The long-awaited FDA bans on the sale of flavored cigars and menthol cigarettes will not be announced in 2023.
Earlier today, the White House Office of Management and Budget Office of Information and Regulatory Affairs unveiled its Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions, a semi-annual update of various planned rules and regulations. In doing so, it confirmed earlier reports that the U.S. Food & Drug Administration’s (FDA) finalized rules regarding flavored cigars and menthol cigarettes had been delayed until next year.
Both rules now have a final rule date of “03/00/2024” though it’s unclear if either rule will be announced in March 2024 as the dates in the Unified Agenda are not legally binding.
Technically, these are two separate rules—one for flavored cigars and another for menthol cigarettes—though they have been intertwined during the rulemaking process, something that continues with today’s delays.
The rules would ban the sale of the products throughout the United States. The text of the proposed rules unveiled in 2022 did not contain any language that would exempt the sale of some products, such as larger flavored cigars.
Currently, there are statewide restrictions on the sale of most flavored cigars in California and Massachusetts, though both states have exemptions for certain types of flavored cigars. California has also banned the sale of menthol cigarettes, though tobacco companies have found ways around that ban.
Both rules are going through the final steps before they can be enacted as laws. FDA unveiled proposed rules in April 2022 and allowed for comments on its proposals later that year. Since then, the agency has been reviewing comments and crafting final rules, which went to the White House Office of Management & Budget (OMB) in October 2023, one of the last steps before a proposed rule can become law. FDA must get approval from OMB, which is supposed to determine the legality and financial impact of the rules before proposed regulations become law.
Various groups—ones in favor of and opposed to the rules—have been lobbying OMB since then. In November, the Cigar Association of America (CAA) and Premium Cigar Association (PCA)—two cigar trade groups—announced that they had met with OMB regarding the flavored cigar proposal.
In the last week, anti-tobacco groups have raised concerns that the menthol cigarette ban was on track to be delayed until 2024, with some suggesting that the White House will ultimately delay the final rule until after the November 2024 election. Various groups have lobbied against menthol cigarette bans, arguing for decades that it would give law enforcement a reason to target minorities for smoking menthol cigarettes. The proposed rules would not make it illegal to smoke menthol cigarettes or flavored cigars; it would introduce regulations regarding the sale and distribution of these products.
Delaying the rule until after the election could place the future of the law in the hands of voters. If Republicans were to win the November 2024 election, it would mean the rules could be subject to a regulatory freeze, a longstanding tradition when a new president halts executive actions taken during the final days of the previous administration. Donald Trump, the Republican frontrunner, would presumably be interested in not enacting a Biden-era regulation but also is noted for his personal aversion to tobacco products. While Trump was president, he signed a law that increased the federal minimum age to purchase tobacco products from 18 to 21. That said, a new Republican administration could effectively scrap the law in its entirety.
Today’s update is the second time this year the rule has been delayed. In March, Brian King, the director of FDA’s Center for Tobacco Products, told a conference that the agency would announce the finalized rule in the fall. That was later pushed back to be before the end of 2023, which will no longer happen.
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,” meaning it won’t be until at least 2025 before it becomes illegal to sell these products.
It is widely expected that whenever the finalized rules are announced, FDA will be sued by various companies and groups that are affected by the laws.
Today’s delay does not prevent states or local governments from enacting their own bans on the sale of flavored cigars or menthol cigarettes.