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 Guidance maintains explanation FDA stated in 2016 draft guidance that approval of a Premarket Tobacco Product Application depends on showing a tobacco or nicotine product has some smoking cessation-like utility.
You may also be interested in...
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.
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.
FDA has made clear since e-cigarette sales emerged that they're not approved for labeling as products to help consumers stop using combustible tobacco. Agency also has acted on concerns about products' safety and appeal of flavored nicotine to minors. But likelihood of sales in US ending, not whether products help smokers quit, was discussed at FDLI conference.