FDA Sends Proposed Flavored Cigar, Menthol Cigarette Bans to OMB

Last Friday, FDA’s plans to ban the sale of flavored cigars and menthol cigarettes in the U.S. took a notable step.

The U.S. Food & Drug Administration (FDA) formally submitted the proposed rules—while similar, the actions are two separate rules—to the White House Office of Management & Budget (OMB), one of the last steps before the final rules will be unveiled. The rules will be reviewed by OMB, which serves as a clearinghouse of sorts for executive actions like this. While the Biden administration is in favor of both bans, OMB is also likely to add scrutiny to FDA’s plans, including asking the agency questions about the economic impacts of the bans—both for the government and businesses—as well as questioning certain legal aspects of the proposal.

Historically, OMB has also been a place where the tobacco industry has lobbied to try to soften the impact of rules.

FDA announced plans to ban both flavored cigars and menthol cigarettes in 2021, the conclusion to a citizen’s petition that was filed in 2013. The petitioners argued to a federal court that FDA had not met the requirements in responding to the citizen’s petition to ban menthol cigarettes, which the judge agreed with. FDA was ordered to respond to the petition by April 29, 2021. It did so by saying that it was planning on banning both flavored cigars and menthol cigarettes, plans that it said would be announced within a year.

Nearly a year to the date—April 28, 2022—FDA announced that it was moving forward with both proposed regulations, starting the formal rulemaking process that the agency must follow when it crafts new regulations. This included creating proposed rules, as well as allowing for comments about the proposed rules. The commenting period ended in early August 2022. So far, FDA has been working with a policy that would ban all cigars with a characterizing flavor other than tobacco, regardless of their size or price.

Previously, FDA indicated that the final rules would be announced this fall, though it’s unclear whether the agency still plans on meeting this timeline, though the rules are widely expected to be announced before the end of the year.

FDA has said that there will be a one-year compliance period before the agency takes action by punishing those selling the two types of products, i.e. flavored cigars and menthol cigarettes will be sold for at least one year after the finalized rules “go into effect.” The tobacco industry is likely to sue FDA and will likely ask for an injunction until after those lawsuits are resolved, further delaying the enforcement.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.