Tobacco Companies Helped Turn FDA’s Menthol Comment Process Into a Flood

Nearly a quarter-million comments landed in two US Food and Drug Administration dockets in 2022, responding to proposed rules that would have barred menthol as a characterizing flavor in cigarettes and prohibited characterizing flavors in cigars. The sheer volume later became part of the explanation for delaying a decision. But a new analysis finds that the apparent groundswell was, overwhelmingly, made from repeated text.

Of the 246,808 submissions, researchers at Rutgers University identified 169,440 form letters in the menthol-cigarette docket and 66,640 in the flavored-cigar docket. After filtering out those letters, exact duplicates, and substantially similar submissions, just 3,342 menthol comments and 1,432 cigar comments counted as unique.

Seventeen Templates Shaped the Record

The comments were not simply sorted by hand. Researchers first reviewed a random sample of 3,000 submissions to identify recurring language, then used text-mining software to detect common phrases and calculate whether comments resembled one another. The process identified 17 distinct form-letter templates. A similarity score of 0.5 or more against another comment was enough to remove a submission from the final pool of unique comments.

The result is less a measure of public opinion than of how efficiently an organized campaign can use a federal comment portal. Public commenting is meant to let people raise concerns before agencies finalize rules. In this case, volume obscured the difference between independently written testimony and text that had circulated through advocacy systems.

Content associated with tobacco companies appeared in 77,445 menthol-cigarette comments, or 44% of the full menthol docket, and 6,883 flavored-cigar comments, about 10% of that docket. The study linked the largest identifiable cluster to RAI Services’ “Own It, Voice It” campaign, while others contained wording associated with Altria campaigns.

“The sheer volume of comments was used as a reason to delay a public health policy that would have saved lives,” says Andrea Villanti, lead author of the study and a professor at the Rutgers School of Public Health. “What wasn’t considered was how few of those submissions were unique or how much tobacco company influence had shaped both the volume and the content of the comments.”

The Remaining Comments Focused on Business

Even after the repeated submissions were removed, opposition dominated. About 96% of unique menthol-cigarette comments and 99% of unique flavored-cigar comments opposed the proposed rules. The most common themes were projected losses of sales or revenue, concern that prohibition would shift products into illicit markets, and calls for education or other approaches instead of product restrictions.

Health evidence was much less visible in the remaining record. Only 5% of unique menthol comments and 3% of unique cigar comments discussed targeted marketing in Black communities. Still fewer mentioned evidence on how menthol and flavors can facilitate tobacco use.

That imbalance matters because menthol use is not evenly distributed across the population. In 2020, about 81% of non-Hispanic Black adults who smoked cigarettes used menthol cigarettes, compared with 34% of non-Hispanic White adults who smoked. The CDC says menthol cigarettes contribute to US tobacco-related health disparities and notes the industry’s long history of targeted marketing. CDC data on menthol smoking disparities

“Taken together, these findings show how the tobacco industry influence can shape policy debates in ways that obscure scientific evidence and distort perceptions of public opinion,” says Kymberle Sterling, a study co-author and associate professor at the Rutgers School of Public Health. She says delayed, weakened, or withdrawn protections leave Black communities and other populations disproportionately targeted by menthol-cigarette and flavored-cigar marketing bearing an unequal burden of tobacco-related harm.

Menthol’s cooling sensation can reduce the harshness of cigarette smoke, and federal health authorities say it can increase nicotine dependence and make quitting harder for some people. The 2024 Surgeon General’s report on tobacco-related disparities concluded that policies restricting menthol-cigarette availability can reduce smoking initiation and prevalence in groups that have disproportionately high use.

A Delayed Rule, Then a Withdrawal

The FDA opened the comment periods in May 2022 and extended them to 90 days. The agency sent final rules to the White House for review in 2023, but the Biden administration postponed action in April 2024. In January 2025, the menthol-cigarette rule and the flavored-cigar rule were withdrawn from regulatory review. The federal regulatory record lists the menthol rule as withdrawn on January 21, 2025, while the corresponding cigar rule received the same disposition. The cigar-rule record

The new study does not establish that form letters caused the delay or withdrawal. It instead examines a crucial premise in the public account of the delay: that the agency faced an unusually large volume of independent feedback. The authors argue that their findings expose a weakness in a process that treats all submissions as equal units of public response, regardless of whether the text arose from an individual or a coordinated campaign.

There are important limits. The team may have missed additional templates, did not analyze attached files, and could not identify many commenters because docket metadata were incomplete. The researchers recommend that federal docket systems collect referral-source information and require more submitter data, changes that could make the next flood of comments easier to trace back to its source.

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