FDA Poised to Gain Regulatory Power Over Synthetic Nicotine

March 8, 2022

Lawmakers have inserted language into a federal spending bill that would give the Food and Drug Administration (FDA) regulatory authority over synthetic nicotine, clamping down on a legal gray area for vapes. The proposed legislation would change the definition of a “tobacco product,” which currently means anything made or derived from tobacco, to include products “containing nicotine from any source”—with the exception of foods with trace amounts.

Legislators are working quickly to pass the omnibus spending bill, in part to avoid a government shutdown. According to a copy of the bill reviewed by Filter, should this version pass, the synthetic nicotine amendments will go into effect 30 days after. Synthetic nicotine producers would then have 60 days from its enactment—or 30 days after it becomes effective—to file premarket tobacco product applications (PMTAs) with the FDA to legally stay on the market. Ninety days after the effective date, or 120 days after the bill’s passing, these manufacturers would have to stop selling their products if the FDA has not authorized them. At that point, the FDA could exercise its enforcement discretion.

Some in the industry, particularly small- and medium-sized producers, see the move as yet another de facto ban.

“This is an enormous win for public health and American consumers,” Representative Frank Pallone (D-NJ), who helped push for the language, told Bloomberg. He added that it will prevent “bad actors attempting to evade FDA regulation and hook a new generation of young people into a lifetime of nicotine addiction.”

But some in the industry, particularly small- and medium-sized producers, see the move as yet another de facto ban. So far, the FDA has only authorized a single, outdated vaping product—and two corresponding tobacco-flavored cartridges—through its PMTA pathway. It has denied thousands of others in a process many insist only favors the largest companies and was flawed from the start. Dozens of vape manufacturers are now suing the FDA, arguing that the agency acted “arbitrarily” and “capriciously” in denying their applications and demanding long-term studies they did not know were required. Others have recently switched—or at least, claim to have done—to synthetic nicotine as a means to keep selling the flavored products preferred by former adult smokers.

Following that precedent, it would be virtually impossible for any synthetic nicotine producer to receive FDA authorization, unless they had preemptively begun long-term studies. And that, too, is assuming the agency would be able to review them in a 120-day period, on top of the thousands of others that remain pending. The feat seems unlikely.

A practical problem with regulation is that, chemically speaking, it’s difficult to tell whether or not nicotine is derived from tobacco or made in a lab.

But political impetus to do this has come from a perceived issue that has long been used to restrict access to harm reduction products: teen vaping. Despite youth vaping rates decreasing over the years, the concern stands for many lawmakers—like Representative Raja Krishnamoorthi (D-IL)—who have now homed in on synthetic nicotine as the latest culprit, the newest tactic to ensnare teens into lifetime dependence on nicotine. Puff Bar, a disposable vape company that last year switched to synthetic nicotine, has become the primary political target for its apparent popularity among youth.

Many states have already been trying to prohibit the sale of synthetic nicotine, either outright or in roundabout ways—developments supported by much of the tobacco industry and large vape companies. Observers have framed the battle as one between Big Tobacco and Small Vape.

The question becomes, then, how genuine you believe either side to be: Are tobacco companies pushing for synthetic nicotine bans because they seek market capture? Or have synthetic nicotine producers simply been exploiting a “loophole” and finally have to play by the same kind of rules?

“This bill ought to be called the Cigarette Protection Act.”

“This bill attempts to create a regulatory framework around synthetic nicotine, but does so without an appropriate and reasonable timeline for submissions of a PMTA,” Ron Tully, a co-founder of Next Generation Labs, one of the largest synthetic nicotine producers in the country, told Filter.

“This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking,” said Amanda Wheeler, the president of the American Vapor Manufacturers association.

An FDA spokesperson told Filter that the agency “does not comment on proposed or pending legislation.”

But as one industry insider, who requested anonymity so as not to affect the PMTA process, asked Filter, “Why should we give the FDA any more authority?”

The FDA has demonstrated both utter incompetence and a willful disregard for the scientific evidence on vaping when it comes to regulating the tobacco derived nicotine industry,” they said. “Giving them the authority to shut down the rest of the market plays right into the hands of the big tobacco companies pushing so hard for a synthetic ban.

 


 

Photograph by Felton Davis via Flickr/Creative Commons 2.0

Alex Norcia

Alex is Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism Review, The Los Angeles Times and The New Republic, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. He is currently based in Los Angeles.

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