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FDA workshop announced

The Food and Drug Administration has announced an information-gathering workshop, to be held December 10-11 in their facilities in Washington DC. The agenda remains to be set, and the agency has invited prospective panelists to submit their credentials by November 4. Those wishing to speak in the open comment session should apply by November 25.

The workshop will be the first of several, and is not to be construed as a further opportunity to comment on the proposed deeming regulations. That comment period ended on August 8. The new series of workshops claim to be designed to take research in new directions.

"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" declares the workshop announcement. Health issues, both individual and "population", will be taken up in later sessions.

The announcement invites scientific, medical, and academic personnel, representatives of public health organizations and governmental agencies at a variety of levels, and "the tobacco industry", to apply. Also "other interested stakeholders". But independent vaping-products suppliers are not specifically mentioned, apparently being lumped together with the tobacco industry, as though vaping products contained tobacco.

You can bet R. J. Reynolds will be there to support its proposal that the FDA ban its competitors. (The Big Tobacco firm has already submitted a 119-page document asking the agency to disallow vapor-tank systems, which they do not manufacture or distribute. These are the systems experienced vapors – people who are successfully quitting smoking through vaping – prefer. The Reynolds proposal would reduce the market to the product it makes, and the market it dominates -- the product that is currently sliding in popularity in favor of the product Reynolds wants outlawed.)

Certainly representatives of the independent vaping supplies industry will get on the agenda. So will vaping advocacy organizations, surely. There may be a chance for individual vapers to get in on the open comment period.

In the first workshop, topics will include product design characteristics, how they affect nicotine delivery, and with what potential risks. Another topic will be the chemistry of e-liquids, as well as interactions of liquids and devices (temperatures, open vs closed, battery issues, and so forth). Packaging and labelling will be another topic category (child-proofing, expiration dates, etc.). Last but not least, environmental impact will be addressed in this first of the workshops.

Those wishing to be considered as presenters or panelists are invited to submit abstracts and bios. Those wishing to participate in the open comment session should declare their intent and their topic with their registration. However, the open comment session will only last an hour, and is likely to be fairly chaotic as a result. But interest groups may apply to give joint presentations, separately from the open-comment period.

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