FDA Kills Menthol Ban: A Triumph for Harm Reduction

On the second day of the Trump administration, the Food and Drug Administration officially withdrew a 2022 proposed rule and announced it was no longer moving forward with a ban on menthol cigarettes. The agency cited concerns over the practical challenges of enforcement and the potential for unintended consequences—similar to the results of failed state-level bans in Massachusetts and California.

Some public health commentators bemoaned the withdrawal of the ban, citing it as a loss for public health. On the contrary, this decision presents a valuable opportunity for the FDA to pivot toward effective public health strategies that focus on decentralization, harm reduction, and self determination.

Available evidence on menthol bans points to unintended harm or meager results. In California, for instance, a discarded pack audit showed that even after the state’s menthol ban, 14.1% of collected cigarette packs were still menthol, and another 7% were flavored by consumers themselves—indicating a thriving illicit market. Meanwhile, in Massachusetts, a 58.6% increase in smoking rates among Black women post-ban underscored how prohibition can backfire, especially in communities that disproportionately prefer menthol products.

By rejecting the ban the agency has capacity to address bigger public health concerns, such as streamlining regulatory frameworks that encourage harm reduction and reducing barriers for innovative alternatives for people who smoke.

Rather than rehash a ban that would be difficult to enforce and unlikely to curb cigarette use, the FDA can channel its resources into strategies that empower individuals to make more choices instead of less.

Mounting evidence from both American and international sources indicates that these choice-based harm reduction strategies are far more effective and sustainable than outright prohibitions. A 2020 review, published in Preventive Medicine, underscores how choice-based harm reduction strategies are effective at significantly cutting down the risks associated with traditional tobacco use. By examining population-level smoking trends, this peer-reviewed research highlights that when vapers have access to lower-risk devices, overall smoking harms decline.

Corroborating these findings, the Royal College of Physicians (RCP) in the United Kingdom concluded in its landmark 2016 report, Nicotine without Smoke: Tobacco Harm Reduction, that regions with choice-based strategies have less smoking-related harms than regions with bans. This level of reduced harm is precisely why top-down bans, which remove these potentially life-saving alternatives from the market, produce counterproductive outcomes. Instead of driving down nicotine use overall, prohibition can push consumers toward unregulated or illegal products, where health risks and misinformation proliferate.

Even the U.S. Food and Drug Administration (FDA) has acknowledged the significance of differentiating among tobacco products. Its 2019 decision to authorize certain snus products as “Modified Risk Tobacco Products” (MRTP) establishes that some tobacco products can indeed present significantly fewer hazards than combustible cigarettes. Granting these products a lower-risk designation not only validates scientific findings but also sends a critical policy signal: When proven by evidence, safer alternatives should be available for consumer choice rather than restricted by blanket bans.

Public health policymakers who embrace harm reduction principles can avert thousands of smoking-related deaths each year. Shifting away from an abstinence-only or prohibition-focused strategy, and instead providing lower-risk options for nicotine consumption, reflects a more pragmatic and research-driven approach.

Taken together, these studies and expert opinions form a clear consensus: Choice-based solutions—allowing smokers access to regulated, lower-harm alternatives—can work in tandem with existing public health tools to drive down smoking prevalence, reduce the burden of disease, and minimize the emergence of black markets. In contrast, top-down bans run the risk of pushing individuals toward illicit products and sidestepping meaningful regulation, ultimately undermining public health objectives. By upholding consumer choice and scientifically vetted harm reduction strategies, policymakers can more effectively protect both individual and societal well-being.

Having pulled back from a top-down prohibition on menthol cigarettes, the FDA should seize the moment to establish a regulatory framework that embraces innovation, self-determination, and meaningful harm reduction.

We need policies that will deter illicit markets by increasing the number of safe alternatives available legally. If we’re serious about curbing smoking-related deaths and protecting public health, the solution is simple: more freedom for safer choices, fewer top-down bans, and a steadfast commitment to empowering consumers, not driving them underground.

As Benjamin Franklin wrote in a letter to the Pennsylvania General Assembly, “those who would give up essential liberty, to purchase a little temporary safety, deserve neither liberty nor safety.” As Americans, we tend to value liberty as much and often more than safety. The FDA should heed this value and implement an effective, choice-based approach to tobacco policy.