CASAA gives presentation in FDA 'Listening Session'

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kristin

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Dr. Carl V Phillips
CASAA Scientific Director

Rockville, MD -- On August 26, 2013, CASAA had the opportunity to have a "Listening Session" with policy staff from the FDA's Center for tobacco Products (CTP). CASAA directors Elaine Keller, Carl V Phillips, Ronald A Ward, and Julie Woessner gave a presentation and answered questions for little over an hour.

Listening Sessions are an opportunity for stakeholders and others to communicate their views to FDA staff. They primarily consist of one-way communication, though the staff typically ask questions. They do not, however, answer questions or provide direct feedback, which would be inappropriate for government decisions-makers to do in a private meeting (consider what would happen if they gave information to a company and not its competitors). Moreover, the participants are asked not to disclose information about the FDA's questions or any suggestions about the implications of their reactions. Without such an agreement, FDA would not be able have sessions like this for obvious reasons.

CASAA focused on two messages: (1) Consumers are the primary stakeholders in discussions of tobacco harm reduction and need a formal seat at the table, which they do not currently have. (2) Specific insights we could offer about tobacco harm reduction (THR) consumer preferences and behavior and the implications of these for making good and avoiding bad regulation. CASAA advocates for consumers and potential consumers of all smoke-free alternatives, but the presentation was focused on e-cigarettes because regulation of this category is currently most in play.

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