The deeming regs and the predicate date
The “Cole Bill,” HR 2058, has picked up additional co-sponsors in the House of Representatives, including two Democrats. Reps. Collin Peterson of Minnesota and Brad Ashford of Nebraska have just signed on to the effort to change the predicate (or grandfather) date, which would allow existing products to remain on the market after the FDA’s two-year grace period set out in the deeming regulations.
The regulations take effect on August 8, but provide a two-year window for manufacturers to submit Premarket Tobacco Applications for their products. Almost no one believes that the FDA intends to act on a substantial number of applications. The cost for just one probably will exceed a million dollars, and each product sold must have a separate application to be considered for approval.
Further, there is no guarantee that the FDA will approve any application. It has already been proven that the FDA’s original plan was to ban e-liquid flavors, other than plain tobacco flavors, on August 8. The Office of Management and Budget forced that to be changed. However, once the deeming rule is in place, the FDA is free to make any additional rules they choose without review.
Changing the predicate date will not fix all the issues that the deeming regulations pose. The market will still be frozen as of August 8. However, it would provide businesses some certainty that the entire market will not collapse in two years, and thus encourage them to remain operating and continue the fight in Congress and the courts. Small businesses like vape shops would be hit especially hard as the 2018 ban approaches, since they would have to make tough decisions on renewing leases and buying inventory.
Confusion over which action to support? Support them all!
HR 2058 and the Cole-Bishop amendment
The Cole bill is one of two legislative efforts to derail the FDA’s attempt to wipe out the independent vapor products industry. The other is an amendment to the Agricultural Appropriations Bill, introduced by Reps. Tom Cole and Sanford Bishop. There has been considerable confusion over which of these vapers should support, which CASAA addressed in its latest newsletter.
HR 2058 continues to gain cosponsors and is part of a long-term effort to change the 2007 predicate date applied to new tobacco products by the Food, Drug, and Cosmetics Act. In fact, with the addition of Representative Collin Peterson (D-MN), HR 2058 is now considered a bipartisan bill. Moreover, although not specifically addressed by this legislation, urging support for this bill is important in our messaging efforts to change hearts and minds in Congress about the critical need to develop appropriate regulation for vapor products.
While it is unlikely that HR 2058 will advance successfully through the legislative process this year, it is wildly inaccurate and irresponsible to suggest that support for this bill is a “lost cause.” The simple truth is that support for this legislation will carry over to 2017 when the language (possibly with some additional language) is reintroduced and renumbered. CASAA also believes that it is unwise to put all of our resources behind one legislative strategy, especially when they are not mutually exclusive. Accordingly, CASAA will continue to offer support for not only HR 2058, but also for the Cole-Bishop Amendment to the Agricultural Appropriations Bill.
The federal lawsuit by the Right to be Smoke-Free Coalition
Additionally, Vaping360 encourages all vapers and vendors to support the Right to be Smoke-Free Coalition lawsuit against the FDA. Your donations go directly toward supporting the suit, which has just been combined by the DC District Court with the suit by Nicopure Labs.