On Oct. 12, FDA announced the marketing authorization for three new tobacco products from R.J. Reynolds (RJR) Vapor Company through the premarket tobacco product application (PMTA) pathway, marking the first set of electronic nicotine delivery system (ENDS) products ever to be given a marketing granted order (MGO) by FDA.
The authorization allows RJR’s Vuse Solo closed ENDS device and two accompanying tobacco-flavored e-liquid pods to be legally sold in the U.S. This action does not mean these products are safe or “FDA approved.” All tobacco products are addictive and harmful to health, and those who do not use tobacco products should not start.
The agency also issued 10 marketing denial orders (MDOs) for flavored ENDS products submitted under the Vuse Solo brand by RJR.
FDA Finalizes PMTA and SE Rules
On Oct. 4, FDA issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of PMTAs and Substantial Equivalence (SE) Reports.
Flavored E-Cigarette Use Remains High Among Youth, According to 2021 NYTS
Youth e-cigarette use remains a serious concern as shown in new data from the 2021 National Youth Tobacco Survey (NYTS) released by FDA and the U.S. Centers for Disease Control and Prevention (CDC). In 2021, an estimated 2+ million U.S. middle and high school students reported currently using e-cigarettes, with more than 8 in 10 of those youth using flavored e-cigarettes.
In Case You Missed It: Recent CTP News
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