September 2026: FDA Names Bret Koplow as Director of the Center for Tobacco Products
The U.S. Department of Health and Human Services has officially appointed Bret Koplow, Ph.D., J.D., as Director of the Food and Drug Administration’s Center for Tobacco Products (CTP). Koplow, who previously served as the center’s Acting Director, steps into the permanent role as part of a broader executive leadership update across the agency.
Koplow brings over a decade of regulatory, policy, and legal experience to the position, having served at the FDA in various capacities since 2011. Prior to taking on leadership at CTP, he served as Senior Counselor to the FDA Commissioner, where he focused on regulatory, policy, and operational matters surrounding tobacco products. His background at the agency also includes legal and legislative roles within the Office of the Chief Counsel and the Office of Legislation.
In his position as CTP Director, Koplow will oversee a core two-part mandate: expanding access to lower-risk alternatives for adult smokers looking to transition away from combustible cigarettes, while implementing regulatory and enforcement strategies to protect youth from nicotine exposure and addiction. His selection was announced alongside three other senior appointments across the FDA, including leadership roles in the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and a newly created office for technology and artificial intelligence.
August 2026: Trump Taps White House Adviser Heidi Overton to Lead FDA Following Months of Agency Turmoil
President Donald Trump has selected Dr. Heidi Overton, a senior White House domestic policy adviser, to serve as commissioner of the Food and Drug Administration (FDA). Overton’s selection, first reported by Bloomberg News, comes as the administration seeks to stabilize the regulatory agency following months of leadership upheaval. If confirmed by the Senate, Overton will replace acting commissioner Kyle Diamantas, who took over after Dr. Marty Makary resigned in May 2026 following a turbulent 13-month tenure.
Makary’s resignation in May 2026 followed a collision of political, policy, and internal management crises:
– Clashes Over Vaping and Tobacco Policy: A major tipping point was a sharp dispute over e-cigarettes. The FDA’s decision to authorize certain flavored e-cigarettes (such as products from Glas Inc.) came under heavy pressure from administration officials and vaping lobbyists. Makary reportedly opposed authorizing flavored varieties but was overruled by other administration figures, creating irreconcilable friction.
– Backlash from Conservative and Anti-Abortion Groups: Anti-abortion advocates publicly criticized Makary for allegedly slow-walking a formal review of the abortion pill mifepristone.
– Internal Mass Exodus and Friction with HHS: Makary struggled to manage the FDA’s career workforce. A wave of resignations and reassignments among veteran FDA scientists left rank-and-file staff deeply demoralized. Leaks from within the agency cited micromanagement, lack of transparency, and tension with Health and Human Services (HHS) Secretary Robert F. Kennedy Jr..
– Pharmaceutical Industry Pushback: Drugmakers expressed frustration over unpredictable decision-making, controversial vaccine policy shifts, and expedited review programs that strained the agency’s understaffed divisions.
Overton is a physician board-certified in preventive medicine with a doctorate in clinical investigation from Johns Hopkins Bloomberg School of Public Health. A former White House Fellow and policy director at the America First Policy Institute (AFPI), she currently serves as deputy assistant to the president for domestic policy. At the White House, Overton has been a central architect of Secretary Kennedy’s “Make America Healthy Again” (MAHA) platform, helping mediate policy negotiations over food guidelines, childhood vaccine recommendations, and drug pricing transparency.
Overton brings strong White House alignment directly into the commissioner’s office. For the tobacco and vaping sectors, her appointment means the Center for Tobacco Products (CTP) will likely operate under tighter executive coordination with the Domestic Policy Council. Industry stakeholders expect greater predictability in regulatory reviews, but health advocates worry political policy priorities could continue to outweigh traditional career scientific guidance on harm reduction and youth vaping enforcement.
Makary’s exit demonstrated that the administration was willing to intervene when FDA leadership resisted broader commercial and policy goals regarding e-cigarettes. The forced approval of flavored vapes signaled a potentially higher tolerance for harm-reduction arguments pushed by the vaping industry, over strict anti-flavor regulatory stances historically favored by public health groups.
July 2026: Public Health Coalition and Parents Sue FDA Over Policy Bypassing Review for E-Cigarettes and Nicotine Pouches
A coalition of leading national public health organizations, pediatricians, and parents filed a federal lawsuit against the Food and Drug Administration (FDA), challenging a controversial enforcement policy that permits unauthorized e-cigarettes and nicotine pouches to remain on store shelves before the completion of the required scientific review. The lawsuit, filed in the U.S. District Court for the District of Maryland, asserts that an enforcement guidance issued by the FDA in May 2026 violates federal law. By creating what plaintiffs describe as an “enforcement safe harbor,” the policy allegedly allows potentially thousands of unauthorized tobacco products to stay on the market indefinitely – including the youth-appealing flavored varieties.
The coalition of plaintiffs includes the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Truth Initiative, and Parents Against Vaping. Joining them are a pediatrician specializing in adolescent tobacco use and a parent of two children who became addicted to nicotine through flavored e-cigarettes. The plaintiffs are legally represented by the Campaign for Tobacco-Free Kids and Democracy Forward.
According to the complaint, the FDA’s guidance violates federal standards on three key fronts. First, it violates the Tobacco Control Act by permitting new tobacco products to be marketed without the mandatory marketing granted order, which requires prior agency authorization based on scientific review. Second, the plaintiffs allege the FDA unlawfully bypassed public notice and comment requirements under the Administrative Procedure Act before implementing the far-reaching policy. Finally, the lawsuit states the FDA provided no meaningful justification for creating an enforcement exemption, nor for altering its longstanding approach to flavored products – which the agency has repeatedly acknowledged pose a substantial risk to youth – making the guidance arbitrary and capricious.
Additionally, the plaintiffs take aim at the FDA’s commitment to publish a list of unauthorized products with pending applications. The lawsuit contends that this public list will effectively serve as an enforcement safe-harbor registry, facilitating the unlawful sale of these products by signaling to retailers that they are exempt from immediate enforcement action.
The chosen venue for the lawsuit is legally significant. The U.S. District Court for the District of Maryland is the same court that struck down a similar 2017 FDA policy. In that case, the court ruled that the FDA had exceeded its statutory authority by allowing e-cigarettes to stay on the market indefinitely without authorization – a policy the court found had directly fueled the youth vaping epidemic.
The legal challenge comes amid ongoing concerns over youth nicotine addiction. While overall youth tobacco use has trended downward in recent years, the 2025 National Youth Tobacco Survey revealed that more than 2 million middle and high school students in the United States still use tobacco products. E-cigarettes and nicotine pouches remain the top two most commonly used products, with roughly 90% of youth users opting for flavored varieties.
June 2026: FDA Proposes New Rules to Crack Down on Illegal Foreign Tobacco and E-Cigarettes
The U.S. Food and Drug Administration (FDA) has issued a proposed rule designed to strengthen its oversight of foreign tobacco manufacturers and close a regulatory loophole that separates them from domestic companies. While American tobacco manufacturers are already legally required to register their facilities and list their products with the FDA, foreign entities are not currently held to the same standard. If finalized, this rule would level the playing field by requiring foreign manufacturers to systematically register their establishments and list all products intended for sale in the United States.
A primary goal of this proposal is to crack down on unauthorized, youth-appealing e-cigarettes, many of which are manufactured overseas and illegally imported into the country. By gathering a complete picture of what is entering the U.S. market and where it originates, the FDA intends to become more proactive, allowing the agency to conduct on-site inspections at international facilities and stop illegal products before they reach American consumers.
Under the new procedures, manufacturers would be required to submit detailed information electronically, including nicotine concentrations, characterizing flavors, package sizes, and specific e-cigarette technical specifications like battery capacity and wattage. Additionally, companies would need to maintain all product labeling, advertising, and consumer information records for at least four years to ensure they are not making unauthorized health claims or marketing products to youth. The proposed rule is currently open for public comment on Regulations.gov until September 14, 2026.
June 2026: Youth Tobacco Use Hits Historic Lows, 2025 FDA Survey Reveals
The U.S. Food and Drug Administration (FDA) has shared the findings from its 2025 National Youth Tobacco Survey and published a peer-reviewed article analyzing the data. The report highlights a significant, positive shift in youth public health trends, showing that overall tobacco use among middle and high school students has hit historic lows.
According to the data, current tobacco use, which is defined as using a product on at least one day in the past thirty days, dropped steadily between 2022 and 2025. This downward trend spans across tobacco products overall, traditional combusted tobacco like cigarettes, and e-cigarettes. In 2025, roughly 2 million students, representing about 7.2% of U.S. middle and high schoolers, reported using a tobacco product. Among the students surveyed, e-cigarettes remained the most common product at 5.2%, followed by nicotine pouches at 1.7%, and cigarettes at 1.4%. While youth use of nicotine pouches saw an uptick between 2022 and 2025, the overall numbers remain low and completely stabilized between 2024 and 2025.
The FDA attributes these historic lows to aggressive public education campaigns and robust enforcement strategies. These efforts include youth prevention initiatives like The Real Cost campaign and retail crackdowns, such as recent warning letters sent to retailers selling unauthorized tobacco products designed to mimic candy, cough drops, and breath strips. Furthermore, the FDA is integrating strict technical restrictions into its product review process, recently authorizing four flavored e-cigarette products that require ID and age verification, smartphone pairing, and repeated biometric checks to ensure users are 21 or older. The data collected from this annual survey will continue to guide the agency’s regulatory decisions and public health efforts moving forward.
May 2026: BAT and Altria Push FDA for Clearer Path on Flavored Vape Approvals
British American Tobacco (BAT) subsidiary Reynolds American and Altria Group are objecting to the FDA’s proposed framework for reviewing flavored vaping products, arguing the agency’s standards remain too vague and restrictive despite recent policy shifts.
The FDA’s draft guidance indicates it still considers fruit- and candy-flavored products particularly risky due to youth appeal, making authorization unlikely for most such products. However, the agency signaled it may be more open to flavors such as coffee, tea, and spices that it believes are primarily attractive to adults.
The debate intensified after the FDA recently authorized mango- and blueberry-flavored e-cigarettes from Glas Inc., marking the first time the agency approved non-tobacco and non-menthol flavored vaping products in the U.S. The decision was widely viewed as a significant regulatory shift and a possible signal that the FDA may gradually loosen its long-standing opposition to non-tobacco flavors.
Nevertheless, industry groups and major tobacco companies argued the framework lacks predictable standards and does not provide enough clarity on what evidence is needed for approval. Reynolds American and Altria reportedly urged the FDA to establish clearer requirements covering flavors, nicotine levels, ingredients and additives, device appearance, and marketing plans, combined with postmarket surveillance and reporting obligations. They argue a more transparent pathway would help move adult smokers toward regulated smoke-free alternatives instead of illicit products.
At the same time, public health groups continue warning that broader flavored vape authorizations could reverse progress in reducing youth vaping. The FDA has emphasized that even under its softer approach, it will continue prioritizing enforcement against products deemed likely to appeal to minors through branding, packaging, or marketing.
May 2026: Controversy Over FDA Authorization of Fruit-Flavored E-Cigarettes Mounts as Internal Staff Report Being Blindsided by Broader Nicotine Policy Shift
The U.S. Food and Drug Administration (FDA) is facing escalating scrutiny after a recent wave of policy decisions on nicotine products triggered not only political backlash, but also internal confusion among agency staff who say they were unexpectedly sidelined from key changes in regulatory direction.
At the center of the debate is the FDA’s recent authorization of fruit-flavored e-cigarettes for adult smokers, including mango and blueberry variants, alongside menthol products. The approvals marked a notable shift for an agency that has historically restricted flavored vaping products due to concerns about youth appeal.
However, the more consequential source of internal friction appears to be not just the authorizations themselves, but a separate and broader policy change: revised FDA guidance that opens the door to allowing additional flavored e-cigarettes and nicotine pouches onto the U.S. market under a more flexible enforcement framework.
According to reporting based on interviews with agency officials, senior staff in the FDA’s tobacco division were blindsided by the rollout of this guidance, with some learning of the policy only shortly before it was published. The document, which outlines an “enforcement discretion” approach for certain unauthorized products, represents a departure from the FDA’s traditional model of requiring full premarket scientific authorization before new nicotine products can be marketed.
Internal reactions described by officials point to a breakdown in standard consultation procedures. Career staff reportedly were not fully involved in drafting the guidance and were left unclear about how the new framework was developed or how it should be implemented. The sudden publication prompted internal meetings and operational uncertainty within the agency’s tobacco control center, as staff worked to interpret the practical implications of the shift.
The revised policy is especially significant because it extends beyond flavored e-cigarettes and also covers nicotine pouches, a rapidly growing segment of the U.S. nicotine market. Under the new approach, products that meet certain criteria may be allowed to remain on the market even if they have not completed full regulatory review, a move critics say effectively lowers the barrier to market entry for a wider range of nicotine products.
This broader opening has intensified concern among public health advocates, who argue that it could accelerate the availability of flavored and alternative nicotine products at a time when enforcement against unauthorized vapes is already inconsistent. At the same time, supporters within parts of the industry argue that the shift reflects a pragmatic recognition of market realities, where large volumes of unauthorized products are already widely available.
The controversy has now spilled into Congress. A group of U.S. senators has formally requested clarification from the FDA on how the fruit-flavored e-cigarette authorizations were evaluated and how they fit within the agency’s broader regulatory framework. Lawmakers are seeking details on the scientific basis for the decisions, as well as assurances that established review procedures were followed consistently.
Beyond the immediate policy dispute, the situation highlights deeper institutional tension within the FDA over the future direction of nicotine regulation. Career staff have historically emphasized strict controls on flavored products due to evidence linking them to youth initiation, while more recent policy signals suggest a shift toward a regulated harm-reduction model focused on adult smokers.
Complicating matters further is the perception that enforcement priorities are being reshaped in real time, with the FDA increasingly focusing on specific product features deemed appealing to minors. Critics argue this approach could create regulatory ambiguity, particularly as illicit flavored products continue to dominate parts of the market.
For now, the combination of internal disruption, congressional scrutiny, and policy recalibration has placed the FDA’s tobacco regulatory strategy under unusually intense pressure. With staff describing a lack of prior consultation on key elements of the new framework, and lawmakers demanding transparency, the agency’s approach to both e-cigarettes and nicotine pouches is likely to remain under close examination in the months ahead.
May 2026: FDA CTP Signals Faster PMTA Review as Efficiency Push Reshapes Tobacco Product Pathway
The FDA Center for Tobacco Products (CTP) Acting Director outlined a procedural shift which aims to accelerate Premarket Tobacco Product Application (PMTA) review timelines while maintaining the statutory “appropriate for the protection of public health” standard. The emphasis is on operational efficiency rather than any change in regulatory threshold, but the implications for e-vapor products and nicotine pouches are still material.
The most immediate development is that the FDA reports no backlog in the “Acceptance Review” stage of the PMTA process. This means newly submitted applications can now proceed more quickly into substantive scientific review instead of experiencing prolonged administrative delays at the intake stage. Historically, this step has been a significant bottleneck, so its removal effectively shortens the front-end timeline for regulatory consideration.
In parallel, the agency is working to streamline the “Filing Review” stage, which determines whether applications contain sufficient information for full scientific evaluation. The FDA indicates that improvements in this area are informed by experience gained from recent reviews of nicotine pouch and ENDS submissions, suggesting a gradual standardisation of review practices across product categories.
A further notable shift is a more granular approach to decision-making within large applications. Rather than treating PMTAs as indivisible packages, the FDA signals greater willingness to separate components of a submission. This allows certain products within a broader portfolio to receive marketing authorization while others remain under review. From an industry perspective, this reduces binary “all-or-nothing” risk embedded in large filings and increases the likelihood of partial approvals.
The Acting Director also highlights increased focus on supplemental PMTAs (sPMTAs) for modifications to already-authorised products. The FDA is exploring faster review pathways where changes are incremental and supported by existing data, particularly in cases involving device updates or product refinements. This effectively creates a more efficient pathway for iterative innovation in categories such as e-vapor devices.
Overall, the key messages point to a more structured and streamlined PMTA system rather than a more lenient one. The FDA is not changing its underlying public health standard, but it is working to reduce administrative friction, shorten early-stage delays, and allow more modular decision-making. For manufacturers, this may translate into faster review cycles, improved predictability in certain stages of the process, and increased optionality around incremental product improvements.
May 2026: FDA Commissioner Resigns as Flavored Vape Approvals Reportedly Trigger White House Clash
FDA Commissioner Marty Makary resigned – or was effectively forced out – following escalating tensions with the Trump administration over flavored vape approvals and broader FDA policy disputes.
The key point of conflict appears to have been the FDA’s authorization of fruit-flavored vaping products. Makary reportedly resisted approving flavored e-cigarettes because of concerns about youth uptake and public health risks, while President Donald Trump and senior administration officials favored a more permissive regulatory approach toward nicotine alternatives and tobacco harm reduction. Pressure intensified after Trump reportedly pushed Makary directly to move forward with the approvals. The FDA subsequently authorized several flavored vape products, including mango and blueberry varieties from Glas Inc. Although the approvals ultimately went through, Makary reportedly opposed the decision internally and viewed it as inconsistent with his public-health position. The dispute over flavored vapes appears to have become the decisive breaking point. Trump had reportedly already approved plans to replace Makary before his resignation became public, leaving the commissioner increasingly isolated politically inside the administration.
The clash also reflected a broader shift in regulatory priorities. Trump allies and some industry groups have increasingly supported flavored vaping products as alternatives for adult smokers, while Makary remained more cautious about products perceived as having stronger youth appeal. At the same time, Makary was facing pressure on multiple fronts, including criticism from anti-abortion conservatives over abortion-pill policy, complaints from vaping advocates that the FDA remained too restrictive, and concerns from pharmaceutical companies and agency staff over regulatory uncertainty and internal instability.
Interim leadership is expected to pass to Kyle Diamantas, the FDA Deputy Commissioner for Human Foods and a former food-industry attorney who has played a central role in the agency’s food regulatory and organizational reform efforts.
May 2026: FDA Shifts Enforcement Priorities for Unauthorized Nicotine Products, Signaling a More Pragmatic Regulatory Approach
The U.S. Food and Drug Administration has issued new enforcement guidance that materially changes how the agency intends to police unauthorized nicotine products in the U.S. market, particularly e-cigarettes and nicotine pouches with pending premarket applications. The policy signals a notable shift away from broad categorical crackdowns toward a more selective, application-based enforcement framework that could reshape competitive dynamics across the nicotine industry.
Under the new guidance, FDA stated that it generally does not intend to prioritize enforcement against electronic nicotine delivery systems (ENDS: vapes or vape pens, personal vaporizers, e-cigarettes, cigalikes, e-pens, e-hookahs, e-cigars, and e-pipes) and oral nicotine pouch products marketed without authorization, provided they are covered by a pending premarket tobacco product application (PMTA) that has successfully passed Acceptance and Filing Review. Supplemental PMTAs (sPMTAs) may also qualify if they have been pending for more than 180 days. For non-tobacco flavored vaping products, FDA additionally requires that the application contain sufficient data to evaluate whether the product is appropriate for the protection of public health (APPH).
The guidance is significant because all “new tobacco products” marketed without authorization remain technically illegal under the Federal Food, Drug, and Cosmetic Act. However, FDA acknowledged that it lacks the resources to pursue enforcement against every unauthorized product currently on the market. Instead, the agency is now explicitly prioritizing enforcement resources toward products it considers higher-risk or more problematic from a public health perspective. The policy applies to both vaping products and nicotine pouches containing nicotine from any source, including synthetic nicotine.
A central implication of the policy is that products with serious, scientifically substantive PMTAs may now be able to remain on the market during lengthy FDA review periods without facing immediate enforcement pressure. This marks a substantial departure from FDA’s earlier posture, particularly under the 2020 enforcement guidance that aggressively targeted flavored pod-based e-cigarettes amid the youth vaping surge associated with products such as JUUL. The new guidance formally withdraws the April 2020 policy.
The revised approach appears partly driven by changing market realities. FDA noted that youth usage patterns have evolved considerably since 2019. According to 2025 National Youth Tobacco Survey data cited in the guidance, disposable devices now dominate youth vaping consumption, accounting for 66.3% of device usage among middle and high school students who currently vape, while pod systems represent a much smaller share.
Rather than targeting product categories broadly, FDA is now emphasizing specific risk characteristics. The agency stated that it still intends to prioritize enforcement against products featuring “presumptively underage-appealing elements,” including products using cartoon imagery, toy-like designs, or products disguised as phones or gaming devices. FDA also highlighted high-nicotine products, products lacking child-resistant packaging, products linked to serious adverse events, and potential fire hazards as priority enforcement targets.
The guidance therefore introduces a more nuanced distinction between “unauthorized” and “enforcement priority.” While unauthorized status remains unchanged legally, certain products may effectively receive temporary market tolerance if FDA views their applications as sufficiently complete and scientifically reviewable. At the same time, the guidance does not represent deregulation. FDA explicitly stated that inclusion under the enforcement policy does not imply a product is likely to receive marketing authorization. Products remain subject to removal if FDA ultimately determines they do not satisfy the APPH standard.
Another notable aspect is FDA’s plan to publish a public-facing list identifying manufacturers and products that generally fall outside prioritized enforcement categories. This could become an important commercial and reputational signal for retailers, distributors, and consumers by differentiating products perceived as being under active scientific review from entirely non-compliant products. The guidance may also reduce regulatory uncertainty for retailers and distributors by creating clearer distinctions between products under scientific review and products viewed as outright enforcement targets.
Taken together, the guidance reflects an increasingly pragmatic regulatory strategy by FDA. Rather than attempting to eliminate all unauthorized products simultaneously – an objective the agency implicitly acknowledges is operationally unrealistic – FDA appears to be moving toward a risk-based framework centered on youth appeal, safety concerns, and scientific review status. For the nicotine industry, the broader message is becoming clearer: the U.S. market is unlikely to become less regulated, but it may become more predictable for companies capable of successfully navigating the PMTA process.
May 2026: FDA Moves to Accelerate PMTA Reviews and Reduce Regulatory Backlog
The U.S. Food and Drug Administration Center for Tobacco Products (CTP) announced a series of measures aimed at accelerating tobacco product reviews and improving efficiency in the premarket authorization process, signaling a potentially more streamlined regulatory environment for nicotine and tobacco manufacturers. The agency has now received premarket tobacco product applications (PMTAs) covering nearly 27 million tobacco products. The FDA said lessons learned over the past five years are being used to improve review timelines and operational efficiency.
A key development highlighted by the agency is the substantial reduction in application backlogs. In 2025, CTP reduced the backlog of pending applications by approximately 70%, while also eliminating the queue for applications awaiting Acceptance Review. The FDA stated that, for the first time in years, newly submitted PMTAs now move into the initial review phase almost immediately after receipt rather than remaining pending for months or years.
The agency is also introducing new efficiencies in Filing Review, the stage in which FDA determines whether an application contains sufficient information for substantive scientific assessment. These faster review approaches have already been applied to nicotine pouch and electronic nicotine delivery system (ENDS) applications.
CTP further indicated that it is exploring ways to streamline scientific review and authorization decisions by separating products within larger submissions. Under this approach, products that meet the public health standard could receive marketing authorization more quickly even if other products in the same application package require additional information.
Another major initiative involves the planned prioritization of supplemental PMTAs (sPMTAs). The FDA stated that it is developing an expedited pathway for certain modifications to already authorized products, particularly where limited supporting information may be sufficient to demonstrate that the modified product remains appropriate for the protection of public health. Potentially eligible changes could include certain technological improvements to existing devices.
The agency also pointed to its nicotine pouch review pilot program, launched in September 2025, as an example of accelerated review capabilities. Under the pilot, FDA authorized six nicotine pouch products within approximately three months of scientific review beginning, which the agency described as a record review timeline for PMTAs. Although no additional products will be added to the pilot, CTP stated that lessons learned from the program will be incorporated into reviews for all nicotine pouch PMTAs going forward.
The announcement comes shortly after the FDA authorized several new ENDS products, including the agency’s first authorization of non-tobacco and non-menthol vaping products, suggesting a broader shift toward faster and potentially more flexible regulation of alternative nicotine products under the current administration.
Download FDA – Enforcement Priorities Guidance
May 2026: Trump Pushes FDA on Flavored Vapes as U.S. Illicit Market Surges
According to The Wall Street Journal, President Donald Trump has pressured FDA Commissioner Marty Makary to accelerate the approval of flavored vaping products, reflecting growing frustration within the administration over regulatory delays1. The issue centers on the FDA’s continued refusal to authorize non-tobacco, non-menthol vape products. As it stands, only a limited number of vaping products – restricted to tobacco and menthol flavors – are legally authorized in the U.S., leaving the regulated market with very little variety.
This has become politically salient. During his 2024 campaign, Trump promised to “save vaping,” marking a clear reversal from his first administration, which imposed a crackdown on flavored e-cigarettes in 2020 in response to a surge in youth use. The WSJ report highlights this shift as part of a broader push to revisit the current regulatory approach.
The situation also underscores a structural imbalance in the U.S. nicotine market. While the FDA maintains strict evidentiary standards – particularly for flavored products due to youth appeal concerns – the lack of authorized options has left a gap between regulation and consumer demand. That gap has been filled by a rapidly expanding illicit vape market. Unauthorized flavored disposable e-cigarettes, often imported from China, now dominate large parts of U.S. sales. As a result, the market has effectively split into two segments: a tightly constrained legal channel with limited product diversity, and a largely unregulated illicit segment offering the flavors consumers seek. This dynamic has intensified criticism that current FDA policy may be counterproductive – failing to eliminate youth access to flavored products while simultaneously restricting regulated alternatives for adult smokers.
The pressure from President Trump highlights a growing policy dilemma: whether maintaining strict limits on flavored vape approvals serves public health goals, or whether it inadvertently sustains the illicit market it aims to curb.
April 2026: FDA Issues Not Substantially Equivalent Orders for 28 Cigarette Products
The U.S. Food and Drug Administration has issued Not Substantially Equivalent (NSE) orders for 28 cigarette products manufactured by Seneca Manufacturing Company and marketed under the Heron and Sands brands.
Under the Family Smoking Prevention and Tobacco Control Act, these products had remained on the market under the “provisional” Substantial Equivalence (SE) pathway pending FDA review. As that review has now resulted in NSE determinations, the 28 cigarette products are no longer authorized for sale. Accordingly, they may no longer be distributed, imported, marketed, or sold in the United States. Retailers holding remaining inventory are advised to coordinate with manufacturers or suppliers regarding appropriate disposition.
For provisional SE products that receive an NSE order, the FDA has indicated it does not intend to initiate enforcement against retailers for at least 30 days from the date the order is posted on its website. After this period, continued sales may expose retailers to compliance and enforcement actions, including warning letters, civil monetary penalties, product seizures, and injunctions.
April 2026: FDA Adds 18 Constituents to Harmful and Potentially Harmful Constituents List
The U.S. Food and Drug Administration has published a Federal Register notice finalizing the addition of 18 constituents to its list of Harmful and Potentially Harmful Constituents (HPHCs) in tobacco products. The HPHC list identifies chemicals and compounds present in tobacco products, as well as in their smoke and/or aerosol, that are known – or suspected – to cause harm to users and non-users. The list focuses on substances linked to the most serious health impacts of tobacco use, including cancer, cardiovascular disease, respiratory effects, reproductive harm, and addiction.
The FDA’s HPHC framework is intended to enhance transparency for the public and provide regulatory clarity for industry. For consumers, it highlights toxic constituents for which there is substantial evidence of harm or potential harm to human health. For manufacturers, the updated list signals areas of focus in the FDA’s review of new tobacco product applications. Importantly, inclusion on the HPHC list does not constitute a ban. Under the Federal Food, Drug, and Cosmetic Act, manufacturers are required to report a full accounting of product constituents, including HPHCs, to the FDA.
With these additions, the HPHC list now includes a total of 111 constituents. These chemicals may be present across a range of tobacco products – including e-cigarettes, hookah tobacco, and cigars – as well as in their emissions. The FDA continues to evaluate emerging scientific evidence and has also proposed adding three further constituents, for which it is currently seeking public comment.
In addition, the agency has finalized a previously tentative determination that substances identified as respiratory toxicants by the National Institute for Occupational Safety and Health will serve as an additional criterion for inclusion on the HPHC list.
Download FDA HPHCs List
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 END
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.
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 CDC).
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 products. 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 lobbyist.
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 statement. 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 ban.
December 2023: FDA Advances Planning for Nicotine Reduction Standard in Cigarettes
The regulatory planning documents indicated that the U.S. Food and Drug Administration (FDA) is preparing to move forward with a proposed tobacco product standard that would set a maximum nicotine level in cigarettes and certain other finished tobacco products.
The initiative forms part of the FDA’s broader strategy to reduce the addictiveness of combustible cigarettes by lowering nicotine content to minimally or non-addictive levels. The policy is intended to increase the likelihood of smoking cessation among current users and reduce the probability of initiation, particularly among youth and other first-time users.
According to regulatory timelines outlined in the federal Unified Agenda, the agency was expected to advance the rulemaking process further in 2024, with a potential proposal stage anticipated in the first half of the year. However, these timelines remained subject to change as the rule progresses through scientific review, interagency coordination, and policy evaluation.
December 2023: FDA Center for Tobacco Products Releases 5-Year Strategic Plan
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) released a five-year Strategic Plan outlining its regulatory priorities and operational objectives for the tobacco and nicotine product landscape. The plan defines five core goals:
1. Develop, Advance, and Communicate Comprehensive Tobacco Regulations and Guidance
The CTP aims to ensure that the evolving tobacco and nicotine marketplace is effectively regulated, while improving public and stakeholder understanding of regulatory frameworks and encouraging engagement in the rulemaking process.
2. Ensure Timely, Clear, and Consistent Product Application Review
The agency seeks to improve the efficiency, transparency, and consistency of tobacco product application reviews, with marketing authorization decisions grounded in the best available scientific evidence.
3. Strengthen Compliance and Enforcement Across the Regulated Industry
The FDA prioritizes removing violative products—particularly those appealing to youth—from the market, while also improving industry understanding of compliance obligations through expanded enforcement and education efforts.
4. Enhance Knowledge and Understanding of Tobacco Product Risks
The CTP emphasizes public education through timely, clear, and evidence-based communication regarding the health risks associated with tobacco product use.
5. Advance Operational Excellence
The plan includes a focus on workforce development, retention, and organizational efficiency to support effective delivery of the agency’s regulatory mission.
The strategic framework is underpinned by four cross-cutting themes:
– Transparency: Improved clarity and consistency in communicating regulatory actions and decisions
– Science: Continued reliance on data- and evidence-driven decision-making
– Health Equity: Integration of health equity considerations across all CTP activities
– Stakeholder Engagement: Strengthened engagement with external stakeholders, including other federal agencies.
December 2023: Unified Regulatory Agenda Pushes Menthol Ban Timeline Into 2024
The U.S. federal government’s Unified Agenda of Regulatory and Deregulatory Actions indicated that the long-anticipated rule to ban menthol cigarettes is now expected in March 2024 at the earliest. The update marked a further delay in the timeline for one of the most significant pending tobacco control measures, which would prohibit menthol as a characterizing flavor in cigarettes. The rule had previously been expected to be finalized by August 2023, with later expectations shifting toward the end of 2023 before being pushed into 2024.
The continued delays drew criticism from public health advocates, who expressed concern that repeated postponements could weaken the policy’s momentum. Some advocacy groups have argued that political considerations may be influencing the timing of the rule, although no official explanation has been provided by the Administration.
December 2023: FDA Expands Civil Money Penalty Actions Against Unauthorized E-Cigarette Sales
The U.S. Food and Drug Administration (FDA) issued civil money penalty (CMP) complaints against 25 brick-and-mortar and online retailers for the illegal sale of unauthorized e-cigarette products, including Elf Bar, EB Design, and other popular disposable brands. The action marked the first time the FDA extended CMP enforcement to include online retailers in this enforcement series. The agency sought the maximum statutory penalty of approximately $19,192 per violation for each retailer involved.
The enforcement was part of a broader FDA initiative to remove unauthorized e-cigarettes from the U.S. market. As of early December 2023, the agency reported:
– More than 400 warning letters issued to retailers, alongside CMP actions against 67 retailers
– More than 630 warning letters issued to manufacturers and distributors, along with CMP actions against 36 manufacturers
– In coordination with the U.S. Department of Justice, injunction actions initiated against 7 manufacturers
The FDA stated that these measures were aimed at addressing continued distribution of unauthorized tobacco products, particularly in the rapidly growing disposable e-cigarette segment.
December 2023: Menthol Cigarette Ban Faces Continued Delay Amid Regulatory Uncertainty
Expectations had increased that the U.S. Food and Drug Administration (FDA) would not finalize its long-awaited rule banning menthol cigarettes and flavored cigars before the end of the year. The proposed regulation, originally advanced in 2022, had already missed earlier internal timelines and remained under review following submission to the White House Office of Management and Budget (OMB) in late 2023.
It is increasingly anticipated that the final rule could be delayed into 2024, reflecting the complexity and political sensitivity surrounding menthol regulation in the United States. The timing uncertainty added to the long history of postponements affecting one of the FDA’s most significant tobacco control initiatives. More broadly, menthol regulation continues to be viewed as a highly politicized policy area, with finalization subject to regulatory, legal, and administrative considerations.
October 2023: FDA Sends Menthol Ban Rule to White House for Final Review
The U.S. Food and Drug Administration (FDA) submitted its proposed rule banning menthol cigarettes and flavored cigars to the White House Office of Management and Budget (OMB) for final interagency review, marking the last regulatory step before potential publication of a final rule. The proposed regulation, first advanced in 2022, would prohibit menthol in cigarettes as well as all characterizing flavors in cigars other than tobacco. The FDA has been evaluating menthol regulation for more than a decade, making it one of the most longstanding tobacco policy initiatives under consideration.
At the state level, flavored tobacco restrictions have already been implemented in several jurisdictions. Massachusetts became the first state to enact a comprehensive flavored tobacco ban, including menthol, in 2020. California also implemented restrictions on flavored tobacco products, including menthol, following voter-approved legislation, although implementation timelines and enforcement have been subject to legal and operational challenges. In response to state-level restrictions and anticipated federal action, some tobacco manufacturers have introduced products incorporating synthetic cooling agents intended to replicate menthol-like sensory effects. It remains unclear whether the proposed federal rule would explicitly address such formulations.
If finalized, the federal menthol and flavored cigar ban is widely expected to face immediate legal challenges from tobacco industry stakeholders, consistent with prior litigation involving major tobacco regulatory measures.
September 2023: FDA Escalates Enforcement with Maximum Civil Money Penalties on Unauthorized E-Cigarette Sales
The U.S. Food and Drug Administration (FDA) filed civil money penalty (CMP) complaints against 22 retailers for the sale of Elf Bar/EB Design e-cigarette products, which the agency identified as unauthorized tobacco products with strong youth appeal. The enforcement actions followed prior warning letters issued to the retailers. According to the FDA, the businesses failed to correct the violations by continuing to sell unauthorized products, prompting escalation to formal penalty proceedings. The agency sought the maximum statutory penalty of approximately $19,192 per violation for each retailer, reflecting a more aggressive enforcement posture against repeated non-compliance.
While the FDA has previously used civil money penalties in tobacco enforcement actions, this wave marked a notable escalation in seeking maximum-level penalties specifically in relation to unauthorized e-cigarette sales, particularly involving popular disposable brands.
September 2023: FDA Misses Target Timeline for Menthol Cigarette Ban
The U.S. Food and Drug Administration (FDA) confirmed that it had missed its internal target of August 2023 for publishing a final rule to prohibit menthol cigarettes and flavored cigars. The proposed regulation, originally advanced in 2022, was expected to be one of the most significant tobacco control measures in decades. However, the agency indicated that the work would continue and that the final rule would instead be completed in the coming months, without committing to a revised fixed deadline. The delay reflected ongoing regulatory complexity, stakeholder opposition, and broader legal and political considerations surrounding flavored tobacco restrictions in the United States.
August 2023: FDA Intensifies Enforcement Against Unauthorized Nicotine Products
The U.S. Food and Drug Administration (FDA) reported expanded enforcement actions targeting unauthorized nicotine products across the tobacco supply chain, including manufacturers, distributors, and retailers. As part of these efforts, the agency issued a warning letter to Amarillo Snuff for manufacturing and marketing unauthorized smokeless nicotine products made using non-tobacco substrates such as corn husks. The products were deemed subject to FDA tobacco product regulations following the expansion of regulatory authority over synthetic and non-tobacco nicotine in 2022. The FDA also issued approximately 600 warning letters to manufacturers of unauthorized tobacco and nicotine products, including more than 100 actions specifically related to non-tobacco nicotine products.
In parallel, the agency intensified enforcement at the retail level, issuing more than 2,800 warning letters and over 825 civil money penalties to retailers for selling e-cigarette products to underage purchasers. A significant portion of these actions also involved violations related to non-tobacco nicotine products sold without proper authorization.
The enforcement wave underscored the FDA’s ongoing efforts to address widespread distribution of unauthorized nicotine products, particularly within the rapidly evolving e-cigarette and alternative nicotine categories.
August 2023: Federal Court Limits FDA Authority Over Premium Cigars
A U.S. federal court ruled against the U.S. Food and Drug Administration’s (FDA) approach to regulating premium cigars, striking down key aspects of how the agency had sought to apply tobacco product regulations to this category. The ruling applied specifically to hand-rolled premium cigars, typically sold in specialty retail outlets and humidors, distinguishing them from mass-produced cigars commonly distributed through convenience stores. The court found that the FDA’s regulatory approach was insufficiently justified under administrative law standards, effectively limiting the agency’s ability to enforce certain regulatory requirements on premium cigar products.
The decision followed years of legal challenges from the cigar industry, which has contested the FDA’s authority over premium cigars since the agency’s Deeming Rule extended tobacco product regulation to cigars in 2016.
June 2023: FDA Regulatory Agenda Outlines Key Tobacco Rulemaking Timeline
The U.S. Food and Drug Administration (FDA) updated its Spring Regulatory Agenda, providing revised timelines for several major pending tobacco and nicotine regulations, including menthol restrictions, nicotine reduction, and product safety standards.
– Menthol and Flavored Cigars Ban: The FDA reiterated its plan to finalize rules prohibiting menthol in cigarettes, roll-your-own tobacco, and heated tobacco products, alongside a ban on all characterizing flavors in cigars other than tobacco. The proposed rules, originally issued in April 2022, had received approximately 247,000 public comments, the majority of which opposed the measures. The agency indicated an intent to finalize the rules, with potential implementation occurring one to two years after publication, although timelines remained subject to change.
– Federal Tobacco Purchase Age: Following the 2020 Consolidated Appropriations Act, which raised the federal minimum age for tobacco and nicotine product sales from 18 to 21, the FDA signaled plans to update and formally align federal regulatory language with the new requirement, with implementation expected in April 2024.
– Nicotine Reduction in Combustible Tobacco Products: The FDA continued development of a proposed product standard to cap nicotine levels in combustible cigarettes. While earlier projections suggested a possible rule publication by October 2023, the updated regulatory agenda pushed expectations toward December 2023, reflecting the complexity of the rulemaking process.
– Nicotine Toxicity Warning Requirements: The agency also outlined plans to introduce acute nicotine toxicity warning requirements for nicotine-containing liquids. The rule aims to improve consumer awareness of risks associated with accidental exposure and ingestion, particularly among children. Publication was projected for October 2024.
– E-Cigarette Safety Standards: In addition, the FDA signaled future rulemaking to establish product standards for e-cigarettes, including limits on certain toxicants and impurities in nicotine and base liquids such as propylene glycol (PG) and vegetable glycerin (VG). This rulemaking was projected for December 2024.
February 2023: CDC Survey Shows Strong Public Support for Tobacco Control Measures
A CDC-linked survey conducted in early 2023 indicated strong public support in the United States for stricter tobacco control policies, particularly targeting flavored tobacco products. The findings showed that approximately two-thirds of respondents supported a ban on menthol cigarettes. Support was also notable among current smokers, with more than one-third expressing approval of a menthol cigarette ban.
Broader policy questions revealed more mixed views. A substantial share of respondents expressed support for more aggressive tobacco control measures, including more than one-quarter indicating support for a complete ban on tobacco product sales, depending on how the policy question was framed. The results highlighted growing public acceptance of regulatory measures aimed at reducing tobacco use, particularly for flavored combustible products such as menthol cigarettes.
February 2023: FDA Introduces Civil Money Penalties for Illegal E-Cigarette Sales
The U.S. Food and Drug Administration (FDA) escalated its enforcement efforts against unauthorized e-cigarette products by issuing civil money penalties (CMPs) to manufacturers and retailers selling products without the required premarket authorization. The agency described the action as a “wake-up call,” signaling a more aggressive enforcement stance against continued marketing of e-cigarettes that had not received authorization under the FDA’s tobacco regulatory framework.
The penalties targeted companies found to be in violation of the premarket tobacco product application (PMTA) requirements, which mandate FDA authorization before new tobacco or nicotine products can be legally marketed in the United States. The move marked a shift toward more direct financial enforcement tools, complementing warning letters and marketing denial orders already used by the agency.
February 2023: FDA Tobacco Center Signals Structural Reset After External Review
Following a critical external review of its operations, the FDA’s Center for Tobacco Products (CTP) signaled a strategic reset aimed at improving regulatory effectiveness and operational clarity. The review highlighted ongoing challenges in enforcement capacity, regulatory ambiguity, and the agency’s reliance on reactive rather than proactive decision-making. In response, CTP committed to developing a five-year strategic plan by the end of the year to define regulatory priorities and strengthen oversight of the largely unauthorized e-cigarette market. The plan was expected to focus on streamlining product review processes and improving enforcement consistency across tobacco and nicotine categories.
January 2023: FDA Advances Menthol Ban Timeline Amid Regulatory Pressure
The U.S. Food and Drug Administration (FDA) advanced its regulatory agenda on flavored tobacco by signaling continued progress toward a federal ban on menthol cigarettes. The agency indicated its intention to publish a final rule by August 2023, following a broader proposed rule issued in 2022 covering menthol cigarettes and flavored cigars.
The proposed menthol ban represented one of the most significant tobacco control measures under consideration in the U.S. regulatory system. Menthol cigarettes remain a key segment of the combustible market and are estimated to account for a substantial share of profits for major tobacco companies, including British American Tobacco (BAT), Imperial Brands and Altria.
In parallel, industry players began adjusting product strategies in anticipation of state-level restrictions. In California, where flavored cigarette bans were implemented, Reynolds American (BAT’s U.S. subsidiary) introduced new cigarette offerings positioned as compliant alternatives. The company launched a non-menthol Newport variant described in marketing as offering “a taste that satisfies the senses” and “a new fresh twist.” Reynolds stated that the products comply with applicable regulations and are not subject to the California ban, arguing that they do not present a distinguishable characterizing flavor or aroma beyond tobacco.
December 2022: Independent Review Finds Structural Challenges at FDA Tobacco Center
A December 2022 independent evaluation of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), conducted by the Reagan-Udall Foundation, identified several structural and operational challenges affecting the agency’s tobacco regulation framework. The review highlighted that a lack of clarity in regulatory processes continues to hinder effective oversight of tobacco and nicotine products. It also noted that the CTP would benefit from more streamlined review procedures and stronger enforcement capacity. In addition, the report characterized the agency’s regulatory posture as largely reactive rather than proactive, pointing to persistent litigation from regulated parties as a key constraint on timely decision-making.
December 2022: Federal Court Blocks FDA Cigarette Graphic Warning Rule
A federal court blocked the U.S. Food and Drug Administration’s rule requiring cigarette packages to display graphic health warnings, ruling that the mandate violated tobacco companies’ First Amendment rights. The regulation, which had been scheduled to take effect in October 2023, would have required larger and more visually explicit warning labels on cigarette packaging. The decision represented a significant setback for the FDA’s labeling policy and delayed implementation pending further legal proceedings.
July 2022: FDA Begins Enforcement on Synthetic Nicotine Products
The U.S. Food and Drug Administration (FDA) issued its first warning letters to manufacturers of synthetic nicotine products, citing unlawful marketing without required premarket authorization. The actions followed a legislative change earlier in 2022 that brought synthetic nicotine products under the FDA’s tobacco regulatory authority. The move marked the beginning of formal enforcement in the synthetic nicotine segment, as manufacturers were required to submit applications to remain on the market under the updated regulatory framework.
July 2022: Federal Court Challenges FDA Authority Over Premium Cigars
A federal court ruled that the FDA’s decision to regulate premium cigars under the same regulatory framework as other tobacco products, such as cigarettes, was “arbitrary and capricious.” The ruling represented a setback for the agency’s regulatory approach and moved the issue into the remedy phase, with both cigar industry groups and the FDA submitting further legal briefs to determine the appropriate next steps.
June 2022: FDA Moves Toward Lowering Nicotine Levels in Cigarettes
The U.S. Food and Drug Administration (FDA) advanced a major tobacco control initiative by issuing an Advance Notice of Proposed Rulemaking (ANPRM) seeking public input on a potential product standard to reduce nicotine levels in cigarettes to minimally or non-addictive levels. The proposal marks an early step in a longer regulatory process. The FDA indicated that it would continue developing the framework for a formal proposed rule, with the goal of eventually establishing a maximum nicotine level in combustible cigarettes, subject to further scientific review and public consultation.
If implemented, the policy would represent one of the most significant tobacco control interventions in decades. Internationally, New Zealand has also explored nicotine reduction as part of its broader Smokefree 2025 strategy, though approaches and implementation timelines differ.
May 2022: Brian King Appointed to Lead FDA Center for Tobacco Products
In May 2022, FDA Commissioner Robert M. Califf appointed Brian King, then Director of the CDC’s Office on Smoking and Health, as the new head of the FDA’s Center for Tobacco Products (CTP). King brought extensive experience in tobacco control policy and public health regulation to the role. The appointment was welcomed by anti-tobacco advocacy groups, who viewed it as a continuation of a strong regulatory approach to tobacco and nicotine products. In contrast, some industry stakeholders expressed concerns about potential regulatory tightening and its implications for product approvals.
At the time, Commissioner Califf emphasized the agency’s need for additional resources to accelerate the review of e-cigarettes and other emerging nicotine products, while also noting the importance of avoiding rushed decisions that could lead to legal challenges from industry actors.
Background Information
The regulation of tobacco products in the United States is primarily overseen by the U.S. Food and Drug Administration (FDA) at the federal level, a responsibility it formally received in 2009 through the Family Smoking Prevention and Tobacco Control Act. This legislation is widely regarded as a major milestone in U.S. public health policy because it brought tobacco products under federal regulatory control for the first time in a comprehensive way.
The core rationale behind the 2009 Act was the significant and well-established public health burden caused by tobacco use. Smoking remains one of the leading causes of preventable disease and death in the United States. Prior to this law, tobacco products were not subject to the same pre-market regulatory standards as pharmaceuticals or medical devices. The Act therefore aimed to reduce tobacco-related harm, prevent youth initiation, ensure accurate product information, and give regulators authority over how tobacco products are manufactured, marketed, and sold.
To implement this authority, the FDA created the Center for Tobacco Products (CTP). The CTP is the dedicated regulatory division within the agency responsible for tobacco oversight. Its role includes reviewing tobacco product applications, establishing product standards, enforcing labeling and marketing rules, and monitoring compliance across the industry. In practice, the CTP serves as the central gatekeeper for tobacco and nicotine products in the U.S. market.
The FDA regulates tobacco products through several key scientific review pathways, the most important of which are Substantial Equivalence (SE), Premarket Tobacco Product Application (PMTA), and Modified Risk Tobacco Product (MRTP).
The Substantial Equivalence (SE) pathway applies to products that are essentially similar to a “predicate” product already legally marketed in the United States, typically those on the market as of February 15, 2007. To be authorized under SE, manufacturers must demonstrate that the new product either has the same characteristics as the predicate or that any differences do not raise new or different questions of public health. This pathway is generally used for incremental product modifications rather than entirely new product categories.
The Premarket Tobacco Product Application (PMTA) pathway applies to new tobacco products that do not qualify as substantially equivalent. This is the most important pathway for modern nicotine products, including many e-cigarettes and nicotine pouches. Under PMTA, manufacturers must provide scientific evidence showing that allowing the product to be marketed is “appropriate for the protection of public health.” This standard requires the FDA to consider both the risks to current users and the potential impact on non-users, including youth initiation, as well as the possibility that existing smokers may switch to potentially less harmful alternatives.
The Modified Risk Tobacco Product (MRTP) pathway applies when a company seeks to market a product with explicit or implicit claims of reduced risk or reduced exposure to harmful substances. To obtain MRTP authorization, manufacturers must demonstrate that the product will significantly reduce harm and disease risk to individual users and that its marketing will benefit population health overall. This includes assessing whether reduced-risk claims might encourage non-users to start using tobacco or lead to dual use rather than complete switching. Importantly, MRTP authorization does not mean a product is safe, but rather that its modified risk claims are scientifically supported under strict regulatory standards.
Overall, the FDA’s tobacco regulatory framework is designed to evaluate not only the characteristics of individual products, but also their broader impact on public health. Through the CTP and these regulatory pathways, the agency aims to balance adult access to nicotine products with efforts to reduce addiction, prevent youth uptake, and lower the long-term burden of tobacco-related disease.
