Smoking Cessation Indication For E-Cigarettes Could Fade Under Cloud Of Nicotine Packaged For Children
This article was originally published in The Pink Sheet & The Rose Sheet
You may also be interested in...
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 Guidance maintains explanation FDA stated in 2016 draft guidance that approval of a Premarket Tobacco Product Application depends on showing a tobacco or nicotine product has some smoking cessation-like utility.
In four days before Scott Gottlieb's stint as commissioner ended, FDA announced official start of initiative to consider regulatory pathways to make CBD compliant as a dietary ingredient, launched another shot across kratom sector's bow and noted more examples of e-cigarette marketers crossing regulatory lines.
FDA for several years has noted opportunity for e-cigarettes and other electric nicotine delivery systems products to help adult smokers switch to a potentially less harmful form of nicotine delivery. "But we’ve also been clear that, even for adults, e-cigarettes are not risk free," says FDA Commissioner Gottlieb and Principal Deputy Commissioner Abernethy. Most seizures reported by youth and young adult e-cigarette users.