The Food and Drug Administration (FDA) has authorized several tobacco-flavored e-cigarettes and heat-not-burn devices produced by Logic, which is owned by Japan Tobacco International (JTI). The agency also denied other, flavored product applications from Logic, while indicating that menthol-flavored products remained under review.
It’s just the second time the FDA has authorized vapes.
The agency determined that a host of products from the Logic Power, Logic Pro, and Logic Vapeleaf brands were “appropriate for the protection of public health”—deemed more likely to help adult smokers reduce or cease their cigarette use than to introduce a new generation to nicotine.
It’s just the second time the FDA has authorized vapes, following its authorization of Vuse Solo, an outdated product used by very few people, in October 2021. Logic products may be more widely used, but only just: According to Goldman Sachs, which analyzes Nielsen data, Logic holds less than 1 percent of the vapor market in the United States.
“Logic has always supported effective, proportionate and evidence-based regulation of ENDS (Electronic Nicotine Delivery Systems),” a JTI spokesperson told Filter. “From the moment FDA issued the Deeming Rule regulating ENDS, Logic has been engaged in a robust and committed effort to comply with all FDA requirements.”
“Logic received marketing denial orders (MDOs) for flavored products that are not currently on retailers’ shelves,” the spokesperson added. “Logic is reviewing the FDA’s determination and rationale before taking further action.”
Like other vape manufacturers, Logic had to submit premarket tobacco product applications (PMTAs) by a court-ordered September 2020 deadline to legally stay on the market. The company appears to have been one of the earliest to file its PMTA, leading many observers to believe that the FDA might be making piecemeal decisions in chronological order.
The agency—which had a year to evaluate what became more than 6 million PMTAs for every single product and e-liquid—has since denied most of them, applying to some of them a “Fatal Flaw” approach that searched for randomized control trials (RCTs) and longitudinal cohort studies and, if the applications did not contain them, sent rejection letters.
Of the newly authorized products, Logic Power and Logic Pro are both capsule-based; Vapeleaf, which acts and looks like a vape, is technically a heat-not-burn product (HTP) that produces an aerosol by heating a tobacco cap at the end. In other parts of the world, Logic markets Vapeleaf as Ploom Tech; in 2015, James Monsees and Adam Bowen, the eventual co-founders of Juul Labs, sold the intellectual property for Ploom Technology in order to exit a financial relationship with JTI.
The news, coming less than a month before Mitch Zeller, the director for the FDA’s Center for Tobacco Products (CTP) plans to retire, marks the most significant acknowledgement to date of the FDA’s “continuum of risk” strategy—the idea that some nicotine products are safer than others and vice versa. Scott Gottlieb, the FDA commissioner from 2017 until April 2019, had long touted this approach, writing in June 2017 that we need to imagine “a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.” But Gottlieb was sidetracked by what he later labeled a youth vaping “epidemic”—as parents, media and lawmakers seized on rising youth vaping rates that have significantly subsided in recent years.
In a press release announcing Logic’s authorization, the FDA also indicated that it was “close” to issuing decisions on other applications that account for “a large part” of the marketplace.
“It’s mildly gratifying to hear FDA say out loud the obvious and simple truth that vaping is helping Americans quit smoking.”
“As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products,” Robert Califf, the new commissioner of the FDA, said in a press statement.
“We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine,” he continued. “The balance of these issues was considered by the agency’s career scientists when evaluating the potential marketing of e-cigarette products. They have made great progress and I know they will use the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.”
“It’s mildly gratifying to hear FDA say out loud the obvious and simple truth that vaping is helping Americans quit smoking,” Amanda Wheeler, the owner of Jvapes and the president of American Vapor Manufacturers, told Filter. “But meanwhile in the bureaucratic shadows, they are strangling the life out of our entire innovative, entrepreneurial industry. That crushing force is costing lives and it’s destroying businesses, and it is morally reprehensible no matter what soothing rationalizations FDA tells itself about finding balance.”
A lingering question remains, though, about what the FDA will do with menthol-flavored e-cigarettes, as it has recently signaled it will soon move to prohibit the sale of menthol combustibles. While a group of disparate voices push for a menthol ban, another diverse collection of harm reductionists and racial justice advocates fear it will increase interactions between Black people and the police. With the exception of the usual anti-nicotine types, like the Michael Bloomberg-funded Campaign for Tobacco-Free Kids, most at least agree that a menthol ban would be ill-advised if menthol smokers cannot easily switch to safer nicotine alternatives of the same flavor.
Advocates have repeatedly raised concerns that the agency is giving the market to companies owned by or tied to Big Tobacco.
The authorization also did little to quell the concerns of tobacco harm reduction proponents and small- and medium-sized vapor manufacturers, who fear the FDA will not authorize any flavors, despite most adult vapers’ preference for them. These advocates have repeatedly raised concerns that the agency is giving the market to companies owned by or tied to Big Tobacco.
“The FDA should be thoroughly embarrassed that the only vaping products with PMTAs are ones that have been rejected by adult consumers,” Greg Conley, the president of the American Vaping Association, told Filter. “If JTI did not have cigarette sales to subsidize their minimal effort offerings in next-gen products, market forces would have caused them to stop selling these products years ago.”
In the past couple of months, dozens of smaller vapor companies whose applications were denied have filed lawsuits with the FDA, mainly alleging that the agency acted “arbitrarily” and “capriciously” in evaluating their applications through its “Fatal Flaw” approach. Some have received administrative or judicial stays, as their products have gone back under the FDA’s consideration; others await a decision from a federal court of appeals.
In order to keep making the flavored vaping products that ex-smokers prefer, many companies transitioned to synthetic nicotine, a substance that has only just been brought under the FDA’s regulatory authority.
The Influence Foundation, which operates Filter, has received grants and donations from the American Vaping Association, Juul and Reynolds, the manufacturer of Vuse. Filter’s Editorial Independence Policy applies.