Other tobacco/nicotine presentations at FDLI annual conference

[Bill Godshall]

There were three excellent sessions (with 12 presentations) at the FDLI annual conference in DC this week on tobacco/nicotine products, regulatory policies, and tobacco harm reduction. Slides are available for many presentations below.

I was very pleased that presentations by Altria's Jeffrey Walker and Reynolds' James Swauger were very similar to presentations I've been giving on tobacco Harm Reduction products and policies since 2005.

Was also pleased that presentations by Bryan Haynes, Dan McGee and Kevin Altman exposed FDA's failure to dispense with any of the 3,700 Substantial Equivalent applications already submitted, and revealed that the Deeming regulation would significantly (and perhaps exponentially) increase the number of SE applications submitted to FDA. Kevin bluntly told Mitch Zeller to not propose the deeming regulation until after FDA dispenses with all 3,700 SE applications.

Meanwhile, Jonathan Foulds delineated FDA's positive and negative actions (for THR) in its proposed NRT product warnings, as FDA did NOT propose informing NRT consumers (i.e. smokers) that NRT can be used as a temporary substitute for cigarettes, for reducing cigarette consumption, or before quitting smoking, and did NOT inform consumers that NRT is less hazardous than cigarettes. If FDA still won't inform consumers of those facts about NRT, don't expect the agency to acknowledge them for e-cigarettes antime soon.

Jed Rose presented a study finding that NRT use prior to quitting smoking increased quit rates and reduced cigarette consumption.

Rebecca Maisel of FIN presented a background on e-cigarettes, and cited concerns about the Deeming regulation's potential impact on e-cigarettes. And I delineated and criticized FDA's actions and fear mongering claims about e-cigarettes since 2009, and pointed out that a Deeming regulation would once again threaten public health by banning and by imposing other unwarranted restrcitions on e-cigarettes.

FDA's Grail Sipes and Mitch Zeller provided very little useful information and acknowledged that agency faces many difficulties, but of course both insisted that the agency knows what's best for public health, and that the agency is doing an excellent job of protecting public health.

Meanwhile, CTFK's Mark Greenwold made a fool of himself (without even realizing it) by repeatedly criticizing Big Tobacco for actions that occurred decades ago, by claiming the industry can never be trusted and has no credibility, by urging FDA to take more aggressive regulatory actions against tobacco companies, and by praising FDA's leadership. After one of Greenwold's tirades against Big Tobacco, Kevin Altman put him in his place by saying that while the tobacco industry is working with FDA to resolve regulatory problems, that Greenwold just wants to focus on the past.

CTFK must have forgot to tell Greenwold that most of his audience at FDLI work for the tobacco industry (as his presentation sounded like one that CTFK routinely gives at anti tobacco conferences).

2013 FDLI Annual Conference Handouts and Audio
Handouts and Audio


Harm Reduction and Innovation: Update on FDA’s Regulation of NRTs and Smoking-Cessation Products
Grail Sipes, Senior Regulatory Counsel, Office of Regulatory Policy, CDER, FDA
Jonathan Foulds, Phd, Professor of Public Health Sciences & Psychiatric, Penn State University, College of Medicine, Cancer Institute, Cancer Control Program | Slides
Jed E. Rose, PhD, Director, Center for Smoking Cessation and Professor, Department of Psychiatry and Behavioral Science, Duke University Medical Center | Slides
Jeffrey P. Walker, MD, Vice President and Chief Medical Officer, Altria Client Services | Slides
Moderated by Carlos Angulo, Partner, Zuckerman Spaeder LLP

Jonathan Foulds: Citizens Petitions & FDA Actions Related to Nicotine Replacement Therapies and Smoking Cessation Products
http://www.fdli.org/docs/default-document-library/foulds_2013new.pdf?sfvrsn=0

Jed Rose: Pre-Quit Initiation of Nicotine Patch Treatment for Smoking Cessation
http://www.fdli.org/docs/default-document-library/rose_2013.pdf?sfvrsn=0

Jeffrey Walker- Altria: Lower-Risk Tobacco Products and Harm Reduction
http://www.fdli.org/docs/default-document-library/walker_2013.pdf?sfvrsn=0

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Tobacco Product Deeming Regulations - Are They Appropriate and What Should They Look Like?Bryan M. Haynes, Partner, Troutman Sanders LLP | Slides
Bill Godshall, Executive Director, Smokefree Pennsylvania
Rebecca Maisel, Vice President and General Councel, FIN Branding Group, LLC | Slides
Daniel P. McGee, General Counsel, General Cigar Co., Inc. | Slides
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP

Bryan Haynes: Tobacco Product Deeming Regulations
http://www.fdli.org/docs/default-document-library/haynes.pdf?sfvrsn=0

Rebecca Maisel: Electronic Cigarettes
http://www.fdli.org/docs/default-document-library/maisel.pdf?sfvrsn=0

Dan McGee: Regulatory Issues Impacting Premium Cigar Industry (FDLI)
http://www.fdli.org/docs/default-document-library/mcgee.pdf?sfvrsn=0

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Tobacco: FDA Center Director Presentation
Mitchell R. Zeller, J.D., Director, Center for Tobacco Products, FDA
Alfred Kevin Altman, Consultant, Council of Independent Tobacco Manufacturers of America | Slides
Mark Greenwold, Senior Consultant, Campaign for Tobacco Free Kids
James E. Swauger, Vice President, Regulatory Oversight. R.J. Reynolds Tobacco Company | Slides
Moderated by Coleen Klasmeier, Partner, Sidley Austin LLP

Kevin Altman: Substantial Equivalence – What it is, where we are and where we need to be!
http://www.fdli.org/docs/default-document-library/altman_2013.pdf?sfvrsn=0

James Swauger- Reynolds: Embracing the Continuum of Risk
http://www.fdli.org/docs/default-document-library/swauger_2013.pdf?sfvrsn=0