On April 29, 2021, the Food and Drug Administration (FDA) announced it's working toward issuing proposed product standards within the next year to ban all characterizing flavors (including menthol) in cigars.

Where We Stand:

 

  • Existing science and evidence is 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 remains unclear
  • FDA has not defined "characterizing flavors"

 

Any action by FDA to establish a product standard for cigars will require formal rulemaking, including public notice and comment. There is no required deadline or timeline for the FDA to act.

Additional Background and Activity

In 2018, as part of its Comprehensive Plan for Nicotine and Tobacco Regulation, FDA published an Advance Notice of Proposed Rulemaking in which it solicited comments on the role of flavors in tobacco products, including cigars. We submitted extensive comments demonstrating that the science and evidence did not support any restrictions on flavors in cigars.

In 2019, in response to the growing number of youth using e-vapor products, FDA proposed Draft Guidance revisiting its enforcement policy related to all newly deemed flavored products, including e-vapor products and cigars. As relates to cigars, FDA proposed changing its compliance policy to remove from the market flavors in cigars that had not yet received a marketing order.

We submitted comments to the Draft Guidance in which we showed that FDA's proposed action for cigars was not supported by science and evidence.1 FDA ultimately determined that "[a]fter consideration of the data regarding youth use of cigars generally and comments received on this issue, we have decided to not prioritize enforcement of flavors in cigars..."2


1ALCS "Docket No. FDA-2019-D-0661 (84 Fed. Reg. 9,345, March 14, 2019) – Comments on "Modifications to Compliance Policy for Certain Deemed Tobacco Products; Draft Guidance for Industry." April 30, 2019. Available at https://www.regulations.gov/document?D=FDA-2019-D-0661-15209.

2Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised). April 2019, p30. Available at https://www.regulations.gov/document?D=FDA-2019-D-0661-15434.