Legislators in three different states—Georgia, Maryland and Mississippi—have recently introduced bills that would only allow the sale of vapor products authorized by, or pending authorization from, the Food and Drug Administration (FDA). Each piece of legislation would also establish directories to inventory authorized vapor products. The lists would eventually be made public.
The proposed restrictions seem somewhat counterintuitive, since the FDA has denied thousands of producers through its premarket tobacco product application (PMTA) process. These manufacturers already cannot legally sell their products in the United States, even if some are fighting back in court. On the surface, then, the state bills just reiterate what the federal government has decided.
“The reality is that these bills would shut down licensed small businesses that are operating in full compliance with federal, state and local laws.”
But observers have noted another intention of the bills: a roundabout way to ban the sale of synthetic nicotine, which some manufacturers have turned to as a “loophole” of sorts to keep making the flavored e-liquids preferred by their adult customers.
“The elected officials sponsoring these bills may be under the mistaken impression that their proposals are only targeted at illicit and counterfeit dealers,” Greg Conley, the president of the American Vaping Association, told Filter. “The reality is that these bills would shut down licensed small businesses that are operating in full compliance with federal, state and local laws.”
A trio of Republican lawmakers—State Senator JB Jennings (Maryland), State Senator Jeff Mullis (Georgia) and Representative Nick Bain (Mississippi)—have introduced SB 990, SB 572 and HB 976 in their respective states. The three also have something in common besides their party: They’ve each received campaign funds (albeit modest) from Juul Labs, the vape company that has itself frequently been a target of prohibitionist efforts.
Records reviewed by Filter—which are public—show that Juul contributed totals ranging from $500 to $4,800 to the politicians’ PACs or campaigns in the past two years.
There’s a suggestion that the vaping giant and other large companies want to see synthetic nicotine—and, subsequently, competition—diminished. It’s a rare moment of apparent unity with anti-nicotine organizations like the Campaign for Tobacco-Free Kids (CTFK) and Parents Against Vaping E-Cigarettes (PAVE), which have both started to focus on synthetic nicotine.
“To preserve the harm reduction opportunity for adult smokers, Juul Labs supports a fully regulated, science-based marketplace,” a Juul spokesperson told Filter. “Illegally marketed and illicit products and products designed to evade federal and state oversight undermine harm reduction and a responsible e-vapor category.”
Jennings, Mullis and Bain did not respond to Filter’s requests for comment by publication time.
“Selling synthetic nicotine products is how mom-and-pop vape shops who just want to help smokers quit are attempting to legally navigate the absurd government treatment of the industry,” one industry insider, requesting anonymity so as not to affect the PMTA process, told Filter. “It’s a shame the makers of cigarettes are hell-bent on making sure they all go out of business.”
“This is not about selling products that have already been restricted by the federal government,” echoed Conley. “Getting through this [PMTA] process is a nearly impossible task for all but out-of-state corporate behemoths like Juul Labs, which is pursuing policies like this in an attempt to reform their battered image and knock out thousands of small business competitors.”
The lawmakers’ justification, of course, is the same one vaping has faced for the last few years: teenagers. Despite youth vaping rates significantly dropping in 2021, federal data show middle- and high-schoolers migrating away from pod-based devices and toward disposables. Their favorite brand now appears to be Puff Bar, which has switched to synthetic nicotine and has almost become synonymous with the substance. Many in the industry, however, are quick to point out that it’s common to mistake counterfeit devices for genuine Puff Bars.
Nonetheless, Puff Bar has become the new prime target for public health organizations that oppose vaping, like the American Heart Association and Truth Initiative. And large manufacturers that see the future as a carefully regulated—if massively less diverse—marketplace may blame Puff Bar for renewing a perception of e-cigarettes as a tool to lure a new generation into nicotine dependence. Puff Bar has attempted to save its reputation of late, with the two owners giving interviews to the Wall Street Journal and CBS.
It’s a thorny situation, as usual. With Puff Bar in their sights, politicians have begun to address the question of synthetic nicotine regulation, but for now the chemical exists in a legal gray area, as it technically does not fall under the FDA’s jurisdiction. 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.” Because synthetic nicotine is made in a lab—that is, not derived from tobacco—it doesn’t qualify.
“If you require a PMTA for a product that the FDA doesn’t accept PMTAs for, you ban that product.”
The FDA may, therefore, have to wait for an act of Congress. And perhaps not for much longer. In November, Representative Raja Krishnamoorthi (D-Illinois), a longstanding antagonist of tobacco harm reduction advocates, sent interrogatory letters to Puff Bar and Next Generation Labs, one of the largest synthetic nicotine producers in the US. That same month, nine Democratic senators—including Elizabeth Warren (Massachusetts), Richard Blumenthal (Connecticut) and Amy Klobuchar (Minnesota)—wrote to the FDA’s then-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.”
By December, Representative Mikie Sherrill (NJ-11, also a Democrat) had introduced a bill that would place synthetic nicotine under the “tobacco product” umbrella. Meanwhile, the Senate narrowly confirmed Dr. Robert Califf to be the next FDA commissioner in February, and Mitch Zeller, the director of the agency’s Center for Tobacco Products (CTP), is set to retire in April—moves that have caused speculation on next steps.
Should a bill like Sherrill’s pass, synthetic nicotine products will likely have to go through the PMTA process. But at the moment, no legal pathway exists for vapor manufacturers to receive FDA authorization for synthetic nicotine. So prohibiting the sale of synthetic nicotine on a state level is seen as a kind of remedy, even if it blocks adult smokers from accessing the products they need to switch in the name—yet again—of protecting the children.
In the spring of 2021, Alabama effectively banned the sale of synthetic nicotine, requiring it to have FDA “approval” under the Food, Drug and Cosmetic Act. As Vaping360 reported, tobacco company Altria, which has a minority stake in Juul, backed the legislation—a move Ron Tully of Next Generation Labs said doesn’t shock him. “I am never surprised by the big guys’ willingness to destroy anything they perceive as real competition,” he told Filter.
States aside, the question on seemingly everyone’s minds now is not how the FDA will get jurisdiction over synthetic nicotine but when. But for David Sweanor, an industry expert and chair of the advisory board for the Centre for Health Law, Policy and Ethics at the University of Ottawa, this line of inquiry might be the wrong one. Should the FDA, he asks, even have that authority?
“By permitting only products authorized by the FDA, such laws would seek to ban low-risk alternatives to cigarettes and protect the cigarette business from its leading competitive threat,” Sweanor told Filter of the states’ proposed bills. “It would be like protecting the internal combustion auto sector by only allowing electric automobiles approved by the Department of Agriculture. It’s a Catch-22: only allow products authorized by an agency that has no oversight of such products.”
There’s also fear, as Conley noted, that the Georgia, Maryland and Mississippi bills in their current forms could effectively bar nicotine-free e-liquid (the final stage for some vapers looking to transition completely off nicotine) and could pose problems for devices and their components, which could be used with non-nicotine vapes, such as for THC for medical and recreational use.
“If you require a PMTA for a product that the FDA doesn’t accept PMTAs for, you ban that product,” the industry insider said. “It’s like putting quarters in a vending machine that only takes credit cards.”
Ironically enough, authorizing even some flavored products might help close the synthetic nicotine loophole, noted another industry insider, requesting anonymity for the same reason. From their perspective, a marketplace with some available flavors—even one not as robust as many vapers and harm reduction proponents would prefer—will at least give adults the option to choose authorized flavored products. And who, the logic goes, will pick an unregulated synthetic product over one that has passed the agency’s high scientific threshold?
“In many ways, I respect all these irreconcilable differences,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network and former vice president for tobacco control at the American Cancer Society, told Filter. “And I respect the vape shops that are truly in the business of saving lives who have turned to synthetic nicotine. But the market cannot function as a Wild West without regulation. We need to protect consumers and best serve public health.”
Update, March 3: After publication, a Juul spokesperson sent comment. The article has been updated with their statement.
Photograph by Vaping360 via Flickr/Creative Commons 2.0
The Influence Foundation, which operates Filter, has received grants and donations from Altria, the American Vaping Association and Juul Labs. Filter’s Editorial Independence Policy applies.
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