Azim Chowdhury Quoted in Law360 Article on FDA E-Cigarette Enforcement Guidance Challenge

Keller and Heckman Partner Azim Chowdhury was recently quoted in a Law360 article discussing efforts by American Vapor Manufacturers (AVM), Helix Innovations LLC, and NJOY LLC to intervene in litigation challenging the U.S. Food and Drug Administration's guidance on enforcement priorities for certain new tobacco products. 

According to the article, AVM, represented by Keller and Heckman, is seeking to participate in the litigation to ensure that the court hears directly from businesses that could be significantly affected by the outcome of the case. The challenged FDA guidance addresses enforcement priorities for certain e-cigarette and nicotine pouch products with pending premarket tobacco product applications (PMTAs). 

Discussing the potential impact of the litigation, Azim noted that, “These businesses have invested substantial resources in scientific studies and FDA submissions, and the outcome could affect their employees, customers, and ability to fund continued regulatory review.” He further emphasized that, “FDA's guidance does not grant marketing authorization or waive the statutory premarket review requirements. It sets enforcement priorities for certain products while their applications remain under review, and FDA retains authority to take enforcement action.” Azim added that “AVM believes the Court should hear directly from the businesses affected by the challenged policy.” 

The article highlights the broader implications of the case for manufacturers navigating the FDA's tobacco product review process and the potential effects on businesses with products currently under agency review. 

For more information, see the Law360 article here (subscription required).