I would like to thank Kimberly Adams of Marketplace ( http://www.marketplace.org/people/kimberly-adams )for giving me and the TVECA the opportunity to be interviewed about the debate currently being held about how the FDA should regulate e-Vapor products. Her initial question though was interesting as she asked IF e-Vapor products should be regulated as tobacco products and then HOW this would occur. I greatly appreciate her asking about this very important debate, but it has already been settled. On December 10, 2010 the DC Appellate Court ruled that the FDA can regulate e-Vapor products as a tobacco products and the FDA agreed:
“The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera. ”
This very important judicial action defined HOW e-Vapor will be ultimately regulated. The stifling issue for legislators and regulatory bodies is how they will fit this fabulous round peg of technology that now 6 Million Americans are using into the square hole that is the FDA’s “Substantial Equivalency”. It’s not going to happen as e-Vapor cannot be deemed anything but what it actually is; five household ingredients that work harmoniously together to safely deliver to consumers their desired nicotine.
How this saga will end is anyone’s guess but there are millions of Americans relying on the e-Vapor industry to supply them with the first product that they have successfully transitioned to over the one product, tobacco cigarettes, that we know kills over 450,000 Americans annually.