The FDA has not yet finalized its plan to remove flavored cigars from store shelves, but it is facing strong pressure from industry groups to abandon the rule that was originally due by the end of the year.
The agency’s proposed rule (RIN 0910-AI28) is in its final review stages at the Office of Management and Budget. If implemented, the rule would prohibit the sale of cigars with flavors other than tobacco, such as strawberry, grape, cocoa, and fruit punch, in an effort to reduce the appeal of cigars to youth and young adults, according to the FDA.
The cigar industry is resisting the rule and has asked the OMB to reject the FDA’s proposal.
“We presented evidence to OMB that FDA’s proposed flavored cigar ban dramatically fails to meet the necessary criteria and offers little or no public health benefit while having a devastating economic impact on the industry,” said David Ozgo, president of the Cigar Association of America.
Opponents of the ban are likely to sue to block it. The cigar industry’s lengthy legal fight against the FDA’s inclusion of premium cigars in a rule regulating various tobacco products led a federal judge to strike down the rule in August.
“You can expect we will do whatever it takes to defend the industry and its consumers,” Ozgo said. The association represents manufacturers, distributors, importers, and suppliers in the cigar industry. It members include AJ Fernandez Cigars, Cheyenne International, and Davidoff of Geneva.
Judge Amit P. Mehta of the US District Court for the District of Columbia in that case was also unconvinced by the agency’s public health concerns over premium cigars since they’re “legally available to only a small segment of the population,” because of state laws against selling cigars to youths. The FDA appealed the ruling in September.
The proposed rule received more than 71,000 comments, with many members of the public stating that the FDA’s decision will reduce disease and death from tobacco product use. Those that disagreed with the agency commented that the rule would harm businesses and the economy.
The FDA proposed an effective date for the flavored cigar ban of one year after the date of publication of the final rule.
Scientific Evidence
The cigar association met with the OMB on Nov. 6 and told officials the ban would “cost the industry nearly $4 billion in sales—up to 47 percent of industry sales—and destroy 16,000 jobs.”
The group said the FDA’s scientific evidence concerning the risks and benefits for the ban’s creation falls short.
Ozgo pointed to the Federal Food, Drug, and Cosmetic Act’s tobacco product standards, which require that the agency consider whether a tobacco product standard is appropriate for the protection of the public health, taking into consideration scientific evidence concerning the risks and benefits to the population as a whole; the increased or decreased likelihood that existing users of tobacco products will stop using such products; and the increased or decreased likelihood that those who don’t use tobacco products will start using such products.
The proposed ban “fails on all three accounts,” Ozgo said. “Youth usage rates of cigars, and of flavored cigars in particular, are at all-time lows and these low rates reflect a stable and sustained trend.”
The association cited the recently released 2023 National Youth Tobacco Survey that showed past 30‐day youth cigar use declined to 1.6%. The 2022 survey showed youth cigar use at 1.85%.
The FDA in its proposal said it “carefully considered the scientific evidence and complex policy issues related to characterizing flavors in cigars.”
The agency in March 2022 released a report exploring whether the addition of characterizing flavors to tobacco products, including cigars, impact product appeal and product use, and how flavors impact youth and young adult experimentation with tobacco products.
“People who smoke cigars regularly are at increased risk for many of the same diseases as cigarette smokers, including oral, esophageal, laryngeal, and lung cancer,” the agency said in its proposal.
Groups like the American Lung Association, Campaign for Tobacco-Free Kids, and the American Cancer Society are urging the White House to finalize the rule soon, along with a rule to ban menthol cigarettes.
Two Tobacco Rules
The cigar industry is also concerned about the way the flavored cigar ban was proposed to the public with another tobacco standard on menthol in cigarettes (RIN 0910-AI60).
The rules target “two completely different products in how they are used, patterns of usage, and the health effects,” Ozgo said. “We believe the FDA has purposely tried to confuse that by linking the two rules. However, we believe that FDA should follow the science and follow the law.”
Richard Williams, the former director for social sciences at the Center for Food Safety and Applied Nutrition at the FDA, said the risk analysis is different between the products and the pairing of two rules could confuse the public.
“What they’re doing is they are conflating two rules,” Williams said in an interview. “One is a very risky product—there’s no question about cigarettes. The other is cigars.”
“With cigarettes, you have something that people smoke every day and that everyone inhales, that’s the way cigarettes work and that’s what makes them risky, besides the fact that they’re combustible. With cigars, you have a product that people smoke, at best, intermittently,” Williams said.
But when the rules were proposed and created, it was significant they “traveled together” from a public health perspective, according to Mitch Zeller, the former director of the Center for Tobacco Products at the FDA.
“If the only thing that happened was the menthol rule and you allowed strawberry and cherry and all of these flavors to remain in mass-produced cigars, then there was a likelihood that kids would simply migrate from menthol cigarettes to flavored cigars,” Zeller said.
“It was critical that the administration not create another whack-a-mole scenario where you fix a problem over here, but you don’t address and anticipate that you might simply be moving kids to another flavored product,” he added.
The administration has “seen this movie before,” where the banning of flavored cigarettes migrated consumers to flavored cigars.
“When the Tobacco Control Act passed in 2009, it ended the sale of all flavored cigarettes except for menthol cigarettes. What we immediately saw was the industry switch to flavors in little cigars and cigarillos, and in some cases, even the bigger cigars,” said Erika Sward, assistant vice president of national advocacy for the American Lung Association.