The U.S. Food and Drug Administration on Thursday released proposed rules - first announced a year ago - to ban menthol cigarettes and flavored cigars.
"The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit," U.S. Health and Human Services Secretary Xavier Becerra said in an FDA news release.
FDA Commissioner Robert Califf discussed the proposed bans Thursday while appearing before a congressional subcommittee, the Washington Post reported.
Califf told the panel that the proposed bans would "reduce the mortality risk of current smokers of menthol cigarettes or flavored cigars by substantially decreasing their consumption and increasing the likelihood of cessation," the Post reported.
Califf's remarks came nearly a year to the day after his predecessor, acting FDA Commissioner Dr. Janet Woodcock, announced the same proposed ban on menthol cigarettes and flavored small cigars.
The ban would "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," Woodcock said at the time.
"Flavored tobacco, including flavors found in some cigars and cigarillos, makes smoking more appealing by reducing initial aversive responses, particularly for young people," Woodcock explained.
Menthol cigarettes have been marketed aggressively to Black Americans for decades. About 85% of Black smokers use menthol brands compared with 30% of white smokers, the FDA said, and research shows menthol cigarettes are harder to quit than traditional tobacco products.
Anti-smoking and civil rights advocates applauded the proposed ban.
"This is a giant step forward" in reducing health disparities caused by smoking, Carol McGruder, co-chair of the African American Tobacco Control Leadership Council, told the Post.
In 2019, there were over 18.5 million menthol cigarette smokers aged 12 and older in the United States, with particularly high rates of use by young people, Black people and other minorities, the FDA said. Modeling studies have estimated a 15% reduction in smoking within 40 years if menthol cigarettes are no longer available, the agency said, and those same studies estimate that 324,000 to 654,000 smoking-related deaths overall (92,000 to 238,000 among Black Americans) would be avoided over the course of 40 years.
Experts agreed that the public health impact of following through on the proposed ban could be enormous. Black men have the highest rates of lung cancer in America, largely due to smoking, according to the U.S. Centers for Disease Control and Prevention.
"FDA's actions today send a clear message that Big Tobacco's strategy to profit off addicting Black Americans will no longer be tolerated," Lisa Lacasse, president of the American Cancer Society's Cancer Action Network, said in a statement. "Currently, lung cancer death rates in Black males are 15% higher than those of white males in the U.S. If we're going to address these very real health disparities, we must take strong action to end the industry's targeting of Black communities."
Dr. Raja Flores is chair of thoracic surgery at Mount Sinai Health System in New York City. He said, "It's a crime that this has gone on for so long - that they've focused on the most vulnerable population, like the African American community.... We see the disparities and the results in Black patients because of menthol cigarettes. They don't do as well as white patients with lung cancer. It's about time that we do something to stop this."
Geoffrey Fong, principal investigator of the International Tobacco Control Policy Evaluation Project, said as many as 1.3 million people could quit smoking and potentially hundreds of thousands of premature deaths could be averted if the United States' experience mirrors that of Canada after it banned menthol cigarettes.
"This is potentially an extraordinary, landmark intervention to reduce the No. 1 preventable cause of death and disease," Fong told The New York Times.
American Lung Association President and CEO Harold Wimmer said the proposed ban could "be the single most significant action taken by FDA in its almost 13-year history of regulating tobacco products."
"Tobacco use is the number one cause of preventable death among Black Americans, claiming 45,000 Black lives every year," Wimmer said in a statement. "Black men have the highest rates of lung cancer in the U.S., and Black middle and high school students smoke flavored cigars at rates higher than cigarettes. These statistics did not happen by accident. They are the results of decades of marketing directed at Black communities by the tobacco industry. Halting the sale of these flavored tobacco products lays the groundwork for reversing decades of disparities in tobacco use, disease and death in Black and brown communities."
However, anti-smoking advocates predicted that the effective dates of the bans remain at least two years away.
"The FDA has a duty to protect public health with nothing short of ending the sale of all flavored tobacco products," the American Heart Association said in a statement. "The American Heart Association and our nationwide network of advocates will relentlessly work with FDA to ensure the final rules are as strong and comprehensive as possible. We urge the agency to quickly issue final rules and remove these harmful products from the market."
Public comment on the proposed rules starts May 4, and the FDA will also hold public hearings on June 13 and June 15.
The U.S. Food and Drug Administration has more about menthol and flavored tobacco products.
SOURCES: U.S. Food and Drug Administration, news release, April 28, 2022; Raja Flores, MD, chair of thoracic surgery, Mount Sinai Health System, New York City; American Heart Association, statement, April 28, 2022; American Lung Association, statement, April 28, 2022; American Cancer Society, statement, April 28, 2022; Washington Post; The New York Times