Azim Chowdhury Quoted in Crain’s Detroit Business Article on Breeze Smoke and FDA Crackdown

Keller and Heckman Partner Azim Chowdhury was quoted in the Crain’s Detroit Business article, “Once a vaping giant, this Detroit-area company is ensnared in an FDA crackdown.” The article discusses FDA’s recent enforcement crackdown against unauthorized ENDS, and the impact on Breeze Smoke, one of the largest ENDS distributors in the United States.

Azim told Crain’s that FDA’s inconsistency with enforcement has made it impossible for American vape companies to operate. “The PMTA process requires a very high burden of proof,” he said. “Even higher than the drug standard for the pharmaceutical industry. It’s not this black and white issue where it’s approved or not. The entire process has created confusion and is frankly throwing the baby out with the bath water to combat counterfeits from China.”

Pointing out that the scientific studies required by FDA can take years and cost millions of dollars to produce, he noted that Big Tobacco corporations “can spend millions on these studies,” while “small companies can’t. There’s a bias against small entrepreneurial companies that are fighting to stay in the market.”

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