SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) on April 28 announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors other than tobacco in cigars.
FDA commissioner Robert Califf announced the proposal while testifying before the U.S. Senate Appropriations Committee Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, saying according to an Axios report that “these actions are appropriate for the protection of public health.”
“These proposed product standards are based on clear science and evidence establishing the addictiveness and harm of these products,” the FDA also said in its official announcement, and they build on the Family Smoking Prevention and Tobacco Control Act, which prohibited all characterizing flavors other than tobacco and menthol in cigarettes in 2009.
They moves are also part of the Biden administration’s “Cancer Moonshot” to reduce the death rate from cancer by at least 50% over the next 25 years, it said, citing tobacco use as a leading cause of cancer and death from cancer, and that approximately 30% of all cancer deaths in the United States are caused by smoking.
Menthol is a flavor additive with a minty taste and aroma that reduces the irritation and harshness of smoking. This increases appeal and makes menthol cigarettes easier to use, particularly for youth and young adults, according to the agency. Menthol also interacts with nicotine in the brain to enhance nicotine’s addictive effects. The combination of menthol’s flavor, sensory effects and interaction with nicotine in the brain increases the likelihood that youth who start using menthol cigarettes will progress to regular use. Menthol also makes it more difficult for people to quit smoking, the FDA said.
In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the United States, the agency said, with particularly high rates of use by youth, young adults and African American and other racial and ethnic groups. Published modeling studies have estimated a 15% reduction in smoking within 40 years if menthol cigarettes were no longer available in the United States, said the FDA. These studies also estimate that 324,000 to 654,000 smoking attributable deaths overall (92,000 to 238,000 among African Americans) would be avoided over the course of 40 years.
When finalized, the proposed menthol product standard will reduce the appeal of cigarettes, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.
Characterizing flavors in cigars, such as strawberry, grape, cocoa and fruit punch, increase appeal and make cigars easier to use, particularly among youth and young adults, according to the FDA. More than a half million youth in the United States use flavored cigars, it said, and in recent years more young people tried a cigar every day than tried a cigarette.
When finalized, the proposed flavored cigar product standard will reduce the appeal of cigars; decrease the likelihood of experimentation, development of nicotine dependence and progression to regular use; and improve public health by increasing the likelihood that existing cigar smokers may quit.
Enforcement and Justice
These proposed regulations do not include a prohibition on individual consumer possession or use. The FDA cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If these proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who manufacture, distribute or sell such products within the U.S. that are not in compliance with applicable requirements.
The FDA is seeking comment, beginning May 4, on how it can best make clear the respective roles of the agency and state and local law enforcement, as well as policy considerations related to the potential racial and social justice implications of the proposed product standards.
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