Partner Azim Chowdhury Quoted in Tobacco Asia Article on FDA’s Regulatory Reset

Keller and Heckman Partner Azim Chowdhury was quoted in the Tobacco Asia article, “The US Food and Drug Administration’s Regulatory Reset.” The article examines the U.S. Food and Drug Administration’s (FDA) evolving approach to tobacco product regulation, including increased scrutiny of foreign manufacturers, proposed registration and product listing requirements, and enhanced enforcement capabilities. 

Discussing FDA’s enforcement priorities, Azim noted that foreign manufacturers face a new regulatory reality. “For foreign manufacturers, that means US compliance is no longer only a question of whether a distributor or retailer may be targeted. FDA is increasingly looking upstream at the product, the application status, the importer, and the manufacturer.” 

The article also highlights FDA’s proposed registration and listing rule, which would provide the agency with more comprehensive information about tobacco products entering the U.S. market. According to Azim, “Today, FDA often sees the product at the border or in the marketplace and then has to work backward. A registration and listing system would allow FDA to link products to establishments, product identifiers, submission numbers, labeling, advertising, import channels, and potentially foreign inspections. That would make FDA more proactive rather than purely reactive.” 

Azim further explained the proposed rule’s applicability to cigar and pipe tobacco manufacturers, stating, “The proposed rule would not, however, apply to ‘premium cigars’ that are currently outside Chapter IX as a result of the premium-cigar litigation, provided they meet the applicable court-defined criteria. That treatment could change through further litigation or future FDA rulemaking. Foreign manufacturers of non-premium cigars, including many flavored, machine-made, and filtered cigars, as well as foreign pipe tobacco and pipe manufacturers, would generally be required to register and list products if those products are imported or offered for import into the United States.” 

To read the full article, please click here.