(Left to Right) Laura Macherelli, associate, BakerHostetler; Lindsey Stroud, senior fellow, Taxpayers Protection Alliance; Jeff Stier, senior fellow at Consumer Choice Center.
The Trump administration’s chain-saw approach to the status quo may inexplicably cut open a path for more sensible regulation of novel nicotine products and help curb the illicit market.
Across the US nicotine industry, hopes are growing that under the new Trump administration things will change for the better in terms of tobacco product regulation. Trump’s anticipated more industry-friendly stance probably stems from that RAI Services Company, a subsidiary of tobacco company Reynolds American, and its substantial backing of Trump’s 2024 election campaign. According to a Washington Post report, the company donated a combined US$10 million to Trump’s ‘Make America Great Again’ super PAC, an independent expenditure-only committee that may raise unlimited sums of money from corporations, unions, associations, and individuals and then spend unlimited sums to overtly advocate for or against political candidates. The move made RAI Services Company the biggest corporate donor to the 2024 presidential race.
That Robert F. Kennedy, Jr., Trump’s new health secretary, was spotted placing a nicotine pouch beside his gum during his Senate confirmation hearing on January 30 was also interpreted as a positive sign by industry stakeholders, potentially signaling that tobacco harm reduction will play a greater role under the new administration.
“The second Trump administration is expected to take a more industry-friendly approach to tobacco regulation, with fewer restrictions and an emphasis on economic growth,” predicts Laura Macherelli, associate at law firm BakerHostetler. “While Trump has taken actions in the past that surprised both public health advocates and industry stakeholders—such as raising the federal tobacco purchase age to 21—his recent statements suggest a shift toward easing regulatory pressures.”
She forecasts that state-level efforts to implement generational smoking bans, as considered in Massachusetts and Hawaii, or other state-specific restrictions may face increasing resistance under a federal administration that favors deregulation. “While states have the authority to set their own public health policies, a pro-industry federal government could influence these debates through legal challenges or economic incentives that discourage restrictive measures. Additionally, if the US Food and Drug Administration’s (FDA) loosens regulatory guidance or limits enforcement actions, it could embolden industry groups to push back against state initiatives, making it more difficult for generational smoking bans to gain traction. However, public health advocacy remains strong at the state level, meaning that legal battles over these policies are likely to continue regardless of federal positioning.”
As with other issues, Trump didn’t hesitate for long. Only a day after taking office, the new administration withdrew the FDA proposed ban on the sale of menthol cigarettes and flavored cigars. The previous Biden administration had missed deadlines in December 2023 and March 2024 to issue a final rule on the ban following meetings with dozens of groups opposing the rule.
The withdrawal of the proposal suggests that the Trump administration is prioritizing regulatory rollback over restrictive tobacco policies, particularly those with significant social and economic implications, Macherelli says. “The ban had already faced delays under the Biden administration, with concerns about enforcement challenges, potential black markets, and disproportionate impacts on minority communities.”
Bans aren’t helpful
Given this, the proposed nicotine yield reduction rule—another sweeping regulation aimed at altering tobacco products which FDA submitted during the last days of the Biden administration—could face a similar fate, she adds. “Like the menthol ban, the nicotine reduction rule would require extensive industry adjustments and has been met with skepticism regarding its effectiveness and unintended consequences. The Trump FDA’s decision to halt the menthol ban without issuing an official statement indicates a preference for minimizing regulatory intervention, making it likely that the nicotine yield reduction rule will also be delayed or withdrawn.”
Lindsey Stroud, senior fellow with the Taxpayers Protection Alliance, points out that the proposed menthol and characterizing flavor bans ignored data that finds youth combustible cigarette and cigar use at record lows, while adult use of cigarettes continues to decline. “It would have led to increased use of unregulated products, likely causing more harm than good. The proposed reduced nicotine levels also ignore data – and science. Nicotine is not what causes the most harm in smoking – it is the tar and burning of nearly 700 ingredients, which creates a smoke containing thousands of harmful chemicals. There is very little real-world evidence that such proposed rules will actually reduce smoking, and in fact, could lead adults to smoke greater amounts to reach a sustainable and satisfactory level of nicotine consumption.”
Stroud says that such very-low nicotine (VLN) regulation would push currently regulated, and widely available products, immediately out of the marketplace, while ignoring how adults and consumers respond to bans. “As evidenced in Trump’s 2020 decision to ban flavored e-cigarette pod systems, which created a massive marketplace for unregulated disposable vapes, the proposed nicotine reduction essentially would ban all cigarettes which are on the marketplace – and the market will respond. In California, which banned the sale of menthol cigarettes, there is already an influx in cigarettes from other states – and other countries. In Massachusetts, another state with a current menthol cigarette ban in place, it is common to see adults being arrested for selling narcotic drugs in addition to menthol cigarettes. Ultimately, while trying to reduce smoking rates is a worthwhile goal, banning existing products will only lead to increased profits for criminal enterprises.”
FDA likely to experience changes
One question that comes up in this context is the future role of FDA. The agency, which was given authority to regulate the manufacture, distribution, and marketing of tobacco products under the 2009 Tobacco Control Act, has been repeatedly criticized and even sued for its failure to make timely and transparent decisions on the market authorization of novel nicotine products, while the illicit disposable vapes market in the US has reached unprecedented highs. In FDA’s lengthy and demanding authorization process, the risk of youth uptake of vaping, which the agency considers as a gateway to smoking despite conflicting scientific findings, has been a determining factor, preventing to date any vape products flavored other than tobacco being authorized for sale.
“FDA’s regulation of novel tobacco products has been dismal at best, and a dramatic failure at worst,” comments Stroud. “Despite the science and data, only 76 products have been authorized using the premarket tobacco product application pathway. Of that, only 34 e-cigarette products have been authorized for sale, all of which come in tobacco and menthol flavors. Conversely, in 2023 alone the agency authorized 666 combustible cigarette products, despite these being far deadlier, and that adult cigarette use is at its lowest rates recorded in the US. This is wholly inadequate and questions the agency’s ability to even regulate tobacco products – which is the newest Center at the agency.”
In an analysis piece on the potential meaning of a second Trump administration for tobacco industry regulations, Macherelli hinted at the possibility that Trump might revive his proposal from his first term to move tobacco regulation out of FDA and into a new agency within the HHS.
“The likelihood of Trump reviving this proposal depends on administrative priorities and legal challenges like FDA vs. Wages and White Lion case,” Macherelli explains. The pending case is considered a landmark case for regulatory accountability related to public health and consumer choice. At issue is whether FDA acted arbitrarily and capriciously when denying numerous premarket tobacco product applications (PMTA), as alleged by the manufacturers and affirmed by the US Court of Appeals for the 5th Circuit, which accused FDA of a “regulatory switcheroo”. A decision is expected by the end of the Supreme Court’s term in June.
“A Supreme Court ruling against FDA could justify restructuring its regulatory authority,” Macherelli relates. “Supporters argue that FDA was designed to regulate food and drugs, not tobacco, and that a dedicated agency within HHS would provide more focused oversight while reducing bureaucratic inefficiencies. This could streamline product approvals and create a more predictable regulatory environment. However, critics warn that such a shift could weaken public health protections and increase industry influence. The transition would also require significant restructuring, leading to enforcement and compliance uncertainties. If pursued, this move would likely be framed as limiting government overreach while fostering a more industry-friendly regulatory approach.”
But even if the new administration does not remove tobacco regulation from FDA’s authority, they could still revise some of the agency’s guidelines. Prior to being re-elected, one of Trump’s many utterances (“promises?”) was to “save vaping again”. Although his statement was vague, it possibly indicates that he understands the role that flavors play in tobacco harm reduction (THR), says Stroud. She is optimistic that this pledge, coupled with FDA’s recent issuing of marketing orders for flavored oral nicotine pouches, could be a new day for adults who rely on flavors to be smoke-free. On January 16, FDA authorized 20 Zyn nicotine pouch products, among them several non-tobacco or menthol-flavored variants.
“It is ever apparent that FDA is failing on tobacco and vape regulation – and a change must come,” Macherelli says. “There could be a rulemaking change – similar to the deeming regulations in 2016 which defined all newer products as to bacco products and subjected them to FDA regulations. Congress could also introduce legislation that has been introduced in previous Congresses which would change the predicate date – i.e., the arbitrary date set in the Tobacco Control Act which determined which products were ‘new’ products and subject to a more extensive approval process.
Other changes could be establishing a notification process instead of an approval/authorization process. Manufacturers would notify FDA of their products, complying with certain FDA regulations, and focus on post-market surveillance of products to ensure youth use remains low and that there are no issues with consuming these products.”
Revising FDA guidance, Macherelli adds, could make the PMTA process more accessible, particularly for smaller vape and nicotine product manufacturers. “If the Trump administration encourages a more flexible approach, it could lead to a clearer, less burdensome pathway for market authorization. However, regulatory oversight will likely remain strict, meaning that while revisions could open opportunities for smaller companies, compliance will still be a significant hurdle.”
Trust the science
Jeff Stier, senior fellow at the Consumer Choice Center, is optimistic that under a president who was elected under the premise of reducing regulation and improving American business, the US will see improvement in the regulatory environment. He expects a change in personnel at FDA and the Department of Health and Human Services (HHS).
While the latter got new leadership with Kennedy Jr.’s confirmation as health secretary, the nominations of Martin Makary, a surgical oncologist and previous adviser at conservative think tank Paragon Health Institute, for FDA Commissioner, and Jay health economist Bhattachary as director for the National Institutes of Health were still pending at press time. In an article for the DC Journal, Brad Rodu wrote the two nominees were “renowned for challenging the rigid healthcare orthodoxy rampant in federal tobacco policy,” having “the potential for transformative leadership in tackling massive mortality from smoking.” The changes in personnel at FDA, Stier predicts, will result in the agency following the science in its decisions. “And the science continues to move in the same direction – in favor of tobacco harm reduction,” Stier comments. “The only thing that derailed it, from an FDA perspective, was the alleged youth vaping epidemic. But now, FDA itself has acknowledged that it has dissipated and there is no epidemic. As such, the environment is now ripe to begin, as originally envisioned by FDA, to begin harnessing the public health benefit for adult smokers, while continuing to remain vigilant against youth usage.”
Youth vaping in the US has declined to one-third from its peak in 2019 and, according to the 2024 National Youth Tobacco Survey (NYTS), to its lowest level in a decade. Approximately 1.63 million middle and high school students (5.9%) reported current (past 30-day) e-cigarette use, down from 2.13 million (7.7%) in 2023. Similarly, youth cigarette smoking in the United States has declined to the lowest levels since the survey began in 1999. Approximately 1.4% of middle and high school students reported current cigarette smoking in 2024, down from 1.9% in 2023, 2024 NYTS data finds.
“Right now, all of the e-cigarettes being used by youth are, by definition, already illicit, because we’ve banned the sale of all nicotine products to anyone under 21,” Stier notes. “The source of youth vaping is an unregulated illicit market that is widely available. Currently, 85% of the US e-cigarette market is illicit. The alternative to that, which I would like to see the Trump administration embrace, is the opportunity to move in the right direction in terms of having a well-regulated market for adult smokers to make available the products that they want, which is flavors, and to make sure they’re being marketed appropriately through the PMTA process. Instead of banning flavors, FDA should ban only products that are marketed to kids which, in this wild-west environment the bans have created, are too present.
FDA would be wise to authorize a wide range of legitimate flavored, but responsibly marketed products. Doing so would move almost all of that illicit market into a well-regulated and safer market. In addition, to further tamp down youth usage, FDA, can authorize and encourage the use of emerging technology that will help ensure that the only user of the product is the one who purchased it after undergoing age-verification.”
A well-regulated market based on actual consumer demand and scientific evidence, not on bans of certain products or product categories, would make menthol cigarette bans or VLN regulation unnecessary, Stier argues.
“If Trump follows through on his pledge to ‘save vaping again,’ FDA could face pressure to streamline the premarket tobacco product application (PMTA) process,” confirms Macherelli. “At the same time, increased scrutiny on illicit disposable vapes—many of which evade FDA regulation—could lead to more targeted enforcement actions against unauthorized sellers. A balance between easing the regulatory pathway for legal products while cracking down on illicit ones would align with Trump’s pro-business stance while addressing concerns about unregulated products flooding the market.”