Hirono Presses FDA for Timely Implementation of Ban on Menthol Cigarettes, Flavored Cigars

WASHINGTON, D.C. – U.S. Senator Mazie K. Hirono (D-HI) joined 21 of her Senate Democratic colleagues in a letter to the Food and Drug Administration (FDA) Commissioner Robert Califf, urging the FDA to promptly finalize its April 28, 2022 announced proposed rules to end the sale of menthol flavor in cigarettes and all flavors in cigars.

“We urge the FDA to act with urgency to solidify and enforce the ban on these harmful products,” wrote the Senators. “The harmful effects of these products on public health have been well-understood for several years and cannot be overstated. In 2013, your agency released a report that found that menthol cigarette use is associated with increased smoking initiation among youth and young adults, greater signs of nicotine dependence, and less success in smoking cessation.”

The 2013 findings, reinforced by more recent data from 2019, reports nearly 18.6 million Americans smoke menthol cigarettes. Youth who smoke are more likely to smoke menthol cigarettes, with almost half of cigarette smokers ages 12-18 choosing to smoke menthol cigarettes. Furthermore, the Senators’ letter spotlights how Big Tobacco aggressively targets minority communities through efforts at the point of sale, branding, and sponsorship to push these products. As a result, nearly 85 percent of African American smokers use menthol cigarettes, compared to 47.7 percent of Hispanic smokers, 41.1 percent of Asian smokers, and 30.3 percent of white smokers.

These scientific findings and concerning statistics, along with the FDA’s slipping deadlines, strongly support the need for swift action in finalizing and enforcing these critical regulations. However, the Senators’ letter notes that past rulemaking processes have shown a concerning trend of inaction from the FDA. In 2013 and again in 2018, the FDA published a notice of proposed rulemaking to obtain information related to the potential regulation of menthol in cigarettes. In March 2019, the FDA announced that it was considering removing flavored cigars that were on the market as of August 8, 2016. And a year ago, in April 2022, the FDA announced its intention to ban menthol as a characterizing flavor in cigarettes, and all flavored cigars. The Senators call attention to delays in the comment period for these rules—the original deadline was pushed from July 5, 2022 to August 2, 2022. Now, a year after the proposed rule was issued, the rulemaking is still not resolved. Despite these repeated overtures, the FDA has yet to issue a final rule on these topics, much less begin enforcement.

“While we appreciate the need for thorough, well-informed rulemaking, it is clear that these products pose significant and persistent threats to public health,” they continue. “The longer these products are allowed on the market, the more harm consumers and the American public will face.”

In order to better understand the FDA’s timeline for finalizing and enforcing these regulations, the Senators request responses to the following questions:

1. When does the FDA anticipate that it will finalize these rules regarding the ban on menthol cigarettes and flavored cigars?
2. How does the FDA plan to coordinate with other federal agencies for the purposes of enforcing these bans and increasing consumer and retailer awareness?
3. How does the FDA plan to address attempts from cigarette manufacturers to circumvent the ban on menthol cigarettes by offering “fresh” or “crisp” alternatives to menthol?[1]
4. Are there additional resources that Congress can provide to facilitate the enforcement of these rules once finalized?

In addition to Senator Hirono, the letter was signed by Senators Jeff Merkley (D-OR), Dick Durbin (D-IL), Alex Padilla (D-CA), Jack Reed (D-RI), Richard Blumenthal (D-CT), Ron Wyden (D-OR), Tammy Baldwin (D-WI), Sheldon Whitehouse (D-RI), Tom Carper (D-DE), Martin Heinrich (D-NM), Chris Coons (D-DE), Edward J. Markey (D-MA), Brian Schatz (D-HI), Elizabeth Warren (D-MA), Patty Murray (D-WA), Chris Van Hollen (D-MD), Sherrod Brown (D-OH), Tina Smith (D-MN), Tammy Duckworth (D-IL), and Maggie Hassan (D-NH).

This letter is supported by the Campaign for Tobacco-Free Kids, the American Lung Association, American Cancer Society Cancer Action Network, and the American Heart Association.

The full text of the letter is available here.

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