Why Are Congress Members Demanding That the FDA Halt Its Evaluation of Flavored Vapes?

    Last week, dozens of United States Congress members demanded that the Food and Drug Administration (FDA) strip flavored vaping products from the market by halting a long-awaited federal product review process.

    In March 23 letter to acting FDA commissioner Janet Woodcock and director of the FDA Center for Tobacco Products director Mitch Zeller, the representatives wrote that “flavored e-cigarettes are putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use.”

    “And these products are widely available and popular with kids,” the letter continues. “Unfortunately, the vast majority of these tobacco products that are undergoing premarket review have already been on the market for several years with observable negative consequences for public health.”

    According to the Centers for Disease Control and Prevention (CDC), around 20 percent of high school students used e-cigarettes in 2020—a nearly 7 percent drop from the previous year. And though they continue to prefer flavored e-cigarettes, they also list other reasons—like simple curiosity—as a major reason for vaping.

    The letter, spearheaded by Rep. Deborah Wasserman Schultz, a Democrat from Florida, and Rep. Diana DeGette, a Democrat from Colorado, essentially asks the FDA to pause—in part—the Premarket Tobacco Product Applications (PMTA) process that has been in motion since September 2020. Some flavored vaping products—cited by many adults as a vital element in their switching from smoking to vaping—have been able to remain on the US market pending the outcomes of this procedure, even as many state and local jurisdictions have banned them.

    In other words, the legislators seem to imply that the FDA is incapable of doing its job. Or, at the very least, that the agency is doing it too slowly.

    On the surface, it’s a confusing tactic. Abstinence-only tobacco-control organizations and philanthropists, like Michael Bloomberg and the Campaign for the Tobacco-Free Kids, have long clamored for the FDA to take definitive action, including rigorous review. The Family Smoking Prevention and Tobacco Control Act, signed into law by President Barack Obama in 2009, gives the FDA the authority to regulate cigarettes and, because of what’s become known as the “deeming rule,” the ability to create regulations for e-cigarettes and other nicotine and tobacco products not explicitly mentioned in the legislation.

    On the heels of the so-called youth vaping epidemic, the Trump administration issued a partial ban on flavored vaping products in January 2020—barring flavored pods that officials determined were most popular among youth—until the FDA determines if it’ll allow them on the market. The PMTA process requires the agency to review whether “marketing of new tobacco product(s) would be appropriate for the protection of public health.” E-cigarette and vaping companies have a year from September 2020 to continue selling their products, as the FDA pores through what’s likely thousands of PMTAs that have flooded in.

    If the FDA greenlights any of these PMTAs, it should become much easier for the industry and tobacco harm reduction activists to convince the public that vaping products are safer alternatives for adult smokers. And less dangerous substitutes are apparently on the FDA’s radar. In July, the agency for the first time approved a heat-not-burn product (or HTP) to be marketed as a modified risk tobacco product (MRTP)—basically, as a less harmful option than a traditional cigarette.

    One way to understand this letter is that for all the repeated efforts of lawmakers, legislators and abstinence-supporting campaigners to ban flavored vapes, they probably wont get what they want. Not completely, anyway. These legislators appear, in short, to be doubling down—should the FDA approve PMTAs for vaping products and e-cigarettes, it would not be the solution prohibition-minded campaigners have been fighting for. Some of those devices will be readily and legally available—with a federal government, under pressure to present science as science after years of COVID-related misinformation, admitting that they’re safer alternatives to combustible cigarettes.

    To seek to deny access to such products and to override the FDA’s regulatory framework in doing so would please abstinence-only campaigners, protect the cigarette trade and deny harm reduction options to tens of millions of Americans who smoke cigarettes,David Sweanor, a tobacco industry expert and chair of the Advisory Board for Centre for Health Law, Policy and Ethics at the University of Ottawa, told Filter. “It would be on par with making cholera mandatory in municipal water systems, or banning clean needles and automobile safety features.”

    An industry source at a prominent vaping company, who requested anonymity so as not to influence the PMTA process, told Filter that there was little chance the FDA would stop reviewing PMTA applications—especially because the agency has a legal obligation to do so.

    An FDA spokesperson said that the FDA is reviewing the letter and will respond to the Congress members directly.

    The 40 or so representatives who signed the letter also asked the FDA to “end its enforcement exemptions for both menthol and disposable e-cigarettes and clear the market for all flavored e-cigarettes until properly reviewed” and “deny authorizing the marketing of any e-cigarette that poses an increased risk of youth initiation or addiction.”

    Political grandstanding or not, their intervention was yet another blow for the vaping industry, which continues to suffer setbacks from many different directions.

    This month, the Preventing Online Sales of E-Cigarettes to Children Act—commonly referred to as the PACT Act—went into law, effectively stopping vape sales from happening through the mail. Meanwhile, states like Connecticut and Vermont have been trying to push through bans on flavored vaping products as well as menthol combustibles.

    “Mitch Zeller would be wise to ignore calls from members of the House Prohibition Caucus to disregard the clear language of the Tobacco Control Act on product authorizations,” Greg Conley, the president of the American Vaping Association*, told Filter. “If these elected officials want to change the population-level health standard for PMTAs, the proper route is through legislation, not incentive-filled, substance-free letters organized by lobbyists.”

     


     

    Photograph via Vaping360 via Flickr/Creative Commons 2.0 

    *The American Vaping Association has provided donations to The Influence Foundation, which operates Filter. Filter‘s Editorial Independence Policy applies.

    • Alex is a staff writer at Filter. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism ReviewThe Nation and The Daily Beast, among other outlets. He is also a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received both restricted and general support grants from the Foundation for a Smoke-Free World. Alex is currently based in Phoenix, Arizona.

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