Five Factors to Watch with Premarket Tobacco Product Application Decisions

Sept. 9, 2021 is a pivotal day for the Food and Drug Administration (FDA) and reduced-risk tobacco products, such as e-cigarettes. The FDA is expected to announce which products have received approval of their Premarket Tobacco Product Applications (PMTAs). It is a day that those involved in tobacco policy have waited years for, and it will materially alter the conversation about reduced-risk tobacco products.

The intimate details of the PMTA process are extensive; however, there are some key points about the process that are helpful to understand. Section 910 of the Federal Food, Drug, and Cosmetic Act outlines the PMTA process and mandates that all new or modified tobacco products that entered the U.S. market after Feb. 15, 2007 receive premarket approval. The Federal Food, Drug, and Cosmetic Act also introduced the most important regulatory standard of the PMTA, that products must prove that they are “appropriate for the protection of public health.” To assess whether the product meets this standard, the FDA must consider “the risks and benefits to the population as a whole, including users and nonusers of the tobacco product.” Within this, the FDA must account for the likelihood that non-tobacco users will begin using the new product and the likelihood that current tobacco users will stop using other tobacco products.

Now that PMTA decisions are imminent, here are five important determinations these decisions will establish.

  1. The Future of Flavors
    Perhaps the most ardently debated characteristic of novel tobacco products is flavors. Tobacco harm-reduction supporters recognize that flavors play a role in helping smokers switch completely from combustible products. However, there are also concerns that flavors are driving youth use of e-cigarettes. The FDA’s decision to approve or deny applications for products with characterizing flavors will have significant ramifications for manufacturers, retailers and consumers.
  1. Restrictions on Nicotine Concentration
    Another hotly debated characteristic of e-cigarettes is nicotine content. The European Union requires that e-liquids contain no more than 20 mg/ml of nicotine. There is no such cap in the United States. Nevertheless, some U.S. jurisdictions have moved to limit nicotine concentration. Once again, there is disagreement about how much nicotine should be allowed in e-liquids. One side sees high nicotine concentrations as posing a greater risk of developing dependence. The other argues that higher nicotine concentrations that mimic the nicotine delivery of combustible cigarettes are needed to help smokers transition to reduced-risk products.
  2. Pods, Disposables and Tanks
    The FDA could choose to segment the e-cigarette category by the type of system. E-cigarettes that use pods or cartridges are already subject to flavor restrictions that disposables and open-systems (e-cigarettes with refillable tanks) are not. Groups who oppose e-cigarettes often single out pod systems, and disposables to a lesser degree, for being popular among young people. This criticism could play into the FDA’s PMTA decisions.
  3. Menthol versus Other Flavors
    The arguments for and against menthol-flavored e-cigarettes are generally the same as for other flavors. The difference is that menthol-flavored combustible cigarettes are, as of publication, still available. Tobacco harm reduction advocates argue that banning menthol e-cigarettes while allowing much more harmful combustible menthol cigarettes to remain on the market is the antithesis of protecting public health. It is worth calling out menthol as separate from other flavors, because it provides another delineation by which the FDA could segment their approvals.
  1. The Future of Tobacco Harm Reduction in the United States
    It is worth noting that some reduced-risk products have already received PMTAs. The heat-not-burn product, IQOS, has been awarded PMTAs for its device and the menthol and tobacco- flavored heatsticks that the device uses. Additionally, Swedish Match was awarded PMTAs for several varieties of their oral snus product in 2015. The precedent the FDA sets with its approval or denial of e-cigarette types and varieties will almost certainly impact the way tobacco harm reduction is viewed. Approval of some or all e-cigarettes will add legitimacy to the harm reduction argument. Denial of most or all e-cigarette PMTAs will narrow smokers’ options to IQOS and modern oral products like nicotine pouches and snus.

The FDA is, rightfully, playing close to the chest regarding their PMTA decisions. What they have said is that they are prioritizing the applications for products that make up most of the current market. Given the volume of PMTA applications the FDA received, 4.8 million, and that they only had one year to review them all, it is unlikely that every application will be approved or denied by the September 9 deadline. Nevertheless, the decisions that are released will give a good idea of where the FDA has landed regarding e-cigarettes and the protection of public health.

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