A coalition comprising civil rights and medical groups announced Tuesday their lawsuit against the US Food and Drug Administration. The legal action is prompted by the agency's failure to meet its self-imposed deadline to enact a ban on menthol cigarettes.
“At the core of this issue lies prioritizing financial gains over human well-being. We are advocating, representing national associations, for the primacy of people,” stated Dr. Yolanda Lawson, president of the National Medical Association. This organization stands as the oldest representing Black physicians in the nation. She made these remarks during a press briefing held on Tuesday.
Additional plaintiffs include the African American Tobacco Control Leadership Council and Action on Smoking and Health.
"The tobacco industry understands that each year of postponement presents another chance to ensnare more of our population," remarked Carol McGruder, a founding member of the African American Tobacco Control Leadership Council, during the press briefing.
The FDA previously designated this matter as a "top priority" when it submitted the final regulation to prohibit menthol cigarettes and flavored cigars to the White House for consideration in October. Anticipated for the previous year, the ban's regulatory deadline was extended to March following lobbying efforts from diverse stakeholders by year-end.
"There is no scientific or legal justification for this delay, and even the FDA acknowledges its importance," remarked Kelsey Romeo-Stuppy, managing attorney for Action on Smoking and Health. "The postponement appears to be driven by political motives."
"It's almost incomprehensible that it took two lawsuits from non-governmental organizations to compel the implementation of a public health measure that the FDA itself acknowledges is supported by evidence and law."
All cigarette flavors except menthol were prohibited in 2009. The FDA has been deliberating on a menthol ban for over a decade. In a development hailed by public health advocates as significant in April 2022, the FDA proposed a product standard, citing its potential to "significantly reduce disease and mortality," curb "youth experimentation and addiction," and increase smoking cessation rates.
According to Romeo-Stuppy, approximately 40,000 Americans have lost their lives due to menthol cigarettes since the organizations initiated their lawsuit on the matter back in 2020. This legal action aimed to prompt the FDA to make a decision regarding whether menthol should be included among the banned tobacco flavors. In 2013, the Public Health Law Center lodged a citizen petition urging the FDA to outlaw the sale of menthol cigarettes. Upon the FDA's formal commitment to include menthol in the list of prohibited flavors, the groups withdrew their initial lawsuit.
The FDA declined to comment on ongoing litigation but affirmed its commitment to expeditiously issuing tobacco product standards for menthol in cigarettes and characterizing flavors in cigars. These regulations are in the final stages of review by the Office of Management and Budget. Despite constraints on discussing the specifics of the rules, the FDA emphasized that these standards remain a top priority.
The organizations involved in the lawsuit assert that a ban would not only save lives but also reduce healthcare costs. A recent study suggests that over a 20-year span, it could decrease healthcare expenses for all adult smokers by approximately $1.62 billion. Furthermore, another study indicates that it could prevent up to 654,000 deaths in the US within 40 years, including 255,000 lives within the Black community.
The advantages would be particularly notable for Black and LGBTQ+ communities. According to the US Centers for Disease Control and Prevention, tobacco companies have actively targeted these communities with menthol marketing for years. This targeted approach has proven highly effective, contributing to exacerbated health inequalities.
A study conducted in 2020 revealed that while 43% of all adult smokers opted for menthol cigarettes, over 83% of Black smokers did so. In contrast, only around 30% of White smokers preferred menthols.
Black individuals experience significantly higher mortality rates from smoking-related diseases such as stroke, heart disease, and lung cancer compared to White individuals. Despite comprising only 12% of the US population, Black individuals account for 41% of premature deaths attributable to smoking and 50% of the years of life lost due to menthol tobacco product usage between 1980 and 2018, as indicated by a study.
The study revealed that within five years, the removal of menthol cigarettes could narrow the disparity in lung cancer fatalities.
According to the CDC, over half of adolescent smokers opt for menthol cigarettes. Additionally, studies indicate that youngsters who smoke menthols are more prone to transitioning into regular smokers rather than occasional ones.
According to a recent study, a quarter of smokers cease altogether within a year or two of a menthol ban implemented in other countries and in certain US municipalities.
During Tuesday's press briefing, Dr. Valerie Yerger of the African American Tobacco Control Leadership Council emphasized the disproportionate toll tobacco takes on Black Americans. She urged action from the FDA, President Biden, and his administration, highlighting their awareness of the evidence. Dr. Yerger stressed that it's high time for them to overcome whatever obstacles are hindering the removal of these lethal products from the US market.
Certain organizations have highlighted the irony of the Biden administration's declaration regarding April's National Cancer Prevention and Early Detection Month. The American Cancer Society Cancer Action Network, though not involved in the lawsuit, contends that achieving the Cancer Moonshot's ambitious aim of eradicating cancer as we know it would be challenging without a menthol ban.
Dr. Karen E. Knudsen, CEO of the American Cancer Society and the Cancer Action Network, emphasized the administration's missed opportunity to establish a significant, enduring public health legacy and meet its Cancer Moonshot objectives by failing to finalize these regulations.
While not part of the lawsuit, the American Lung Association has voiced its endorsement of such efforts.
"The FDA's findings indicate that menthol cigarettes do not serve the interests of public health. It's frustrating that the prolonged delay in implementing menthol regulations has forced our partners to resort to legal action," stated Harold Wimmer, President and CEO of the association, in a press release issued on Tuesday.
According to Christopher Leung, the attorney representing the groups, the FDA will likely have approximately two months to address the lawsuit in court.
Despite requests for comment, the White House remained silent on the lawsuit.
"We urge President Biden and his administration to safeguard our interests," emphasized McGruder on Tuesday. "We understand that this final rule marks just the beginning of a lengthy process aimed at rectifying the harm inflicted upon our community."
