Troy Johnston swears he wanted to play by the rules.
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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The FDA has had the power to regulate tobacco products since 2009, when then-President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act. That law defines a tobacco product as “any product made or derived from tobacco that is intended for human consumption.”
Under a literal reading, synthetic nicotine falls outside that definition, since it is lab-made and not derived from tobacco. Some e-cigarette companies are using that largely unlitigated loophole as a lifeline.
The Germany-based nicotine wholesaler Contraf-Nicotex-Tobacco GmbH primarily sells tobacco-derived product. But Torsten Siemann, the firm’s managing director, says in recent months there’s been a noticeable increase in interest, particularly from U.S. companies. “There are quite some companies who want to try to avoid [the FDA’s review process],” Siemann says, adding that his company supports synthetic nicotine regulation and would stop sales “as soon as this starts to be an illegal market.”
Whether using synthetic nicotine actually places companies outside the FDA’s grasp is up for debate. An FDA spokesperson, in an email, said only that the agency is “aware of a number of electronic nicotine delivery systems (ENDS) claiming to contain only synthetic nicotine (not nicotine sourced from tobacco). We are considering how best to address such products.” On its website, the FDA says it will handle synthetic nicotine regulation on “a case-by-case basis.”
The issue is “definitely gray,” says Marc Scheineson, a partner at the Washington, D.C. law firm Alston & Bird and a former FDA associate commissioner. For example: while the FDA may not have the authority to regulate synthetic nicotine as a tobacco product, it may be able to regulate it as a drug, he says, since the agency could argue that synthetic nicotine alters the structure and function of the body, one of the definitions the FDA uses to designate something a drug. Congress could also choose to amend the definition of a tobacco product to include non-tobacco-derived nicotine, if it saw fit.
In 2010, a Washington, D.C. circuit court ruled that e-cigarettes that use tobacco-derived nicotine must be regulated as tobacco products, not drugs. But that decision specified that the FDA could regulate other nicotine products—such as patches and gums marketed for smoking cessation—as drugs. That seems to clear a path for regulating synthetic nicotine as a drug, says Dennis Henigan, vice president of legal and regulatory affairs at the anti-smoking Campaign for Tobacco-Free Kids (CTFK).
“We think that’s crystal clear,” Henigan says. “FDA, on the drug side, has the authority to enforce the law against [synthetic nicotine products] right now.”
CTFK, along with six other health groups, argued as much in a Sept. 2 letter to the FDA, noting that some companies were already using synthetic nicotine to circumvent FDA processes. Many of those companies had previously manufactured tobacco-based nicotine products, but were not granted marketing authorization because they could not prove their flavored liquids were beneficial enough to adult smokers to outweigh their risks of appealing to underage users—and now, those manufacturers can make the same flavored juices using synthetic nicotine.
“Continued agency inaction on synthetic nicotine e-cigarette products will undermine the regulatory system established by Congress, both for drugs and for tobacco products,” CTFK and its partners wrote. “And continued inaction will allow the manufacture, sale, and widespread availability of flavored products—exactly the products that caused the current epidemic of youth e-cigarette usage and nicotine addiction—to flourish.”
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This isn’t the first time public-health groups have argued that the FDA needs to crack down on synthetic nicotine. CTFK first wrote to the FDA about it in 2018, in response to marketing by the synthetic nicotine supplier Next Generation Labs. (Next Generation Labs did not respond to TIME’s request for comment.) The same year, several public-health-focused attorneys argued in a Boston College Law Review article that the FDA was leaving open a loophole that companies could “exploit it in order to evade regulation” and “can, and should, address this problem by regulating synthetic nicotine products as drugs.”
Neither missive did much. In March of this year, the Wall Street Journal reported that Puff Bar—which makes a popular line of disposable, flavored e-cigarettes—was using synthetic nicotine to avoid agency regulation, sparking another letter to the FDA from CTFK and other health groups.
Abboud, from the Vapor Technology Association, says he fears that if the FDA regulates synthetic nicotine as a drug, many e-cigarette companies will go out of business, potentially handing the market back to traditional cigarette companies. “The drug [approval] pathways are even more cumbersome, even more time-consuming, and more expensive than any other [regulatory] pathway,” he says.
That may be true. But Henigan, from CTFK, says it’s unacceptable for companies to simply sell products as they see fit. “These companies are proceeding under the assumption that they’re simply unregulated,” he says. “That’s a dangerous situation.”