FDA Takes Steps to Ban Menthol, Flavored Cigar Tobacco Products

This week, the U.S. Food and Drug Administration (FDA) announced its commitment to advancing two tobacco product standards to significantly reduce disease and death caused by using combustible tobacco products. The two standards – a menthol product standard and a flavored cigar standard – will aim to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars. The FDA indicated it will be working to issue proposed product standards within the next year.

The FDA’s announcement builds on previous actions that banned other flavored cigarette products in 2009. Below, additional details on the forthcoming standards are provided:

• Menthol Product Standard – The FDA has granted a citizen petition requesting that the agency pursue rulemaking to prohibit menthol in cigarettes. The 2009 Tobacco Control Act (TCA) did not include menthol in its ban on characterizing flavors in cigarettes, leaving menthol cigarettes as the only flavored combustible cigarettes available on market. Since then, the FDA has explored the presence and differences between menthol and non-menthol cigarettes and the impact of menthol on population health. Notably, the FDA indicates there are nearly 19 million current smokers of menthol cigarettes. However, significant racial disparities exist as nearly 85 percent of all Black smokers use menthol cigarettes compared to 30 percent of White smokers.

• Flavored Cigar Standard – After the 2009 TCA ban on flavors in cigarettes other than menthol, the FDA notes use of flavored tobacco cigars increased dramatically. Flavored mass-produced cigars and cigarillos are combustible products that can closely resemble cigarettes, pose many of the same public health problems, and are disproportionately popular among youth and other populations. The FDA’s standard would prohibit sales of any characterizing flavor (including menthol) in these cigar products.

In announcing these steps, the FDA points to the significant and disproportionate public health implications associated with the use of these flavored products, particularly on certain populations like African Americans. If the product standards are implemented, FDA enforcement of any ban on menthol cigarettes and all flavored cigars will address manufacturers, distributors, wholesalers, importers, and retailers. The FDA cannot and will not enforce against individual consumer possession or use of any menthol cigarettes or any tobacco product.

The next step for the FDA will be publishing the proposed rules in the Federal Register, allowing an opportunity for public comment. Following the FDA’s announcement, Governor Gavin Newsom issued a statement applauding the Biden Administration’s move and urging “the federal government to follow California’s leadership to protect public health and advance racial equity by moving to ban menthol-flavored cigarettes.” The Governor additionally called on the federal government to pursue other actions to limit the availability of tobacco products, including by banning flavored electronic cigarettes.

Recall, Governor Newsom signed into law SB 793 (Hill) last year which prohibits the sale of all electronic cigarette products with characterizing flavor (including menthol). However, tobacco industry representatives filed a referendum against the measure, successfully collecting enough signatures to stop the bill from taking effect until voters have a chance to weigh in during the November 2022 General Election. Since the referendum’s filing, a number of California public health organizations formed the “Campaign to Protect California Kids” to lead the effort to oppose the ballot measure. Committee Co-Chair Malia Cohen issued a statement following the FDA’s announcement this week similarly applauding the move and indicating “we have a moral obligation to continue advocating at the local and statewide level for policies that protect our kids’ health and save Black lives by ending the sale of minty-menthol cigarettes and candy-flavored tobacco across California.” U.S. Health and Human Services Secretary Xavier Becerra also issued a statement about the important public health benefits of banning menthol and flavored tobacco products.

Additional information from the FDA is available here.