MINNEAPOLIS — The U.S. Food and Drug Administration (FDA) is on track to issue proposed product standards in spring 2022 that could ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors in cigars.
The goal is to publish the standards by April, the FDA’s Center for Tobacco Products (CTP) Director Mitch Zeller said while speaking on a webinar held on Dec. 2 by Minneapolis-based trade organization the National Association of Tobacco Outlets (NATO).
The intention behind the standards is based on the clear scientific evidence related to the addictiveness and harm of these products, Zeller said.
“Were these proposed product standards to be finalized and to go into effect, this will help to significantly reduce initiation by kids, increase smoking cessation among current smokers and, very importantly, address some profound health disparities when it comes to the use of these types of products by communities of color, low-income populations and the LGBTQ+ population,” he said.
After the FDA publishes the proposed new rules, there would be a review and public comment period, meaning the bans wouldn’t take effect for between one to two years, if ever.
“[After the proposed standards are published in April], all interested parties will get to see everything in these proposed product standards and with that, very importantly, the opportunity to comment in response to what we’ve proposed,” Zeller said. “And those comments are very carefully considered and are an important part of the assessment that we make after the comments come in.”
When it comes to menthol flavors in the premarket tobacco product application (PMTA) process, Zeller said the FDA continues to review applications for non-tobacco flavored electronic nicotine delivery systems (ENDS) to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth.
The scientific review of menthol electronic nicotine delivery systems (ENDS) raises unique considerations, Zeller said, and the FDA is reviewing every product on a case-by-case basis with the same review standards.
It’s not clear yet whether the FDA will approve menthol-flavored ENDS products. The FDA has approved R.J. Reynolds Vapor Co.’s Vuse Solo ENDS product and accompanying tobacco-flavored e-liquid pods, for example, but its menthol-flavored products remain in limbo.
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