Is the FDA Nicotine-Reduction Rule for Cigarettes Dead? Can it be Revived?

By Eric N. Lindblom

The U.S. Tobacco Control Act (TCA) does not allow the U.S. Food and Drug Administration (FDA) to ban all cigarettes, or other entire categories of smoked tobacco products.[1] Accordingly, issuing a regulatory rule to reduce nicotine to non-addicting levels in cigarettes and certain other combustible tobacco products likely offers the most effective, legally viable way for FDA to use its TCA authorities to prevent youth addiction to smoking, help smokers who want to quit to do so, otherwise reduce smoking among both youth and adults, and shrink overall tobacco-use deaths, health harms, and costs as quickly and sharply as possible.[2] Indeed, FDA has supported issuing a nicotine-reduction rule for some time;[3] and in the very final days of the Biden Administration, FDA issued a proposed nicotine-reduction rule to begin the formal legal process for doing so.[4]

Just days after Donald Trump was sworn in as President, his Office of Management and Budget (OMB) formally withdrew from consideration a pending FDA rule to ban menthol cigarettes that was ready to be issued in final form.[5] In contrast, the Trump Administration has taken no public action on the pending proposed nicotine-reduction rule. But that does not necessarily mean that the nicotine-reduction rule has the support it needs from the White House to be issued before President Trump leaves office.

Getting any new final rule through the notice-and-comment rulemaking procedures established by the Administrative Procedure Act (APA) is unavoidably complicated and time consuming. Among other things, the APA requires FDA to issue a proposed rule for comment by any interested parties, with the subsequent final rule having to be a logical outgrowth of the proposed rule and be published with documentation showing that FDA has considered and provided responses to all relevant, substantive comments submitted on the proposed rule (whether that entails any changes to the proposed rule or not).[6] The APA also requires that FDA decisions relating to the final rule and its final form must not be arbitrary or capricious, given the comments received on the proposed rule and other relevant information, research, and evidence available to FDA.[7] Concurrently, the TCA requires any rule FDA issues to regulate cigarettes, their manufacture, or their marketing to be “appropriate for the protection of the public health”[8]—and the rule must also fall within the authorities given to FDA by the TCA and not violate the First Amendment or any other constitutional provisions or laws that might be applicable.

Right now, the deadline for submitting comments on the pending proposed nicotine-reduction rule is September 15, 2025 (but FDA could extend the comment deadline if requested).[9] Once the comment period officially closes, it would normally take FDA about a year to organize all the comments, develop the legally required responses to all relevant, substantive comments, and make any related desired or necessary changes to the proposed rule before continuing the process to issue it in final form. Whether FDA could move that fast under current conditions, however, seems doubtful.

Hindering FDA rulemaking efforts, the leadership and expert staff at FDA and its Center for Tobacco Products have been sharply diminished by the efforts of the Trump Administration and its unofficial Department of Government Efficiency (DOGE) to reduce personnel throughout the government, which started soon after President Trump took office in January 2025,[10] followed by efforts starting in April 2025 that were specifically targeted at further reducing leadership and other staff at FDA and other health agencies.[11] Among other staff removals, those FDA efforts prompted the Director of FDA’s Center for Tobacco Products to leave government service and eliminated the Center’s expert team in charge of drafting and revising rules.[12]

Even if FDA, with its diminished capacity, were still able to organize and respond to all submitted public comments on the nicotine-reduction rule and prepare a final, legally valid version for possible implementation, it still could not release the final rule without clear White House support.

Beyond the legal requirements for rule making, agencies wanting to release new proposed or final rules have in past administrations—Republican and Democratic—had to get approval from OMB, which receives guidance, if not direction, from the White House Office of Policy. In addition, OMB has traditionally sent drafts of proposed and final rules to all federal departments, agencies, bureaus, and offices that might have an interest in the rule to elicit any comments, questions, or concerns they might have. OMB then asks the regulatory agency to respond, whether or not any changes are made to the draft rule or not, which can prompt another round of comments, questions, and concerns from the responding federal offices. Without a hard deadline from a statute or court order, this circular process can continue indefinitely unless the White House wants the rule issued and sets its own deadline for issuing the rule.

While it is not certain that the Trump Administration will follow these long-standing practices, the Administration’s actions to date regarding regulations and regulatory agencies, including FDA, suggest more active White House involvement compared to past years rather than less.

The importance of White House support to get any final rule issued when there is no statutory or court-ordered deadline is perhaps most clearly illustrated by the fact that FDA—despite the extraordinary powers it has had since 2009 to regulate tobacco products to reduce public health harms—has not been able to implement a single final rule that would significantly reduce the enormous amount of death, disability, disease, and other harms and costs caused by tobacco-nicotine products despite its desire to do so.[13]

The only two substantive final rules FDA has been able to issue—each, in turn, to require graphic health warnings (GHWs) on cigarettes[14]—did not require White House support to be released because they were legally required to be issued by deadlines firmly established, respectively, by the Tobacco Control Act[15] and by court order[16] (with the first GHW rule struck down for violating the First Amendment[17] and the second GHW rule still being blocked by tobacco industry legal challenges).[18]

Currently, there are no laws or court orders explicitly requiring FDA to issue a rule to regulate nicotine in cigarettes or any other tobacco products by a specific date, and it remains unclear whether the Trump White House would ever support issuing any such rule, despite the large public health gains and other benefits the rule would produce.[19]

The Trump Administration’s purging of the leadership and expert staff at FDA’s Center for Tobacco Products suggests a pro-tobacco-industry or anti-tobacco-regulation perspective in the Trump White House. But those actions might also be explained by a general White House desire to reduce the size of the government bureaucracy, replace existing government personnel with staff more loyal to President Trump, or remove leadership and staff from public health agencies who have values and approaches that conflict with those of President Trump and Robert F. Kennedy, Jr., his Secretary of Health and Human Services (HHS), of which FDA is one part.

In the first Trump Administration, the Secretary of HHS and the FDA Commissioner published a joint opinion piece in the October 2018 Washington Post stating that issuing the nicotine-reduction rule was the top tobacco control priority for both FDA and HHS.[20] However, little or nothing was publicly done or said about the nicotine-reduction rule in the Trump Administration after that opinion piece appeared, and the Fall 2019 Unified Agenda, which lists pending or planned new federal regulations, stated that the nicotine-reduction rule listing was being withdrawn, without any explanation provided in the Unified Agenda or by FDA.[21]

Like the first Trump Administration, the new one has generally taken strong positions against any new government regulations. For example, President Trump issued an Executive Order in early 2025 stating that no new regulation should be issued unless the issuing agency had identified at least ten existing regulations it would repeal.[22] Exceptions could be made if President Trump believed there were strong political or policy reasons to do so. However, President Trump, HHS Secretary Kennedy, and FDA Commissioner Makary have not made any public statements supporting the nicotine-reduction rule or any other new or increased government anti-smoking efforts. Even President Trump’s Executive Order “Establishing the President’s Make America Healthy Again Commission” makes no mention of reducing smoking, or any mention of tobacco use at all, despite stating a need to reduce cancer and chronic disease and promote more healthy lifestyles.[23] Moreover, the Trump Administration has shut down the Office of Smoking and Health at the U.S. Centers for Disease Control and Prevention (CDC), which could indicate a deemphasis on reducing smoking.[24]

It is also possible that the tobacco industry’s strong support for Republican candidates for federal office, including President Trump, could make the Trump Administration less likely to support regulations, such as the nicotine-reduction rule, that would sharply reduce industry profits. For example, following past contribution patterns, in the 2024 election cycle, the tobacco industry contributed almost three times as much directly to Republican candidates for federal office as it contributed to Democratic candidates ($3.5 vs. $1.2 million).[25] Separately, the 2024 election’s top corporate donor to Make America Great Again, Inc., the main pro-Trump super PAC, was RAI Services Company, a subsidiary of the second largest U.S. tobacco company, Reynolds American, which contributed $8.5 million.[26] After the election, the Altria tobacco company, the biggest U.S. cigarette company, was one of the largest corporate donors to President Trump’s inauguration, contributing $1 million[27] (it does not appear that any tobacco companies contributed to President Biden’s inauguration).[28]

All the above suggests that the Trump Administration is not likely to be sympathetic to any efforts to issue a final nicotine-reduction rule, especially if the major tobacco companies continue their long-standing, active opposition.[29] Nevertheless, the proposed nicotine-reduction rule has not been withdrawn, and FDA continues to accept public comments.

Might the Trump Administration still issue a final nicotine-reduction rule for cigarettes and certain other combustible tobacco products?

One possibility might be that President Trump, who, as a candidate, made strong public statements favoring e-cigarettes,[30] might see that issuing a final rule to reduce nicotine in conventional cigarettes would promote smokers switching to e-cigarettes; reduce smoking deaths, other harms, and costs; and give President Trump credit for taking strong effective action to “Make America Healthy Again.”

It is also possible that a new, unexpected sharp increase in youth and/or adult smoking, both of which have been declining and are at historically low levels, might increase calls for new FDA anti-smoking measures—especially if the increase in smoking and related harms were linked to the Trump Administration’s termination of CDC’s Office of Smoking and Health and its efforts that removed leadership and staff at FDA’s Center for Tobacco Products.

However, the most likely possibility for getting a final nicotine-reduction rule issued during this Administration might be a lawsuit by public health organizations demanding that FDA and the Trump Administration issue a nicotine-reduction rule for cigarettes based on language in the Tobacco Control Act supporting such a rule and on FDA’s findings that a nicotine-reduction rule for cigarettes would be “appropriate for the protection of the public health” (the standard for FDA action in the TCA).

Such a lawsuit would directly parallel the lawsuit during the Biden Administration by African-American and public health organizations demanding FDA action on menthol cigarettes.[31] In the menthol case, the court rejected government efforts to dismiss the lawsuit for being without merit or certain to lose; and the only way FDA and the federal government could get the court to dismiss the case and avoid the significant risk of an adverse final ruling was to issue the proposed menthol rule.[32] Once the case was dismissed, however, the Biden Administration repeatedly delayed issuing any related final menthol rule and ultimately never issued one,[33] which prompted the plaintiffs to refile the underlying lawsuit, which is currently still pending.[34]

Like the menthol lawsuit, a lawsuit to prompt a new nicotine-reduction rule would likely avoid being dismissed by the courts and could prompt a constructive settlement. It is also more likely to prompt a favorable final court ruling, as the public health gains from implementing a final nicotine-reduction rule that applies to almost all smoked tobacco products are much larger than those from implementing a menthol rule that applies only to a minority of currently consumed cigarettes.[35] More importantly, the statutory support for requiring FDA to issue a final nicotine-reduction rule is much stronger.

For example, “menthol” is mentioned only seven times in the Tobacco Control Act, but “nicotine” is mentioned 42 times. In addition, the TCA directs FDA’s Tobacco Products Scientific Advisory Committee to provide information to FDA about the effects of altering nicotine yields from tobacco products and on whether there is a threshold level below which nicotine yields do not product dependence, presumably to guide FDA efforts to regulate how much nicotine cigarettes and other tobacco products deliver to consumers.[36] Even more powerfully, the TCA subsection, “Content of Tobacco Product Standards,” states: “A tobacco product standard established under this section for a tobacco product – (A) shall include provisions that are appropriate for the protection of the public health, including provisions, where appropriate – (i) for nicotine yields of the product.”[37]

With nicotine, a proposed rule is also already in place and the lawsuit could immediately focus on the need for a court order to ensure that a related final rule will be issued promptly, despite the change in Administration since the proposed rule was issued, the new Administration’s opposition to new regulations, and the actions already taken by the new Administration against government anti-smoking efforts. Indeed, the menthol lawsuit and related Biden and Trump Administration actions could be cited to show the court that having a proposed rule issued for public comment does not in any way ensure that a final rule will ever be issued, no matter how beneficial for the public health and how necessary to fulfill the purposes of the Tobacco Control Act.

Whether any public health groups will initiate any such lawsuit to try to force FDA action to reduce nicotine in cigarettes and other combustible tobacco products remains to be seen. But the pending menthol lawsuit or a new nicotine lawsuit against FDA might be the only ways to try to ensure that there will be some major, substantive government action to reduce smoking and overall tobacco use deaths and harms during this second Trump Administration.

 

[1] U.S. Family Smoking Prevention and Tobacco Control Act (TCA), Sec. 907(d)(3)(A)[21 USC 387g(d)(3)(A)].

[2] Benjamin J. Apelberg, Shari P. Feirman, Esther Salazar, Catherine G. Corey, Bridget K. Ambrose, Antonio Paredes, Elise Richman, Stephen J. Verzi, Eric D. Vugrin, Nancy S. Brodsky & Brian L. Rostron, “Potential Public Health Effects of Reducing Nicotine Levels in Cigarettes in the United States,” New England Jnl of Medicine 378(18): 1725–1733 (May 3, 2018), https://pubmed.ncbi.nlm.nih.gov/29543114/; Eric N. Lindblom, What Tobacco Control Rules Would an Ethically Responsible FDA Implement (If the White House Let It)? − Would a Nicotine-Reduction Rule Pass Muster?, O’Neill Institute Working Paper (Sept. 27, 2021); Micah L. Berman, Patricia J. Zettler & David L. Ashley, Anticipating Industry Arguments: The US Food and Drug Administration’s Authority to Reduce Nicotine Levels in Cigarettes, 133 Public Health Reports 502–06 (July–Aug. 2018), https://pubmed.ncbi.nlm.nih.gov/29879366/.

[3] FDA, Advance Notice of Proposed Rulemaking, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, Federal Register 83(52) 11818–843 (Mar. 16, 2018).

[4] FDA, Proposed Rule, Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products, Federal Register 90(10): 5032–5144 (Jan. 16, 2025).

[hereinafter FDA, Proposed Rule].

[5] Office of Information and Regulatory Affairs, Office of Management and Budget, OIRA Conclusion of EO 12866 Regulatory Review, RIN: 0910-A160 (Jan. 21, 2025).

[6] Administrative Procedures Act (APA) at 5 USC 553; Long Island Care at Home, Ltd. v. Coke, 551 U.S. 158 (June 11, 2007).

[7] APA at 5 USC 706; Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43–44 (June 24, 1983).

[8] TCA Sec. 907(a)(3) et seq.[21 USC 387g(a)(3) et seq.]; Sec. 906(e)[21 USC 387f(e)]; Sec. 906(d)[21 USC 387f(d)]; Eric N. Lindblom, “What Is ‘Appropriate for the Protection of the Public Health’ Under the U.S. Tobacco Control Act?,” Food and Drug Law Journal 74(4): 523–585 (June 2020) [with a correction and further information provided in Eric N. Lindblom, “FDA Can’t Follow a Pure Harm-Reduction Approach in its Upcoming E-Cigarette PMTA Orders,” O’Neill Institute Blog (Aug. 17, 2021)].

[9] FDA, Proposed Rule, supra note 4.

[10] Elaine Shao & Ashley Wu, “The Federal Work Force Cuts So Far, Agency by Agency,” The New York Times (updated May 12, 2025); Matthew Chapman, Jason McLure & María Pérez, “Mass firings hit US tobacco regulators overwhelmed with thousands of new products,” The Examination (Feb. 28, 2025).

[11] Sheryl Gay Stolberg, Christina Jewett & Apoorva Mandavilli, “Mass Layoffs Hit Health Agencies That Track Disease and Regulate Food,” The New York Times (Apr. 1, 2025); Matthew Perrone, “FDA tobacco official is removed from post in latest blow to health agency’s leadership,” Associated Press (Apr. 1, 2025); Truth Initiative Website, “What Federal Health Agency Cuts Mean for Tobacco Control,” https://truthinitiative.org/FederalCuts, accessed Aug. 8, 2025; Christina Jewett, “Trump Budget Cuts Hobble Antismoking Programs,” The New York Times (May 15, 2025).

[12] Perrone, supra note 11; Truth Initiative Website, supra note 11; Jewett, supra note 11.

[13] FDA Website, “Rules and Regulations Related to Tobacco Products,” https://www.fda.gov/tobacco-products/rules-regulations-and-guidance-related-tobacco-products/rules-and-regulations-related-tobacco-products, accessed Aug. 8, 2025.

[14] FDA, Final Rule, Required Warnings for Cigarette Packages and Advertisements, Federal Register 76(120): 36628 et seq. (June 22, 2011); FDA, Final Rule, “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements,” Federal Register 85(53): 15638 (Mar. 18, 2020).

[15] TCA Sec. 201, amending FCLAA subsection 15 USC 1333, creating new Sec. 4(d).

[16] American Academy of Pediatrics v. U.S. FDA, 330 F.Supp.3d 657 (D. Mass. 2018).

[17] R.J. Reynolds v. FDA, 696 F.3d 1205 (DC Cir. 2012).

[18] R.J. Reynolds et al. v. US FDA, No. 6:20-cv-00176 (E.D. Texas, Jan. 13, 2025).

[19] Apelberg et al., supra note 2; Lindblom, What Tobacco Control Rules Would an Ethically Responsible FDA Implement, supra note 2; FDA, Proposed Rule, supra note 4.

[20] Alex M. Azar, & Scott Gottlieb, “We cannot let e-cigarettes become an on-ramp for teenage addiction,” The Washington Post (Oct. 11, 2018).

[21] Unified Agenda, HHS/FDA, “Tobacco Product Standard for Nicotine Level of Certain Tobacco Products; Request for Information,” RIN: 0910-AH65 (Fall 2019).

[22] Executive Order, Unleashing Prosperity Through Deregulation (Jan. 31, 2025).

[23] The White House, Presidential Actions, “Establishing the President’s Make America Healthy Again Commission” (Feb. 13, 2025).

[24] Truth Initiative Website, supra note 11; Jewett, supra note 11.

[25] Open Secrets, Tobacco PACs contributions to candidates, 2023–2024, https://www.opensecrets.org/industries/totals?cycle=2024&ind=A02, accessed Aug. 8, 2025.

[26] Isaac Stanley-Becker, Dan Diamond & Josh Dawsey, “Why Big Tobacco is betting on Trump,” The Washington Post (Sept. 18, 2024).

[27] Clara Ence Morse, Cat Zakrzewski, Aaron Schaffer, Luis Melgar & Nick Mourtoupalas, “Meet the top donors to Trump’s $239 million inauguration fund, The Washington Post (May 9, 2025).

[28] Federal Election website, PIC [Presidential Inaugural  Committee] 2021, Inc., Itemized Donations Accepted, https://docquery.fec.gov/cgi-bin/forms/C00765040/1513848/f132, accessed Aug. 8, 2025.

[29] “Comment from RAI Services Company” (16 documents), FDA, Advance Notice of Proposed Rulemaking on Tobacco Product Standard for Nicotine Level of Certain Tobacco Products, Docket No. FDA-2017-N-6189 (July 13, 2018); “Comment from Altria Services, LLC,” FDA, Advance Notice of Proposed Rulemaking on Tobacco Product Standard for Nicotine Level of Certain Tobacco Products, Docket No. FDA-2017-N-6189 (July 16 2018).

[30] Juliann Ventura, “Trump vows to ‘save vaping’ despite previous support for ban,” The Hill (Sept. 21. 2024).

[31] African American Tobacco Control Leadership Council, et al. vs U.S. HHS, FDA, et al, Case No. 4:24-cv-1992-HSG (USDC No. District of CA); Public Health Law Center Website, “African American Tobacco Control Leadership Council et al. v. U.S. Dept. of Human Services et al. (2020),” www.publichealthlawcenter.org/litigation-tracker/african-american-tobacco-control-leadership-council-et-al-v-us-dept-human, accessed Aug. 8, 2025.

[32] Public Health Law Center Website, supra note 31.

[33] Dan Diamond, “Biden Administration Delays Menthol Cigarette Ban Again Amid Political Concerns,” Washington Post (Apr. 26, 2024); Dan Diamond & David Ovalle, “Biden ban on menthol cigarettes to be delayed amid political concerns, officials say,” Washington Post (Dec. 6, 2023).

[34] Public Health Law Center Website, “AATCLC v. DHHS (2024),” https://www.publichealthlawcenter.org/litigation-tracker/aatclc-v-dhhs-2024, accessed Aug. 8, 2025.

[35] Apelberg et al., supra note 2; FDA, Proposed Rule, supra note 4; FDA, Proposed Rule, Tobacco Product Standard for Menthol in Cigarettes, Federal Register 87:86: 26454–26502 (May 4, 2022).

[36] TCA, Sec. 917(c)[21 USC 387q(c)].

[37] TCA, Sec. 904(b)(4)[21 USC 387d(b)(4)].

 

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