The Food and Drug Administration under the Biden administration has returned — as expected — the banning of menthol traditional cigarettes to its priority agenda for 2021.
The U.S. Department of Health and Human Services and the FDA released Friday their unified agenda and regulatory agenda.
There were seven items related to tobacco on the agenda, including “tobacco product standard for menthol in cigarettes” listed in the proposed rule stage set for an April update.
The FDA has said 30% of all adult smokers and more than 40% of all youth smokers consume a menthol style.
The style has been particularly popular in Black communities. The FDA said that 85% of Black smokers prefer menthol flavoring compared with 30% of white smokers.
“Banning menthol in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” acting FDA commissioner Dr. Janet Woodcock said in an April 29 statement.
“With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.”
Barclays analyst Jain Gaurav said Monday that the menthol ban on traditional cigarettes “has negative implications for U.S.-exposed tobacco stocks ... since menthol accounts for 35% of traditional cigarettes sold in the U.S. and more than 50% of traditional cigarettes volumes” for British American Tobacco Plc’s and Imperial Brands Plc’s U.S. businesses.
Gaurav estimates that 25% of BAT’s overall profits come from the U.S. menthol traditional cigarette sales of R.J. Reynolds Tobacco Co.
“We expect any rulemaking process to take two years,” Gaurav said.
“Post that, potential litigation from the industry could lead to another two years of delay, and implementation at retail may add another year.
“Thus, any menthol ban seems five years away to us.”
Gaurav cautioned that he “doesn’t expect any flavored tobacco ban or other anti-tobacco measure to pass the Senate.”
“There are a number of more important issues that the Biden administration needs to deal with — COVID and climate change in particular.
“Biden-Harris have spoken of cannabis decriminalization.”
In February 2020, the U.S. House of Representatives passed a bill by a 213-195 vote that would dramatically tighten federal tobacco regulations, including banning all non-tobacco flavorings for tobacco products.
However, the Democratic-sponsored H.R. 2339, titled “Reversing the Youth Tobacco Epidemic Act,” has not been taken up by the U.S. Senate.
Very low nicotine
Notably absent again from the FDA’s agenda was reducing nicotine level in traditional cigarettes to non-addictive levels.
22nd Century Group Inc., which has its manufacturing plant in Mocksville, has been attempting for several years to persuade the FDA to approve allowing the company to market and sell very-low-nicotine traditional cigarettes.
The company has been waiting since Feb. 14, 2020, on the FDA to rule on its modified-risk tobacco product application. A modified-risk tobacco product application seeks authorization to advertise products as reduced harm or reduced risk compared with traditional cigarettes.
22nd Century’s ultimate goal is for the FDA to mandate that tobacco manufacturers only sell very-low-nicotine traditional cigarettes.
22nd Century has said it is prepared to begin shipping its very-low-nicotine cigarettes within 90 days of FDA authorization.
If the FDA does implement very-low nicotine standards in traditional cigarettes, the end result could be 22nd Century having a sharp increase in revenue and a potential buyout by a global tobacco manufacturer.
However, some analysts continue to question the appeal of very-low nicotine traditional cigarettes, and whether they could lead smokers to more consumption to obtain the nicotine levels to which they are accustomed.