Modified FDA Policy Means Some Flavored eCigarettes Won't Be Sold

FDA Commissioner Dr. Scott Gottlieb said FDA intends to review comments on the draft compliance policy and finalize it as fast as possible. He said FDA expects the policy changes to mean some flavored e-cigarette products and flavored cigars will no longer be sold at all. Other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access.

FDA Commissioner Dr. Scott Gottlieb has announced his resignation, but he's continuing to take aim at tobacco products, including e-cigarettes and cigars. On March 13, Gottlieb announced FDA is proposing to end its current compliance policy as it applies to flavored electronic nicotine delivery system products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products). The agency expects manufacturers of all such flavored products that remain on the market under the new conditions to submit premarket applications to FDA by Aug. 8, 2021, a year earlier than the agency previously proposed.

He said FDA intends to review comments on the draft compliance policy published March 13 and finalize it as fast as possible. He said FDA expects several things to happen because of these policy changes:

  • Some flavored e-cigarette products will no longer be sold at all.
  • Other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021.
  • Some flavored cigars will no longer be sold.

FDA released a comprehensive plan for tobacco and nicotine regulation in July 2017, and it continues to implement that plan, he said, but it has become clear that a recent surge in e-cigarette use among American youths, which had appeared to be leveling off at the time the plan was announced, "is threatening the progress we've made in reducing youth tobacco use," he said. "The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018. This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017. This is particularly troubling given that research shows that kids using e-cigarettes are more likely to take up combustible cigarettes. The epidemic-level rise in youth e-cigarette use has prompted a series of escalating actions by the FDA in both enforcement and public education. It has also required us to take a critical look at our policies and regulatory priorities," he explained.

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