Keller and Heckman Partner Azim Chowdhury was interviewed for the CSP Magazine article, “Regulations 2023: One Thing After Another.” The article discusses the many regulatory updates coming for tobacco products in 2023, including a likely ban on menthol cigarettes, an effective ban on non-tobacco flavored vapor products, new retail signage requirements, and even the likelihood of federal action on cigarette nicotine levels. “It’s one thing after another,” said Azim.
The U.S. Food and Drug Administration (FDA) has received nearly 250,000 comments on the menthol cigarette ban, which is expected to be finalized later this year. FDA wants to “make sure they have addressed all the major comments in the final rule,” commented Azim. “That will allow them to better defend themselves in a judicial challenge. The bottom line is that the FDA has made clear that they’re going to go forward with this flavor ban” for menthol cigarettes and characterizing flavors in cigars.
Additionally, FDA has not officially banned non-tobacco flavors in e-cigarettes and vapor products, but its continued denial of Premarket Tobacco Product Applications (PMTAs) for all such products has had the same effect. “While we won’t see an official tobacco product standard from FDA banning flavored vapor products, for e-cigarettes it won’t matter. At this point, it seems virtually impossible to meet the new evidentiary standard for flavors,” said Azim.
In terms of enforcement, according to Azim, the virtually impossible premarket authorization process for e-cigarettes combined with an overall lack of enforcement and an almost perverse enforcement focus on small vape shops who failed to obtain PMTA authorization has resulted in a thriving black market. “The reality is the FDA simply cannot remove everything off the market.”
Lastly, Azim commented on FDA’s plan to reduce nicotine levels in cigarettes, saying, “It would be a huge change.” Once the proposal comes out, there will be a public comment period, like with any FDA rule. “That will be an interesting rulemaking,” reflected Azim. “It will be critical for the industry to put lots of data and science into the record to set up future challenges to that rule.”
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