WASHINGTON -- The future of electronic cigarettes and vaping hit another roadblock this past weekend with the scrapping of an amendment to the newly passed Congressional budget that would have sheltered most vaping products on the market today from a rigorous and costly FDA approval process.
The Cole-Bishop Amendment submitted by Reps. Tom Cole (R-Okla.) and Sanford Bishop (D-Ga.) would have allowed electronic cigarettes and related products that were on the market from the predicate date of Feb. 15, 2007, through potentially Aug. 8, 2016, to qualify for a less-stringent approval process from the U.S. Food and Drug Administration (FDA).
That may not be the last word on the matter, however. Hope now hangs on two measures, one being a stand-alone version of the Cole-Bishop Amendment submitted by Cole in mid-April and a more recent bill from Rep. Duncan Hunter, R-Calif., asking that e-cigarettes be removed from the FDA’s so-called “deeming rule” altogether.
This past Sunday, leadership in the U.S. House and Senate struck a deal on an omnibus, government-funding bill to keep the government operating through October. Democrat leaders, who hold a great deal of power in budget negotiations due to the 60-vote threshold in the Senate and the unwillingness of some House Republicans to vote for spending bills, “immediately celebrated their victory over small businesses and ex-smokers,” said Gregory Conley, president of the American Vaping Association, Hoboken, N.J. He said that anti-tobacco groups often overlook the potential of products such as e-cigarettes as a way to reduce the risk of harm for current smokers.
House Minority Leader Rep. Nancy Pelosi, D-Calif., said, “We have eliminated more than 160 Republican poison-pill riders.” Among those riders was the Cole-Bishop proposal.
“It is absolutely shameful that Democrat leaders stood in the way of this job-protecting amendment from becoming law,” Conley said. “Democrats are setting themselves up to experience a reality check on vaping in the November 2018 midterm elections.” The FDA’s deeming regulations are set to take effect less than three months before Senate Democrats have some of their toughest election fights, Conley said.
Conley cautioned that while Democrat leaders ultimately sunk the Cole-Bishop Amendment, it would be a mistake for vapers to blame the entire party. As of this past Monday, six House Democrats have sponsored the stand-alone version of Cole-Bishop.
Having the Cole-Bishop Amendment pass along with the new budget would have been a quicker remedy than passing the bills now left to address vaping, Conley told CSP Daily News. “Passing legislation in today’s political environment is extremely difficult,” he said. “It took [Richmond, Va.-based] Altria nine years and millions of dollars to get the Tobacco Control Act passed [in 2009].”
Speaking about the bill Hunter introduced, Conley said it’s unlikely Congress will enact it quickly. “Getting vapor out of the Tobacco Control Act is an obvious long-term goal for vapor consumers and the industry," he said. "[The Hunter bill] is a great conversation starter and a great way to have meetings and build up support.”
Conley points out that measures such as Cole-Bishop would still limit the grandfather clause to products made before Aug. 8, 2016. So while products on the market before that date would be allowed to go through a less strict, less expensive approval process with the FDA, products introduced after that date would have to undergo the more rigorous process. Although vaping as an industry would be saved (since most vaping products were not on the market in 2007), it leaves little room for innovation after 2016.
“Whether or not Cole-Bishop [or the Hunter bill] passes, you’ll see new products only sold in the U.K., China or Belgium, and that includes products that improve the safety [of current devices],” Conley said.
But Conley said the fight is not over. “We must redouble our efforts, focusing on not only Congress, but also the executive branch,” he said. “If Congress refuses to act, President Trump and Health and Human Services Secretary Tom Price must act to avert this oncoming disaster for public health and small businesses.”