Hopes in the e-cigarette industry for regulatory relief were dashed this week as Congressional Democrats, with the help of a number of Republicans, killed an amendment to the Tobacco Control Act that would have reined in some of the FDA’s “deeming” regulations. Had the amendment passed and the complete bill signed into law, it would have made it easier for small businesses to carry, market and sell e-cigarettes and vaping products.
The FDA “deeming” rule subjects new products that have come onto the market since February 15, 2007 to what the e-cigarette industry advocates describe as “a burdensome pre-market review process” they claim “achieves very little in the way of protecting public health.” According to their letter to Congress, dated April 26,
“The FDA’s own estimates found that the cost of completing and submitting the required Pre-Market Tobacco Application (PMTA) would exceed $300,000 per product and take at least 500 hours of time per application.”
Under current regulations, PMTA applications for all domestically-manufactured vaping products must be submitted no later than August 8, 2018. According to the letter (signed by representatives of virtually every major conservative lobbying group), without regulatory relief, tens of thousands of jobs would be lost as businesses relying on vaping product sales would be forced to close their doors.
This week, the Cole-Bishop Amendment, which would have provided the regulatory relief the e-cigarette industry had hoped for, went down to defeat. Senator Patrick Leahy of Vermont was pleased, noting “this bipartisan agreement eliminates more than 160 poison pill riders” – one of which was the Cole-Bishop Amendment.
Gregory Conley, President of the American Vaping Association, had a different view. He said, “It is absolutely shameful that Democrat leaders stood in the way of this job-protecting amendment from becoming law.” Conley went on to threaten the Democrats, warning that they are “setting themselves up to experience a reality check on vaping in the November 2018 mid-term elections,” and that vapers will be voting them out of office when their products begin disappearing from retail shelves three months before they go to the polls.
The vaping industry isn’t backing down on their fight. On April 24, the Vapor Technology Association sent a letter to Health and Human Services Secretary Tom Price (himself a physician who has questionable ties to Big Pharma), calling on him to repeal the FDA Deeming Rule. There is also a stand-alone version of the Cole-Bishop bill that so far has six Democratic sponsors.
The industry continues to claim that vaping is a much less harmful alternative to combustible tobacco, citing studies from the U.K. Royal College of Physicians and the University of Victoria in Canada. However, a different study, published earlier this year in Pediatrics, indicates that vaping among young people actually increases the chances that they will become cigarette smokers. Two more recent medical studies found associations between the use of e-cigarettes and heart disease, childhood asthma and other risk factors.
Besides the health hazards of vaping itself, e-cigarettes are continuing to explode in people’s mouths, causing serious and disfiguring injuries. Given these dangers, it appears that in this case, Congress made the right call in rejecting the Cole-Bishop Amendment.