USA: Federal Tobacco Regulation

May 2026: A Bipartisan Bill Seeks to Fund FDA Oversight of E-Cigarettes Through Manufacturer User Fees

The Resources to Prevent Youth Vaping Act, a bipartisan piece of legislation, aims at strengthening the U.S. Food and Drug Administration’s (FDA) capacity to oversee the e-cigarette industry by requiring manufacturers of nicotine-containing vaping products to pay user fees. The proposal seeks to address a funding gap by bringing e-cigarette companies in line with traditional cigarette manufacturers, which already contribute fees that help finance FDA tobacco regulation, enforcement activities, and public health programs.

The central objective of the bill is to generate dedicated funding to expand the FDA’s regulatory resources. These funds would be used to enhance the agency’s ability to review products, improve enforcement against unauthorized or non-compliant e-cigarettes, and support public education efforts focused on youth vaping prevention. Supporters argue that without a comparable user-fee structure for e-cigarettes, the FDA’s ability to keep pace with the rapidly evolving nicotine market is constrained.

First introduced in 2021, the legislation has consistently attracted bipartisan support and has been reintroduced in subsequent congressional sessions. Despite this sustained backing, it has not yet been enacted into law and has remained in the committee stage throughout its legislative history. In the current 2025–2026 Congress, the bill has once again been introduced and referred to the Senate Committee on Health, Education, Labor, and Pensions (HELP Committee). So far, it has not advanced to hearings, markups, or floor consideration, indicating that it remains in the early stages of the legislative process.

Looking ahead, the bill’s progress will depend on whether it receives active committee engagement and broader legislative prioritization. If advanced, it would still need to pass both chambers of Congress and be signed into law. At this stage, it represents an ongoing policy proposal aimed at improving the FDA’s long-term capacity to regulate the e-cigarette market rather than an imminent regulatory change.

April 2026: FDA Opens Public Consultation on Flavored E-Cigarette Approval Framework

The U.S. Food and Drug Administration (FDA) has opened a public comment period on its new draft guidance outlining how it will evaluate applications for flavored e-cigarettes (Electronic Nicotine Delivery Systems, ENDS). The guidance is non-binding but signals the agency’s latest thinking and invites stakeholder input before finalization. At the core of the draft is a clearer framework for premarket tobacco product applications (PMTAs), emphasizing that manufacturers must demonstrate their products are “appropriate for the protection of public health.” This involves balancing potential benefits for adult smokers – such as helping them switch away from combustible cigarettes – against risks, particularly youth uptake.

The FDA reiterates that flavored products face a higher evidentiary burden, especially those with strong youth appeal like fruit, candy, and dessert flavors. Applicants must provide robust scientific evidence, including data on consumer behavior, switching patterns, and overall population-level impact. At the same time, the guidance suggests a more nuanced approach: certain flavors perceived as less attractive to youth – such as mint, coffee, or spices – could potentially meet regulatory standards if they demonstrate clear benefits for adult smokers.

Overall, the draft reflects the FDA’s attempt to balance harm reduction for adults with continued safeguards against youth vaping, while seeking industry and public feedback to refine its regulatory approach.

Download U.S. FDA Draft Guidance on Flavored ENDS

April 2026: FDA Slows Nicotine Pouch Fast-Track Approvals Over Youth and Addiction Concerns

A recent report by Reuters states that the U.S. Food and Drug Administration has slowed down its fast-track review process for nicotine pouches due to concerns about youth usage, scientific evidence, and the potential for creating new nicotine users rather than only converting smokers¹. The fast-track pathway was originally expected to speed up regulatory decisions for nicotine pouch products under the FDA’s premarket tobacco application processes. However, regulators are now taking a more cautious approach than the industry expected.

One of the main concerns inside the U.S. Food and Drug Administration is that the scientific evidence submitted by companies does not clearly prove that nicotine pouches primarily attract existing smokers rather than new users. Regulators are particularly worried about young adults and people who have never previously used tobacco starting nicotine use through pouches. The youth usage of nicotine pouches is still relatively low compared with vaping; however, it is increasing which has made regulators more cautious about approving many new products quickly. The FDA is trying to balance the potential public health benefit of smokers switching away from cigarettes with the risk of increasing overall nicotine addiction in the population.

So far, only 26 pouch products have received authorization, while many applications from major tobacco companies remain under review, in some cases for several years. The slow approval process is creating frustration in the industry, especially as the U.S. nicotine pouch market continues to grow rapidly.

Overall, the key message from the Reuters report is that the FDA is not halting nicotine pouch approvals, but the fast-track process is proceeding more slowly than expected. Regulators are prioritizing youth protection and broader population health, rather than approving a wide range of products simply because they may be “appropriate for the protection of public health.”

December 2025: FDA Introduces “Chain of Risk” Framework as a New Approach to Tobacco Harm Reduction

The U.S. Food and Drug Administration (FDA) introduced a regulatory concept known as the “Chain of Risk” framework to advance tobacco harm reduction. Announced in late December 2025, this framework represents a shift in how tobacco and nicotine products are classified and regulated with the aim of better protecting public health while recognizing the diversity of products on the market.

At its core, the Chain of Risk framework is a system for ranking tobacco products according to their relative health risks – from the most harmful to the least harmful. Under this approach, products are evaluated based on features such as the mode of use (e.g., combustion versus non-combustion), levels of toxicants and nicotine content, and their potential for addiction and long-term health effects. This risk spectrum helps regulators differentiate between traditional high-risk combustible products like cigarettes and potentially lower-risk alternatives such as e-cigarettes, heated tobacco, or modern oral nicotine products (i.e. nicotine pouches). The concept builds on the FDA’s longstanding scientific recognition that tobacco products exist on a spectrum of risk, where combustible cigarettes generally pose the greatest harm and some non-combustible products may pose lower risks to individual users – though no tobacco product is entirely safe.

The Chain of Risk framework marks a pragmatic shift in regulatory thinking:

– Regulatory Prioritization: Instead of treating all tobacco and nicotine products identically, the FDA will prioritize oversight and control measures based on where products fall on the risk spectrum. The most harmful products (like combusted cigarettes) will remain the primary focus of restriction and cessation efforts, while potentially lower-risk products may be regulated differently.

– Harm Reduction Emphasis: The framework intentionally incorporates harm reduction strategies – acknowledging that some adult smokers who cannot quit may benefit from switching to products that present fewer health risks than cigarettes.

– Youth Protection and Market Transparency: Even as the FDA considers harm reduction for adults, it continues to emphasize preventing youth access to all nicotine products and maintaining a transparent, legal market where products are properly authorized, labeled, and regulated.

– Policy and Authorization Pathways: In practice, the framework could influence how the FDA assesses premarket tobacco product applications (PMTAs) and modified risk tobacco product (MRTP) claims by placing them within a broader context of relative product risks and potential health impacts. This may shape future regulatory decisions, marketing permissions, and public communications about product risks.

Overall, the Chain of Risk framework reflects an evolving regulatory paradigm – one that retains core public health protections while recognizing that a nuanced, risk-based approach may help reduce the overall disease burden from tobacco use.

October 2025: FDA will mail 300,000 retailers a list of new nicotine products that can be legally sold in the U.S.

The U.S. Food and Drug Administration (FDA) announced that it will mail materials to 300,000 retailers nationwide that sell vapes, including convenience stores, with a reminder of which products stores are legally allowed to sell. The materials include a list of the 39 vapes (Logic, NJOY, VUSE and JUUL products) and 20 ZYN nicotine pouch products that are authorized by the FDA and can be legally marketed in the United States.

The FDA highlighted that products it has not yet authorized are prohibited to sell – currently, as much as 54% of vaping products sold nationally are illicit. FDA said it has received questions from retailers about which products are legal to sell, and that the purpose of the initiative is to help retailers better understand relevant laws and regulations. However, the materials do not address products that are still under review in the Pre-Market Tobacco Application (PMTA) process or products that have been denied and are tied up in court or administrative review – which could be legally allowed for sale in the U.S. The mailing materials also include information on accessing FDA’s Searchable Tobacco Product Database, as well as education materials with retailer requirement reminders such as age verification.

The mailing of information materials to 300,000 retailers is part of FDA’s attempt to address the illicit vape crisis by guiding and educating the retailers – including providing lists of what can and cannot be on the market.

September 2025: Public Health groups urged U.S. FDA to prevent major tobacco companies from marketing new nicotine products in the U.S. without FDA authorization

In a letter sent to the U.S. FDA Commissioner, six leading public health and medical organizations urged the U.S. FDA to take immediate action to prevent major tobacco companies from marketing new nicotine products in the United States without FDA authorization. The letter was sent by the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.

Recently, British American Tobacco’s U.S. affiliate, Reynolds American, and Altria revealed their plans to launch flavored disposable vapes, VUSE ONE, and nicotine pouches, on! PLUS, respectively, without marketing authorization. Reynolds American is in the process of introducing VUSE ONE in Florida, Georgia, and South Carolina. The disposable vape product will be available in fruit flavors, including Raspberry Chill, Watermelon Chill, and Berry Melon. Altria announced the planned launch of on! PLUS nicotine pouches in North Carolina, Texas, and Florida in Q4 2025.

Six organizations asked U.S. FDA, with the necessary involvement of the U.S. Department of Justice, to take immediate and appropriate action to prevent Reynolds American and Altria from their planned and intentional violation of the law. The letter highlights that under the Family Smoking Prevention and Tobacco Control Act (TCA), no new tobacco product is permitted to be introduced for sale in the U.S. without first undergoing a thorough scientific evaluation and obtaining marketing authorization (called a marketing granted order or MGO) from the FDA. Although both companies have stated they have submitted an application for these products, none of the products in question have received marketing authorization.

Although Reynolds American and Altria have asserted that their applications have been pending beyond the 180-day statutory review period, the letter notes that “nothing in the statute remotely suggests that surpassing the 180-day period confers a right to market a product without the issuance of a MGO.”

September 2025: The debate on the rule to cap nicotine levels in combusted tobacco products is heating up in the U.S.

The U.S. Food and Drug Administration’s (FDA) proposal to mandate a sharp reduction in nicotine levels for cigarettes and other combusted tobacco products represents one of the most significant regulatory efforts in decades. The idea dates back to 2017, when the FDA first signaled interest in capping nicotine to reduce the addictiveness of cigarettes, and in 2018 the agency issued an advance notice of proposed rulemaking. On January 15, 2025, the FDA formally proposed a rule that would cap nicotine in cigarettes, cigars, roll-your-own, and pipe tobacco at 0.70 milligrams of nicotine per gram of total tobacco, a reduction of about 95% compared to current levels. In September 2025, a group of Democratic senators urged the FDA to finalize the rule quickly, highlighting the scale of smoking-related health costs and preventable deaths. At the same time, tobacco companies intensified their opposition, pointing to both legal and practical challenges.

Industry groups argue that the proposal is effectively a ban, since the Family Smoking Prevention and Tobacco Control Act explicitly prohibits reducing nicotine to zero. In their view, the proposed cap is so low that it approaches this limit. Companies also warn that the timeline for compliance is unrealistic, citing the need for years of research and manufacturing adjustments (i.e. up to 8 -12 years). They question whether the FDA’s testing and enforcement methods are robust enough, and highlight the cost burden the rule would place on manufacturers. From a commercial perspective, the industry fears erosion of market share, the growth of illicit trade, and substitution effects, with smokers turning to products not covered by the rule. Tobacco companies also cast doubt on whether the policy will deliver the promised public health gains, noting risks that smokers could inhale more deeply or smoke more frequently to compensate for lower nicotine.

On the other side of the debate, public health advocates and Democratic senators maintain that nicotine addiction is the core driver of cigarette use and the leading barrier to quitting. They argue that the proposed rule is essential to curb the nearly half a million deaths in the United States each year linked to smoking and to reduce the estimated $600 billion annual burden in health and productivity costs. According to these lawmakers, reducing nicotine to minimally addictive levels would make it easier for smokers to quit and would prevent millions of young people from ever becoming addicted. They stress that the FDA has the statutory authority to implement such a standard, provided nicotine is not reduced to absolute zero, and point to evidence that very low nicotine cigarettes already exist and can be produced at scale. Senators have also called for the rule to apply broadly, including to heated tobacco products, to avoid loopholes that could undermine its impact.

The outcome of this debate will depend on several factors, including whether the FDA finalizes the proposal in its current form, how quickly it enforces compliance, and how courts respond to what are certain to be aggressive legal challenges. Supporters believe the rule could transform U.S. tobacco use, leading to millions of quitters and preventing millions more from starting. Industry opponents, meanwhile, emphasize the legal risks, technical difficulties, and potential unintended consequences. The policy’s future now hinges on regulatory priorities, political will, and the balance between public health ambitions and the economic weight of a powerful industry. At this stage, we do not expect the nicotine level reduction rule to be issued during the term of the Trump Administration.

September 2025: US FDA will fast-track nicotine pouch reviews amid White House pressure

The U.S. Food and Drug Administration plans to fast-track reviews of four tobacco firms’ nicotine pouches in a pilot program, amid pressure from the Trump administration to speed up approvals. The FDA aims to finish reviewing the pouches from Philip Morris International (PMI), Altria, British American Tobacco (BATS) and Turning Point Brands (TPB) by December 2025. The Agency had been pressured by the Trump Administration to review nicotine pouches more efficiently².

PMI’s ZYN Ultra, Altria’s on! and on! Plus, BAT’ Velo Mini, and TPB’s FRE and ALP products will be included in the expedited process. These products will be subject to an application process featuring streamlined and reduced reviews, more frequent communication between FDA staff and applicants, and expedited clearance. Reviewers will focus only on information essential to start the scientific review of nicotine pouches, core product characterization, manufacturing consistency and stability, and abuse-liability data.

July 2025: House Appropriations Bill removes longstanding language prohibiting use of federal funds to engage in tobacco affairs abroad

Since 1998, U.S. Congress has included language in appropriations bills, called the “Doggett Amendment”, that prohibits the use of federal funds to promote the sale or export of tobacco or tobacco products or to assert influence on other countries’ tobacco control laws. The Amendment language recognizes that the U.S. government should not be in the business of promoting tobacco products. Prior to 1998 when the Amendment was first adopted, the U.S. government provided the same assistance to the tobacco industry in exporting and marketing its products that it provided to other consumer industries.

The longstanding language is left out of the National Security, Department of State, and Related Programs Appropriations Bill that was recently approved by a House Appropriations Subcommittee. If the bill is enacted as written, it would allow the tobacco industry to leverage the State Department and U.S. embassies in foreign market affairs.

June 2025: FDA launches Elsa, a generative AI tool designed to help scientific reviews

The U.S. Food and Drug Administration (FDA) launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees in scientific reviews and investigations. Following a successful pilot program with FDA’s scientific reviewers, FDA set an aggressive timeline to scale AI agency-wide by June 30, 2025. Built within a high-security GovCloud environment, Elsa offers a platform for FDA employees to access internal documents while ensuring all information remains within the agency. The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff.

The agency is already using Elsa to accelerate clinical protocol reviews, shorten the time needed for scientific evaluations and identify high-priority inspection targets. Elsa is a large language model–powered AI tool designed to assist with reading, writing, and summarizing. It can summarize adverse events to support safety profile assessments, perform faster label comparisons, and generate code to help develop databases for nonclinical applications. As the AI tools mature, the agency has plans to integrate more AI in different processes, such as data processing and generative-AI functions.

The point of interest for the tobacco industry: Deployment of Elsa may reduce the timeline for the review of PMTA/MRTP applications for tobacco products. FDA completes these reviews in 2-3 years despite the 180-day requirement.

April 2025: CTP Director is removed from post

U.S. FDA’s top tobacco official, Director of Center for Tobacco Products (CTP), Dr. Brian King is placed on administrative leave. He is removed from his position and offered reassignment to the Indian Health Service. Dozens of staffers in CTP also received notices of dismissal, including the entire office responsible for enforcing tobacco regulations.

Dr. King joined the Agency in July 2022. Dr. King’s removal comes just days after Dr. Makary becomes the new FDA Comissioner. CTP has been under fire due to the illegal Chinese vape products (“flavored disposable vapes”) flooding the U.S. market. Read more: USA: Illegal Vapes.

March 2025: Dr. Marty Makary becomes the new U.S. FDA Commissioner

The U.S. Senate confirmed Dr. Marty Makary as the new U.S. Food and Drug Administration (FDA) Commissioner in a 56-to-44 vote. Subsequently, he was sworn in by the Health and Human Services Secretary, Robert F. Kennedy Jr.

Formerly, Dr. Marty Makary was a surgeon at John Hopkins University Hospital. He takes over charge at a challenging time for the Agency, which has recently seen significant staff and facility reductions initiated by the Department of Government Efficiency (DOGE) and the consequent resignation of some of senior staff members.

March 2025: FDA staff struggles to meet product review deadlines after DOGE layoffs

The U.S. Department of Government Efficiency (DOGE) fired around 1,000 probationary U.S. Food and Drug Administration (FDA) employees in February 2025, mostly from the Agency’s centers for tobacco, food and medical devices, but brought some back later. Recently, the Government announced an additional 3,500 headcount reduction, a follow-on to earlier layoffs. In total, U.S. FDA’s 20,000-people staff will be reduced by more than 20%.

According to the Reuters report, U.S. FDA is struggling to meet the deadlines to review the medical devices and tobacco products for safety and efficacy due to the Trump Administration layoffs. We need to note that they were not meeting the deadlines before the layoffs either.

Some staff members are assigned to around double the number of new product applications for review since the onset of the headcount reduction and were instructed to shelve other work, including oversight of other reviewers and providing early feedback on planned product applications before they are submitted for review. US FDA’s Center for Tobacco Products delayed starting new applications, while the staff worked on existing submissions, and several tobacco-related research projects have also been canceled. Reviews that must be completed within 180 days under the U.S. law takes much longer than that.

The Agency is currently reviewing high-profile projects, including one from Philip Morris International (PMI) that seeks the authorization of IQOS ILUMA, the latest generation of its IQOS heated tobacco device. A PMI spokesperson stated that the average wait time for a tobacco-product application (PMTA) is closer to 700 days than 180 days. PMI expects the authorization of IQOS ILUMA device in the second half of 2025 to launch IQOS at scale in the U.S.; however, it is likely that the authorization is further delayed into 2026.

January 2025: US FDA withdrew its proposed rules on menthol cigarettes and flavored cigars

The U.S. Food and Drug Administration (US FDA) officially withdrew its proposed rules 0910-AI60 “Tobacco Product Standard for Menthol in Cigarettes” and 0910-AI28 “Tobacco Product Standard for Characterizing Flavors in Cigars”. Although the proposed rules are effectively removed from the regulatory agenda, there is a possibility that similar measures are re-introduced in the future (i.e. when the political climate is more suitable for extending the tobacco-related restrictions).

The FDA has been mulling over flavored tobacco ban since the issuance of an ANPRM (Advance Notice of Public Rule Making) initiative for flavored tobacco in 2018. The Agency announced its plans to ban menthol in cigarettes and “characterizing flavor” in cigars in 2022. The Biden Administration postponed the ban on menthol cigarettes in April 2024 – presumably due to the upcoming 2024 Presidential Election (- see below for further details).

January 2025: US FDA proposes a rule to reduce nicotine to minimally addictive or non-addictive level in cigarettes

The U.S. Food and Drug Administration (FDA) issued a proposed rule to limit the level of nicotine in cigarettes and certain combusted tobacco products to make them minimally addictive or non-addictive. The FDA first announced its intent to propose such a rule in 2018 and, if finalized, the United States will become the first country in the World to take such an action.

The FDA is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco, which is significantly lower than the average concentration on the market today (i.e. mean nicotine concentration in cigarettes in the US is 19.2 milligrams per gram of tobacco, according to the CDC³).

The FDA’s proposal applies to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars and pipe tobacco. The proposed rule does not include e-cigarettes, nicotine pouches, heated tobacco products, waterpipe tobacco (hookah), smokeless tobacco products and premium cigars. In addition to preventing initiation among youth and promoting cessation, the US FDA expects that the proposal would also help smokers switch to lower-risk alternatives.

The FDA seeks input on the proposal. From January 16 to September 15, 2025, public will have the opportunity to provide comments. In addition to general comments, the FDA is specifically requesting input on several topics, including, the products covered by the proposed product standard; the proposed limit to the nicotine level; the proposed two-year effective date and likelihood that companies will be able to comply within that timeframe; and the potential for illicit trade resulting from the proposed product standard and any related impact to public health. The FDA also intends to refer the proposed product standard to the Tobacco Products Scientific Advisory Committee for a public meeting and consider additional opportunities for public engagement on the proposal.

January 2025: The rule to lower nicotine levels in cigarettes moves forward

The Office of Management and Budget cleared the US FDA’s proposal to set a nicotine limit on tobacco products and require tobacco companies to significantly reduce the amount of nicotine in traditional cigarettes. The new rule aims to reduce the addictiveness of cigarettes and other combusted tobacco products.

It is unclear whether the US FDA will issue the regulatory outline in the final days of the Biden Administration. In any case, the proposed rule will go through a a public comment period and the process will eventually be finalized by the President-elect Donald Trump’s Administration, including the Health & Human Services secretary-designee Robert F. Kennedy Jr. and FDA commissioner-designee Marty Makary.

December 2024: US FDA submits the proposal to set a nicotine limit on tobacco products

The US Food and Drug Administration (FDA) submitted a proposed rule to the Office of Management and Budget that could significantly lower the amount of nicotine in tobacco products⁴. The FDA has been signaling its intentions to limit nicotine levels at least since 2018 and, in 2022, the FDA commissioner announced that the Agency was developing a rule that would require tobacco companies to significantly reduce the amount of nicotine in traditional cigarettes.

“A proposed product standard to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain combusted tobacco products, when finalized, would be among the most impactful population-level actions in the history of US tobacco product regulation,” the FDA said in a statement. When the FDA announced its initial plans to reduce nicotine in 2022, it estimated that reducing nicotine levels could keep more than 33 million people from becoming regular smokers and help about 5 million additional smokers quit within a year.

The Office of Management and Budget’s review can take months. There will also be a public comment period and the tobacco industry is likely to sue the Government to stop new regulations. More importantly, it’s also unclear whether the FDA will insist on the proposal under President-elect Donald Trump whose future Chief-of-Staff has worked as a tobacco lobbyist⁵.

September 2024: The US FDA pushes back the enforcement of cigarette health warnings by 15 months

The US FDA provided guidance on the “Tobacco Products: Required Warnings for Cigarette Packages and Advertisements” final rule which establishes new required health warnings for cigarette packages and advertisements with the aim to promote greater public understanding of the negative health consequences of smoking.

The final rule was issued in March 2020 and was challenged in the U.S. District Court for the Eastern District of Texas. In December 2022, the District Court struck down the rule. The Government appealed the decision and in May of 2024, the U.S. Court of Appeals for the Fifth Circuit reversed the District Court’s decision. The plaintiffs’ petition for Supreme Court review is pending.

According to the new guidance, the FDA intends to exercise enforcement discretion and generally not enforce requirements of the final rule (which is currently in effect following the decision of the U.S. Court of Appeals) for 15 months, or until December 12, 2025. With respect to products manufactured before December 12, 2025, the enforcement start date is a month later, or January 12, 2026.

The FDA decided to delay the enforcement by 15 months to provide an orderly transition period. This decision is in alignment with the 15-month compliance period originally contemplated by the Family Smoking Prevention and Tobacco Control Act, before that timing was disrupted by litigation.

The final rule also requires the Industry to submit a plan and obtain FDA approval for the random and equal display and distribution of required warnings on cigarette packages, as well as the quarterly rotation of required warnings in cigarette advertisements. Accordingly, the FDA recommends that entities that do not already have approved cigarette health warning plans submit such plans as soon as possible, but in any event within five months, or by February 10, 2025. Entities that previously submitted cigarette plans to the FDA do not need to resubmit their plans unless they wish to make changes.

September 2024: US FDA releases the 2024 National Youth Tobacco Survey (NYTS)

Half a million fewer US youth reported current use of e-cigarettes in 2024 compared to 2023, according to new data from the National Youth Tobacco Survey (NYTS). The nationally representative data includes findings on e-cigarette and nicotine pouch use among US youth, two categories of tobacco products the FDA and CDC are monitoring closely, particularly regarding youth use and appeal. 

NYTS is an annual school-based, self-administered survey of US middle (grades 6-8) and high school (grades 9-12) students conducted from Jan 22 to May 22, 2024. Findings showed there was a significant drop in the number of US middle and high school students who reported current (past 30 days) e-cigarette use – a decrease from 2.13 million (7.7%) youth in 2023 to 1.63 million (5.9%) youth in 2024. This decline was largely driven by reduced e-cigarette use among high school students (from 1.56 million to 1.21 million), with no statistically significant change in current e-cigarette use among middle school students within the past year. The number of youth who used e-cigarettes in 2024 is approximately one-third of what it was at its (JUUL-fueled) peak in 2019, when over five million youth reported current e-cigarette use.

Among youth who currently used e-cigarettes, 26.3% reported using e-cigarettes daily. The vast majority of youth who currently used e-cigarettes used flavored products (87.6%), with fruit (62.8%), candy (33.3%) and mint (25.1%) being the top three most commonly used flavors. Disposable e-cigarette products were the most common product type used; however, the most popular brands included both disposable and cartridge-based products. Among youth who currently used e-cigarettes, the most commonly reported brands were Elf Bar (36.1%), Breeze (19.9%), Mr. Fog (15.8%), Vuse (13.7%) and JUUL (12.6%). 

Over the past year, a substantive drop occurred in youth reporting use of e-cigarette products under the Elf Bar brand – from 56.7% in 2023 to 36.1% in 2024. Elf Bar is not authorized by the FDA and has been the subject of focused compliance and enforcement actions by the Agency since early 2023, including more than 1,000 warning letters and 240 civil money penalties to retailers and others in the supply chain. The FDA has also issued import alerts that include products under the Elf Bar brand, which places them on the “red list” and allows the Agency to detain products without conducting a full inspection at the time of entry. 

Youth nicotine pouch use did not show a statistically significant change from 2023 (1.5% in 2023 and 1.8% in 2024). Of the nearly half a million middle and high school students who reported current nicotine pouch use, 22.4% used them daily. The most commonly reported brands among that group were ZYN (68.7%), on! (14.2%), Rogue (13.6%), Velo (10.7%) and Juice Head ZTN (9.8%). Among those who currently used nicotine pouches, the vast majority used flavored products (85.6%), with mint (53.3%), fruit (22.4%) and menthol (19.3%) being the most commonly used flavors. 

August 2024: FDA issues final rule increasing the minimum age for certain tobacco sales restrictions

The US Food and Drug Administration (FDA) announced a final rule that raises the minimum age for certain restrictions on tobacco product sales. These requirements follow the legislation signed into law on December 20, 2019 (“Further Consolidated Appropriations Act”) which immediately raised the federal minimum age of sale of tobacco products in the United States from 18 to 21 years of age. Once implemented, US FDA expects the new requirements to to maximize the public health impact of the original 2019 legislation and help decrease underage tobacco sales.

As of September 30, 2024,

– retailers must verify with photo identification the age of anyone under the age of 30 who is purchasing a tobacco product, including e-cigarettes (previous requirement: under the age of 27)

– retailers are not allowed to sell tobacco products via vending machine in facilities where individuals under 21 are present or permitted to enter at any time (previous requirement: individuals under 18)

US FDA notes that more than 95% of the adult daily smokers in the US smoked their first cigarette by the age of 21. Thereby, FDA focuses on to effectively enforce the federal minimum age of sale for tobacco products. To date, the Agency has conducted more than 1.5 million compliance checks of tobacco retailers to ensure compliance with federal age restrictions. These inspections have resulted in 134,000 warning letters, more than 33,000 civil money penalties and 230 no-tobacco-sale orders for violations related to federal age restrictions.

April 2024: Menthol cigarette ban further delayed

The Biden Administration delayed its decision on the proposed menthol cigarette rule (ban) in the US. “This rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement. It’s clear that there are still more conversations to have, and that will take significantly more time”, said the Secretary of Health and Human Services in a statement⁶. Government officials declined to provide a new target date for the finalization of the menthol rule.

The US FDA formally proposed the menthol ban in April 2022. There were 18.5Mn menthol cigarette smokers in the US [at the time of the proposal] and menthol cigarettes accounted for close to 40% of all cigarettes sold. According to the CDC, 81% of non-Hispanic Black smokers use menthol cigarettes, compared to 34% of non-Hispanic White smokers. It is claimed that, in an election year, the Biden Administration has been weighing the potential public health benefits of banning menthol cigarettes against the political risk of angering Black voters. A recent poll [commissioned by Altria] found that 54% of core Biden supporters, defined as minority voters or non-conservative white voters under age 45, oppose the proposed menthol ban⁷.

December 2023

The US FDA plans to announce the tobacco product standard⁸ that would establish a maximum nicotine level in cigarettes and certain other finished tobacco products in April 2024. By limiting the nicotine levels, FDA aims to reduce addictiveness of cigarettes, thus giving smokers a greater ability to quit and preventing experimenters (mainly youth) from initiating regular use.

December 2023

The US FDA’s Center for Tobacco Products (CTP) released a 5-year Strategic Plan⁹ that defines five goals and the desired outcomes for each goal.

1. Develop, Advance and Communicate Comprehensive and Impactful Tobacco Regulations and Guidance: The evolving marketplace is comprehensively regulated while the public and stakeholders are aware of and contribute to regulations and guidance

2. Ensure Timely, Clear and Consistent Product Application Review: Tobacco product applications are reviewed using an efficient, transparent and consistent process while the marketing decisions are supported by the best available science

3. Strengthen Compliance of Regulated Industry Utilizing All Available Tools, Including Robust Enforcement Actions: Violative tobacco products, particularly the youth-appealing ones, are not in the marketplace while the regulated industry is educated on how to be compliant with the law

4. Enhance Knowledge and Understanding of the Risks Associated With Tobacco Product Use: The public receives timely, clear and evidence-based health communication and education

5. Advance Operational Excellence: A talented, diverse and engaged workforce is attracted and retained while the business operations are efficient and effective in supporting program goals.

These goals are reinforced by four overarching themes:   

– Science: Maintaining the commitment to use data and evidence-driven approaches to inform CTP decision-making

– Health Equity: Pursuing the highest level of health for all people by integrating health equity into all CTP activities

– Stakeholder Engagement: Continuously striving to optimize engagements with interested parties both external and internal to FDA, including other federal agencies

– Transparency: Promoting understanding of tobacco regulation through clear, consistent and comprehensive communication

December 2023

The US federal government published the Unified Agenda of Regulatory/Deregulatory Actions (i.e. regulatory to-do list)¹⁰ which confirms that the final menthol rule (that would ban menthol flavored cigarettes) is now expected in March 2024. The delay angered health advocates who claim that the Administration postponed the ban to avoid alienating African American voters, who mostly smoke menthol-flavored tobacco products.

The Administration had originally planned to have the rule finalized by August 2023 and, later, signaled that the rule would come before the end of 2023. Now, the rules are not expected until March 2024, at the earliest. 

December 2023

The US FDA issued complaints for civil money penalties (CMPs) against 25 brick&mortar and online retailers for the illegal sale of unauthorized Elf Bar, EB Design and other e-cigarettes. The complaints include cases against online retailers for the first time and seek the maximum CMP of $19,192 for a single violation from each retailer.

In order to remove unauthorized e-cigarettes from the marketplace, as of December 5, FDA has

– issued more than 400 warning letters to retailers and filed CMPs against 67 retailers

– issued more than 630 warning letters to manufacturers/distrubutors and filed CMPs against 36 manufacturers

– (in coordination with the US Department of Justice) sought injunctions against 7 manufacturers.

December 2023

It is speculated that the long-awaited ban on menthol cigarettes in the US may not be announced by the end of the year¹¹ and the delay could be announced as early as next week. It is also a possibility that the ban could be delayed well into 2024 – even to after the November presidential election.

This is in line with our expectations that there is more than fair chance of US menthol ban not being finalized by the end of this year. It is always challenging for an administration to take such a highly-politicized & wide-ranging decision when less than a year is left before the elections.

October 2023

The US FDA sent the rule banning menthol cigarettes and flavored cigars to the White House Office of Management and Budget for final review¹² (the last regulatory step before the rule becomes final). The FDA has been considering menthol regulations for more than a decade. In June 2020, Massachusetts became the first to ban all flavored tobacco products, including menthol. In December 2022, California’s menthol ban went into effect. In an effort to work around the state bans and to lay the groundwork for a potential federal ban, tobacco companies have introduced cigarettes with a menthol-like synthetic cooling agent. It is not clear whether the final rules would address the workarounds. Once the federal government makes its final rules, tobacco companies are expected to sue.

September 2023

The US FDA issued complaints for civil money penalties (CMPs) against 22 retailers for the sale of Elf Bar/EB Design¹³ (referred as “a popular, illegal youth-appealing e-cigarette brand” by the FDA). CMP action is a result of the retailers not correcting the violations (i.e. selling an unauthorized tobacco product) despite being warned. The complaints seek the maximum penalty of $19,192 for a single violation from each retailer. While the FDA has issued CMPs to retailers for selling unauthorized tobacco products in the past, this is the first time the Agency is seeking CMPs for the maximum amount for this type of violation.

September 2023

The US FDA missed the self-imposed deadline (August 2023) to publish the final regulation that would prohibit the sale of menthol cigarettes and flavored cigars¹⁴. The Agency will instead complete the work “in the coming months” (presumably, still in 2023).

August 2023

FDA provided an update on its efforts to curb the marketing of unauthorized nicotine products across the tobacco product supply chain¹⁵:

– Issued a warning letter to Amarillo Snuff for manufacturing & selling unauthorized smokeless (non-tobacco) nicotine products, including products that are made with corn husks instead of tobacco leaves

– Issued ~600 warning letters to manufacturers of unauthorized tobacco products (including 100+ warning letters for unauthorized non-tobacco nicotine products)

– Issued 2,800+ warning letters and 825 civil money penalties to e-cigarette retailers selling products to underage purchasers (including 1,000+ warning letters and 140+ civil money penalties for violations in relation to sale of non-tobacco nicotine products to underage purchasers).

Meanwhile, a federal judge struck down the FDA’s authority to regulate premium, hand-rolled cigars in the US¹⁶. The judge’s order applies to cigars that are hand-rolled and tend to be sold in humidors in specialty stores, rather than the mass-produced cigars typically sold in c-stores. The cigar industry has been fighting the FDA’s efforts at regulation in court since 2016.

June 2023

The US FDA provided updates on pending tobacco regulations as part of the Spring 2023 Regulatory Agenda¹⁷.

Flavor (Menthol) ban: In May 2022, the FDA proposed prohibition of the use of menthol in cigarettes, RYO and heated tobacco products and prohibition of all characterizing flavors (other than tobacco) in cigars. The public comment period ended on July 5, 2022. The FDA received ~247k comments on these two proposals, mostly opposing the bans. The FDA reiterates its intent to publish final regulations in Aug 2023 – with menthol regulation becoming effective 1-2 years after the date of publication.

Legal Age: The 2020 Consolidated Appropriations Act raised the federal minimum age for tobacco purchase from 18 to 21 years. The FDA plans to update the federal legal requirement to 21 in April 2024.

Nicotine level in combustible tobacco products: In June 2022, the FDA announced the plan to place a cap on the max amount of nicotine allowed in combustible tobacco products. The FDA previously stated that the regulation would be published by Oct 2023; now it is moved to Dec 2023.

Nicotine toxicity warnings: The FDA is planning to establish acute nicotine toxicity warning requirements for nicotine-containing liquids – in order to increase consumer awareness & knowledge of acute toxicity risks as a result of accidental nicotine exposure. The FDA expects to publish this regulation in Oct 2024.

E-cigarette safety standards: The FDA plans to set safety standards for toxicants and impurities in nicotine and PG/VG used in e-cigarettes – including setting of limits on the level of toxicants. The FDA expects to publish this regulation in Dec 2024.

Feb 2023

FDA’s tobacco unit (CTP)  pledged reset after criticism¹⁸. CTP will deliver a 5-year strategic plan by year’s end outlining priorities, including efforts to clean up a sprawling market of largely unauthorized e-cigarettes.

FDA fined e-cigarette makers for selling products illegally in a “wake-up call”¹⁹. This is the first time that FDA filed (what it calls) a civil money penalty (CMP) against e-cigarette makers who haven’t complied with the federal process.

CDC survey revealed that most US adults support banning sales of all tobacco products²⁰; nearly two-thirds support banning menthol cigarettes. More than a third of current smokers support menthol ban. More than a quarter support complete tobacco ban.

Jan 2023

US FDA committed to complete the PMTA review of the most popular e-cigarettes by Dec 31, 2023²¹. This is six months later than previously anticipated/communicated.

FDA updated the regulatory plan, moving forward the timeline for a federal ban on menthol cigarettes²². FDA intends to publish a final menthol rule by Aug 2023. US menthol cigs account for 25% of BAT’s and 15% of Imperial’s total profits.

Reynolds (BAT) pivoted to new cigarette pitches as the flavor ban takes effect in California. Reynolds launched a new, non-menthol Newport cigarette which offers “a taste that satisfies the senses” and “a new fresh twist”. Reynolds claim that the products introduced in California “meet and comply with all applicable regulatory requirements” and “are not subject to the recently enacted ban because they do not have a distinguishable taste or aroma other than tobacco”.

Dec 2022

[US FDA] Independent review panel identified that²³

– lack of clarity hinders tobacco regulation

– CTP needs better enforcement and a streamlined review process

– CTP is more reactive than proactive and plagued by litigation from frustrated parties.

FDA scored a win in battle against flavored e-Cigarettes²⁴. Avail Vapor lost its challenge to the FDA’s denial of its PMTA for new flavored electronic cigarettes. The court ruled that FDA’s decision was based on scientific evidence. Avail failed to disprove the FDA’s conclusion that its products pose a serious risk to youth without enough offsetting benefits to adults, according to the US Court of Appeals for the Fourth Circuit.

Meanwhile, the US FDA rule mandating graphic warnings on cigarettes was blocked by judge²⁵

– Judge finds rule would violate tobacco companies’ First Amendment rights

– Requirement was set to take effect October 2023.

July 2022

US FDA sent its first two warning letters to manufacturers for unlawfully marketing synthetic nicotine products without authorization²⁶. The FDA is processing 1 million applications for synthetic nicotine products submitted by more than 200 companies.

The US FDA’s decision to regulate premium cigars under the same federal law as other tobacco products like cigarettes was “arbitrary and capricious”, a federal judge ruled²⁷. Cigar groups and FDA will submit briefs on remedy.

June 2022

US FDA committed to slash the nicotine levels in cigarettes. A proposed rule would be issued in May 2023 seeking public comment on establishing a max nicotine level in cigarettes. Only one other nation, New Zealand, has advanced such a plan.

May 2022

The US FDA Commissioner, Califf hired Brian King – a top official at the CDC’s Office on Smoking and Health – to lead the FDA Center for Tobacco Products²⁸. Anti-tobacco groups praised the choice, the Industry pushed back.

“Agency needs more resources to speed up its review of e-cigarettes and is avoiding making hasty decisions that could incite lawsuits from the industry”, said the US FDA Commissioner Califf²⁹.

References:

1. https://www.reuters.com/business/healthcare-pharmaceuticals/worries-over-science-new-addicts-stymie-us-nicotine-pouch-fast-track-scheme-2026-04-01 ↩︎
2. https://www.reuters.com/sustainability/boards-policy-regulation/us-fda-fast-track-nicotine-pouch-reviews-amid-white-house-pressure-2025-09-08 ↩︎
3. https://stacks.cdc.gov/view/cdc/49629 ↩︎
4. https://amp.cnn.com/cnn/2024/12/11/health/fda-tobacco-nicotine-limit ↩︎
5. https://edition.cnn.com/2024/11/09/politics/susie-wiles-trump-chief-of-staff/index.html ↩︎
6. https://www.hhs.gov/about/news/2024/04/26/secretary-becerra-statement-proposed-menthol-cigarette-rule.html ↩︎
7. https://www.nationalreview.com/news/biden-risks-alienating-base-supporters-in-key-battleground-states-with-proposed-menthol-ban-pollster-finds/ ↩︎
8. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI76 ↩︎
9. CTP Strategic Plan | FDA ↩︎
10. Critics charge political concerns have led Biden administration to delay long-awaited ban on menthol cigarettes | CNN ↩︎
11. https://www.nbcnews.com/health/health-news/long-awaited-ban-menthol-cigarettes-delayed-2024-public-health-groups-rcna127608 ↩︎
12. https://edition.cnn.com/2023/10/16/health/fda-menthol-cigarettes-rules ↩︎
13. https://www.fda.gov/news-events/press-announcements/fda-seeks-fines-against-22-retailers-selling-illegal-youth-appealing-e-cigarettes ↩︎
14. https://edition.cnn.com/2023/09/01/health/fda-menthol-regulation/index.html ↩︎
15. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-warns-firm-responsible-illegal-smokeless-products-made-non-tobacco-nicotine ↩︎
16. https://www.nytimes.com/2023/08/10/health/fda-cigar-exemption.html ↩︎
17. https://www.reginfo.gov/public/do/eAgendaHistory?operation=OPERATION_GET_PUBLICATION&showStage=longterm&currentPubId=202304 ↩︎
18. https://apnews.com/article/politics-us-food-and-drug-administration-business-health-vaping-fc7a384693fb91861a6bb17e5b5bb6d9 ↩︎
19. https://edition.cnn.com/2023/02/22/business/fda-fines-ecigs/index.html ↩︎
20. https://edition.cnn.com/2023/02/02/health/tobacco-ban-support/index.html ↩︎
21. https://durbin.senate.gov/newsroom/press-releases/durbin-to-fda-follow-the-law-pull-unauthorized-e-cigarettes-from-the-market-immediately-to-protect-americas-children ↩︎
22. https://journalnow.com/business/local/fda-updates-potential-tobacco-regulatory-timelines/article_7fe11418-8e09-11ed-846d-93735f2ea83d.html ↩︎
23. https://politico.com/newsletters/prescription-pulse/2022/12/20/fda-tobacco-center-needs-clarity-says-expert-panel-00074698 ↩︎
24. https://news.bloomberglaw.com/us-law-week/fda-scores-another-win-in-battle-against-flavored-e-cigarettes ↩︎
25. https://reuters.com/legal/litigation/fda-rule-mandating-graphic-warnings-cigarettes-blocked-by-judge-2022-12-08 ↩︎
26. https://edition.cnn.com/2022/07/14/health/fda-synthetic-nicotine/index.html ↩︎
27. https://reuters.com/legal/government/fda-regulation-premium-cigars-arbitrary-capricious-judge-finds-2022-07-05 ↩︎
28. https://news.bloomberglaw.com/health-law-and-business/califf-taps-cdc-official-to-lead-fda-center-for-tobacco-products ↩︎
29. https://news.bloomberglaw.com/health-law-and-business/fda-must-be-judicious-in-vaping-enforcement-califf-says ↩︎