Not surprisingly, on July 17, 2025, FDA authorized the sale of Juul tobacco and menthol e-cigarettes. I wish I could say that I am “not surprised” because during the 2024 campaign President Trump announced that he would “save vaping,” but, on reading FDA’s scientific justification (the Technical Product Lead report [TPL]), I found that the authorization reflected FDA’s longstanding pro-e-cigarette bias by ignoring the most recent research on e-cigarettes, including Juul.
Indeed, most of the citations in the Juul TPL date from before 2020, a lifetime ago in e-cigarette years given the rapid accumulation of knowledge.
Rather than basing its decision making on current science, the FDA following the pattern established in its first authorization of an e-cigarette – RJR’s Vuse Solo in 2021. Specifically, FDA continues to follow the outdated approach of relying on the fact that e-cigarettes deliver lower levels of some toxic cigarette combustion products as evidence that e-cigarettes produce substantially less disease than cigarettes and ignores not only peer-reviewed scientific criticisms of its Vuse decision, but also most of the extensive new information about the actual diseases linked to e-cigarette use published in the four years since then.
FDA also focuses its consideration of harmful chemicals to its outdated 2012 HPHC (harmful and potentially harmful compounds) which is heavily focused on cigarette combustion products and does not include many important toxicants e-cigarettes produce. In 2019 FDA proposed updating the HPHC list, to include some of these toxicants, including propylene glycol, an important part of e-liquid that accelerates cancer growth, but never finished the job.
Even Philip Morris has recognized since 2002 that by now FDA should be basing decision making on epidemiology and actual disease effects not just biomarkers (slide from Philip Morris presentation to right). Juul has been on the market since 2015, well beyond the 5 years that Philip Morris thought necessary to determine actual health effects based on epidemiology.
FDA ignores effects of e-cigarette use on actual disease
FDA ignores the substantial literature – mostly published since 2020 — that e-cigarette risks are indistinguishable from cigarettes for cardiovascular disease, stroke, metabolic dysfunction and for respiratory and oral disease only modestly less than cigarettes. This conclusion was based on a meta-analysis of 107 papers on the association between e-cigarette use and disease available as for October 2023. Today there are more than 125 such studies. FDA does not cite any of these studies or explain why it is relying on outdated indirect (biomarker) measures of disease rather than direct measures of disease.
Nor does FDA engage the substantial literature on how e-cigarettes cause disease, including specific evidence that Juul is more toxic to lungs and hearts than earlier generation e-cigarettes and that they damage blood vessel function as much as a cigarette.
FDA assumes that reducing cigarette consumption is a health benefit, ignoring its own meta-analysis showing that there is no “significant difference in all-cause mortality, all-cancer risks, and smoking-/tobacco-related cancer risk among those who reduced” cigarettes per day.
FDA ignores the dangers of dual use
FDA ignores the many studies showing that dual use (continuing to smoke while using e-cigarettes) increases disease risk above that of just smoking. This effect is particularly striking for cancer, where daily dual use is associated with a quadrupling of lung cancer risk compared to just smoking in people, bringing the total odds ratio to 40 compared to not using either product. (The OR for just smoking is 10.) This finding is consistent with animal research (also ignored by FDA) showing that propylene glycol/vegetable glycerin (PG/VG), the base of e-liquid, and nicotine accelerate cancer tumor growth and metastasis.
FDA’s decision to ignore the risks of dual use is particularly troubling in the case of Juul because Juul’s own data reported in the TPL show dual use rates from 69-87% [TPL pages 8, 35 and 37]. These rates of dual use are much higher than has been observed among all adult e-cigarette users and is so high that, even accounting for the fact that sole e-cigarette use is associated with lower risks than cigarettes for respiratory and oral diseases, accounting for dual use results in increased overall risks among all Juul users compared to smokers.
Like the other outdated thinking in the TPL, FDA ignores a well-done 2024 meta-analysis that found that dual use is not an intermediate condition on the way from cigarettes to “switching completely” or quitting. FDA also ignores a well done 3 year longitudinal study using its own PATH dataset that found that fourth-generation e-cigarettes like Juul associated with continued smoking and vaping and another, also using PATH, that found that smokers who used e-cigarettes for smoking cessation are more likely to end up dual users than to “switch completely” or stop smoking and vaping.
FDA sidesteps the tradeoff with youth
The law requires that permitting the marketing of a new tobacco product has to be “appropriate for the protection of public health (APPH). The TPL recognizes that,
The APPH standard requires a showing that permitting the marketing of a new tobacco product would have a net benefit to public health based upon the risks and benefits to the population as a whole, which includes youth, young adults, and other vulnerable populations. … FDA weighs the potential negative public health impacts (e.g., harm from initiation and use among nonusers, particularly youth) against the potential positive public health impacts (e.g., benefit to adults who use combusted cigarettes (CC) and then completely switch to lower risk products). [TPL page 6]
While the FDA did recognize that adult benefits would come at the cost of increased youth use, they failed to engage this issue in a quantitative way. As noted above, FDA ignored the fact that most smokers who used Juul did not “switch completely; they became dual users, which increases risk.
In addition, following the precedent it established when it authorized RJR’s Vuse Solo, FDA ignored the 2020 Surgeon General’s Report on smoking cessation, written during the first Trump Administration, that stated, “The potential benefit of e-cigarettes for cessation among adult smokers cannot come at the expense of escalating rates of use of these products by youth. [page 25 of the report]”
FDA ignored its own conclusion that the adverse effects of authorizing menthol JUUL on youth exceeded benefits to adults
With regard to their decision to authorize Juul menthol sales, the TPL gave Juul a pass even though the TPL noted:
The applicant did not provide adolescent data on appeal of specific flavor or nicotine variants of the new products as it did for adults. These data may have been helpful in evaluating the likelihood of initiation among adolescents for each of the flavor and nicotine variants of the new products, in the context of the broader literature on the known risks to youth of marketing flavored ENDS [electronic nicotine delivery systems], including menthol flavor. [TPL page 38]
…
Youth use of flavored ENDS (87.6%) is significantly higher than youth use of tobacco-flavored ENDS (8.5%), demonstrating that flavored ENDS—including menthol-flavored ENDS—pose a greater risk to youth. In addition, changes in the availability of products affect patterns of youth use, such that the reduced availability of certain flavored ENDS products may lead to increased use of available flavored ENDS products (Park-Lee et al., 2024).
…
In the PATH Study Wave 5.5 (2020), 67.4% of youth ages 13-17 using ENDS reported using fruit, followed by 53.8% for mint/menthol, 23.4% for candy/dessert/other sweets, and 13.3% for tobacco flavor {internal FDA analysis). [emphasis added, Page 43]
Because FDA prohibited all non-menthol flavors for cartridge e-cigarettes in 2020, including Juul, all flavored Juul will be menthol, it is likely that most youth using Juul will be using menthol. (Youth who use menthol e-cigarettes are also more likely to still be using them as young adults than youth who start with fruit flavors.)
FDA accepts the cost to youth because Juul reports a 11-15% increase in the likelihood that adults will switch to menthol Juul compared to Virginia Tobacco Juul [aRR=1.11-1.15; page 10].
FDA makes this decision without bothering to calculate the number of youth who will become addicted to Juul compared to the number of adult switchers, much less using the available epidemiological data to see if there is any reduction in disease risk for adult switchers.
The FDA’s conclusion that the benefit to smokers outweighs the risk to kids is particularly surprising because the JUUL TPL characterizes the benefit to smokers of JUUL menthol vs. tobacco as “moderately beneficial” [page 9] but the risk to kids from flavored products, including menthol, as “known and substantial” [page 6]. How does a “moderate” risk trump a “substantial” risk? In fact, these findings support a conclusion that authorizing JUUL menthol would not be appropriate for the protection of public health, the legal standard for authorizing a new tobacco product.
FDA failed to impose any meaningful marketing restrictions on Juul
Juul told FDA that they would possibly or probably or voluntarily do something to the device or the way it was marketed to make it hard for youth to access, but those sections are redacted from the TPL and the marketing order authorizing the sale of Juul and Juul menthol. In any event, the marketing order does not require Juul to include whatever that is, but notes that Juul might voluntarily implement those actions.
FDA does not explain why additional or more strict readily available restrictions and requirements are not also included to better protect against youth initiation, use, and addiction or to prevent various harm-increasing uses (e.g., relapse into Juul use by former smokers, switching instead of quitting). For example, FDA could have required Juul to be sold only in adult-only venues or only allowed advertising via direct communications to pre-identified, pre-verified adult smokers or e-cigarette users with those communications including text to discourage harm-increasing use.
Implications beyond Juul
When FDA authorized Vuse Solo “original” in 2021, it denied applications for flavors other than menthol. Its authorization of Juul menthol opens the door for RJR to poke the FDA to act on (approve) its application for Vuse Solo menthol. Or, perhaps, RJR will just take advantage of FDA allowing Vuse Solo menthol to remain on the market while it thinks about it.
Beyond the US, Juul will almost certainly use the FDA authorization to lobby governments around the world to allow its products, just as PMI did when FDA authorized their “reduced exposure” claim for IQOS in 2022.
The bottom line
FDA’s conclusion that authorizing Juul and Juul menthol was “appropriate for the protection of public health” may be bad for public health and an arbitrary and capricious decision from a legal perspective, but at least it did not incur President Trump’s wrath.
It is time for one or more public health groups or attorneys general who have sued Juul to challenge these authorizations in court.
Here are all my blog posts on Juul.
Thanks to Eric Lindblom for the comments on the marketing order and Lauren Lempert for the Vuse Solo comparisons.
Stanton Glantz blog 