Online Program

Update from the fda's center for tobacco products

Monday, November 4, 2013 : 11:30 a.m. - 11:50 a.m.

Mitchell Zeller, J.D., Center for Tobacco Products, Food and Drug Administration, Rockville, MD
The evolution in the marketplace for tobacco and nicotine over the past decade poses profound questions for FDA now that it is regulating tobacco products. Under the public health standard that is central to key provisions in the Family Smoking Prevention and Tobacco Control Act, FDA has to assess the net population level health impacts of new products and potential health-related claims for these products. This presentation will explain that new standard and describe the most relevant provisions of the Act. The opportunity for an agency-wide comprehensive nicotine regulatory policy will also be reviewed. Finally, recent regulatory actions by FDA will be explained.

Learning Areas:

Public health or related laws, regulations, standards, or guidelines
Public health or related public policy
Public health or related research

Learning Objectives:
Describe key provisions of the Family Smoking Prevention and Tobacco Control Act; Identify regulatory policy issues related to the harm reduction debate; Discuss regulatory status of e-cigarettes.

Keyword(s): Tobacco, Policy/Policy Development

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have a J.D. from Dartmouth College and the American University Washington College of Law and have been working on FDA issues for more than 30 years. I am the Director of the Center for Tobacco Product for the US Federal Drug Administration. I also served as an official U.S. delegate to the World Health Organization (WHO) Working Group for the Framework Convention on Tobacco Control.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.