E-cigarette Market Chills: PMTA Guidance, Claims Enforcement Sought
Guidance on keeping electronic cigarettes available comes a month after medical organizations and public health advocacy groups asked agency to investigate alleged smoking cessation claims by leading e-cigarette firm. Guidance maintains explanation FDA stated in 2016 draft guidance that approval of a Premarket Tobacco Product Application depends on showing a tobacco or nicotine product has some smoking cessation-like utility.
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E-cigarette NRT Outlook Heated By Combining With Counseling, Nicotine-Tapering Strategy
Results of three-year study conducted at 17 Canadian sites suggest that e-cigarettes use combined with counseling significantly increased abstinence from smoking cigarettes compared to receiving counseling alone.
US Health Market In 2019: Unfinished Business Leaves Lasting Impression
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
Long-term E-cigarette Use Could Spark More Smoking, French Study Suggests
Research in JAMA Internal Medicine studied "longitudinal associations between [e-cigarette] use and tobacco smoking patterns in a large population-based cohort study" and found use was associated with reduction in smoking and an increased probability of smoking cessation. But the researchers saw that e-cigarette users who quit tobacco "tended to relapse to smoking more frequently than" former smokers who didn't use e-cigarettes.