March 9, 2026
On March 9, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance addressing premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). The guidance provides additional clarity on how the agency evaluates youth initiation risk and potential public health benefits when determining whether a product may be authorized for marketing.
At the center of FDA’s review is the statutory requirement that a product be “appropriate for the protection of the public health” (APPH). Under this standard, FDA must evaluate whether the potential benefits of a product, such as helping adult smokers transition away from combustible cigarettes, outweigh potential risks, including the possibility of youth initiation and continued use.
The draft guidance explains FDA’s risk-proportionate approach to evaluating flavored ENDS products. Because some flavor profiles have historically been associated with higher youth appeal, these products may face a greater evidentiary burden in demonstrating public health benefit. In particular, flavors commonly linked to youth use, such as fruit or candy-like flavors, would need to demonstrate stronger evidence that the product meaningfully supports adult switching or significant reductions in combustible cigarette use relative to tobacco-flavored alternatives.
At the same time, FDA acknowledges that flavors can play a role in adult switching behavior, and some flavor categories may present comparatively lower youth appeal. The guidance notes that certain flavors, such as menthol, mint, or other less youth-appealing flavor profiles, may present a different risk profile and therefore may require a comparatively smaller incremental benefit to meet the APPH standard, provided sufficient scientific evidence supports the application.
Regardless of flavor category, FDA emphasizes that PMTA applicants must provide robust scientific evidence, which may include behavioral studies evaluating switching and cessation patterns, research assessing youth appeal and initiation risk, and other epidemiological or observational data examining real-world product use.
The guidance also discusses the potential role of device access restriction technologies (DAR), such as biometric authentication or other user-verification technologies, designed to help prevent underage use. However, FDA notes that such measures alone may not be sufficient to mitigate youth risk, particularly for flavors already known to have high youth appeal.
For manufacturers and brand holders pursuing PMTA authorization, the draft guidance provides additional transparency into how FDA intends to weigh flavor-specific youth risk against potential harm-reduction benefits for adult smokers, and reinforces the importance of developing comprehensive scientific evidence packages early in the regulatory process.
Accorto Regulatory Solutions will continue monitoring this evolving regulatory framework and helping clients align their scientific evidence strategies with FDA expectations. If your organization is navigating the regulatory challenges associated with ENDS products or other complex FDA pathways, Accorto’s regulatory experts are ready to help.
About Accorto Regulatory Solutions
Accorto Regulatory Solutions, LLC is a U.S.-based regulatory consulting firm specializing in FDA regulatory strategy, application development, and compliance support for FDA-regulated products. Accorto works with companies at all stages of growth, from early-stage and startup organizations to established international manufacturers entering or expanding within the U.S. market. With experience across emerging and mature regulatory environments, Accorto helps clients translate regulatory requirements into practical, scalable solutions that support product development, market entry, and long-term compliance.
