Where We Stand
On April 29, 2021, the FDA announced its intention to issue proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and to ban all characterizing flavors (including menthol) in cigars.
The science and evidence do not support these potential product standards.
- We share the goal of moving adult smokers from cigarettes to potentially less harmful alternatives, but prohibition does not work.
- Criminalizing menthol will lead to serious unintended consequences, including an illicit market, an impact to state and federal excise taxes and master settlement agreement payments, and to jobs throughout the legitimate distribution chain.
- Youth smoking rates, including menthol cigarettes, are at historical lows and the federal legal age of purchase is now 21.
- A far better approach is to support the establishment of a marketplace of FDA-authorized smoke-free alternatives for helping to switch adult smokers away from smoking.
The use of menthol in cigarettes has been evaluated several times since the inception of FDA's regulation of tobacco. The Tobacco Control Act directed the FDA's Tobacco Products Scientific Advisory Committee to provide a report and recommendation on the impact of menthol cigarettes on public health. The committee submitted its report to the FDA in March 2011.
In 2013, the FDA published an Advance Notice of Proposed Rulemaking (ANPRM) seeking information from the public regarding potential regulation of menthol in cigarettes. With this notice, the FDA also released its independent review of the science related to menthol in cigarettes. This included an external peer review of the FDA's assessment of the science.
Later in 2018, FDA issued an ANPRM on flavors in tobacco products which sought information on topics including menthol in cigarettes.
FDA's intention to propose a product standard to ban menthol in cigarettes will require formal rulemaking, including public notice and comment. There is no required deadline or timeline for the FDA to act.
In 2018, FDA also solicited comments on the role of flavors in cigars. We submitted extensive comments demonstrating that the science and evidence did not support any restrictions on flavors in cigars.
In 2019, an FDA Draft Guidance proposed removing from the market flavored cigars that had not yet received a marketing order. We submitted comments in which we showed that:
- Existing science and evidence are inadequate to support restrictions on the use of flavors in cigars
- Cigars with flavors have not been shown to play a unique role in initiation, dependence or cessation
- Youth cigar smoking rates, including flavors in cigars, are low and continue to decline
- The effects on health risks of flavors in cigars compared to unflavored cigars remain unclear
- FDA has not defined "characterizing flavors"
FDA's intention to issue a product standard to ban characterizing flavors in cigars requires formal rulemaking, including public notice and comment.