As the vaping industry increasingly turns to age verification technology to strengthen PMTA applications—especially for flavored products—2Firsts sought clarification from the U.S. Food and Drug Administration. On Thursday, March 27, 2025, FDA Press Officer James McKinney responded to 2Firsts’ written interview request, outlining the agency’s view on age-gating technologies, public health standards, and its case-by-case approach to product reviews.
Industry Turns to Age-Gating Tech as Regulatory Pressure Builds
As U.S. regulators tighten controls on flavored e-cigarettes, more manufacturers are investing in age verification technologies to strengthen their chances of passing the premarket tobacco product application (PMTA) process. SMOORE International revealed in its 2024 financial report that it supported strategic clients in submitting PMTAs for flavored products equipped with such technologies.
Major tobacco firms are also exploring this path. Juul Labs proposed a new device with ID verification; Altria’s NJOY launched a Bluetooth-based system; BAT’s Vuse Pro requires users to confirm they are 21+; and Ispire introduced a blockchain-based solution, which FDA indicated may qualify for priority review.
These developments reflect the industry’s effort to meet FDA’s stringent requirements—particularly the need for flavored products to demonstrate an “incremental benefit” for adult smokers while limiting youth access.
FDA: We Welcome Innovation, But Public Health Standard Comes First
In a written response to questions from 2Firsts, FDA spokesperson James McKinney affirmed that the agency is open to reviewing PMTAs featuring effective age verification technology.
"The FDA welcomes submission of premarket applications for e-cigarette products with effective age verification technology," McKinney stated. However, he emphasized that approval hinges on a broader requirement: "Applicants must demonstrate to the agency that permitting the marketing of a new tobacco product would meet the necessary public health standard prescribed by law."
This standard is rooted in the Federal Food, Drug, and Cosmetic Act, which requires that new tobacco products be shown to be "appropriate for the protection of public health" (APPH). In practice, this involves evaluating both the potential benefits to adult smokers and the risks to youth and non-users.
Case-by-Case Review: What This Means for Flavored Products
When asked whether age verification technology could pave the way for broader approval of flavored e-cigarette products, the FDA pointed to its case-by-case review model.
"In the context of reviewing an individual premarket application, technology that effectively reduces risks to youth would be a relevant consideration," said McKinney. "However, it is important to note that tobacco product applications are reviewed on an individual, case-by-case basis."
This nuanced stance suggests that while age-gating could strengthen a PMTA, it does not guarantee approval, especially for flavored products, which the FDA has repeatedly identified as particularly appealing to youth.
For Applicants: Request a Meeting with FDA and Show Innovation
So far, no age verification technology has received explicit FDA approval. Still, the agency encourages companies to explore such tools. According to McKinney, potential applicants can request meetings with the FDA to discuss research and development plans.
The agency’s website offers a guidance document to assist with requesting and preparing for such meetings, as well as tips for compiling strong premarket submissions. Importantly, companies must adhere to the final rule on PMTA and recordkeeping requirements.
"The FDA welcomes the use of technological innovation to prevent youth access to tobacco products and takes such innovation into account when reviewing marketing applications," McKinney noted.
The Road Ahead: Balance, Evidence, and Policy Evolution
As companies seek to comply with FDA standards while still meeting consumer demand, age verification technology is emerging as a potential bridge between innovation and regulation. But the road ahead will likely depend on scientific validation, consistent enforcement, and continued policy evolution.
The FDA’s position is clear: innovation is welcome, but it must be accompanied by evidence, and all applications must be judged by the same rigorous public health standard. For companies hoping to bring flavored e-cigarettes to market, age-gating may soon become less of an option and more of a necessity.
