Bill Godshall: FDA Public Comment Period on Smokeless Tobacco and E-cigs Ending!
Tobacco Harm Reduction Advocates:
The deadline for FDA comments on Section 918 of the FSPTCA is midnight tonight (I think eastern time). If you haven’t already done so, please submit comments to
http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0011.
Suggested NRT, e-cigarette and smokeless tobacco policy recommendations to encourage FDA to implement:
– Keep e-cigarettes and ALL other smokefree tobacco/nicotine products legally accessible and affordable for smokers,
– Approve NRT products for long term and temporary use as a harm reduction substitutes for cigarettes,
– Disapprove FDA approval of NRT for “treating tobacco dependence” because NRT products have >95% failure rate for treating nicotine dependence and for smoking cessation,
– Approve RJ Reynolds’ citizen’s petition to change the 27 year old deceptive mandatory warning on smokeless tobacco products from “This product is not a safe alternative to cigarettes” to “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”
Suggested scientific and educational measures to encourage FDA to adopt and implement:
– Acknowledge that long term use of nicotine poses negligible if any disease risks,
– Acknowledge that all smokefree tobacco/nicotine products (including NRT, smokeless tobacco and electronic cigarettes) are far less hazardous alternatives to cigarettes,
– Acknowledge the mountain of evidence that millions of cigarette smokers have quit smoking and/or sharply reduced cigarette consumption by switching to e-cigarettes, smokeless tobacco products and/or NRT, and
– Correct/clarify all false, misleading and fear mongering propaganda about the health risks of smokeless tobacco products and e-cigarettes at all of the following FDA and DHHS websites:
http://www.fda.gov/TobaccoProducts/ResourcesforYou/ucm255658.htm/
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm297895.htm
http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM173405.pdf
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173401.htm
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
http://betobaccofree.hhs.gov/about-tobacco/Electronic-Cigarettes/index.html
http://betobaccofree.hhs.gov/about-tobacco/Smoked-Tobacco-Products/index.html
http://betobaccofree.hhs.gov/about-tobacco/tobacco-and-nicotine/index.html
http://betobaccofree.hhs.gov/about-tobacco/smokeles-%20tobacco/index.html
http://betobaccofree.hhs.gov/health-effects/smokeless-health/index.html
http://betobaccofree.hhs.gov/about-tobacco/tobacco-and-nicotine/index.html
Sincerely,
Bill Godshall
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FDA Public Hearing December 17, 2012: FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence
http://www.fda.gov/Drugs/NewsEvents/ucm324938.htm (archived webcasts available)
DA 12/17/12 Hearing: 1 of 4 webcast (FDA’s Grail Sipes 0:00-0:08, Gregory Conley 0:08-0:15, Lorie McClung 0:15-0:23, Carl Phillips 0:23-0:39, Linc Williams 0:40-1:00, CASAA’s Elaine Keller 1:00-1:14, SRNT’s Jonathan Foulds 1:14-1:47)
FDA 12/17/12 Hearing: 2 of 4 webcase (ATTUD’s Michael Steinberg 0.00-0.10, CTFK’s Danny McGoldrick 0.11-0.17, ACS’ Angela Jones 0.18-0.24, Legacy’s David Abrams 0.24-1.10, Smokefree Pennsylvania’s Bill Godshall 1:11-1:28, TCLC’s Kathleen Dachille 1:28-1:37)
FDA 12/17/12 Hearing: 3 of 4 webcast (ACSH’s Gil Ross 0:00-0:11, Scott Ballin 0:12-0:22, Altria’s James Dillard 0:22-0:37, Johnson & Johnson’s James Walmsley 0:38-1:09, GlaxoSmithKline’s Howard Marsh 1:09-1:38, What A Smoke’s Mark Anton 1:38-1:47)
FDA 12/17/12 Hearing: 4 of 4 webcast (Blue Mist Vaping’s Robert Jack 0:00-0:08, American E-Liquid Manufacturing Standards Association’s Lou Ritter 0:08-0:32, Legacy’s David Abrams 0:33-0:36)
FDA Hearing December 17 – FDA Panel
Grail Sipes (Senior Regulatory Counsel, Office of Regulatory Policy, FDA Center for Drug Evaluation and Research)
Sandra Queer (Deputy Director, Office of New Drugs, FDA Center for Drug Evaluation and Research)
Chistine Wing (Acting Deputy Director, Office of Drug Evaluation, FDA Center for Drug Evaluation and Research)
Bob Rappaport (Director, Division of Anesthesia, Analgesia and Addiction Products, FDA Center for Drug Evaluation and Research)
Lucillia Winchel (Medical Team Leader for Addiction Products, FDA Center for Drug Evaluation and Research)
Andrea Leonard Siegel (Director of Nonprescription Clincial Evaluation, FDA Center for Drug Evaluation and Research)
Corrine Huston (Senior Medical Advisor, FDA Center for Tobacco Products)
Eric Lindblom (Director of Policy, FDA Center for Tobacco Products)
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