Wednesday, January 2, 2013

FDA Public Hearing & Comments on Smoking Cessation Products

The Food and Drug Administration (FDA) held a 1-day public hearing December 17, 2012 to obtain input on questions related to the implementation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The public hearing was held to:
  • obtain comments from the public on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs)
  • request input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence

View the archived FDA public hearing on smoking cessation products webinar:

Public comments will be accepted into the docket through January 16, 2013. We encourage partners to submit comments regarding the public hearing and FDA Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products (published in the November 28, 2012 issue of the Federal Register).

Submit public comments:!documentDetail;D=FDA-2012-N-1148-0001

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