The Food and Drug Administration set in motion a controversial plan Thursday to ban menthol flavorings in traditional cigarettes and cigars.
Product standards are projected to be unveiled in 2022.
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 a 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.”
Analysts and industry experts anticipated the FDA clamping down on menthol flavorings as one dramatic regulatory shift from the Trump administration to the Biden administration.
In December, the Trump administration’s FDA and the U.S. Department of Health and Human Services did not list banning menthol cigarettes or reducing nicotine levels in traditional cigarettes among its 2021 priorities.
Woodcock said Thursday the FDA has “full support from the administration.”
It has been projected that it will take years for the FDA to go through the regulatory process to implement any heightened restrictions.
The FDA likely will face multiple lawsuits from tobacco manufacturers and anti-smoking groups.
In 2009, Congress exempted menthol from banned flavorings in traditional cigarettes in the federal Tobacco Control Act.
The FDA said in a statement its decision to ban menthol flavorings “is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.”
Yet, in 2013, the Obama administration FDA said its evaluation on menthol cigarettes concluded there is little evidence to suggest they are more or less toxic than regular cigarettes, or contribute to more disease risk.
The FDA took action in February 2020 to remove some flavored electronic cigarette products but allowed tobacco and menthol flavors to remain in the marketplace.
Also 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,” was not taken up by the U.S. Senate.
U.S. Sens. Richard Burr and Thom Tillis, both Republicans from N.C., issued statements questioning the U.S. House bill’s strategy, citing it was a Democratic-controlled Congress that created a legal exemption for menthol cigarettes in 2009.
On Thursday, Burr said in a statement his concern about FDA banning menthol flavorings “is the same I’ve raised for years: the FDA has yet to provide sufficient new scientific data justifying a ban on menthol cigarettes.”
“I also remain concerned that after more than 10 years and $5 billion, the FDA still has not released official guidance for reduced harm tobacco products.
Burr said that “it’s only fair it issue foundational rules for the approval of reduced harm tobacco alternatives.”
“Doing so is essential for having a robust discussion about the future of an industry that is vital for millions of American consumers and workers.”
A ban on menthol traditional and electronic cigarettes could deliver a major financial blow to the tobacco industry, in particular to British American Tobacco Plc, which owns top-selling U.S. menthol cigarette brand Newport through Reynolds American Inc.
Newport also is the No. 2-selling traditional cigarette with about a 15% market share.
Reynolds has about 2,500 employees in Forsyth County, primarily at its 2-million-square-foot manufacturing plant in Tobaccoville.
Reynolds said in a statement Thursday that “the published science does not support regulating menthol cigarettes differently from non-menthol ... nor does it support that menthol cigarettes adversely affect initiation, dependence or cessation.”
“Reynolds will evaluate any proposed regulation and will participate in any consultation and the rulemaking process by submitting robust, science-based evidence.”
On Wednesday, retiring BAT chairman Richard Burrows told shareholders that “any such regulation (of menthol cigarettes) would be highly complex and could take many years to implement.”
“We support regulation that is clearly founded on scientific evidence and which considers all unintended consequences” that could include a potential expansion of the black market for menthol traditional cigarettes.
The FDA said “there is strong evidence that a menthol ban will help people quit. Studies show that menthol increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults.”
The FDA cited a study that “suggests that banning menthol cigarettes in the U.S. would lead an additional 923,000 smokers to quit, including 230,000 African Americans, in the first 13 to 17 months after a ban goes into effect.”
The FDA cautioned the regulatory ban on menthol flavorings “will only address manufacturers, distributors, wholesalers, importers and retailers.”
“The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product. The FDA will work to make sure that any unlawful tobacco products do not make their way onto the market.”
That enforcement decision has critics of the FDA saying it will just lead to a thriving black market network for menthol tobacco flavorings involving criminal enterprises and cartels.
In January, N.C. Attorney General Josh Stein joined a bipartisan group of 23 attorneys general who sent a letter to the FDA urging a ban on menthol traditional cigarettes.
“Menthol cigarettes are designed to be easier to smoke,” Stein said in a statement.
“That means they make it easier to get hooked. What’s more, they’re marketed in ways that disproportionately harm young people and people of color.”
The anti-tobacco Campaign for Tobacco-Free Kids praised the FDA initiative and urged the agency “to expedite this time frame and move swiftly to propose, finalize and implement the necessary regulations to turn this decision into life-saving action.”
“The administration’s new policy has the potential to be the strongest action our nation has ever taken to drive down the number of kids who start smoking and the number of Americans who are sickened and killed by tobacco,” the group said.
Gregory Conley, president of the American Vaping Association, said the FDA’s initiative has the potential to backfire if the agency does not promote nicotine and tobacco harm-reduction products along with the menthol ban.
Those products include electronic cigarettes, snus and heat-not-burn traditional cigarettes.
“Evidence from other countries suggests that a menthol ban is not a magic wand that will spur a majority of users to quit nicotine entirely,” Conley said.
“There will be no massive public health benefit if the response from most menthol and little cigar smokers is to switch to Marlboros or use illicit products bought off the street.
“It is critical that the FDA take the lead in informing the public that bans on (traditional) tobacco products will not succeed if satisfying safer alternatives are kept out of the hands of adult smokers,” Conley said.