FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance
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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Scott Gottlieb claimed higher profile than most previous FDA commissioners with frequent Twitter posts and by including his remarks in many agency communications to industries and consumers. In his nearly two years in post, he also had more central role in FDA initiatives in areas such as keeping unsafe products labeled as supplements off the market and explaining why hemp and CBD are available and supplements even though FDA considers the products noncompliant as dietary ingredients.
E-cigarette use among people with cancer increased from 8.5% in 2014 to 10.7% in 2017, with the greatest increase among people younger than 50, according to a JAMA Oncology study. A recently NEJM study also questions safety of growing dependence on e-cigarettes by people trying to quit smoking.
The first review of ad claims for a vitamin vapor device by a Council of Better Business Bureaus investigative unit comes as marketing of the products is proliferating and with FDA stating that "a vitamin product for inhalation cannot be legally marketed as a dietary supplement" in the US.