The debate over the FDA deeming regulations and the Cole-Bishop Amendment which would adjust the related predicate date is heating up on Capitol Hill, and hopeful FDA Chief Scott Gotllieb is right in the middle it already. Anti-vaping advocacy groups like the Campaign for Tobacco-Free Kids are being joined by a number of Democrats in demanding that Gottlieb recuse himself from all future decisions involving e-cigarettes during his tenure.
Gottlieb does not yet have the job. His confirmation hearing only began last Wednesday, but his selection by Donald Trump is already drawing some serious questions from certain Democratic politicians. When asked by Sen. Patty Murray (D-Wash) about his views on banning certain e-liquid flavors like Gummy Bears and Cookies and Cream, Gottlieb refused to commit one way or the other.
"I recognize there is a line here somewhere, and I don't know where that line gets drawn," Gottlieb said. "I think that line needs to get drawn by people who are experts in evaluating that science, and I want to support that." - The Hill
Anti-vaping groups and Democrats alike do not like to hear that the FDA wants to rely on “experts in science” to make these tough calls. Perhaps this is due to the overwhelming amounts of current scientific evidence showing that vaping is as much as 95 percent safer and healthier than smoking.
Research studies released in the past 6-months from Cornell University, Princeton, Yale, and multiple other highly regarded organizations support this claim. And numerous European public health agencies like the Royal College of Physicians in the UK have been on board with this concept since early 2015.
Scott Gottlieb and KURE e-cigarettes
But anti-vaping advocates and Democrats have another reason to fear Scott Gottlieb. Scientific experts withstanding, the call for recusal is further supported by the fact that Gottlieb has been a major financial investor in the KURE e-cigarette company.
While Gottlieb has promised to fully divest his interests in the company, many political pundits are somewhat skeptical. After all, his soon-to-be-boss, Donald Trump, has made many similar promises himself in the past, and the President has still not completely severed all ties to the Trump Empire.
Scott Gottlieb promises a one-year recusal
Another issue that might complicate matters even further, particularly for the American vaping industry, is that Gottlieb has already promised to recuse himself from all future decisions related to e-cigarettes for a period of one year. This could be a devastating blow to a vaping industry that has been extremely optimistic that the surprise presidential win by the Republican Trump would lead to an immediate repeal of the Obama-enacted FDA deeming regulations.
Will Gottlieb and the Republican-controlled Congress give in to the demands of left-leaning anti-vaping groups and politicians? Probably not. Gottlieb’s confirmation by the Senate is almost certain.
Still, the fact that Gottlieb has promised to recuse himself from all matters related to e-cigs and vaping for one year is rather concerning. If he goes through with this promise, then the American vaping industry’s current hopes for immediate repeal of the FDA deeming regulations may be dashed once and for all.
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