The proposed Cole-Bishop Amendment to the FDA e-cig regulations is back in the news again as two new congressman agree to co-sponsor the bill in an effort to help change the February 15, 2007 predicate date. Democratic House Representatives Brad Ashford of Nebraska and Collin Peterson of Minnesota help boost the perceived importance of the bill just as the new deeming regulations are about to officially take effect on August 8, 2016.
Manufacturers will then have an additional two years to comply with the controversial Pre-Market Tobacco Applications process (PMTA). A separate application for each product released for sale after the predicate date must be completed and approved by the FDA at a potential cost of up to $1 million or more, and FDA approval is not guaranteed. With a predicate date that is retroactively inclusive by almost ten years, this results in nearly 99% of all current products on the market falling under this new regulation. The Cole-Bishop Amendment wants to move this predicate date forward to the current day so that the entire industry doesn’t collapse overnight.
The Cole-Bishop Amendment: Where is it now?
The Cole-Bishop Amendment passed the House Appropriations Committee on April 19, 2016, making its creators Rep. Sanford Bishop (D - GA) and Rep. Tom Cole (R - OK) very happy. However, due to bureaucratic “red tape,” the bill has largely remained stalled in Congress. By attracting two additional co-sponsors in Reps. Ashford and Peterson, the proposed legislation gains an extra punch of political power to move forward towards final approval at a substantially faster pace. It may also encourage other congressional leaders to jump on board as co-sponsors, as well.
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Vaping advocacy groups remain optimistic that the amendment will eventually pass, but moving the predicate date forward will not resolve all of the problems associated with the new FDA e-cig regulations. Currently, there are several lawsuits already pending in the District Court of Washington, D.C. that question the legality of the PMTA process and the regulations themselves. Since e-cigs and vaping devices are essentially 100% tobacco-free, the argument is that the Pre-Market Tobacco Applications process does not apply.
Can the FDA e-cig regulations be overturned?
The Cole-Bishop Amendment is only a first step in what many believe will be a years-long battle to officially overrule the FDA. If the predicate date can be moved forward to the present day, then retailers will no longer be responsible for the costly fees involved with the PMTA process, except for new products yet to be released. The passage of HR 2058 will give the entire industry a bit more breathing room to fight the other pending court cases, and the addition of two new co-sponsors only increases its chances of passing considerably.
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