States Urged to Act in Absence of FDA Action on Majors

The Campaign for Tobacco-Free Kids (CTFK) is urging U.S. states and cities to step up their efforts to eliminate all flavored nicotine products, including e-cigarettes, in the wake of the Food and Drug Administration’s failure to rule on the premarket tobacco product applications (PMTAs) of market leaders Juul, Vuse, NJOY, Blu, and Logic by yesterday’s deadline.

On Sept. 9, the FDA announced it had denied market access to nearly 1 million electronic nicotine delivery devices owned primarily by smaller vapor companies. At the same time, the agency indicated it would require more time to process the remaining PMTAs, including those submitted by Juul Labs, BAT, NJOY, Imperial Brands and Japan Tobacco International, which account for the lion’s share of U.S. e-cigarette sales. Juul alone has a U.S. market share of more than 40 percent.

“The FDA will leave our kids at risk unless it acts quickly on the remaining applications, including for products like Juul that have driven the youth e-cigarette epidemic, and eliminates all flavored e-cigarettes, including menthol-flavored products that are widely used by kids,” wrote CTFK President Matthew L. Myers in a statement. “Every day these products remain on the market, our kids remain in jeopardy.”

The FDA’s failure to act on the market leaders is remarkable given that the agency had previously indicated it would prioritize those brands while processing marketing applications. Decisions on the bestselling brands would likely have the greatest impact on public health, the agency explained in earlier communications. The failure also raises legal questions, considering that the Sept. 9 deadline was ordered by a court following litigation from public health groups, including the CTFK.

The CTFK indicated if the FDA does not decide on major application soon it would return to court to have the court enforce its order requiring the FDA to begin removing unauthorized products.