be at least 20 years old to enter. You can sign up to go to war at a younger age than that.

      4) Are you against the idea of working with the government on anything? Don't get me wrong, I'm skeptical of the government (I'm skeptical of a lot of things) as well, but I am also not anti-government in its entirety.

      I'd be curious to hear/read your thoughts:-)