FDA Not Expected to Include ENDS in Menthol Ban

The U.S. Food and Drug Administration is unlikely to incorporate electronic nicotine-delivery devices (ENDS) into its proposed rulemaking to ban menthol cigarettes and flavored cigars, according to Azim Chowdhury and Neelam Gill.

Writing on the Food and Drug Law Institute’s website, the Keller and Heckman attorneys say that doing so would only further complicate a rulemaking that is already poised to receive hundreds of thousands of comments and will likely be litigated once final.

On April 29, 2021, the FDA announced that it will initiate a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos within the next year.

In its announcement, the FDA did not mention ENDs, which come in a wide variety of nontobacco flavors and have been the subject of much debate.

Chowdhury and Gill believe Congress is more likely to defer to the premarket tobacco product application (PMTA) process rather than intervene and legislate a flavored ENDS ban. All ENDS products require FDA marketing authorization through that process.

But while a federal ban on flavored ENDS seems unlikely while FDA reviews the science and the manufacturers’ arguments, these products continue to face the threat of prohibition at the local level, according to the attorneys.

Many state and local authorities and attorneys general are pushing for bans or have requested the FDA to deny PMTAs for flavored ENDS. New York, New Jersey, Rhode Island and Massachusetts have already banned the sale of flavored ENDS while Maryland, California and Connecticut are considering similar measures.