E-cigarettes' Future Generates Questions, Not Their Efficacy For Smoking Cessation
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.
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Gum, lozenge and patch NRTs available in US need as much as 30 minutes to deliver nicotine to users’ bloodstreams. Cigarettes are "purposely designed because of inhalation of smoke to deliver nicotine to the receptors in the brain in less than 10 seconds,” says former FDA tobacco programs chief Mitch Zeller.
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.
"Balancing the need to address the existing public health crisis among today’s youth ... and the need to avoid creating an additional public health crisis if e-cigarette availability dropped so precipitously as to push users to combusted tobacco products," Judge Paul Grimm sets a May 2020 PMTA deadline for vaping products, noting the industry’s "lack of effort to obtain approval without an imminent deadline."