Azim Chowdhury Quoted in Vapor Voice Article on FDA Proposed Rules for Vape Manufacturing

Keller and Heckman Partner Azim Chowdhury was quoted in the Vapor Voice article, “Better Late Than Never.” The article discusses the U.S. Food and Drug Administration’s (FDA) new proposed rule on Tobacco Product Manufacturing Practices and its impact on the e-vapor industry. “This proposed rule is long overdue,” Azim commented. “This proposed rule should have come out years ago following the industry-proposed [tobacco product manufacturing practices] that were submitted back in 2012. The vapor industry in particular has been in dire need of this type of regulation, which can only benefit public health.”

According to Azim, large manufacturers will be subject to the TPMP rule as soon as it is finalized, while smaller companies have four years after the effective date to meet the requirements. “However, the question is, will the small vape industry even be around in four years?” Azim said. “The way things are going with the PMTA process and FDA enforcement, it seems that only the larger players will survive to see the implementation of this rule.”

And what about foreign manufacturing? Azim stated, “Unlike domestic manufacturers, this rule does not require foreign manufacturers to register their establishments, submit a product list or be subject to regular biennial inspections. However, FDA’s unified agenda of upcoming rulemakings indicates the agency may soon propose another rule that extends the Tobacco Control Act’s registration and product listing requirement to foreign establishments.”

FDA will need to review comments that are submitted within the next six months before finalizing the rule. “All in all, this rule will likely take at least one [year] to two years to become final,” said Azim. “While it won’t directly impact pending PMTAs, companies should be reviewing this rule carefully and bolstering their existing practices to ensure compliance. We now know what FDA expects.”

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