On Monday, March 5, the Smoke-Free Alternatives Trade Association (SFATA) held a 1-day conference at the University of Chicago. Of course the main topic of interest was the industry response to the Deeming Regulations recently published by the Food and Drug Administration.
Panoramic View of the University of Chicago[/caption] The morning's program featured a panel discussion on “Lobbying after Deeming” moderated by NJOY's chief of regulatory affairs, Pamela Gorman (with panelists Ron Tully of Intrepid, Brian Fojtik of NJOY, and EU policy consultant Peter Beckett), followed by a talk by RBC's Nik Modi on “Deeming Regs Effect on Markets.” After lunch, the conference keynote, entitled “Deeming Regulations: A Deep Dive,” was delivered by attorney Ralph Tyler of Venable. CITMA consultant Kevin Altman gave a morning talk on the “True Cost of Substantial Equivalence & FDA Reporting Requirements.”
The FDA's category of “substantial equivalence” is defined as follows: “A substantially equivalent tobacco product has been found by FDA to either have the same characteristics as a predicate (pre-2007) tobacco product, or has different characteristics, but does not raise different questions of public health. If the new product raises different questions of public health, the product is not substantially equivalent.”
ECF's own Oliver Kershaw and Neil McLaren spoke on “Behavioral Insights into the Vapor Sub-Culture.”
Dr. Konstantinos Farsalinos, perhaps the world's foremost scientist studying vaping issues, gave a talk on the crucial topic of “Flavorings in Electronic Cigarette Liquids: Balance between Variability and Safety.”
Also on hand were Mark Burton of Genrich, Inc., Patricia Kovacevic of Lorillard, Arnaud Dumas de Rauly of FIVAPE, and SFATA President Phil Daman, as well as representatives of VapAria, Freedom Smokeless, VaporChem, ProVape, Purbacco, the American E-Liquid Manufacturng Standards Association (AEMSA, the trade group for liquids), and EAS Consulting (a consultancy specializing in FDA regulatory matters).
SFATA was founded three years ago to serve the informational and lobbying needs of vapor industry manufacturers and marketers. Their homepage claims, in a very prominent position, that they represent small and mid-sized businesses, including vape shops as well as manufacturers and distributors, and that they have never received funding from Big Tobacco.
The budget comes from “dues and donations of the businesses it serves.”
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