The White House Cancer Moonshot recently announced new efforts to “End Cancer as We Know It.” Yet, the announcement includes no mention of the FDA, which is not only directed at protecting and promoting the public health but also has existing powers that could reduce cancer deaths and harms more rapidly than any existing or planned Cancer Moonshot initiatives.
The Moonshot announcement stresses the fact that smoking is the “biggest single driver of cancer deaths in this country.” But its newly announced anti-smoking measures are remarkably weak and indirect, focusing largely on increasing cessation services and related smoker awareness. In particular, one new initiative would provide $15 million over 5 years to help increase implementation and enforcement of policies to increase awareness of smoking cessation services among disadvantaged smokers or prohibit the sale of menthol or other flavored tobacco products. But $15 million over 5 years is a drop in the bucket compared to the tobacco industry’s expenditures of more than $7.5 billion per year to promote cigarettes.
Moreover, any new efforts to support state and local policies to prohibit flavored tobacco products would be largely unnecessary if FDA implemented its long-overdue final rules to ban menthol cigarettes (the only added-flavor cigarettes currently allowed under federal law) and prohibit cigars with added flavors. By reducing youth initiation of smoking and prompting many existing smokers to quit, those two rules could sharply reduce cancer and cancer deaths. A recent University of Michigan study, for example, estimated that banning menthol cigarettes, by itself, would prevent 650,000 people from dying from smoking over the next 40 years — and roughly one-third of those prevented deaths would have been caused by smoking-caused cancers. But FDA has not received the support it needs from the White House, either through the Cancer Moonshot or otherwise, to get those final rules issued.
The absence of any mention of FDA or any support for the FDA rules to ban menthol cigarettes and prohibit added-flavor cigars in the new Moonshot announcement is odd given that FDA has otherwise been mentioned as a participant since the Cancer Moonshot was reignited in February 2022. A March 2022 fact sheet even mentioned the planned FDA rules to ban menthol cigarettes and added-flavor cigars as a major part of the Moonshot. In addition, the federal Unified Agenda of upcoming government regulatory action has included references to the two rules for years, and the most recent Unified Agenda said that the menthol cigarette and flavored cigar final rules would be issued by August 2023.
However, FDA missed that August deadline and has subsequently stated only that it expects to issue the final rules “in the coming months.” The Cancer Moonshot says nothing about this inexplicable delay in effective federal anti-cancer measures. Nor has the White House, FDA, or the Office of Management and Budget (which oversees federal regulatory efforts) provided any new deadlines or other assurances that the final rules will actually be implemented soon or at all.
If the White House and its Cancer Moonshot were truly serious about preventing and reducing cancer, they would have not only ensured that these two FDA rules were already fully implemented but would have also supported additional FDA anti-smoking rule-making that would reduce cancer deaths and harms even more quickly and sharply. Most notably, an FDA-coordinated study found that a new rule to reduce nicotine levels to non-addictive levels in cigarettes would, at a minimum, save millions of lives through reducing smoking initiation and increasing quitting. In addition, since fall 2017 the Unified Agenda has repeatedly said that FDA planned to issue a nicotine-reduction rule. But its announced date for issuing just the preliminary proposed rule has been repeatedly postponed, with the nicotine rule falling completely off the Agenda between spring 2019 and spring 2022; and implementing such a rule has never been part of the Cancer Moonshot. The most recent Unified Agenda says the proposed nicotine reduction rule will be issued before the end of this year. But if that were a real deadline that FDA was actually going to meet — or if FDA were actually going to issue its final rules on menthol cigarettes and flavored cigars soon — one would think the Cancer Moonshot would have at least mentioned that as a major upcoming success in federal efforts to reduce cancer deaths and harms.
Unfortunately, the White House Cancer Moonshot’s failure to support these FDA anti-smoking rules is nothing new. Since 2009, when the Tobacco Control Act first provided FDA with extensive powers and resources to regulate cigarettes and other tobacco products and their labeling, marketing, distribution, and sale, no U.S. president, vice president, or major White House official has publicly expressed any support for any FDA rulemaking to prevent or reduce smoking or overall tobacco use deaths and harms.
Thanks in large part to this absence of White House support, FDA has not yet been able to implement any substantive rule that would significantly reduce smoking or overall tobacco-caused deaths and harms. Without such support (or a statutory or court-ordered deadline), it is extremely difficult for FDA to get a draft proposed or final rule successfully through the federal bureaucracy’s behind-the-scenes prior review and clearance process. The Unified Agenda listings stating that FDA would issue final rules to ban menthol cigarettes and added-flavor cigars in August 2023 suggested that FDA was finally getting the White House support it needs to take effective action. But those missed deadlines and the absence of any reference to those or any other FDA anti-smoking rules in the subsequent Cancer Moonshot announcement suggests otherwise. It is also especially troubling that the White House Moonshot highlights a new initiative to support state and local policies to ban flavored tobacco products when the White House could simply ensure that FDA quickly did that nationwide instead.
This 14-year and counting absence of any major FDA tobacco control rule is a national tragedy. It is difficult to imagine any public health or policy justification for FDA not using (or not being allowed to use) its extensive tobacco control powers and resources, not only to reduce cancer deaths and harms more sharply and quickly than any other Moonshot initiative but also to prevent and reduce enormous amounts of other unnecessary smoking-caused death, disability, disease, and other harms and costs.
Eric N. Lindblom, JD, is a former official at FDA’s Center for Tobacco Products and a long-time tobacco control policy analyst. He currently serves as an independent consultant to researchers, lawyers, and investors on tobacco-related issues and is a senior scholar at Georgetown Law’s O’Neill Institute for National and Global Health Law.