FDA Deeming Regulations of Vapor Products Moves Forward
The planned “deeming regulation,” with which the FDA will assume regulatory authority over e-cigarettes, has finally started moving forward again. It is now under review at the Office of Information and Regulatory Affairs (OIRA), the White House office that is tasked with making sure regulations create more benefits than costs. There is little doubt that the proposed regulation will eliminate the legal market for 99.99% — perhaps even 100% — of the products over which FDA asserts jurisdiction after a grace period. (The grace period in last year’s draft version of the regulation was two years.) There is an unconfirmed rumor that FDA will attempt to ban all non-tobacco flavors almost immediately.
CASAA is currently working on our presentation to OIRA at a meeting that is scheduled for December 15, 2015. This is a process in which we and other petitioners are required to provide analysis to OIRA without the benefit of seeing the exact current regulation. However, we have every reason to believe that it is, unfortunately, basically the same as the draft FDA published last year. As of now, it is our assessment that OIRA altering or rejecting this proposed regulation is the best hope of saving the diverse e-cigarette marketplace until Congress changes the law. (Please note that some have suggested that individual vapers try to schedule meetings with OIRA. We are not recommending this to our members. We are, however, asking consumers to submit their stories as part of CASAA’s Testimonials Project. We will be sharing those testimonials with OIRA at our meeting next month.)
Store
