Tobacco

31 Attorneys General Ask FDA to Deny PMTAs for Certain E-Cig, Oral Nicotine Products

Group wants to restrict products with high nicotine levels, flavors
New York Attorney General Letitia James
Photograph: Shutterstock

NEW YORK — A coalition ofstate attorneys general is urging the U.S. Food and Drug Administration (FDA) to deny all premarket tobacco product applications (PMTAs) for e-cigarette and oral nicotine products containing high levels of nicotine and containing menthol or other flavors.

The effort, led by New York Attorney General Letitia James, also calls on the FDA restrict marketing for those products, which include pouches, gum and lozenges.

“Flavored nicotine products attract kids to dangerous, habit-forming products that only jeopardize their health,” James said. “New York has taken important steps to protect our kids by banning non-tobacco flavored vapor products and limiting the sale of e-cigarettes, but the FDA must also do its part to curb the youth nicotine epidemic. The health and wellbeing of our kids is our top priority, and the federal government must act now.”

James and the coalition argue that banning candy, mint, fruit and menthol flavors is “essential to eliminating the appeal of the products to youth consumers." They also ask the FDA to address the “youth nicotine epidemic” by imposing restrictions and age verifications on traditional and digital marketing tactics aimed toward youth and limiting the amounts of nicotine in products due to nicotine’s particularly harmful effects on the developing brain, James said.

“Although the full scope of the health risks posed by e-cigarettes and the newest generation of oral nicotine products is not yet known—including how their harm compares to that of traditional tobacco products—these products contain nicotine and will serve as a gateway to nicotine addiction for young people,” the letter, sent to Acting FDA Commissioner Janet Woodcock on Wednesday, read.

The European Union allows only 20 milligrams per milliliter of nicotine in e-cigarettes, while the United States has products with more than twice that limit, the attorneys general said.

The attorneys general note that oral nicotine products—most notably pouches—are the fastest-growing nicotine category in convenience stores. According to year-to-date numbers as of June 13 from Chicago-based market research firm IRI, spitless tobacco was up 52.4% in unit sales in c-stores, the highest growth among the tobacco categories for that period.  

Currently, the FDA is reviewing what flavored e-cigarette products can be legally marketed through the PMTA process. The agency has until Sept. 9 to determine what products it will authorize, or allow to legally be sold in the United States, although the FDA’s Center for Tobacco Products (CTP) Director Mitch Zeller has said they are unlikely to make this deadline.

The FDA has also said it will make banning menthol cigarettes and flavored cigars a priority; however, it hasn’t said where it stands on other menthol-flavored products like e-cigarettes. The FDA did not immediately respond to CSP’s request for comment.

Those signing the letter to Woodcock, in addition to James, were Lawrence Wasden of Idaho, Kwame Raoul of Illinois, Douglas Peterson of Nebraska, Josh Stein of North Carolina, Herbert Slatery of Tennessee, Treg Taylor of Alaska, Leslie Rutledge of Arkansas, Rob Bonta of California, Phil Weiser of Colorado, William Tong of Connecticut, Kathleen Jennings of Delaware, Karl Racine of the District of Columbia, Leevin Taitano Camacho of Guam, Aaron Frey of Maine, Brian Frosh of Maryland, Maura Healey of Massachusetts, Dana Nessel of Michigan, Keith Ellison of Minnesota, Aaron Ford of Nevada, John Formella of New Hampshire, Andrew Bruck of New Jersey, Hector Balderas of New Mexico, Ellen Rosenblum of Oregon, Josh Shapiro of Pennsylvania, Domingo Emanuelli-Hernandez of Puerto Rico, Peter Neronha of Rhode Island, Sean Reyes of Utah, T.J. Donovan of Vermont, Robert Ferguson of Washington and Eric Wilson of Wisconsin.

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