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The Food and Drug Administration (FDA) has recently authorized several tobacco-flavored e-cigarettes and heat-not-burn devices produced by Logic, a brand owned by Japan Tobacco International (JTI). This decision comes as the FDA denied other flavored product applications from Logic, while mentioning that menthol-flavored products are still under review. It is worth noting that this marks only the second time the FDA has authorized vapes, following its approval of Vuse Solo, an outdated product with limited usage. Although Logic products hold less than 1 percent of the vapor market in the United States, the FDA has determined that these authorized products are deemed appropriate for the protection of public health, as they are more likely to assist adult smokers in reducing or quitting their cigarette use.
Logic's Compliance and Product Review
Logic, as a responsible player in the industry, has consistently supported effective, proportionate, and evidence-based regulation of Electronic Nicotine Delivery Systems (ENDS). Since the FDA issued the Deeming Rule regulating ENDS, Logic has been actively engaged in complying with all FDA requirements. While Logic received marketing denial orders (MDOs) for flavored products that are not currently available in retail stores, the brand is carefully reviewing the FDA's determination and rationale before deciding on its next steps.
Premarket Tobacco Product Applications (PMTAs) and Evaluation Process
Like other vape manufacturers, Logic had to submit premarket tobacco product applications (PMTAs) by a court-ordered September 2020 deadline to continue legally operating in the market. As the FDA had a year to evaluate over 6 million PMTAs for every product and e-liquid, the majority of them were denied. The FDA employed a "Fatal Flaw" approach, which involved searching for randomized control trials (RCTs) and longitudinal cohort studies in the applications. If these studies were absent, rejection letters were sent to the respective applicants.
Newly Authorized Products and Their Characteristics
Among the recently authorized products, Logic Power and Logic Pro are both capsule-based e-cigarettes, while Vapeleaf, resembling a vape, is technically a heat-not-burn product (HTP). Vapeleaf produces an aerosol by heating a tobacco cap at the end. In other regions, Logic markets Vapeleaf as Ploom Tech. Notably, in 2015, the intellectual property for Ploom Technology was sold by James Monsees and Adam Bowen, who later became the co-founders of Juul Labs. This sale allowed them to sever their financial ties with JTI.
The FDA's Continuum of Risk Strategy and Acknowledgment
The recent authorization of Logic's tobacco-flavored products is a significant acknowledgment of the FDA's "continuum of risk" strategy. This strategy recognizes that some nicotine products are safer than others, promoting harm reduction. Former FDA commissioner Scott Gottlieb had long advocated for this approach, emphasizing the importance of providing less harmful alternative forms of nicotine delivery to adults who need or desire them. However, youth vaping rates, which had previously been a concern, have significantly decreased in recent years.
FDA's Future Decisions and Public Health Protection
The FDA, in an announcement regarding Logic's authorization, revealed that it is nearing decisions on other applications that play a significant role in the marketplace. The agency aims to strike a balance between meeting the demand among adult smokers to switch from more harmful combustible cigarettes and addressing the increasing number of youth using and getting addicted to nicotine products. The FDA's evaluation process, conducted by career scientists, ensures that the potential marketing of e-cigarette products is based on robust methods and the best available evidence to protect public health.
Concerns and Critics' Perspectives
While the FDA's authorization of Logic's products has been met with some gratification, concerns persist regarding the fate of menthol-flavored e-cigarettes. The FDA has signaled its intention to prohibit the sale of menthol combustibles. However, advocates of harm reduction and racial justice fear that such a ban may lead to increased interactions between Black individuals and law enforcement. It is widely agreed that a menthol ban would be ill-advised if menthol smokers cannot easily switch to safer nicotine alternatives with the same flavor.
Furthermore, advocates have raised concerns about the FDA's allocation of the market to companies affiliated with or owned by Big Tobacco. Tobacco harm reduction proponents and small- to medium-sized vapor manufacturers remain unconvinced that the FDA will authorize any flavors despite the strong preference for them among adult vapers. They argue that the only vaping products with PMTAs are those that have been rejected by adult consumers, suggesting that market forces would have naturally phased out these products if not for the cigarette sales subsidizing the minimal effort offerings by JTI.
Legal Actions and Transition to Synthetic Nicotine
In recent months, several smaller vapor companies whose applications were denied have filed lawsuits against the FDA. These lawsuits claim that the agency acted arbitrarily and capriciously when evaluating their applications through the "Fatal Flaw" approach. While some have obtained administrative or judicial stays, allowing their products to undergo further consideration by the FDA, others await a decision from a federal court of appeals.
To continue producing the flavored vaping products preferred by ex-smokers, many companies have transitioned to synthetic nicotine. Synthetic nicotine has only recently come under the FDA's regulatory authority, offering an alternative path for vape manufacturers to meet regulatory requirements.