More and more manufacturers are looking at synthetic nicotine as a means of skirting the FDA regulations.
But there’s general concern among vaping manufacturers, consumers and advocates that the FDA will only authorize the companies with the biggest market share, consequently putting a majority of the mom-and-pop vape shops and smaller- and medium-sized producers out of business.
Or those producers will devise new and unique ways to potentially escape from the FDA’s regulatory crosshairs. Like Vapor Salon, the small manufacturer in Fort Worth, Texas, that just had its products denied by the FDA.
In a public Facebook post, on the same day the company declined to comment for a Washington Post article, Vapor Salon wrote that it would be switching to Synthetic Nicotine by Friday, August 27—less than 24 hours after the FDA ordered the company to remove its products from the market. (Vapor Salon did not respond to Filter’s request for comment.)
“VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the post reads. “The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement which takes full effect on Sept 9th 2021 with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to-date.”
As Filter previously reported, more and more manufacturers have begun looking at the possibility of synthetic nicotine—that is, nicotine made in a lab and not derived from tobacco—as a means of potentially skirting around FDA regulations.
The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.” On the closest and most technical readings, the phrasing would preclude the agency from treating Synthetic Nicotine as it does other nicotine products, which are almost always derived from tobacco.
Still, synthetic nicotine is expensive—Vapor Salon indicated that many of their rejiggered products will now have “an upcharge”—and it’s unclear how long the FDA will standby if another Wild West-scenario develops, as the agency issues more PMTA denials and additional manufacturers try to inevitably transition to synthetic nicotine.
Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, explained recently to Filter that the FDA typically waits to act until a “crisis” emerges or Congress orders the agency to do something. (With vaping, for example, it was the spiraling outcry around teen use.)
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