Tuesday, December 18, 2012

CASAA testifies at FDA hearing

Silver Spring, MD, December 17, 2012 --

Yesterday, the FDA held a public hearing to obtain input on certain questions related to the implementation of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA). CASAA President Elaine Keller spoke on behalf of the organization.  Also presenting before the FDA panel* as private citizens or as representatives of other organizations were CASAA's Legal Policy Director Gregory Conley, CASAA's Scientific Director Carl V Phillips, and CASAA advisor Bill Godshall.

Dr. Carl Phillips, CASAA Science Director
 speaking at FDA hearing
The hearing was held for the FDA's consideration of new regulations regarding already approved smoking cessation products such as gums, patches and lozenges (NRTs) and the possible "fast tracking" of innovative new products that are intended to promote 1) total abstinence from tobacco use, 2) reductions in consumption of tobacco, and 3) reductions in the harm associated with continued tobacco use.

While electronic cigarettes and low-risk, smoke-free tobacco products were not being considered at this hearing, CASAA supports the consideration of NRT for long-term use as a form of tobacco harm reduction (THR) for smokers who cannot or will not quit, rather than requiring the products to be used solely as tools for complete nicotine abstinence. It is CASAA's opinion that this could open the door for products such as electronic cigarettes and low-risk, smoke-free tobacco products to also be considered as THR products. Therefore, CASAA's presence at the hearing was to speak on behalf of tobacco harm reduction policies.

The topic of electronic cigarettes did arise several times and some known opponents of electronic cigarettes admitted that testimony given by electronic cigarette consumers was compelling and warranted future study. Surprisingly, most of the anti-tobacco speakers at the hearing seemed to agree with THR advocates that smoking cessation is a far more urgent goal than total nicotine abstinence.

"Risk needs to be assessed not in comparison to abstinence but in comparison to a percentage scale of harm impact," CASAA's Dr. Phillips told members of the FDA panel. "Smoke-free alternatives are far healthier. A lifetime of [smoke-free nicotine/tobacco] use is less harmful than a couple months of relapse smoking."

Written public comments will be accepted until January 16, 2013. If you would like to submit comments supporting tobacco harm reduction policies, you may find information on how to submit and what to say here: CASAA Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products

Recordings of yesterday's hearing may be watched using these links:


CASAA Media Contact
Elaine Keller, President

*FDA Panel: Grail Sipes, JD  Senior Regulatory Counsel, Office of Regulatory Policy Center for Drug Evaluation and Research; Sandra Kweder, M.D., Deputy Director of FDA Office of New Drugs, Center for Drug Evaluation and Research; Christine Win, Acting Deputy Director of FDA Office of New Drugs, Center for Drug Evaluation and Research; Bob A. Rappaport, M.D., Director Division of Analgesics, Anesthetics, and Rheumatology Products, FDA’s Center for Drug Evaluation and Research; Dr. Celia Winchell, Team Leader with the Division of Anesthesia, Analgesia and Rheumatology;  Andrea Leonard-Segal, M.D., Director, Division of Nonprescription Clinical Evaluation, Center for Drug Evaluation and Research; Corinne Huston, MSPH, M.D., Senior Medical Advisor in the Office of the Director, Center for Tobacco Products; and Eric Lindblom, J.D., Director, Office of Policy, FDA Center for Tobacco Products.

1 comment:

Maria Verven said...

Thank you for your testimony and I am watching this debate very closely as are thousands of people who are strongly in favor of the electronic cigarette as a tool to help people quit smoking. I find it terribly ironic that the FDA's own NRT tools such as the nicotine patch is woefully ineffective, yet they seem so resistant to e cigarettes. To me, it is intuitively obvious that someone who is addicted to nicotine would rather mimic the act of smoking rather than sticking a patch on their skin.

In fact, I created a site called www.SkipThePatch.com and cite the studies on both the nicotine patch and the e cigarette. I would love any feedback you have on this site, as I want to make sure my facts are accurate.

Maria Verven
Vaping Vamps (www.vapingvamps.com)
Skip The Patch (www.skipthepatch.com)