FDA FDA webinar on March 24th at 2PM to delineate how 2007 Substantial Equivalence policy blocks SE pathway for >99.9% of e-cigs

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Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
ECF Veteran
Apr 2, 2009
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FDA webinar on March 24th at 2PM to delineate agency’s 2007 Substantial Equivalence policy to exclude >99.9% of vapor products from SE pathway (if “Deeming” reg/ban is imposed), to further increase withdrawals and rejections of SE applications filed since 2011, and to NOT review SE applications filed more than 4 years ago for virtually all cigarette brands on the market.

Guidance for Industry - Demonstrating the Substantial Equivalence of a New tobacco Product: Responses to Frequently Asked Questions
FDA Tobacco Compliance Webinars?
Tobacco Product Marketing Orders

FDA reports 101 SE Orders, 43 NSE Orders, 20 Refusals to Accept letters for SE, 648 Report Withdrawals (to date) for cigarettes, RYO and smokeless tobacco products (i.e. FDA approved 101 SE Orders, rejected 711 SE applications).
Tobacco Product Marketing Orders
 
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