FDA Citizen Petition

On Friday February 12, 2010 the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) submitted a
Citizen Petition to the FDA asking they adopt a more flexible evidence-based regulatory approach to the treatment of tobacco dependence and that Nicotine Replacement Therapy (NRT) labeling indications and instructions be modified to be consistent with current science.

This is the culmination of over 2 years of work by ATTUD and SRNT members (including Jonathan Foulds, Matt Barry, Mitch Zeller, Kathleen Dachille, and Ken Wassum). Funding for this initiative was originally provided by the Robert Wood Johnson Foundation. A critical part of the petition process was the writing of a white paper, Barriers to the Use of Smoking Cessation Medications.

The petition urges the FDA to provide health-concerned smokers with more flexible pathways towards becoming tobacco-free, such as using nicotine replacement products (NRT) in combination, using NRT for a longer period of time, using NRT to reduce tobacco use while trying to quit, and making NRT available in true one-day pack sizes. The full petition and the accompanying review white paper are attached.

Financial support was provided by the Robert Wood Johnson Foundation as well as a grant from the Tobacco Control Legal Consortium for the legal services provided by Kathleen Dachille at the University of Maryland Law School.

• Citizen Petition to the FDA
• Barriers to the Use of Smoking Cessation Medications.