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.
The legislators were aware of the fact that pre-2007 products are obsolete by definition and are unlikely to be found on the market now. Thus, the substantial equivalence loophole is in fact not a real concern, as nothing now existent is in any way equivalent to pre-2007 products, and the entire e-cig/vapor industry would have to comply with the PMTA hurdles.
I agree with American Vaping Association president Greg Conley when he suggests that the FSPTCA is actually more accurately termed the Marlboro Protection Act, because it grandfathered in existing tobacco products while making it nearly impossible for small firms to introduce new items. While the law is pretty specific, I believe that the FDA and its tobacco products head, Mitch Zeller, could if they so desire ease up on the burdensome requirements when the final rule is published. They could blame it on OMB/OIRA, the final arbiter of most such rules whose authority comes directly from the White House. I am pessimistic that that will happen, since Zeller is a battle-scarred veteran of the tobacco wars of the 20th century and not so amenable to any appearance of compromise. Also, he s been in the employ of an arm of drug-giant Glaxo SmithKline, a major seller of nicotine patches, and I doubt he s changed his stripes that much.