The FDA Has 120 Days to Regulate Synthetic Nicotine. That’s Impossible.

    On March 15, tobacco controllers gathered at a hotel in Baltimore for an annual conference hosted by the Society for Research on Nicotine and Tobacco (SRNT), the preeminent scientific society in the field. This year, the board decided to bar the industry from presenting research, in a move some notable scholars and academics have criticized as a suppression of science. But the meeting still seemed well-attended. Mitch Zeller, the departing director of the Food and Drug Administration’s Center for Tobacco Products (CTP), gave perhaps his last public speech in that role. At one point, he reportedly looked down at his watch, signaling a clock would soon start ticking.

    It was not the countdown to his retirement. Instead, just 40 or so miles away, President Joe Biden was about to sign an omnibus spending bill, giving the Food and Drug Administration (FDA) the power to regulate synthetic nicotine like any other “tobacco product.” The law will go into effect in 30 days.

    It’s possible the FDA—which is in no reasonable position to authorize the applications in that period—could order every single synthetic nicotine product off the market.

    Once that date arrives in mid-April, producers of synthetic nicotine vapes and other products like pouches will have 30 additional days to file premarket tobacco product applications (PMTAs) with the FDA. The agency would have to deem products “appropriate for the protection of public health” to authorize them⁠—the same threshold that tobacco-derived vaping product manufacturers were meant to meet for applications filed in September 2020.

    Then, after 60 further days, it’s possible the FDA—which is in no reasonable position to authorize the applications in that period, as past delays have shown—could order every single synthetic nicotine product off the market completely.

    Industry insiders and observers expect that companies will file PMTAs despite what they note is an expedited and unrealistic time frame, considering that the FDA appears to require specific long-term studies that would surely be impossible to conduct in 30 days. (At the least, they would take six months.)

    Nobody, however, seems to know whether the FDA will exercise its enforcement discretion to allow continued sales of synthetic nicotine products with pending PMTAs, as it has with countless tobacco-derived nicotine vapes.

    If so, some synthetic nicotine companies—those the agency likely believes have the resources to eventually send the appropriate data—could continue to operate. Their products would be technically illegal, but the FDA would choose not to enforce that.

    If not, however, the agency will effectively ban synthetic nicotine⁠—which is made in labs but is chemically ⁠almost indistinguishable from the traditional version—before it has even had a chance to be scientifically understood. Some in the industry contend that synthetic nicotine could, in fact, be safer than tobacco-derived nicotine, but they are not optimistic the FDA will give a thorough review, judging by its past track record. Nonetheless, this potential decision would remove a bevy of vapes, pouches and other products that currently provide people with alternatives to combustible cigarettes.

    “If I get an MDO this time, I’ll be suing the next day.”

    “We have to get some kind of enforcement discretion,” Amanda Wheeler, the owner of Jvapes and the president of American Vapor Manufacturers (AVM), told Filter. “People can get the bare bones of their PMTAs filed, but beyond that, they’re going to need more time.”

    Like many other small- and medium-sized manufacturers, Jvapes transitioned to synthetic nicotine after receiving an FDA marketing denial order (MDO) for its flavored, tobacco-derived vaping products. The company switched because the FDA did not then have the power to regulate synthetic nicotine. Many federal legislators labeled that a sort of “loophole” they had to fix, as products like Puff Bar, which uses synthetic nicotine, seemed to become popular among youth. (This was despite steeply declining youth vaping rates overall.)

    “I think you’ll see a lot more companies file lawsuits when MDOs come out,” Wheeler continued. “I didn’t file a lawsuit the last time I got an MDO. But if I get one this time, I’ll be suing the next day.”

    “We’re not just playing games here. We’re making legitimate arguments for public health.”

    Still, “companies will be looking to file compliant PMTAs,” echoed Azim Chowdhury, a regulatory and public policy attorney who represents a number of vapor companies. “We’re not just playing games here,” he told Filter. “We’re making legitimate arguments for public health.”

    As Chowdhury noted, the same post-MDO legal option to petition a court of appeals now applies to synthetic products as it does to tobacco-derived ones⁠—an option that numerous smaller companies have pursued. The decisions of those cases could have ramifications for synthetic nicotine as well and might prompt the FDA to administer more thorough reviews than it previously has.

    The FDA did not respond to Filter’s request for comment by publication time.

    If nothing else, the synthetic nicotine PMTAs are “going to dispel this notion that companies were only introducing the product to avoid regulations,” Tony Abboud, the executive director of the Vapor Technology Association (VTA), told Filter. “Synthetic nicotine as a technological innovation,” he added, “represents the opportunity for a true and complete break from tobacco.”



    Photograph by John Voo via Flickr/Creative Commons 2.0

    • Alex was formerly Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in the New York Times Magazine, the 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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