FDA Permits Sale of First E-Cigarette Products Through PMTA Pathway

October 26, 2021

The Food and Drug Administration (FDA) recently authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products to be authorized by FDA through the Premarket Tobacco Product Application (PMTA) pathway. The agency issued Marketing Granted Orders to R.J. Reynolds Vapor Company for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods. The FDA has noted that this authorization allows these products to be legally sold in the U.S.—it does not mean these products are safe or “FDA approved.”

The Association for Clinical Oncology (ASCO) and FDA reiterate that all tobacco products are harmful and addictive, and that individuals who do not use tobacco products should not start.

ASCO will continue to urge FDA oversee the sale and use of tobacco products to ensure the protection of public health. Such oversight is particularly necessary in light of the results of the 2021 National Youth Tobacco Survey, which showed that more than 2 million middle and high school students reported using e-cigarettes in the first half of this year. Furthermore, an alarming percentage of youth e-cigarette users report frequent or daily use (43.6% of high school users report frequent use—at least 20 days a month—and 27.6% report daily use). This means that youth e-cigarette use remains a serious public health concern.

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