Response to the FDA’s “ENFORCEMENT PRIORITIES FOR CERTAIN NEW TOBACCO PRODUCTS MARKETED WITHOUT PREMARKET AUTHORIZATION.”

Published on May 11, 2026

WASHINGTON – May 11, 2026 – Today, the FDA announced new guidance for industry regarding enforcement priorities for certain products marketed without premarket authorization. This will allow companies that have submitted all the necessary scientific information for a PMTA to remain on the market and ensure FDA enforcement remains focused on products trying to circumvent the application process.

This decision is a critical first step towards establishing real reform that will finally fix a broken PMTA system through the creation of predictable and transparent, science-based regulations that will drive innovation and ensure safety.

VTA has engaged constructively with FDA staff over the past few months, and the conversations have been productive. We are pleased to see the FDA focused on targeting specific products clearly marketed toward youth and committed to publishing lists of products working through the PMTA process, both things VTA has long advocated for. We hope that today’s announcement marks the first step towards radical reform that prioritizes science and are eager to continue working alongside the FDA’s team to ensure real progress is made. What’s needed is a clear scientific guideline that would provide certainty for responsible companies, make it obvious which products qualify for authorization and which do not, and give regulators a much stronger foundation to enforce against bad actors operating outside the rules.

Statement attributable to Tony Abboud, Executive Director of the Vapor Technology Association.

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