The FDA greeted the delay in implementation of its vape regulation with a statement which read: “This extension will allow new leadership at the Food and Drug Administration and the Department of Health and Human Services additional time to more fully consider issues raised by the final rules that are now the subject of multiple lawsuits in federal court.”
While some may see this delay (of at least three months) as a good thing, others remain concerned that vape businesses are going out of business because they simply can’t meet the demands of the deeming regulation, especially the ridiculously excessive approval cost.
Senator Ron Johnson welcomed the delay, and wrote to Health and Human Services Secretary Tom Price and Vice President Pence, asking them scrap the deeming regulations entirely. The chairman of the Homeland Security and Governmental Affairs Committee has followed this up with a letter to Scott Gottlieb: "As you begin your tenure as commissioner of the FDA, I respectfully urge you to review the FDA's e-cigarette regulation so that the industry can continue to innovate and offer vapors [as] an alternative to smoking."
At his confirmation hearing, Gottlieb stated that his decision-making would “be guided by the science”, and it’s a welcome change from the anti-science zealotry that appeared to inform his predecessor’s actions. Industry officials cite that individual local vape shops currently need to find one million dollars just to stay in business, and estimate that 99% of them have or will close shortly.
Johnson’s letter continues: “The rules threaten an emerging industry as well as former smokers who have switched to vaping. The regulations require e-cigarette manufacturers to complete costly and time-consuming applications to get federal approval to sell e-cigarette products. Based on some estimates, these applications could cost manufacturers, many of which are small businesses, more than $1 million to complete. That is a cost that these businesses cannot afford.”