FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance
This article was originally published in The Pink Sheet & The Rose Sheet
Commissioner Gottlieb highlights the first of two draft guidances US FDA will publish on developing "novel, inhaled nicotine replacement therapies that could be submitted to the FDA for approval as new drugs, similar to current" OTC nicotine replacement therapies. FDA has had a contentious history with manufacturers of electronic nicotine devices, but officials have said the products are eligible for review as NRTs through the NDA process.
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The Center for Science in the Public Interest urges the US Food and Drug Administration to seize products from marketers of 15 dietary supplements that claim to treat nicotine addiction. In an April 24 letter, the advocacy group says none of the marketers could present evidence in support of claims promising quick relief from addiction and/or results comparable to FDA-approved Rx and OTC drug products.
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.
FDA's NRT clinical draft guidance is latest piece of its evolving strategy for making available more products to help smokers quit. But FDA maintains requirements that keep approval bar high and its separate draft guidance published in 2018 on nonclinical trials put NRT progress on hold, says Saul Shiffman, an OTC switch consultant with work includes multiple NRT proposals.