Vape Companies Are Using Synthetic Nicotine to Outsmart FDA
Synthetic Nicotine, Johnston, who owns the Texas-based vaping company VaporSalon, tried to follow the U.S. Food and Drug Administration’s (FDA) guidelines for selling e-cigarette products, which required all manufacturers to file paperwork known as premarket tobacco product applications (PMTAs) by Sept. 9, 2020. In these applications, companies were tasked with proving that their products were, on balance, good for U.S. public health—namely by giving adult smokers a less-dangerous alternative than traditional cigarettes.
As required, Johnston filed applications for all 47,000 nicotine e-liquids his company sells, an undertaking that he says cost his business thousands of dollars and countless hours of work. But he wanted a back-up plan, just in case the FDA’s decision didn’t go his way. So in August, he looked into purchasing synthetic nicotine—a product that some in the vaping industry argue the FDA doesn’t have the power to regulate as it does other e-liquids, since it is not derived from tobacco.
When the agency rejected the vast majority of VaporSalon’s PMTAs on Aug. 26, Johnston was ready. “VaporSalon is switching to TOBACCO FREE NICOTINE,” he posted from VaporSalon’s Facebook page that day, adding that “the main purpose” was to skirt FDA regulations. “We never wanted to switch to [Synthetic Nicotine], but the FDA forced us to make that decision as we have so many adults relying on us” for alternatives to cigarettes, Johnston wrote in an email to TIME.
Johnston may have been unusually candid in his post, but he’s not alone in searching for a savior in Synthetic Nicotine. The FDA has so far rejected PMTA paperwork for more than 5 million e-cigarette products, many of them flavored vaping liquids. Faced with the choice of removing their products from the market entirely or working in a regulatory gray area, some of those manufacturers are embracing uncertainty and pivoting to Synthetic Nicotine.
Tony Abboud, executive director of the Vapor Technology Association, a trade group for the e-cigarette industry, says there are plenty of non-regulatory reasons a company might want to use Synthetic Nicotine—its purity, for example, or freedom from traditional tobacco, with all its baggage and sordid history. But he concedes that the FDA authorization process has forced some hands. “The process has been so convoluted and so opaque that, without question, it’s driven companies in this direction,” he says.
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