Last year, the U.S. Food and Drug Administration (FDA) held the first of three public workshops to gather scientific information about electronic cigarettes and the public health. The FDA has announced that the second workshop will be held on March 9-10, 2015.
The agenda for the March 2015 e-cigarette workshop focuses on the impact of e-cigarettes on a person’s individual health. The specific topics to be discussed include, (1) exposure to nicotine and toxicological considerations; (2) pharmacokinetics (the movement of drugs within the body) and pharmacodynamics (the effects of drugs) regarding nicotine exposure in users; (3) abuse and dependence; (4) short- and long-term health effects of using e-cigarettes; (5) considerations for high-risk or vulnerable populations; and (6) human factors.
The information obtained through this series of workshops will not impact the FDA’s pending deeming regulations. If the deeming rule is finalized as proposed, then e-cigarettes would be subject to FDA regulations and the agency could use the scientific information obtained from the series of workshops to propose additional regulations on e-cigarettes.
Even though the FDA has not yet finalized the deeming regulations to formalize its authority to regulate e-cigarettes, these workshops are intended to provide more information about e-cigarettes to the FDA now so that the agency does not need to wait until after the deeming regulations are finalized to gather more scientific data.
The first workshop held by the FDA on e-cigarettes covered the topics of product science, protective packaging, labeling, and the environmental impact. The agency plans to follow up this second workshop with a final workshop that will address the impact of e-cigarettes on the population, including discussions of product appeal (e.g., impact of advertising, marketing, flavorings, consumer perceptions), impact on nonusers (second- and third-hand exposures), and product labeling.
If you wish to attend the workshop in person or by a webcast, you need to register by submitting either an electronic or written request no later than February 20, 2015.