In 2022, the U.S. Food & Drug Administration (FDA) announced that it was advancing proposals to ban the sales of menthol cigarettes and flavored cigars in the U.S.
While largely tied to one another, the two proposals were technically separate actions, though the agency tended to approach them as a pair of actions. The May 2022 announcement led to a legally required comment period for both proposals, which allowed anyone to submit their thoughts on what the FDA was proposing. Nearly two years later, the Biden administration announced that the menthol cigarette proposal had been formally delayed. Xavier Becerra, the secretary of the Department of Health and Human Services at the time, said that this was due to “historic attention and the public comment period has yielded an immense amount of feedback,” though many speculated that the delay was related to the upcoming 2024 presidential elections.
In the early days of the second Trump administration, the proposals were formally pulled from the docket, meaning they are no longer under active consideration.
A new study from tobacco researchers, “Public Comments and Federal Rulemaking for Menthol Cigarettes and Flavored Cigars,” published in JAMA Network Open, looked at the nearly 250,000 total comments submitted for the two rules and found that the vast majority were against the two rules. The researcher determined that 97 percent of the comments submitted regarding the menthol cigarette study were “form comments,” i.e., identical submissions that are believed to have come from a form. It found that 93 percent of the comments regarding flavored cigars were “form comments.”
There is nothing improper about form comments. Many trade groups, including those like the Cigar Association of America, Cigar Rights of America and Premium Cigar Association, craft comments for people to submit during comment periods. These allow the organizations the ability to make it easier for people to submit their comments and keep them focused on specific talking points. The researchers found that some form comments were generated by tobacco companies and distributed to consumers, retailers and employees, which is also legal. While there were form comments that were supportive of the bans, the overwhelming amount of comments were against the two proposals
“Interestingly, the main opposing themes present in these comments differed from those identified in content analyses of national news coverage of FDA’s proposed rules related to MCs and FCs. Most national news stories (75%) highlighted the potential health benefits of FDA’s proposed rules. In contrast, only 3% to 5% of unique comments in the dockets addressed tobacco and health harms,” wrote the authors. “Additionally, concerns about enforcement against individuals and increased criminalization of Black or African American individuals were conveyed as prominent opposing arguments in the news articles, while top opposing arguments in the FDA comments were economic, relating to loss of revenue and sales and potential for an illicit market. Differences in themes across these data sources may reflect activation of tobacco consumers and retailers to submit comments given the presence of known industry arguments against these policies. They also reflect a difference in the goal of each medium—that is, to inform the public on a policy issue via news articles vs to advocate for a specific policy outcome based on more individualistic concerns in the public comments.”
Of the two proposals, more than 70 percent (175,285 comments) were submitted regarding the menthol cigarette ban. There were 71,523 comments submitted regarding the flavored cigar proposal. Of that, the researchers concluded that 66,640 were form comments and more than 51,000 were the same form letter, identified as Letter 2A.
Interestingly, the contents of the letter mention the sales of menthol cigarettes and not flavored cigars. Letter 2A was submitted nearly 30,000 times to the menthol cigarette docket.
Letter 2A:
As a small-business operator in [STATE], I’m very disappointed to learn that the FDA is considering a ban on licensed retailers selling menthol cigarettes to adults 21 and older. Please do not move forward with this rule that could harm my business by shifting a large part of my sales to illegal, unregulated markets.
Our company adds to the local economy. Banning menthol cigarettes could have a direct and negative impact on our sales, threatening jobs and the economic contributions our business provides. With inflation and gas prices so high, regulators should not compound the economic hardship convenience store operators are facing by removing their ability to sell flavored tobacco products.
This ban targets a significant portion of my revenue, since menthol cigarettes alone make up 36% of all cigarette sales in the United States. This proposal to ban the legal, regulated sale of menthol could undermine my ability to operate by significantly impacting my revenue. Plain and simple: it’s misguided and could force small businesses to close.
Further, this ban could harm retailers and businesses across the country by pushing many sales away from legal businesses like mine. Instead of being sold in stores that follow the law, menthol cigarettes could move into illegal markets where any sale and distribution would be treated as a crime under the laws of all 50 states. Flavor bans create illegal markets that sell unregulated bootleg products, cause massive tobacco tax revenue losses, and lead to more underage access and crime.
Underage use of menthol cigarettes is down to less than 1%, a historic low. These reductions have happened not by prohibiting product choices for adults, but with education, underage prevention, and, most recently, a national minimum age of 21.
Please consider the possible harm to small businesses and our communities this ban could cause. Instead of banning legal products for adults, FDA should focus on solutions that work, like education, cessation support, underage prevention, and authorizing less harmful alternatives for all adult smokers.
Of the cigar-specific letters, one that opposed the ban but argued that “a significant percentage of all cigars may be considered to have a characterizing flavor. This is true for premium cigars…” was submitted 2,238 times (though 2,456 times in the menthol cigarette docket). This form comment appears to have come from a company or trade group concerned with selling mass-market flavored cigars and not handmade cigars.
There was a form comment that looked to have come from a hand-made cigar trade group, though it appeared just 342 times, less than half of a percent of all the comments submitted to the flavored cigar docket.
The researchers also found 638 comments from employees of Swisher and 78 from Drew Estate, which is owned by Swisher. Employees of Universal Leaf, a major tobacco supplier, submitted 68 comments to the menthol cigarette docket and 71 to the flavored cigar ban. Drew Estate was the only handmade cigar company mentioned by name.
Given the Biden administration’s effusiveness about why it pulled the proposed bans, it’s unclear whether the comments had much to do with the delay of what are much-debated proposals. While it is true that the FDA is required to respond to these comments, it’s unclear whether the volume of comments, many of which were identical, mattered. Of the nearly 250,000 total comments, researchers found that fewer than 5,000 were unique comments.
The researchers looked at when the comments were posted and found that in both dockets, there were days in which no comments or virtually no comments were posted, and then spikes when tens of thousands of form comments were posted. It’s unclear whether this is due to a rash of comments being submitted on a single day or rather that this represents the processing of these comments.
While states like California and Massachusetts have passed their own flavored cigar and menthol cigarette bans, there are some exemptions to both. So far, the Trump administration has given every indication that it will not advance either proposal.
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FDA
FDA Center for Tobacco Products
Flavored Cigars
Flavored Tobacco Products
Menthol
U.S. Food & Drug Administration
