Juul Labs Submits Comments in Response to FDA’s Draft Guidance on Applications for Flavored E-Cigarettes

Policy

May 14, 2026

On May 11, 2026, Juul Labs filed a comment in response to FDA’s March 2026 Draft Guidance on Applications for Flavored E-Cigarettes.  We appreciate FDA’s engagement and the opportunity to present our position, and the scientific data which supports it, on this important issue. Our submitted comment is available here and a brief summary is below. 

The United States can end smoking within a decade. We have the scientific knowledge, the regulatory structure, and the technological tools to achieve this monumental public health goal and provide adults with less harmful smokefree alternatives while protecting youth. Since 2014, adult smoking rates in the US have dropped from ~17% to ~10%, while adult use of vapor products has risen to 7%.¹ More than 18 million American adults use nicotine from smokefree vapor alternatives. As adult use of vapor and other smokefree products has increased, underage use of vapor products has dropped from 20% to 5.2% –– its lowest point in more than a decade –– and underage smoking has reached historic lows of 1.4%.² The continued decline in vapor product use among youth –– occurring at a time when illicit flavored products are widely available and marketed inappropriately –– underscores the public health benefit regulated vapes can provide for adults who smoke.  

From 2021 to 2026, over 100,000 vapor products have been illegally introduced to the U.S. market,³ and these illicit products now represent an estimated 80% of the U.S. vapor market, or $11 billion.The illicit segment has expanded to fill that gap, with illegal actors moving quickly to innovate and meet the demand of adult consumers who use flavored products to remain smokefree. The growth of this segment has a simple implication: adults want to use flavored ENDS, and unfortunately there are no authorized non-tobacco or menthol flavored products that are currently available. And Juul Labs believes flavors are important in expanding both switching efficacy and reaching adults who smoke, especially those who want to distance themselves from flavors reminiscent of the harmful behavior – smoking – they are trying to shed.

However, the public health benefit is tempered by an unregulated system. Manufacturers of illicit vapes bypass U.S. regulatory requirements and cut corners on manufacturing quality and supply chain integrity, maximizing profits at the expense of public health. These products — including their nicotine, flavor ingredients, sweeteners, chemicals, metals, and other constituents — are entirely unregulated. And many engage in aggressive and inappropriate youth-oriented marketing without the oversight that comes with FDA authorization and postmarket responsibilities. Most adults who use these products are not aware that the products they purchase in stores and inhale into their lungs are illegal and unregulated.

Juul Labs appreciates the Agency’s May 8, 2026, assessment: “FDA is committed to combating illicit tobacco products in this country. The illicit market undermines the regulatory framework and puts consumers at risk from products that haven’t undergone any scientific review.”⁴ We believe the most effective way to address this risk is to transition from the current unregulated environment to a robust, authorized marketplace of products that adults actually want to use as an alternative to combustible cigarettes. This can be done while keeping stringent safeguards and leveraging postmarket surveillance to protect youth.

As expressed in our comment, we support FDA’s efforts to create a regulatory framework to bring flavored vapor products under the Agency’s regulatory oversight.  To that end, we believe the guidance would benefit from: 

• Specifying how a flavored vapor product PMTA can demonstrate the “outsize benefit” compared to tobacco-flavored vapor products that FDA suggests is required. 
• Recognizing the role of reach — the proportion of adults who smoke who adopt a product — in evaluating population benefit.  This is particularly important as adults strongly prefer flavored vapor products and flavors are instrumental in switching them off of cigarettes.
• Accounting for the substantial decline in youth vapor product use that has occurred even while 80% of the market is illicit, flavored products. 
• Addressing the public health risks posed by the illegal market itself, including for youth.

Serving adults and protecting youth are not conflicting goals–they are shared priorities. We believe the FDA can do more to expand the availability of authorized products — including flavors — that adults will actually use to transition away from smoking, while simultaneously maintaining effective measures to keep these products out of the hands of youth. The latest National Youth Tobacco Survey results suggest that targeted interventions, including raising the legal age of purchase from 18 to 21 for all tobacco products, have been instrumental in preventing youth access to tobacco products. As we shared in our comment, Juul Labs strongly encourages FDA to establish categorywide marketing standards for all vapor products, including potentially more stringent limitations on authorized flavored products. We also urge FDA to develop a national standard for age verification for purchasing tobacco and nicotine products in all retail locations. This could include the use of novel technology at retail such as integrating mandatory ID scanning or age estimation into a point-of-sale technology system, for which we have long advocated. 

The Tobacco Control Act granted FDA expansive authority to regulate tobacco products, including the introduction of less harmful smokefree alternatives. Juul Labs believes in the importance of a strong regulatory framework focused on protecting public health and respectfully urges FDA to take decisive, near-term action to establish a regulated marketplace that advances the intent of the Tobacco Control Act. The regulatory process should be based on the goal of introducing science-backed, legal, reduced-risk nicotine products that give Americans who smoke the widest array of compelling options to help them switch. 25 million Americans still smoke and 13.5 million are using illicit flavored vapor products. They deserve better.

 

¹ National Health Interview Survey 2024

² JLI Analysis of NYTS 2025

³ JLI estimates based on tracked and untracked channels.

⁴ U.S. Food and Drug Administration. (2026). FDA issues guidance on enforcement priorities for unauthorized ENDS and nicotine pouch products. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-guidance-enforcement-priorities-unauthorized-ends-and-nicotine-pouch-products