Following Outside Review, FDA Prepares Rules For Menthol In Cigarettes

Here’s an easy New Year’s prediction: Lawyers for nicotine marketers will be as busy as they’ve ever been in 2023.

One tipoff is this week’s coinciding actions by the U.S. Food and Drug Administration and Altria Group.

Yesterday, the FDA held its latest Grand Rounds webcast to provide an update on the agency’s proposed ban on menthol in cigarettes.

On the same day, Altria Group announced a New Year’s resolution of sorts in the form of a pledge to conduct an “equity and civil rights assessment” to address “the harm associated with tobacco use and the effectiveness of our harm reduction efforts.”

The assessment will include an evaluation of the company’s policies, practices, programs and services on “communities of color and youth.”

Back to the FDA: As previously reported, for more than a century tobacco marketers have targeted menthol cigarettes to Black communities and those with lower incomes using everything from advertisements to sponsorships of community organizations.

Because of the high propensity of Blacks to favor menthol cigarettes, the FDA has framed its case as “a pivotal moment for health equity.”

Having sought public comments (resulting in more than 175,000) until Aug. 2 of last year, the FDA is a few months from issuing rules regarding menthol cigarettes—a roughly $30 billion business that represents more than one-third of all cigarette sales.

Yesterday’s FDA webcast was based on research dating to 1980 regarding the effect of menthol in cigarettes on tobacco addiction.

Two findings were that menthol is viewed as contributing to a positive smoking experience, while it’s also associated with greater youth dependence.

Another easy prediction: Given the money at stake, if the FDA bans menthol it will be challenged by litigation that would likely result in an injunction while the legal tussle plays out over several years.

Back to Altria: In announcing its business assessment—which Altria attributes to a shareholder proposal last year—the company addressed legal concerns.

“Because the topics raised in the shareholder proposal are subject to active and pending litigation involving our companies’ tobacco products, the Assessment plan considers mitigating litigation risk while including extensive third-party perspective and oversight,” Altria stated in a news release.

The company is no stranger to courtroom battles, many of which stem from its 35% stake in vape marketer Juul Labs, and both companies’ battles with the federal government over antitrust issues and Juul’s youth-marketing tactics.

In a rare skirmish after the FDA abruptly rejected Juul’s premarket tobacco production applications (PMTA) for vape devices last June—only to see the rejection quickly suspended in court—Juul lashed out publicly at the FDA.

At the Global Tobacco and Nicotine Forum in September, Juul chief regulatory officer Joe Murillo said “The very integrity of the FDA review process is now called into question.”

An outside investigation of the FDA’s Center for Tobacco Products (CTP) called for by FDA Commissioner Robert Califf in July did not exactly drape the CTP in glory.

In a 39-page report, the Reagan-Udall Foundation acknowledged “the sheer volume of production applications” submitted to the CTP and the “near constant litigation it has encountered.”

Having solicited input from outside stakeholders including Altria, Juul, the American Vapor Manufacturers Association and nonprofit organizations, Reagan-Udall concluded that the CTP “has also struggled to function as a regulator in part due to some of its own policy choices.”

Among the criticisms of outside stakeholders were “a lack of consistent implementation of what they understood to be CTP’s policies” and that “policy shifts with broad impact on the industry occurred without notice.”

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