National Working Group for ACTTION

February 23, 2010

In an effort to increase the number of smokers who successfully quit, the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT) have joined in submitting a “citizens’ petition” to the Food and Drug Administration. The petition aims to reduce barriers to the use of nicotine replacement therapy and generally make cessation more “user-friendly.” The premise of the petition is that “Tight constraints imposed by the Food and Drug Administration (“FDA”) on manufacturers of NRT interfere with full and effective use of NRT by individuals and across the population.” The petition asks the FDA for 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.”

Among the changes requested in the petition:

• allow use of nicotine replacement products (NRT) in combination,
• use of NRT for a longer period of time,
• use of NRT to reduce tobacco use while trying to quit, and
• make NRT available in one-day pack sizes. 
• use of NRT should be compared with continued smoking, with the obvious benefits from the use of nicotine that is not smoked. 
• make NRT available as widely as possible, including all stores where cigarettes are sold.

The petition is well documented with references to the extensive research base on cessation and cessation therapy.  In addition, a report entitled “Barriers to Use of FDA-Approved Smoking Cessation Medications: Implications for Policy Action” was filed to support the petition. The report presents a review of barriers to smokers’ demand for cessation treatment medications and suggested policies to remove or reduce those barriers. The Society for Research on Nicotine and Tobacco (SNRT) conducted the review and prepared the report.

The full petition and report can be found at http://www.attud.org/.