Looming E-Cigarette Regulation Could Shift Cessation Playing Field
This article was originally published in The Tan Sheet
Approval as smoking cessation products is an expensive option for e-cigarette firms due to the costs of preparing and submitting an NDA to FDA’s drug center. Regulation under the agency’s tobacco center could lead to modified risk status, but might make the NDA route more appealing.
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The U.K. pharma regulator requires all electronic cigarettes to be licensed as nonprescription medicines beginning in 2016, noting concerns about product quality. Meanwhile, FDA considers allowing e-cigarettes to be marketed as nicotine replacement therapy on a case-by-case basis.
CN Creative’s plan to include harm reduction with smoking cessation in claims for its Nicadex electronic cigarette was key to Advent Life Sciences investing in the firm, which is prepared to ask U.K. regulators for approval this summer before applying in the U.S.
FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.