fda tobacco product standards


As you may be aware, on April 29, 2021, the U.S. Food and Drug Administration (FDA) announced it is committing to advancing two tobacco product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors in cigars. 

In order to do this, the FDA will need to complete “notice and comment rulemaking” in compliance with the Administrative Procedure Act other applicable laws and Executive Orders. “Notice and comment rulemaking” is the process that FDA generally uses to create or modify regulations. This process involves drafting and publishing a proposed rule in the Federal Register that describes the planned regulation and the basis for it (e.g., scientific and policy reasons), and seeks public comment. Section 907 of the Tobacco Control Act also describes the process and requirements for proposing and promulgating product standards. Under section 907(c)(4) of the Act, FDA must provide for a comment period of at least 60 days, but the comment period can be 90 days or longer for more complex rulemakings or if FDA grants an extension request. If, based on all the information, FDA decides to issue a final rule, it would then need to draft a final rule for publication that includes a statement of basis and purpose for the regulation and that discusses the issues raised in public comments.  

While the public health goals of the FDA and other federal agencies may be well-intentioned, we believe the science and evidence does not support a ban on characterizing flavors in cigars. Currently we do not know the full details of the proposal put forth by the FDA, however, the company is adamantly opposed to any proposal that would remove flavors from our cigar products. 

In addition, we believe there are less intrusive yet more effective public health measures that are already in  place including the increase in the federal minimum purchase age of tobacco products to 21 as well as the FDA’s own pre-market approval process also already in place. Furthermore, there are many adult products including alcohol, beer and seltzers that contain characterizing flavors that are consumed by adults. We are prepared to  participate in the notice and comment rulemaking process to outline the lack of a scientific justification for the proposed ban as well as the detrimental effects that would result from its implementation.  

We will continue to monitor the situation and will continue to work closely with our legal and government relations teams and advisors to keep you informed with facts and any potential developments on this. As a reminder, any inquiries related to this topic should be directed to Joe Augustus, Executive Vice President, Global Affairs. 

Thank you.