According to Politico, the Commissioner of the US Food and Drug Administration (FDA), Robert Califf, is leading a campaign to pressure the White House to approve a regulation banning menthol cigarettes. Califf, appointed by President Joe Biden, has asked friends and health experts to "put pressure on their contacts in the White House to find out the status of this long-delayed policy.
Once finalized, the regulation will prohibit the sale of menthol cigarettes and flavored cigarettes in the United States. Carif has been a strong supporter of this policy, claiming that it will reduce the initiation of smoking among adolescents and make it easier for adult smokers to quit.
According to Politico, in addition to seeking external assistance, Kariv also "enlisted senior officials from the White House and the Department of Health and Human Services to help advocate for this ban," and personally lobbied senior aides in the Biden administration.
Politico's description of Kariv's "behind-the-scenes encouragement of external pressure" as an "unconventional policy-making strategy" may underestimate the impact of these actions. It is hard to imagine that anyone in the country's top leadership would not be extremely infuriated by backdoor lobbying efforts carried out by appointed officials from lower cabinet agencies. Biden is already well aware of Kariv's stance on the proposed ban.
The FDA's ban on menthol cigarettes may be influenced by political pressure.
Since early December 2023, the FDA's regulation on menthol cigarettes has been in a state of limbo, with the expected date changed from 2023 to March 2024 in the White House's planned fall agenda (the 2024 date is tentative, not a firm commitment). The final regulation was sent to the White House Office of Management and Budget (OMB) for review in October of last year.
The Office of Information and Regulatory Affairs (OIRA) reviews all agency rules before they are finalized and implemented. From October to December last year, OIRA held meetings with opponents and supporters of the menthol cigarette regulation before making a final decision.
Opponents of the ban are concerned about law enforcement actions in minority communities and the rise of illegal sales. Supporters argue that the menthol ban will improve public health, especially within the African American community in the United States, but they dismiss concerns about unwelcome police interactions and potential backlash from angry menthol smokers as significant voter losses.
During the OIRA review, White House staff may have steered clear of the menthol cigarette ban due to warnings of political consequences, including potential decreases in Black voter turnout in November 2024. Biden understands the critical importance of Black voters to his chances for reelection. (Most Black smokers prefer menthol cigarettes.)
We are currently in a political season, which will only become more difficult for them," Campaign for Tobacco-Free Kids CEO Rhonda Richardson told Politico. "All delays are advantageous for the tobacco industry. It simply gives them more time to allow tobacco products to circulate in the market, prolonging the addiction among children.
However, there are now not many children smoking cigarettes. According to responses from the 2023 National Youth Tobacco Survey, only 1.6% of middle and high school students reported smoking in the past 30 days (even just a puff), marking the third consecutive year that this number has remained below 2.0%.
FDA refuses to authorize mint-flavored e-cigarettes to help smokers.
The FDA announced its intention to ban menthol cigarettes in 2021, a move that comes four years after FDA Commissioner Scott Gottlieb, appointed by President Trump, included the possibility of a menthol ban in his "comprehensive" tobacco and nicotine plan. The agency released a draft menthol cigarette regulation in April 2022.
Under President Biden's administration, the FDA is also planning to restart a key component of the Gottlieb plan: mandating cigarettes to contain very low levels of nicotine. However, the ban on menthol has garnered the most attention, largely because tobacco control organizations have been advocating for the ban on menthol cigarettes since the establishment of the FDA Center for Tobacco Products (CTP).
Gottlieb's "comprehensive plan" also includes the intention to authorize various e-cigarette products, with the former commissioner believing that these products will be embraced by many smokers as a substitute for traditional cigarettes. The FDA seems to believe that if their preferred menthol cigarettes are banned, menthol-flavored e-cigarettes could be a valuable tool in preventing menthol cigarette smokers from turning to the black market.
Even in the first year of Karif's leadership at the FDA, when the agency rejected the marketing of most flavored e-cigarette products, mint-flavored e-cigarettes and e-liquids largely escaped the banned fate and are still under review.
After Brian King, an official at the Centers for Disease Control and Prevention (CDC), took over leadership of the Center for Tobacco Products (CTP), there have been changes in how the Food and Drug Administration (FDA) handles menthol-flavored e-cigarette products in comparison to other flavors. Since King's appointment, the FDA has treated menthol products the same as other flavors, as research shows that young people primarily use flavored products (smokers of all ages). Under the leadership of Kariv and King, the agency no longer seems to believe that menthol cigarette smokers facing a ban need attractive e-cigarette alternatives.
Dr. Califf has long been a foe of e-cigarettes. As the last FDA Commissioner under Barack Obama's administration, Califf oversaw the implementation of the 2016 ruling, which initially included a total ban on flavored e-cigarette products. Califf later complained that the White House Office of Management and Budget had removed the ban from the final rule.
Before his return to the FDA in 2021, Kariv advocated for banning all flavored e-cigarettes and even proposed restricting e-cigarette products to a prescription-only model.
This three-way regulatory win,” Carruth wrote in 2019 during his time at the FDA, “would involve: 1) requiring the tobacco industry to reduce the nicotine content in their products to sub-addictive levels (if nicotine can be increased through irradiation and selective breeding, then even if the law prohibits reducing to zero levels, it can be lowered); 2) banning over-the-counter e-cigarette products; and 3) supporting prescription e-cigarettes so that the current 30 million smokers do not simultaneously experience acute withdrawal symptoms.
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