August 10, 2022
When FDA plans to issue a new regulation or revise an existing one, the regulation is formed with the public’s help. A key way FDA solicits feedback from the public on such regulations is by publishing it in the Federal Register, which describes the planned regulation and provides background on the issue. Anyone in the general public can submit comments on the regulations FDA proposes. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule.
On May 4, 2022, FDA published two proposed tobacco product standard rules in the Federal Register:
- Tobacco Product Standard for Menthol in Cigarettes and
- Tobacco Product Standard for Characterizing Flavors in Cigars.
Initially, FDA provided a 60-day comment period for the rules, but FDA later extended the comment period to a total of 90 days. On Aug. 2 the comment period closed. FDA received a very large number of comments - nearly 250,000 comments on these two proposed rules combined, including approximately 175,000 for the menthol cigarettes proposed rule and approximately 71,000 for the flavored cigars proposed rule.
In addition to accepting written public comments, the agency convened public listening sessions on June 13 and June 15 to expand direct engagement with the public. The listening sessions were another opportunity for individuals, communities, and organizations to share their perspectives with FDA.
FDA appreciates the public’s active engagement in the rulemaking process, and has already begun to review the comments, scientific data, expert opinions, and facts that have been submitted. FDA is committed to completing the rulemaking process as quickly as possible; however, the agency will need ample time to comprehensively review and analyze all of the comments. As additional information is available, FDA will continue to provide updates on the status of this rulemaking process.