EMA Urges FDA to Publish a List of Electronic Nicotine Delivery Systems to Eliminate Confusion and Uncertainty in the Marketplace

Last week, the Energy Marketers of America (EMA) submitted a citizen petition to the Food and Drug Administration (FDA) to implore them to publish a clear and comprehensive list of electronic nicotine delivery systems (ENDS) to eliminate confusion and uncertainty in the marketplace. Although the FDA has provided a list of products with marketing granted orders (MDOs) and a list of companies that received MDOs, those lists have not proven useful to EMA’s members who need to determine which products can and cannot be legally sold.

Specifically, EMA requested that the FDA “publish a list by brand and category of (i) ENDS and other deemed tobacco products with tobacco-derived nicotine that were on the market as of August 8, 2016, and (ii) ENDS and other deemed tobacco products with nicotine not derived from tobacco that were on the market as of April 14, 2022, that indicates whether each of those products:
• Has received a marketing granted order;
• Has received an MDO that has been stayed by a court or FDA, rescinded by FDA, or vacated by a court; and/or
• Has a timely filed premarket tobacco product application (“PMTA”) pending and is not subject to one of FDA’s enforcement priorities identified in FDA’s Enforcement Priorities for ENDS and Other Deemed Products on the Market Without Premarket Authorization.”

“The delays and uncertainty have a very real impact on the daily lives of American entrepreneurs including EMA’s member companies who require predictability and transparency to operate. EMA’s member companies and other retailers are well positioned to aid in the fight against illegal and dangerous products by keeping them off their shelves, but the ability to do so requires clear and rational regulatory framework, with changes communicated consistently and transparently,” said EMA President Rob Underwood.

CLICK HERE to read EMA’s Citizen Petition.