FDA’s Flavored Vape Guidance: A Step Forward That Still Leaves Millions of Adults Behind

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Key Points:

• FDA Draft Guidance Released: The U.S. Food and Drug Administration published draft guidance outlining how the agency will evaluate flavored e-cigarette products submitted through the PMTA pathway.

• Regulatory Context: The guidance interprets the “appropriate for the protection of public health” (APPH) standard established under the 2009 Family Smoking Prevention and Tobacco Control Act, balancing benefits to adult smokers against risks of youth initiation.

• Limited Market Authorization: Despite millions of applications submitted through the PMTA process, the FDA has authorized only 41 e-cigarette products, all in tobacco or menthol flavors and manufactured by just five companies.

• Youth Risk Framework: The agency asserts that flavored products – particularly fruit, candy, and dessert flavors – pose higher risks for youth initiation and will face the highest evidentiary burden during PMTA review.

• Graduated Evaluation System: Under the draft guidance, tobacco-flavored products face the lowest evidentiary burden, menthol products require additional evidence, and sweet or fruit flavors must demonstrate particularly strong benefits for adult smokers.

• Potential Lower-Risk Flavor Categories: The FDA acknowledges that some flavors – such as coffee, tea, or spice flavors – may have lower youth appeal and could potentially meet the APPH standard with less extensive evidence.

• Evidence Requirements: Manufacturers seeking authorization for flavored products must submit clinical trials, observational studies, real-world behavioral data, population modeling, and switching studies demonstrating benefits to adult smokers.

• Youth Mitigation Strategies: The guidance suggests potential safeguards including advertising restrictions, adult-only retail sales, face-to-face purchase requirements, and enhanced online age verification.

• Technological Controls: The FDA also points to emerging technologies – such as biometric unlocking, geo-fencing near schools, device authentication systems, and advanced age-verification tools – as potential methods to limit youth access.

• Youth Vaping Declines: According to the 2025 National Youth Tobacco Survey, youth vaping fell to 5.1 percent of U.S. middle and high school students, the lowest level recorded in more than a decade.

• Adult vs Youth Use: In 2024, approximately 8 percent of adults used e-cigarettes compared to 5.9 percent of youth, and adult use exceeded youth use by roughly 30 percent.

• User Population Gap: An estimated 21.4 million U.S. adults were current e-cigarette users, compared to about 1.2 million high school students reporting past-month use.

• Adult-to-Youth Ratio: For every one high school student vaping in 2024, roughly 18 adults were using e-cigarettes.

• Youth Motivations: According to the 2021 National Youth Tobacco Survey, the most common reasons youth reported vaping were stress or anxiety (43.4 percent) and seeking a nicotine buzz (42.8 percent).

• Limited Role of Flavors: Only 13.2 percent of youth who currently vape cited flavors as a reason for use, while 57.8 percent reported trying vaping because a friend used them.

• Adult Flavor Preferences: Surveys consistently show adults prefer flavored products; a 2020 PATH analysis found 72.9 percent of adult vapers used flavored e-cigarettes.

• Smoking Cessation Evidence: A survey of nearly 70,000 U.S. adult vapers found 83.3 percent of those who quit smoking used fruit flavors, compared to only 15 percent using tobacco flavors.

• Switching Outcomes: A 2021 study found adults using fruit or sweet-flavored e-liquids were more likely to transition away from combustible cigarettes than those using tobacco flavors.

• Retail Market Trends: U.S. e-cigarette sales increased 47 percent between 2019 and 2023, with flavored products accounting for roughly 80 percent of the sales growth.

• Youth Trends During Sales Growth: During the same period, youth vaping declined by 70.5 percent nationwide.

• Bottom Line: While the FDA’s draft guidance acknowledges the potential benefits of flavored e-cigarettes for adult smokers, the agency’s slow regulatory process and high evidentiary burdens continue to limit access to products that millions of adults rely on as alternatives to combustible cigarettes.

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The U.S. Food and Drug Administration recently published draft guidance outlining how the agency will evaluate flavored tobacco and nicotine products submitted through the premarket tobacco product application (PMTA) pathway for regulatory authorization. While alarming to some public health groups, the move represents a modest step forward for an agency that claims to rely on science to maintain a robust and regulated marketplace capable of meeting the needs of more than 21 million adult e-cigarette users.

Unfortunately, the guidance does little to address the reality of today’s marketplace. The FDA has authorized the sale of just 41 e-cigarette products – available only in traditional tobacco and menthol flavors and manufactured by only five companies. Meanwhile, millions of adults continue to rely on products that remain in regulatory limbo. Rather than acting solely as a regulator, the agency increasingly operates as an extension of the tobacco control movement, restricting adult access to flavored harm reduction tools based largely on outdated assumptions about youth vaping.

In March, the FDA released a draft guidance document titled Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Tobacco Applications – Considerations Related to Youth Risk. The document outlines how the agency evaluates PMTAs for flavored e-cigarette products. Under the 2009 Family Smoking Prevention and Tobacco Control Act, manufacturers introducing a product without a substantially equivalent predecessor must submit a PMTA demonstrating that the product is “appropriate for the protection of public health” (APPH). To meet this standard, the FDA weighs the potential benefit to adult smokers – particularly the likelihood that users will completely switch from combustible cigarettes – against the risks that non-users, especially youth, may initiate use.

According to the guidance, flavored e-cigarettes pose a greater risk to youth than tobacco- or menthol-flavored products. The FDA cites the dramatic rise in youth vaping reported by the National Youth Tobacco Survey (NYTS), noting that flavored products “played a major role in [the] surge, as most youth users reported using fruit flavors.” Although the agency acknowledges that youth e-cigarette use has “significantly declined since 2019” – falling to 5.9 percent of U.S. middle and high school students in 2024 – it emphasizes that 87.6 percent of youth who reported current vaping in 2024 used fruit, candy, dessert, or other sweet flavors.

As a result, the updated guidance introduces a graduated evaluation approach for flavored products. Manufacturers submitting PMTAs for tobacco-flavored e-cigarettes will face the standard evidentiary burden, while menthol products may require slightly more robust evidence. The FDA also acknowledges that certain flavors – such as “coffees, teas, or spices” – may have lower youth appeal and “may be APPH if the added benefit they provide compared to tobacco-flavored products is relatively small.” In contrast, fruit, candy, and sweet flavors will face the highest evidentiary burden because of their documented popularity among youth.

The FDA outlines several types of evidence that manufacturers may use to demonstrate that flavored products meet the APPH standard. These include randomized clinical trials, observational studies, real-world behavioral data, population modeling, and product-specific switching studies. Such evidence must show that flavored products help adults reduce cigarette consumption or completely transition away from smoking. The agency also suggests that manufacturers conduct studies evaluating youth appeal, including sensory perception testing, consumer preference studies, and comparative analysis against benchmark flavors.

The guidance further indicates that the FDA will consider mitigation strategies intended to reduce youth access, including advertising restrictions, limiting sales to adult-only retail locations, online age verification systems, and face-to-face sales requirements. However, the agency cautions that these measures may not sufficiently reduce youth access because of social sourcing and loopholes in online age verification.

The FDA also points to emerging technological tools that could limit youth use, including biometric unlocking mechanisms, age-verification software, geo-fencing that blocks device operation near schools, and device authentication systems. Still, the agency notes that technology alone is unlikely to overcome youth-risk concerns for flavors that are particularly appealing to youth.

Ultimately, the draft guidance formalizes a sliding-scale regulatory framework for evaluating flavored e-cigarette applications. Under this approach, manufacturers seeking authorization for fruit and candy flavors must provide particularly strong evidence that the products help adult smokers quit or substantially reduce smoking in order to offset concerns about youth initiation.

While the FDA’s concerns about youth use are understandable, the agency continues to weigh youth risks against the needs of millions of adult smokers while overlooking other important evidence. Youth surveys consistently show that although many young users choose flavored products, flavors are not the primary reason youth initiate vaping – even during the period when youth vaping reached its peak. At the same time, real-world retail sales data and population surveys increasingly show that adults are using flavored e-cigarettes to move away from combustible cigarettes.

Interestingly, just one week before releasing the draft guidance, the FDA quietly published the 2025 NYTS results, which found youth vaping at its lowest level in more than a decade: only 5.1 percent of U.S. middle and high school students reported past-month e-cigarette use. This represents a dramatic decline. According to the FDA’s own data, 5.9 percent of U.S. youth reported vaping in 2024, while approximately 8 percent of adults did – a difference of roughly 30 percent. Even more notable, the percentage of adults using e-cigarettes in 2024 (8 percent) exceeded the percentage of high school students vaping (7.7 percent). In total, an estimated 21.4 million adults were current e-cigarette users, compared to approximately 1.2 million high school students reporting past-month use. For every one high school student vaping in 2024, roughly 18 adults were using e-cigarettes.

The FDA also overlooks survey data examining why youth report vaping. According to the 2021 NYTS, the most common reasons middle and high school students reported using e-cigarettes were because they were “feeling anxious, stressed, or depressed” (43.4 percent) and to “get a high or buzz from nicotine” (42.8 percent). Only 13.2 percent of youth who were currently using e-cigarettes cited flavors as a reason for use. Among students who had ever tried vaping, just 13.5 percent cited flavors as a reason, compared to the most common explanation – having a friend who used them – reported by 57.8 percent.

In contrast, numerous consumer surveys indicate that adult smokers rely on flavors – including fruit and sweet varieties – to quit smoking and remain smoke-free. Retail sales data and population surveys also show that adult vaping continues to grow even as youth use declines.

For example, a 2020 study examining 2018 PATH survey data found that 72.9 percent of current adult vapers used flavored e-cigarettes. A separate survey of nearly 70,000 U.S. adult e-cigarette users found that 83.3 percent of adults who quit smoking with vaping used fruit flavors, compared to 68 percent who used dessert or bakery flavors, while only 15 percent used tobacco flavor. Another 2021 study found that users of fruit and sweet-flavored e-liquids were more likely to transition away from smoking than those using tobacco-flavored e-cigarettes.

Retail sales data reinforce these trends. A 2024 report found that e-cigarette sales at U.S. retailers increased by 47 percent between 2019 and 2023, with flavors including candy, dessert, fruit, menthol, and mint accounting for roughly 80 percent of the sales growth. Over the same period, the percentage of U.S. middle and high school students currently using e-cigarettes declined by 70.5 percent.

The FDA’s draft guidance acknowledges that limiting tobacco harm reduction options to only traditional cigarette flavors may hinder the potential for smokers to transition away from combustible cigarettes. Yet the agency’s regulatory approach continues to move slowly, leaving millions of adults without access to the products that surveys, consumer behavior, and retail data increasingly show they prefer. Until meaningful reforms occur, the needs of more than 21 million adult e-cigarette users will remain secondary to a regulatory framework that struggles to reconcile declining youth use with the growing role of vaping in adult smoking cessation.

Nothing in this analysis is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.