Azim Chowdhury Quoted in Reason Article on FDA Reevaluating the PMTA Process

Keller and Heckman Partner Azim Chowdhury was quoted in the Reason article, “The FDA Promises To Streamline the Dauntingly Complex Rules for Approving Nicotine Products.” The article discusses the U.S. Food and Drug Administration’s (FDA) plans to reform the Premarket Tobacco Product Application (PMTA) process. According to Azim, “there is a tremendous amount of potential redundancy” in PMTA submissions, and many companies “are asking FDA to tell them, in a clear and predictable way, what they need to do,” noting that compliance can cost “millions or even tens of millions of dollars” and is therefore easier for large tobacco companies than smaller manufacturers. 

Azim also emphasized that alternatives to combustible cigarettes can play an important harm-reduction role, stating, “If the goal is a regulated marketplace, then there has to be a realistic pathway from the marketplace we have today to the marketplace FDA wants.” He warned that “if we create a regulated market so narrow that it doesn't reflect what adult consumers actually want, we're going to miss opportunities to move people away from combustible cigarettes.”

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