Azim Chowdhury Quoted in Nicotine Insider Article on FDA’s PMTA Rule

Keller and Heckman Partner Azim Chowdhury was quoted in the Nicotine Insider article, “NGN26: FDA’s PMTA Rule Creates ‘Three Buckets’.” The article refers to Azim’s presentation at the Next Generation Nicotine Delivery 2026 conference in Miami, where he discussed the U.S. Food and Drug Administration’s (FDA) new guidance on tobacco enforcement priorities.

According to Azim, the guidance effectively creates what he described as three categories of products: “You have the green bucket, which is the list of limited products that have received marketing granted orders. Then you have the yellow bucket of products that are unauthorized, but under this new guidance document are not going to be prioritized for enforcement. Then you have, of course, the red bucket, which are products that are unauthorized and will be prioritized for enforcement.”

He also noted that the policy under the new guidance is a significant shift away from the deadline-driven approach. “For many years, what mattered was when you submitted the application, not necessarily the contents of that application,” he said. “Now things are changing. FDA is moving away from deadline-focused or timeliness-focused enforcement policies, and now they’re focusing on the contents of the application.”

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