FDA Public Workshop For E-Cigarettes

Electronic Cigarettes and the Public Health: A Public Workshop

December 10, 2014
8:00 a.m. to 5:00 p.m.

December 11, 2014
8:30 a.m. to 3:30 p.m.

FDA White Oak Conference Center
Building 31, Room 1503, Section A
10903 New Hampshire Avenue
Silver Spring, MD 20993

Workshop Objective:

The purpose of this workshop is to gather scientific information and stimulate discussion among scientists about electronic cigarettes (e-cigarettes). This is the first of a planned series of workshops intended to obtain information on e-cigarettes and the public health. The information presented and discussed during the workshop series is not intended to inform the Agency’s rulemaking  related to deeming additional tobacco products to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Proposed Rule, 79 FR 23141, published April 25, 2014).  All comments regarding the proposed rule were to be submitted to the agency by August 8, 2014 (Docket No. FDA-N-0189).

If the deeming rule is finalized as proposed, e-cigarettes that are tobacco products would be subject to FDA regulation under the FD&C Act.  As stated in the proposed deeming rule, FDA “is aware of the recent significant increase in the prevalence in e-cigarette use” (79 FR 23152), and there is much to be learned about these relatively new entrants to the market.  These workshops are intended to better inform FDA about these products.  Should the agency move forward as proposed to regulate e-cigarettes, additional information about the products would assist the agency in carrying out its responsibilities under the law.  This would be true regardless of the details of any such final rule.   Accordingly, FDA is working to obtain such information now rather than waiting for the conclusion of the deeming rulemaking.

The focus of this first workshop will be product science (specifically device designs and characteristics, and e-liquid and aerosol constituents), product packaging, constituent labeling and environmental impact. Future workshops will address the individual health and population health effects of e-cigarettes.

To Read More Please Click on The Link Provided: FDA E-Cigarette Workshop


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