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Old 07-28-2017, 11:08 AM   #1
grtrx
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CRA/IPCPR Joint Release on FDA and Regulation of Premium Cigars

also posted in CRA room

CRA & IPCPR Joint Statement on FDA's Policy Announcement Regarding the Regulation of Premium Cigars



FOR IMMEDIATE RELEASE
July 28, 2017




WASHINGTON, D.C. - Today, Commissioner of the U.S. Food & Drug Administration, Dr. Scott Gottlieb, announced a new comprehensive plan for the approach the agency will take to the regulation of tobacco products, placing an emphasis on a science-based method, that notes a "continuum of risk" that recognizes the differences in tobacco products.

Importantly, Dr. Gottlieb stated that FDA will reexamine the treatment of premium cigars under the agency's current regulatory structure. Ultimately, the agency will open a new rule making process to engage with the industry to better understand premium cigars, specifically. As representatives of the premium cigar industry, Cigar Rights of America ("CRA") and the International Premium Cigar & Pipe Retailers Association ("IPCPR") are encouraged by the FDA's renewed and objective approach to the industry, and welcome the opportunity to again demonstrate the skilled artisan nature of premium cigars, and how they are truly distinctive, at all levels.

For premium cigar manufacturers and retailers, today's announcement provides some clarity on the path forward. Of note, CRA and IPCPR applaud the decision to provide targeted relief to some pending deadlines dictated in the 2016 final rule. This includes revising the pre-market application deadline to August 8, 2021. Moreover, under today's guidelines tobacco products with pre-market applications submitted to the FDA can stay on the market for the duration of the application review process. In addition to changes announced today, CRA and IPCPR are awaiting further information from the FDA, regarding other key future compliance deadlines. Importantly, compliance requirements that have already gone into force will remain in effect for manufacturers and retailers alike.

CRA, IPCPR, and other industry partners look forward to working with the FDA as it implements the approach announced today.

CRA Exective Director Glynn Loope and Mark Pursell IPCPR CEO stated upon FDA's announcement, "This has been a long and complicated process, which is not over. However, we commend the objective approach announced today by the Commissioner of the FDA. This revisiting of the rule is testament to the recognition that you cannot regulate all products in the same manner. We would like to thank our bipartisan coalition of congressional allies that have assisted in reinforcing that message to the administration, as we begin the next steps in this process."

For comments, questions, or additional information regarding the FDA's announcement, please contact the individuals listed below.

CRA

Glynn Loope
glynn.loope@cigarrights.org

Cody Carden
cody.carden@cigarrights.org
(202) 469.3444
IPCPR

Mark Pursell
mark@ipcpr.org

Daniel Trope
daniel@ipcpr.org
(202) 849.6045
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Old 07-29-2017, 06:42 AM   #2
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Here is cA's take.
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Old 07-29-2017, 07:38 AM   #3
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What they didn't mention is that they are also going to phase out nicotine levels in cigarettes to under addictive levels. My tobacco stocks are down 15+% on the news.
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Old 07-29-2017, 12:08 PM   #4
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Are the nicotine levels artificially high in cigarettes? If the nicotine levels were reduced, would it have any affect on the smoking experience other than to reduce or eliminate nicotine addiction?
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Old 07-29-2017, 12:40 PM   #5
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By artificially high, do you mean adding more nicotine to the tobacco than it has naturally? I could make a case for doing so in terms of delivering a consistent product. Different tobacco's have varying amounts given species, terrain and weather. One would think that this could be homogenized out with batch sizes and blends, but it isn't perfect and once you get above a certain sized batch, it's cost prohibitive to toss it out and start over. Additives, while alien to most smokers... particularly cigar smokers...are a cost effective way to ensure consistency.

As for the addictive quality of the nicotine in cigarettes, inhaling the smoke is the ideal delivery device for nicotine, even more so than snuff. Outside of the habitual nature of cigarette smoking and its rituals, it is really about maintaining a steady dose of nicotine to the body. Were the nicotine levels that low, what's the point of smoking them?

I could believe that this was the point, but the FDAs campaign against electronic cigarettes...a much healthy way to deliver the drug...belies that. I have to believe that the tobacco lobby is going to have none of this and the proposal will be quietly 86'ed.
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Old 07-29-2017, 01:05 PM   #6
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cigarettes are manipulated in multiple ways to increase the nicotine delivery
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