Science1 publisher3 min readPublished
Form letters made up 97% of the 175,000 comments on the FDA's menthol ban
Rutgers researchers found that 97% of the 175,000 comments on the FDA's proposed menthol ban were form letters, with only 2% unique. The Biden administration later cited that response when it postponed the rule, and the study shows how little of it was independent.
The Scientist · Science desk
What happened
- The FDA's 2022 draft rule to outlaw the manufacture of menthol cigarettes drew 175,000 public comments over a three-month comment period.
- Rutgers researchers, writing in JAMA Network Open, found that 97% of those comments were form letters opposing the ban and just 2% were unique.
- Nearly half of the letters matched language from campaigns run by Altria Group or Reynolds American, and most of the rest echoed industry talking points.
- After its March 2024 deadline passed without action, the Biden administration postponed the ban indefinitely that April, citing the vast public response.
- The proposed ban was officially scrapped the following year, after President Trump took office.
Compiled by The ScientistSomething wrong?How this is made
Why it matters
- contradiction Balla describes agencies answering the substantive few and discounting the rest, yet at the top of HHS the sheer size of the response was offered as a reason to wait.
- precedent Once identical letters have been cited as grounds for delay, any regulated industry facing a rule has a cheap, documented reason to generate them.
- exposure With the rule gone, menthols stay on sale to the group the ban was partly meant to protect: about 80% of Black smokers use them.
Applied to the full docket, the study's percentages leave about 169,750 form letters [1] and about 3,500 unique comments [2]. In ordinary rulemaking the second number is the one that counts. Agencies typically consider the substance of comments over their volume, said Steven Balla, co-director of the Regulatory Studies Center at George Washington University [7]. "You can imagine a case where there are a million 'I hate this rule' comments," Balla said. "But the agency's response will mostly be to the handful that are substantive." [8]
Volume is cheap to produce. During the Federal Communications Commission's 2017 net neutrality proceeding, one college student filed more than 7.7 million comments [6], at least 44 times the entire menthol docket [4]. The tobacco industry has run letter campaigns at federal agencies since at least the 1980s, when it targeted airline smoking restrictions [5].
The unusual part of the menthol case is what officials did with the total. When the comment period closed in August 2022, the FDA said it would "need ample time to comprehensively review and analyze all of the comments" [9]. It missed its deadline to issue the rule the following August and set a new one for March 2024 [10]. When the ban was shelved in April 2024 [14], Xavier Becerra, then secretary of Health and Human Services, pointed to the response. "This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback," Becerra said. "It's clear that there are still more conversations to have, and that will take significantly more time." [15]
The thing this count doesn't tell you is whether the letters caused the delay. Establishing that would take a comparison case, such as a rule that faced the same politics without a flood of identical mail. STAT's own phrasing is that the tactic "seems to have worked" [20], and the evidence supports that strength of claim and no more. Other pressures ran through the same months. President Biden needed the support of Black Americans, a key market for menthols, to win re-election [13]. In late 2023 a conservative organization bought television ads against the proposal [12]. The White House scheduled dozens of meetings, among them with law enforcement and civil rights groups that had taken tobacco industry money and argued the ban would bring illicit sales and biased policing [12]. Researchers have not found either outcome in Canada or the European Union after menthol bans there [19].
In my view the most useful output here is the classification itself. A published figure like 97% [2] gives anyone reading an official statement about "immense" feedback a number to check it against. The rule at stake covered a product that makes up more than a third of all cigarettes sold in the U.S. [17].
What to watch
- Any renewed federal menthol rule, and whether the agency reports what share of its docket was duplicated before citing the public response.
- Studies that compare rules hit by mass form-letter campaigns with similar rules that were not, which could test whether comment volume changes a rule's timing.