The U.S. Food & Drug Administration (FDA) is aiming to finalize proposed rules that would ban, or limit, the sales of flavored cigars and menthol cigarettes by this fall.
That information was shared by Brian King, the director of FDA’s Center for Tobacco Products, at the Society For Research On Nicotine & Tobacco’s 2023 forum. King told those in attendance that the agency is working through roughly 250,000 comments that were submitted regarding the two proposed rules. Technically, FDA is considering the flavored cigar rule separately from the menthol cigarette, though the agency has—to date—kept the same public timelines for the similar rules.
AATCLC asks 2 fantastic questions clarifying timeline on menthol cig rule, and on menthol products that are cropping up that could get around rule. King says he’s hoping fall, and that FDA is “fully aware of the issue” of new menthol products on the market
— Katherine Ellen Foley (@katherineefoley) March 1, 2023
Previously, FDA has said that it will have a one-year compliance period for the rules, meaning that if the final rule went into effect in fall 2023, the agency wouldn’t be issuing no-sell marketing orders to companies until fall 2024, clearing the way for those products to legally be sold. That said, lawsuits challenging the validity of the regulations are virtually guaranteed and could delay the regulations similar to how a federal lawsuit has delayed certain parts of the deeming regulations, enacted in August 2016, from taking effect.
FDA announced plans to ban both flavored cigars and menthol cigarettes two years ago, the conclusion to a citizen’s petition that was originally 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 given no indication that larger flavored cigars would be exempt from the flavored cigar ban.
King also indicated the agency is working towards announcing a proposed rule that would establish nicotine limits for cigarettes and combustible tobacco products, which would include cigars. However, depending on the outcome of the Cigar Association of America, et al. v. United States Food and Drug Administration, et al. lawsuit, FDA may be unable to apply those limits to premium cigars. Per a July ruling in that case, it seems likely that cigars defined as “premium cigars”—handmade cigars that are not flavored—will no longer be subject to FDA regulations. The agency would inevitably have a chance to deem those products for regulation again, but it is likely that it will have to start the regulatory process over from the beginning.
Last June, the White House Office of Management and Budget (OMB), which oversees FDA in certain ways, said that an ANPRM regarding nicotine limits was coming in May 2023. FDA immediately walked back the May 2023 timeline, saying that it was “not intended to be a precise estimate.”
In Massachusetts, the exemption allows for specialty cigar lounges to continue to sell flavored cigars, while California’s allows for flavored cigars that have a wholesale price of $12 to continue to be sold.
Companies have taken different approaches in response to the bans, but their impacts are being felt. For example, Drew Estate announced that it would no longer sell three lines—Ambrosia, Isla del Sol and Tabak Especial—to California retailers. That said, the company is still selling its popular ACID line. Drew Estate told retailers it believes that the rest of its portfolio would not be banned in California “as they do not have a distinguishable taste or aroma that could be deemed a ‘characterizing flavor.’”
Meanwhile, some cigarette companies have responded to the California law by replacing menthol cigarettes with new cigarettes that are said to contain a synthetic cooling agent that could produce a similar effect as menthol.