Thursday, November 12, 2015

CASAA Newsletter No.1 (November 2015)

November 12, 2015
This new newsletter will be sent to CASAA members to keep you informed about our recent activities and upcoming important matters. If you are reading this and did not receive it via email directly, consider joining CASAA! The more members we have, the more effective we are.

FDA Deeming Regulations of Vapor Products Moves Forward

The planned “deeming regulation,” with which the FDA will assume regulatory authority over e-cigarettes, has finally started moving forward again. It is now under review at the Office of Information and Regulatory Affairs (OIRA), the White House office that is tasked with making sure regulations create more benefits than costs. There is little doubt that the proposed regulation will eliminate the legal market for 99.99% -- perhaps even 100% -- of the products over which FDA asserts jurisdiction after a grace period. (The grace period in last year’s draft version of the regulation was two years.) There is an unconfirmed rumor that FDA will attempt to ban all non-tobacco flavors almost immediately.
CASAA is currently working on our presentation to OIRA, which is scheduled for December 15, 2015. This is a process in which we and other petitioners are required to provide analysis to OIRA without the benefit of seeing the exact current regulation. However, we have every reason to believe that it is, unfortunately, basically the same as the draft FDA published last year. As of now, it is our assessment that OIRA altering or rejecting this proposed regulation is the best hope of saving the diverse e-cigarette marketplace until Congress changes the law. (Please note that some have suggested that individual vapers try to schedule meetings with OIRA. We are not recommending this to our members. We are, however, asking consumers to submit their stories as part of CASAA’s Testimonials Project. We will be sharing those testimonials with OIRA at our meeting next month.)
You will find some of ongoing analysis of the current situation posted by CASAA's Chief Scientific Officer, Dr. Carl Phillips, on his antiTHRlies blog. Already posted are why this is not really regulation (but rather a ban pretending to be regulation) and why the history of FDA’s actions (and the US government more generally) related to low-risk smokeless tobacco suggest that FDA will not behave moderately or rationally once it has authority. If you want to read about the implications of FDA regulation in more depth, check out CASAA’s comment on the draft version of the regulation (pdf).
Watch For CASAA's Survey
We will be launching a survey of our members that will provide critical information we can present to OIRA. Please watch for the invitation to participate and then do so. This is an important survey that could make a real difference, but we will need members to participate!

CASAA Files Comments With FDA
CASAA recently filed two comments on FDA’s proposed rules about child-safety features for e-cigarettes and dissolvable smokeless tobacco products. Our main comment on the proposed rules can be found here. In it, we point out that consumers could genuinely benefit from appropriate warning labels and child-resistant packaging. However, we also make it clear that those modest benefits cannot possibly justify the FDA’s deeming regulation. We also wrote this response to one of the many comments from anti-tobacco activists that -- as we predicted -- were trying to use this reasonable proposal as an opportunity for vilifying e-cigarettes and nicotine. That comment period is now closed. Before it closed, hundreds of CASAA members responded to our Call To Action and submitted their own comments.

CASAA is pleased to announce that Brian Carter, PhD and Bruce Nye have joined our Board of Directors.

Dr. Brian Carter’s field of study is addictive behaviors with a focus on the pharmacological, psychological, and behavioral foundations of tobacco and nicotine use, dependence, and motivation. As a former faculty member in the Department of Behavioral Science at the University of Texas M. D. Anderson Cancer Center, he conducted multiple National Cancer Institute funded laboratory studies on the emotional, genetic, physiological, and behavioral aspects of nicotine use in cigarette smokers. His work has been published in the journals Addiction, Experimental and Clinical Psychopharmacology, Nicotine and Tobacco Research, and other national and international outlets. He lends his expertise to the review of current research on smoke-free alternatives, collaborates on research projects with other tobacco harm reduction scientists, and assists with the preparation of CASAA’s science-based reports to government agencies and the public at large.

Bruce Nye, RN made the switch to electronic cigarettes on September 27, 2012, immediately ending a 43-year smoking habit he had failed numerous times by all other means to stop. He retired in 2003 from his first career of 25+ years engineering software and hardware solutions as a consultant to become an award-winning nurse specializing in acute care of trauma / surgical patients at a Level I Trauma Center in the Midwest for over 10 years. He joined CASAA as a member within months of discovering vapor products and quickly became an active and passionate advocate for THR. Bruce brings to CASAA’s leadership a strong ability to strategize and craft communications in the legislative, regulatory, and public arenas.
Successful Fundraising For Study
CASAA has completed our fundraising for a study on claims that e-cigarettes and other low-risk products are a gateway to smoking - thanks again to all who donated! A grant was awarded to Karyn Heavner, PhD, a long-time Tobacco Harm Reduction (THR) researcher who is the principal investigator for a research team that includes CASAA’s Chief Scientific Officer, Carl V Phillips. As you may know, gateway claims play a major role in anti-vaping rhetoric and policy proposals. The research will trace back to their sources prominent claims that there is such a gateway effect occurring, and critically evaluate whether those sources really support the claim. We expect that this research will be very useful for advocacy, providing the first comprehensive look at whether any scientific support exists for this common claim. You can view the research proposal here.
Global Tobacco Networking Forum
CASAA representatives presented at the GTNF, the world’s leading tobacco industry meeting, which now tends to focus more on e-cigarettes than all other products combined. You can read here the presentations by CASAA Executive Director Julie Woessner, JD, and CASAA Chief Scientific Officer Carl V Phillips, PhD.
More FDA Rules
FDA has issued a new proposed rule that could have major implications limiting anything vendors can say about alternatives to smoking. This is complicated and we are reviewing it, with the expectation that we will issue a Call to Action and also submit a comment on behalf of the consumers we represent.

The following Calls to Action are still live as of the time this newsletter was sent:
National Call to Action: Support HR 2058 which would change the “grandfather date” for FDA e-cigarette regulation.
California: A ballot initiative (15-0081) has been proposed that would redefine e-cigarettes as “tobacco products” and enact a damaging tax on liquids and devices. CA residents are urged to register to vote so they can Vote NO on the initiative when it is added to the ballot next year. CASAA will issue an alert in the coming weeks.
Cook County, IL: Take action now to oppose a damaging per-milliliter tax on e-liquid by contacting County Commissioners.
Everyone: If you used e-cigarettes, smokeless tobacco, or some other tobacco harm reduction product to quit smoking and have not yet provided a CASAA Testimonial, please add your story to the nearly 7,000  we have already collected! The testimonials are an important tool in our advocacy efforts, providing hope and inspiration to those considering making the switch and also helping regulators, policymakers and legislators to understand that e-cigarettes really do work and that real people's lives are being affected. Testimonials collected will be presented to OIRA at our meeting in December to help OIRA understand the profound implications of these policies on the lives of consumers who rely on these products.

Recently Closed Calls To Action
These deadlines for these calls-to-action have passed, but they are listed FYI. If you live in these places, you should have received an email asking you to take action. (If not, please update your contact information!)

These are a few recent publications that CASAA members might find useful, enlightening, or entertaining. For those that are not CASAA publications, some of the content may not necessarily reflect CASAA’s views.

Follow CASAA on Twitter, Facebook and InstaGram.
Share your story on the CASAA Testimonials page.
Check out our weekly podcasts.

The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is the leading consumer advocate working in the area of tobacco harm reduction (THR), the substitution of low-risk alternatives to cigarettes. It is a 501(c)(4) nonprofit consumer-membership NGO (nongovernmental organization). We defend the rights of consumers and would-be consumers of low-risk alternatives by providing testimony and comments to U.S. legislators, policymakers, and regulators and mobilizing our members to do the same. We provide education and outreach nationally and internationally.

CASAA | 4225 Fleur Drive #189, Des Moines, IA 50321 | 202-241-9117

No comments: