FDA "ready" to speed up examination of e-cigarettes

The Food and Drug Administration "stands ready" to begin examining e-cigarettes in the midst of a "vaping epidemic," Acting Commissioner Ned Sharpless said in a statement on Monday.

The FDA review process asks the agency to weigh the net profit for public health – which means it must weigh how many adults will benefit from them and how many teens could be harmed – when she decides whether to allow the products to stay on the market. The applications were originally scheduled to be filed last summer, until former FDA Commissioner Scott Gottlieb postponed the deadline to 2022, starting in 2018.

A teenage vaping push forced Gottlieb to change course. This spring, the agency has proposed to postpone the deadline of one year to 2021, which would give it the means to start withdrawing certain products from the market in an "epidemic" context. .

A US district court last week ordered the FDA to begin accepting applications in 10 months, alongside public health groups that sued the agency for allegedly fleeing its legal obligations. The Department of Justice or industry can appeal the decision. However, the FDA may change the deadline during the course of the legal proceedings.

Sharpless, in a statement, said on Monday that the FDA "stood ready," suggesting that the agency plans to call applications earlier than planned, regardless of how the company is changing. ;case.

"This court decision comes at a time when, like many others, I am extremely concerned about the growing consumption of electronic cigarettes among young people in our country and in particular their potential to become traditional cigarette smokers" said Sharpless. "We can not allow the next generation of young people to become addicted to nicotine because of e-cigarettes."

If the agency respects the judge's schedule, companies would be required to submit applications in May 2020. They would be allowed to stay on the market for a year while the agency reviews the documents. Sharpless encouraged companies not to wait and start submitting their applications now.

"Let's be clear with the tobacco industry: responsible manufacturers certainly do not need to wait 10 months to act," Sharpless said. "We have submitted our recommendations regarding the expectations of the FDA (…)." We encourage the industry to use these resources now as a guide for their submissions to the agency. "