VUSE Alto Menthol and Mixed Berry PMTA MDO Key Takeaways
VUSE Alto Menthol and Mixed Berry PMTA MDO Key Takeaways
October 12, 2023
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VUSE Alto Menthol - VUSE Alto Mixed Berry Marketing Denial Order Memo.pdfCTP determined that there were insufficient brand and flavor-specific studies demonstrating reduction of risk to youth in the PMTA to warrant a marketing granted order. CTP did not view Vuse Solo as an equivalent product to Vuse Alto.
CTP reviewed the included PATH and Colorado Longitudinal Studies data as well as RJR longitudinal studies and presumably raised deficiencies to RJR in 2022 with an additional information letter. When the responses were not sufficient, CTP declined to move forward withadditional scientific review.
Time from submission to decision was ~3 years
23-60545 VUSE Alto appeal and stay 2-5-24.pdfR.J. Reynolds Vapor Company et al., v. Food & Drug Administration et al., No. 23-60037 (“Vibe”) (consolidated with Nos. 23-60128 (“Solo”) and 23-60545 (“Alto”)) - Appeal and Stay of MDO
R.J. Reynolds Vapor Company et al., v. Food & Drug Administration et al., No. 23-60037 (“Vibe”) (consolidated with Nos. 23-60128 (“Solo”) and 23-60545 (“Alto”)) - Appeal and Stay of MDO
January 10, 2024
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