Report: FDA Seeking More Time for Some PMTA Decisions

The U.S. Food and Drug Administration is expected to ask for more time before deciding whether some “e-cigarettes from market leader Juul Labs Inc” and others can be sold in the United States, the Wall Street Journal reported today, citing people familiar with the matter. The FDA is expected today to announce the fate of more than 2 million vaping products that had submitted a premarket tobacco product application (PMTA).

Many businesses have already received marketing denial orders (MDO) from the FDA. Many companies have gone out of business, filed a lawsuit, or switched to synthetic nicotine after receiving MDOs.

Concerning the FDA asking more time for a Juul Labs PMTA review, Greg Conley, president of the American Vaping Association, tweeted, “I want Juul’s five applications to be authorized. I want Reynolds’ two or three dozen applications to be authorized. But to see them likely get more time from FDATobacco after good small businesses spent the last month getting wrecked … Just wrong. Good job, FDA.”

He also tweeted: “If I had the choice between 50,000 flavored vaping products being available or Juul surviving, I’d walk Juul over the plank myself. But that’s not the choice we have.”

After news of the FDA request was reported, Guy Bentley, director of consumer freedom research at the Reason Foundation, tweeted, “The FDA couldn’t get it together to make a decision on one of the biggest companies in this space. Complete shambles.”

No further information was provided. The FDA did not immediately respond to Reuters’ requests for comment.