Synthetic nicotine has been on the radar of state-level and federal lawmakers in the past, but never with the mainstream traction it’s received in the past few weeks. Despite decreasing youth vaping rates, it has quickly morphed into the next target for policymakers.
On November 16, North Carolina Attorney General Josh Stein launched an investigation into Puff Bar, the disposable vape producer that recently switched to using synthetic nicotine and appears to have surpassed Juul as the popular e-cigarette among teens. That same day, nine Democratic senators—including Elizabeth Warren (D-Massachusetts), Richard Blumenthal (D-Connecticut) and Amy Klobuchar (D-Minnesota)—wrote to the FDA’s acting commissioner, Janet Woodcock, “express[ing] great concern over the public health challenge presented by synthetic nicotine products, including their role in prolonging the youth vaping epidemic.”
“We write to urge your agency to act without delay to ensure that these products do not evade regulatory oversight by using the authority granted by Congress through the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate synthetic nicotine products as drugs,” they stated. “We also write to ask what additional authorities or resources would be helpful for the FDA to regulate synthetic nicotine as a tobacco product.”
The development—and potential panic—should not come as much of a shock.
Days later, Tony Dokoupil, a host of CBS Mornings, sat down with Patrick Beltran and Nick Minas, the two mysterious, Lamborghini-driving 27-year-olds who identified themselves as the co-owners and co-CEOs of Puff Bar. (They are not, as they explained to Dokoupil, lurking in the shadows any longer.)
The development—and potential panic—should not come as much of a shock. The writing, as they say, has been on the wall: Many small- and medium-size manufacturers have failed to gain authorization through the Food and Drug Administration’s premarket tobacco product application (PMTA) process for their tobacco-derived flavored nicotine products—which fall under the FDA’s jurisdiction. Several have publicly claimed they’ll be switching to lab-made synthetic nicotine—which, technically, may not. (Through the PMTA pathway, companies had to prove their vapes would be “appropriate for the protection of public health”—meaning, essentially, that they had to show their products would help adult smokers transition to safer alternatives without introducing a new generation to nicotine.)
Because the FDA, which received the authority to regulate tobacco in 2009, defines a “tobacco product” as anything “made or derived from tobacco,” some in the vape industry view synthetic nicotine, which is chemically just about impossible to distinguish from the regular kind, as a loophole. At the moment, skirting this regulatory gap allows manufacturers to keep selling flavors. It’s a gap, of course, that will close if the FDA manages to find a way to regulate it as a drug, or if an act of Congress redefines a “tobacco product” to include synthetic nicotine—both options that senators like Warren and Blumenthal are actively encouraging.
Earlier this month, on November 8, Representative Raja Krishnamoorthi (D-Illinois)—the chair of the Subcommittee on Economic and Consumer Policy and frequent foe of tobacco harm reduction proponents, arguably got this ball rolling: He sent interrogatory letters to both Puff Bar and Next Generation Labs, perhaps the largest synthetic nicotine producer in the United States. He demanded more information on the companies’ business practices as well as how they use, purchase or manufacture synthetic nicotine.
It’s easy to portray this situation as self-inflicted.
For those who see the continuing availability of vapes in the non-tobacco flavors that most adults prefer as vital for harm reduction, there’s an image problem here. Much like Juul with pod-based devices, “Puff Bar” has transformed into something of a generic term for disposables and, now, synthetic nicotine. (For the average consumer, it’d be difficult to distinguish between a counterfeit Puff Bar or a genuine one.) And the new faces of Puff Bar—a pair of millennials flaunting their wealth on social media—are not helpful in PR terms. They are, however, convenient scapegoats for short-sighted attorneys general and senators who grasp how simple it is to find a manufacturer in China and flood the US market.
But amid a predictable cycle of alarm—previously seen with the onset of the alleged teen vaping “epidemic,” with the “EVALI” outbreak of lung diseases and with claims that vaping exacerbated COVID—it’s also easy to portray this situation as self-inflicted. The FDA’s drawn-out bureaucracy, the flavor bans emerging from city council meetings, and now—perhaps—the federal tax that could make vaping products more expensive than cigarettes have at least propelled the synthetic surge, if not outright caused it.
Synthetic nicotine has stepped center-stage because science and tobacco policy—policy that should surely be dedicated to helping smokers switch successfully—have, for so long, been out of step.