SILVER SPRING, Md. — When it comes to the U.S. Food and Drug Administration’s proposed rules prohibiting menthol cigarettes and flavored cigars, people had a lot to say.
The agency received nearly 250,000 comments on the rules before the comment period closed on Aug. 2—30 days later than originally planned. Those comments included about 175,000 for the menthol cigarettes proposed rule and about 71,000 for the flavored cigars proposed rule, the FDA said.
In addition to accepting written public comments, the FDA held public listening sessions on June 13 and 15 where individuals and organizations also had a chance to share their perspectives with the FDA.
As part of the rulemaking process, the FDA must review all these comments—but it will take some time, the agency warned.
“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,” the agency said in a statement. “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.”
On April 28, the FDA announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors, other than tobacco, in cigars.
The proposed regulations would not include a prohibition on individual consumer possession or use, and would only address manufacturers, distributors, wholesalers and importers of these products in the U.S.
The FDA must address all comments received, among other items, before submitting the rule again to the Office of Management and Budget. If the final rule is ultimately issued, there is a statutory one- to two-year delay before it can be legally implemented, meaning it would take years for these rules to take effect, if ever.
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