House Republican leadership urges FDA to loosen its grip on the e-cig market

The Family Smoking Prevention Tobacco Control Act, passed in 2009, gave regulatory authority over tobacco products to the FDA. One of the law’s edicts was that the agency had to figure out how to deal with novel (newer) products, especially including e-cigarettes. Earlier this year (April 25th), the FDA announced that henceforth, e-cigs were to be “deemed” a tobacco product — even though they contain no tobacco and emit no smoke. Further, they determined that products introduced into the market after a “grandfather” date of 2/15/07 would have to apply to remain on the market via something called a Premarket Tobacco Product Application (PMTA), researching and preparation of which would require, conservatively, thousands of man-hours and millions of dollars. Now, a letter, authored by Speaker Boehner and others in the House leadership, urges the DHHS and the FDA to loosen these deadlines and allow products on the market after the deeming regulations were announced (4/14) or, preferably, after the rule goes into effect (probably 2016), to submit a modified-risk application of much less complexity, possibly saving most of the small businesses from bankruptcy.