On November 8, Representative Raja Krishnamoorthi (D-Illinois), the chair of the Subcommittee on Economic and Consumer Policy and a longstanding antagonist of tobacco harm reduction proponents, sent ominous letters to two companies that sell synthetic nicotine.
Krishnamoorthi asked Puff Bar, the disposable vape producer that has come under fire for alleged youth-centered marketing practices, and Next Generation Labs, the largest synthetic nicotine producer in the United States, to provide a bevy of information. From the former, Krishnamoorthi demanded, among other things, “all documents and communications referring or relating to the use of synthetic nicotine in Puff Bar products, including the decision to switch to synthetic nicotine, and all documents relating to the purchase of synthetic nicotine.” From the latter, he called for “documents sufficient to show all companies to which you supply synthetic nicotine capable of being used in e-cigarettes and/or e-liquids” as well as “documents sufficient to show that your synthetic nicotine products are not tobacco-derived.”
Synthetic nicotine has morphed into the next concern for politicians and regulators.
Krishnamoorthi’s move aptly illustrates how synthetic nicotine—that is, nicotine made in a lab and not derived from tobacco—has morphed into the next concern for politicians and regulators. Because the Food and Drug Administration (FDA), which received the power to regulate tobacco in 2009, defines a “tobacco product” as anything “made or derived from tobacco,” some in the vape industry have come to view synthetic nicotine as a potential loophole. Technically, the FDA’s terminology does exclude synthetic nicotine from its jurisdiction. But few observers expect this to be a permanent state of affairs. Especially considering that tobacco-derived nicotine and synthetic nicotine are chemically difficult to tell apart.
Citing reporting from Filter, Krishnamoorthi quoted Ronald Tully of Next Generation Labs about the current lack of regulation: “If the statute has been ill-conceived, and the regulation has been ill-drafted, it is not the responsibility of the industry to conform to some kind of idea that you can’t innovate in those spaces where the legislation doesn’t occur.”
“Representative Krishnamoorthi lacks even the slightest evidence that the target of his latest investigation has broken a single law,” Greg Conley, the president of the American Vaping Association (AVA), told Filter. “As per the usual, he is playing politics, and we are hopeful the demands specified in his letter will be resisted.”
“With youth vaping numbers and the associated moral panic continuing to decline,” he continued, “it remains to be seen whether Representative Krishnamoorthi’s primary goal—getting media attention focused on Representative Krishnamoorthi—will actually be met with this campaign.”
In the past few months, the FDA has, through its premarket tobacco product application (PMTA) process, stripped a majority of the vapor products from many small- and medium-sized manufacturers off the market. Companies have had to prove their vapes would be “appropriate for the protection of public health”—meaning, in large part, that they had to show their products would help adult smokers’ transition to a safer alternative without attracting a new generation of nicotine users. (A federal court of appeals recently agreed with the industry that the FDA’s process has been opaque and, at best, flawed.)
As a result, many smaller companies have announced they’d be switching to synthetic nicotine.
“You have apparently made the vile decision to continue enriching yourselves by poisoning children.”
Last February, Puff Bar transitioned to synthetic nicotine. Meanwhile, Next Generation Labs, which produces “tobacco-free” nicotine under its trademark TFN, has seen sales apparently skyrocket since the FDA began denying regular-nicotine vaping products.
“We have [the letter] in hand and are reviewing and will respond accordingly,” Ronald Tully, a co-founder of Next Generation Labs, told Filter. “Next Generation Labs has always believed that synthetic nicotine should subject to a fair and appropriate regulatory structure and that a pathway needs to be created for the future oversight of products on the market today that contain TFN.”
He also noted that Puff Bar is “not a customer,” explained that synthetic nicotine “has the potential to significantly offset the carbon footprint created from the global production of tobacco and tobacco-extracted nicotine,” and welcomed “a well-conceived, appropriate and reasonable future FDA regulatory framework and pathway for products containing synthetic nicotine.”
“It is important to consider the role of synthetic nicotine in this broader context and not just as a narrow substitute to tobacco nicotine,” Tully continued.
It has long been assumed that it would take an order from Congress before the FDA took any definitive action against synthetic nicotine. Now, that might not be far off.
“You have apparently made the vile decision to continue enriching yourselves by poisoning children,” the letter to Puff Bar’s owners reads. “Puff Bar’s meteoric rise in popularity among kids resulted in $156 million in sales in 2020 alone. Puff Bar should not be allowed to continue harming children due to FDA’s failure to regulate synthetic nicotine, and I intend to put an end to your predatory practices.”
Update, November 9: This article has been updated to include comment from Ronald Tully.
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