FDA Moves to Ban Menthol Cigarettes, All Flavors in Cigars

FDA's step toward additional flavoring bans in tobacco products advances its commitment to reducing tobacco-related death, officials said.

The FDA announced that it will move to ban menthol in cigarettes and all flavors in cigars, based on evidence that suggests the change will reduce disease and death linked to tobacco products. The FDA said that it plans to issue 2 standards to enforce the flavor bans within the next year.

The new standards will ban menthol flavoring in cigarettes and all flavor additives in cigars, including menthol. The decision was based on scientific evidence showing the addictiveness and harm these products can cause and will build upon the 2009 Tobacco Control Act (TCA), which banned characterizing flavors in cigarettes.

The 2009 TCA left menthol cigarettes as the only flavor permitted in combusted cigarettes, but the law instructed the FDA to eventually reevaluate whether menthol cigarettes should be marketed.

“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” said Janet Woodcock, MD, the acting FDA commissioner.

“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,” Woodcock continued.

Studies have shown that a ban on menthol flavoring will help people to stop using tobacco products. Menthol is used to mask unpleasant flavors and harshness of tobacco, thus, making it easier for people to start using tobacco products and become addicted. Menthol-flavored tobacco products also enhance the effects of nicotine, making them more addictive and harder to quit than nonflavored products.

One study suggested that a ban on menthol cigarettes in the United States could lead to 923,000 smokers to quit, including 230,000 Blacks in the first 13 to 17 months after the ban goes into effect. Additionally, a separate study estimated that 633,000 deaths could be avoided, including about 237,000 deaths among Blacks.

“For far too long, certain populations, including African Americans, have been targeted, and disproportionately impacted by tobacco use. Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally,” said Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products.

If implemented, the FDA will have the ability to enforce flavor bans on all cigarettes and cigars for manufacturers, distributors, wholesalers, importers, and retailers to ensure that any unlawful products are kept off the market.

However, the agency said that they cannot and will not enforce against consumer possession or use of the newly banned products.

The announcement comes after the Center for Tobacco Products provided an update on their work conducting premarket review of electronic nicotine delivery systems (ENDS), such as vaporizers and e-cigarettes. The center issued warning letters to ENDS product manufacturers and retailers who continue to sell illegal products on the market.

The FDA had also invested in a public multimedia educational campaign targeted at nearly 10.7 million young people aged 12 to 17 to warn them against trying e-cigarettes and about the potential risks of using e-cigarettes.

In response to the announcement, the American College of Physicians released a statement expressing support for the FDA’s decision, saying that its members believe that the plan will greatly strengthen public health in the United States.

“As physicians, we are constantly confronted with the adverse effects of tobacco use and we know the danger they present to our patients’ health. Menthol cigarettes are detrimental to not only an individual’s health but public health as well,” said the ACP.

Xavier Becerra, HHS secretary, released a statement supporting the FDA’s plan, saying that the public health measures will likely save lives and that tobacco-related deaths need to become part of the United States’ past.

“We also recognize it is critical to ensure that routine smokers who seek to quit have broad and equitable access to all of the tools and resources they may need to succeed. I will continue to work closely with agencies within the Department of Health and Human Service on this important issue,” wrote Becerra, in a statement.