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.
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.
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