Azim Chowdhury Quoted in Tobacco Reporter Article on Confusion Surrounding FDA’s Recent Approval to Market Certain ENDS Products
Keller and Heckman Partner Azim Chowdhury was quoted in the Tobacco Reporter article, “Clouded in Confusion.” The article discusses the uncertainty surrounding the U.S. Food and Drug Administration’s (FDA) recent across-the-board denials of Premarket Tobacco Product Applications (PMTAs) for over a million non-tobacco flavored electronic nicotine delivery systems (ENDS), as well as the first-ever ENDS authorized by FDA – the tobacco-flavored Vuse Solo. Some of the many companies who have received Marketing Denial Orders (MDOs) have challenged the denials in court, arguing FDA’s “box checking” review in lieu of the full scientific assessment of the PMTAs to determine if the products are “appropriate for the protection of the public health” was arbitrary and capricious, and in violation of the Administrative Procedure Act as well as the Tobacco Control Act. According to Azim, “[The] FDA clearly jumped the gun with at least some of these companies in the way that they issued the MDO without giving the PMTAs a full scientific review as required by the statute. That being said, even if some of these lawsuits are ultimately successful, the outlook for flavored ENDS, to me, looks pretty grim.”
To read the full article, please click here.
Save the Date: Registration now open for 2022 E-Vapor and Tobacco Law Symposium
Keller and Heckman's Annual E-Vapor and Tobacco Law Symposium returns in 2022! Join us virtually on February 2-3, 2022 for a two-day comprehensive seminar focused on legal and regulatory issues critical to e-vapor, tobacco, and CBD industries following the aftermath of FDA’s decisions on millions of premarket applications. Register here.