FDA ‘stands ready’ to accelerate review of e-cigarettes

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The Food and Drug Administration “stands ready” to start reviewing e-cigarettes amid a teen vaping “epidemic,” acting Commissioner Ned Sharpless said Monday in a statement.

The FDA’s review process calls for the agency to weigh the net public health benefit — meaning it needs to weigh how many adults will benefit from them versus how many teens might be harmed — when deciding whether to allow products to stay on the market. Applications were originally due last summer, until former FDA Commissioner Scott Gottlieb delayed the deadline to 2022 from 2018.

A surge in teen vaping forced Gottlieb to change course. The agency this spring proposed moving the deadline up by a year to 2021, giving it a way to possibly start removing some products from the market amid a teen vaping “epidemic.”

A U.S. District Court last week ordered the FDA to start taking applications in 10 months, siding with public health groups who sued the agency for allegedly shirking its legal duties. The Department of Justice or the industry can appeal the decision. However, the FDA can tweak the deadline while the court proceedings play out.

Sharpless in a statement Monday said the FDA “stands ready,” suggesting the agency plans to call in applications sooner than it previously intended regardless of how the case progresses.

“This court decision comes at a time when I, like many others, are tremendously concerned about the rising use of e-cigarettes among our nation’s youth and especially the potential for them to become traditional cigarette smokers,” Sharpless said. “We cannot allow the next generation of young people to become addicted to nicotine because of e-cigarettes.”

If the agency follows the judge’s timeline, companies would be required to submit applications in May 2020. They would be allowed to stay on the market for one year while the agency reviews the materials. Sharpless encouraged companies not to wait and to start submitting applications now.

“Let me be clear with the tobacco industry: responsible manufacturers certainly don’t need to wait 10 months to act,” Sharpless said. “We’ve outlined our recommendations for what the FDA expects … We encourage industry to use these resources now as a guide for their submissions to the agency.”



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