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Year-End 2024 Nicotine Industry Summary and Outlook

Author

Jon Dice
December 16, 2024

This will be the final newsletter of Nicotine Next for 2024. See you in 2025.

U.S. Nicotine and Tobacco Industry Analysis 2024

Executive Summary

The U.S. nicotine and tobacco industry underwent a transformative period in 2024, shaped by regulatory actions, evolving consumer preferences, and persistent public health concerns. This report offers a comprehensive analysis of the industry, encompassing the regulatory environment, industry responses, enforcement actions, and a future outlook.

Key highlights of 2024 include:

  • FDA's PMTA Review: The FDA demonstrated significant progress in its review of premarket tobacco product applications (PMTAs), taking action on a substantial portion of e-cigarette product applications1.

  • Enforcement Focus: The FDA and Department of Justice (DOJ) intensified efforts to combat illicit e-cigarettes, particularly youth-appealing products, through a new task force, warning letters, seizures, and civil monetary penalties2.

  • State-Level Regulations: States maintained a crucial role in tobacco control, with all 50 states implementing youth access restrictions and some exploring e-cigarette registries3.

  • Court Decisions: Federal court decisions, including a Supreme Court case on flavored vape denials, shaped the regulatory landscape and enforcement approaches5.

  • Product Development: The industry pursued product innovations, including rechargeable pods, nicotine-free vapes, and devices with advanced temperature control6.

  • Marketing Shifts: Companies adapted marketing strategies to address regulatory changes and consumer preferences, with an emphasis on online channels and harm reduction messaging9.

Looking ahead to 2025, anticipated changes in federal leadership and ongoing legal battles suggest a dynamic regulatory environment. The industry is expected to navigate these challenges through continued product innovation, compliance efforts, and strategic market positioning.

Regulatory Environment

FDA Actions on PMTAs

In 2024, the FDA made significant progress in its review of PMTAs for e-cigarette products that were on the market as of August 8, 2016. By July 22, 2024, the agency had taken action on 185 out of 186 marketing applications for e-cigarette products with significant market share1. These actions included issuing marketing denial orders (MDOs) or granting marketing authorizations. Notably, the FDA issued MDOs to Imperial Brands' Fontem US for four blu disposable and one myblu e-cigarette products due to their characterizing flavors, including menthol, mint, vanilla, and cherry11. Observers indicated that the one remaining application under review was for JUUL products1.

However, in a significant turn of events, the FDA rescinded its MDO for all JUUL e-cigarette products on June 6, 202412. This action reverted JUUL's premarket application to pending status, allowing the company to continue marketing its products while the FDA reevaluates its application.

In June 2024, the FDA authorized the marketing of four menthol-flavored e-cigarette products from NJOY LLC: NJOY DAILY Menthol and NJOY ACE Menthol13. This authorization, granted after an extensive scientific review, marked a significant step in the FDA's regulation of flavored e-cigarettes. The agency emphasized that the authorization included restrictions to mitigate youth risk, reflecting its commitment to balancing harm reduction for adult smokers with youth protection.

Furthermore, the FDA granted marketing orders for Vuse Alto devices and their Golden Tobacco and Rich Tobacco flavor pods at varying nicotine levels (1.8%, 2.4%, and 5%)14. This authorization further expanded the range of legally marketed e-cigarette products in the U.S.

In a move aimed at enhancing transparency, the FDA released regulatory science policy memos in November 2024, outlining its process for prioritizing and reviewing PMTAs, particularly for flavored e-cigarettes 15. The memos also provided information on the criteria used for environmental assessments related to e-cigarette products. In addition to the November releases, the FDA also released memos in April, May, and August of 2024 15. The August releases included a memo on genotoxicity hazard identification and carcinogenicity tiering of constituents in ENDS PMTAs, as well as a memo on calculating excess lifetime cancer risk (ELCR) in ENDS PMTAs 17.

Maximum Nicotine Level Proposal

In December 2024, the FDA submitted a proposed rule to the Office of Management and Budget that could significantly lower the amount of nicotine in cigarettes and other combusted tobacco products16. This proposal, which has been under consideration since 2018, aims to reduce the addictiveness of cigarettes and potentially help millions of smokers quit. The FDA estimates that reducing nicotine levels could prevent more than 33 million people from becoming regular smokers and assist 5 million smokers in quitting within a year16. However, the proposal faces potential legal challenges from the tobacco industry and its implementation under the new administration remains uncertain.

Enforcement Priorities and Actions Against Illicit E-cigarettes

The FDA and DOJ prioritized enforcement against illicit e-cigarettes in 2024, with a particular focus on unauthorized products and those appealing to youth. A key development was the establishment of a task force in June 2024 to coordinate efforts among various law enforcement agencies, including the ATF, FTC, U.S. Marshals Service, and USPIS2. This task force aimed to strengthen enforcement against unauthorized e-cigarettes, particularly those entering the country illegally.

Throughout the year, the FDA conducted various enforcement operations, including:

  • Warning Letters to Retailers: The FDA issued over 800 warning letters to brick-and-mortar and online retailers for selling unauthorized e-cigarette products17.

  • Seizures: In April 2024, the FDA and DOJ, in coordination with the U.S. Marshals Service, seized over 45,000 unauthorized e-cigarettes valued at more than $700,000 from a warehouse in California18.

  • Civil Monetary Penalties: The FDA sought civil monetary penalties against 140 retailers for continuing to sell unauthorized products, with the total amount exceeding $2,600,00019.

These enforcement actions reflect the FDA's commitment to curbing the availability of illicit e-cigarettes, especially those that pose a risk to youth. It's important to clarify that while many flavored e-cigarettes are unauthorized, some remain on the market due to FDA authorization or illicit sales.

Notable State-Level Regulatory Changes

States continued to play a significant role in regulating e-cigarettes in 2024. As of June 30, 2024, all 50 states, the District of Columbia, and various U.S. territories had enacted legislation prohibiting the sale of e-cigarettes to minors3.

Ohio Legislation on Preemption

In response to some Ohio cities banning flavors in e-cigarettes and other nicotine products, the Ohio Legislature overrode the governor's 2023 veto of statewide preemption of the sale of these products4. This legislation establishes a uniform statewide policy for regulating tobacco and nicotine products, effectively preventing local governments from enacting stricter regulations. While proponents argue that statewide preemption ensures consistency and facilitates youth access prevention, critics express concerns that it may hinder local tobacco control efforts.

California's New Rules

California implemented new rules in 2024 to strengthen its existing ban on flavored tobacco products16. Assembly Bill AB 3218 and Senate Bill SB 1230, signed into law by the Governor, outlaw non-menthol coolants, such as WS-3 and WS-23, and prohibit online sales of flavored vapes and nicotine pouches. These rules, which take effect on January 1, 2025, aim to further restrict the availability of flavored tobacco products and reduce their appeal to youth.

State-Level Tobacco Control Policies

In addition to youth access restrictions, states employed various tobacco control policies in 2024. As of June 30, 2024, 36 states had implemented retail licensure requirements for e-cigarettes3. These requirements aim to regulate the sale of e-cigarettes and ensure compliance with existing laws.

Furthermore, 32 states, the District of Columbia, and two territories imposed taxes on e-cigarettes21. These taxes generate revenue for public health programs and potentially discourage e-cigarette use.

Seventeen states, the District of Columbia, and Puerto Rico had comprehensive smoke-free indoor air laws that include e-cigarettes21. These laws prohibit the use of e-cigarettes in indoor public spaces, protecting non-users from secondhand aerosol and promoting a healthier environment.

An emerging trend in state-level regulation was the creation of e-cigarette registries4. These registries aimed to address the uncertainty surrounding the FDA's PMTA process and the proliferation of flavored disposable e-cigarettes on the market. By requiring manufacturers to register their products, states sought to gain better oversight of the e-cigarette market and potentially restrict the sale of unauthorized products.

Impact of Federal Court Decisions

Federal court decisions had a notable impact on the regulation of e-cigarettes in 2024. In a significant case, the Supreme Court agreed to hear the FDA's defense on flavored vape denials5. This case stemmed from a Fifth Circuit ruling that found the FDA's denial of PMTAs for flavored e-liquids to be arbitrary and capricious. The Supreme Court's decision in this case, expected in 2025, could have far-reaching implications for the FDA's authority to regulate flavored e-cigarettes and potentially impact the availability of these products in the market.

Industry Response and Evolution

Industry Consolidation and Strategic Shifts

While no major industry consolidation was observed in 2024, companies demonstrated strategic shifts in response to the evolving regulatory landscape and consumer preferences. One notable trend was the increasing focus on rechargeable pods, driven by demand for sustainable and cost-effective vaping options6. These pods offer enhanced e-liquid capacity and battery life, aligning with the growing emphasis on sustainability within the vaping community.

Another strategic shift involved offering greater nicotine flexibility6. Recognizing the diverse needs of vapers, companies expanded their product lines to include a wider range of nicotine concentrations, from high-strength options to nicotine-free alternatives. This strategy aimed to cater to a broader customer base and capture a larger market share.

E-cigarette Market Size and Types

The U.S. e-cigarette market continued to grow in 2024, with an estimated market size of $34.49 billion22. This growth reflects the increasing popularity of e-cigarettes as an alternative to traditional cigarettes. The market offers various types of e-cigarettes, including disposable, rechargeable, and modular10. Disposable e-cigarettes, designed for single use, have gained significant popularity due to their convenience and affordability. Rechargeable e-cigarettes, with replaceable cartridges or refillable tanks, offer greater flexibility and cost-effectiveness in the long run. Modular e-cigarettes allow users to customize their vaping experience by adjusting various components, such as batteries, atomizers, and tanks.

Changes in Product Development and Marketing Strategies

Product development in 2024 focused on innovation and meeting evolving consumer demands. Key trends included:

  • Sustainability: Manufacturers increased efforts to develop recyclable and reusable vape products to address environmental concerns associated with disposable vapes7.

  • Nicotine-Free Options: The industry responded to the growing health consciousness among consumers by introducing nicotine-free vapes, providing alternatives for those seeking to avoid nicotine7.

  • Advanced Technology: Companies introduced devices with advanced features, such as precision temperature control, custom wattage settings, and longer battery life, to enhance the vaping experience8.

E-cigarette Sales Trends

Data suggests a significant increase in the sales of disposable e-cigarettes. From February 2, 2020, to June 16, 2024, disposable e-cigarette sales increased by 201.3%, with their unit share rising from 26.0% to 58.1% of total e-cigarette sales23. This trend reflects the growing popularity of disposable vapes due to their convenience and affordability.

Furthermore, there has been a notable increase in the nicotine content of e-cigarettes. Studies have shown that disposable e-cigarettes can have nicotine levels comparable to several cartons of cigarettes, with average nicotine strength increasing by 294% in five years19. This trend raises concerns about the potential for increased nicotine addiction, particularly among youth.

Marketing strategies also evolved in 2024. With the increasing restrictions on traditional advertising channels, companies shifted their focus to online platforms and emphasized harm reduction messaging9. Online channels provided a more targeted and cost-effective way to reach consumers, while harm reduction messages aimed to position e-cigarettes as a less harmful alternative to traditional cigarettes.

Marketing Strategies on Social Media

E-cigarette companies have increasingly utilized social media platforms for marketing their products. Studies of e-cigarette marketing on Weibo, a Chinese social media platform, reveal various tactics employed by companies, including emphasizing attractive product features, using trendy characters, implicit promotions, downplaying health concerns, and engaging with users24. These findings suggest that e-cigarette companies are adapting their marketing strategies to reach younger audiences on social media platforms where traditional advertising restrictions may not apply.

Compliance Approaches to New Regulatory Requirements

The industry demonstrated various compliance approaches to navigate the complex regulatory environment in 2024. These approaches included:

  • PMTA Submissions: Companies continued to submit PMTAs to the FDA for their e-cigarette products, seeking authorization to legally market their products in the U.S25.

  • Ingredient Listing and HPHC Reporting: Manufacturers and importers complied with FDA requirements by submitting ingredient lists and reporting harmful and potentially harmful constituents (HPHCs) for their e-cigarette products25.

  • Health Warning Statements: Companies adhered to regulations by including health warning statements on their e-cigarette product packaging25.

  • Establishment Registration: Manufacturers and importers registered their establishments with the FDA as required by regulations25.

  • Adhering to the Tobacco Implementation Guide (TIG) v1.0: Released on June 10, 2024, the TIG v1.0 provides standardized guidelines for the collection, analysis, and submission of data related to tobacco products to the FDA 43. This guide, developed in partnership with the FDA, aims to improve the efficiency and effectiveness of scientific review and regulatory processes.

Compliance with Advertising Regulations

New legislation in 2024 strengthened advertising regulations for e-cigarettes, banning advertising except where specifically authorized26. This ban covers all media platforms, including social media, as well as other forms of advertising, promotion, and sponsorship. The industry is adapting to these regulations by exploring alternative marketing channels and focusing on compliance with the new requirements.

These compliance efforts reflect the industry's commitment to operating within the legal framework and ensuring the safety and legality of their products.

Market Share Changes Among Key Players

While specific market share data for 2024 was not available in the provided research material, the e-cigarette market remained fragmented with several key players9. Altria Group, British American Tobacco (BAT), Imperial Brands, and Japan Tobacco International continued to be major players in the global e-cigarette market14.

Successes and Challenges in Enforcement

Success Rates in Reducing Illicit Product Availability

While illicit e-cigarette products remained a concern in 2024, enforcement efforts showed some success in reducing their availability. Notably, youth reporting use of Elf Bar products, a popular unauthorized brand, decreased from 56.7% in 2023 to 36.1% in 202427. This decline coincided with targeted compliance and enforcement actions by the FDA against Elf Bar products, including warning letters, civil monetary penalties, and import alerts.

Overall, current e-cigarette use among middle and high school students declined significantly between 2023 and 2024, from 7.7% to 5.9%21. This decline, while influenced by various factors, suggests that enforcement efforts, combined with other tobacco control measures, contributed to reducing youth access to e-cigarettes.

Youth E-cigarette Use Trends

In 2024, 3.5% of middle school students and 7.8% of high school students reported current e-cigarette use28. Among high school students who vape, 29.7% reported daily use28. The most commonly used e-cigarette brands among youth were Elf Bar, Breeze, Mr. Fog, Vuse, and JUUL28. These findings highlight the need for continued efforts to prevent youth initiation of e-cigarettes and address the availability of youth-appealing products.

Industry Compliance Rates with Existing Regulations

The industry demonstrated varying levels of compliance with existing e-cigarette regulations in 2024. While many companies actively pursued compliance through PMTA submissions, ingredient listing, and other measures, the availability of illicit products indicated ongoing challenges29.

The FDA's enforcement actions, including warning letters and civil monetary penalties, suggest that some companies and retailers continued to sell unauthorized e-cigarette products30. This non-compliance posed a risk to public health and highlighted the need for continued enforcement efforts.

Civil Money Penalty Complaints

The FDA utilizes a tiered system of civil monetary penalties (CMPs) for retailers who violate regulations related to the sale of tobacco products to underage purchasers29. The CMP amount increases with the number of violations within specific timeframes. For instance, a first violation results in a warning letter, while six violations within a 48-month period can lead to a CMP of $14,232. This tiered system aims to deter repeated violations and encourage compliance with regulations.

Future Outlook (2025)

Anticipated Regulatory Priorities Under the New Administration

With the upcoming change in federal administration in 2025, the regulatory landscape for e-cigarettes is expected to be dynamic. President-elect Donald Trump has signaled a potential shift in approach, pledging to "save vaping again." 31 This suggests a possible easing of restrictions on the vaping industry, potentially impacting product approvals, marketing regulations, and enforcement priorities.

However, the extent to which the new administration will prioritize e-cigarette regulation remains uncertain32. Factors such as public health concerns, ongoing legal challenges, and the composition of the new HHS/FDA leadership will influence the direction of regulatory policy.

NIH Research Funding

The National Institutes of Health (NIH) announced a funding opportunity in December 2024 to support research on tobacco product regulation33. This initiative aims to generate scientific data to inform the FDA's regulatory authority and protect public health. The research will focus on various aspects of tobacco product regulation, including the impact of policies on tobacco use, prevention strategies, and the evaluation of regulatory interventions. This funding opportunity highlights the ongoing efforts to strengthen the scientific basis for tobacco control policies.

National Drug Control Strategy

The White House released its National Drug Control Strategy for fiscal year 2025, outlining its approach to addressing substance use and overdose prevention34. The strategy emphasizes harm reduction as a key component in addressing the overdose crisis. This includes expanding access to opioid overdose reversal medications like naloxone and supporting community harm reduction initiatives. The strategy's focus on harm reduction may influence future policies related to e-cigarettes, potentially leading to a greater emphasis on their role in reducing harm for adult smokers.

Potential Policy Shifts with New HHS/FDA Leadership

The appointment of new leadership within HHS and FDA will play a crucial role in shaping e-cigarette policy in 2025. The new administration's stance on harm reduction, youth prevention, and industry engagement will influence potential policy shifts35.

While President-elect Trump has expressed support for the vaping industry, the FDA's commitment to addressing youth e-cigarette use and illicit product availability may continue under new leadership36. The agency's focus on science-based regulation and enforcement is expected to remain a priority.

Enforcement Actions

Major FDA Enforcement Operations

The FDA conducted several major enforcement operations in 2024 to address the sale and distribution of illicit e-cigarettes. These operations included:

  • Warning Letters to Retailers: The FDA issued warning letters to numerous brick-and-mortar and online retailers for selling unauthorized e-cigarette products, particularly those appealing to youth17.

  • Targeting E-cigarettes Resembling Smart Technology: The FDA issued warning letters to online retailers and manufacturers selling unauthorized e-cigarettes designed to resemble smart technology, such as phones and gaming devices37. These products were deemed to be particularly appealing to youth.

  • Seizures: The FDA, in coordination with other agencies, conducted seizures of unauthorized e-cigarette products from warehouses and retailers18.

  • Import Alerts: The FDA collaborated with U.S. Customs and Border Protection to issue import alerts for unauthorized e-cigarette products, preventing their entry into the country38.

These enforcement actions demonstrate the FDA's multi-faceted approach to combating the illicit e-cigarette market and protecting public health, especially among youth.

State-Level Enforcement Initiatives

States also implemented various enforcement initiatives to address the sale of illicit e-cigarettes. These initiatives included:

  • Retailer Inspections: State authorities conducted inspections of retail establishments to ensure compliance with regulations, such as age restrictions and licensing requirements3.

  • Enforcement of Flavored Tobacco Restrictions: States with flavor bans enforced these restrictions through retailer inspections and other measures39.

  • Collaboration with Federal Agencies: State authorities collaborated with federal agencies, such as the FDA and CBP, to share information and coordinate enforcement efforts39.

These state-level initiatives complemented federal enforcement actions and contributed to a more comprehensive approach to regulating e-cigarettes.

Conclusion

The U.S. nicotine and tobacco industry in 2024 faced a complex landscape characterized by regulatory changes, evolving consumer preferences, and public health concerns. The FDA's progress in PMTA reviews, intensified enforcement against illicit products, and ongoing state-level regulations significantly impacted the industry.

The industry demonstrated resilience and adaptability in response to these challenges. Companies pursued product innovations, such as rechargeable pods, nicotine-free vapes, and devices with advanced technology, to meet consumer demands and address environmental concerns. Marketing strategies shifted towards online channels and harm reduction messaging to navigate advertising restrictions and position e-cigarettes as a less harmful alternative to traditional cigarettes.

Looking ahead to 2025, the anticipated change in federal administration and ongoing legal battles suggest a dynamic regulatory environment. The industry is expected to adapt through continued product innovation, compliance efforts, and strategic market positioning. The interplay between federal and state regulations, court decisions, and public health priorities will continue to shape the future of the U.S. nicotine and tobacco industry.

The FDA's PMTA process has created significant barriers to entry for smaller e-cigarette companies, leading to market consolidation and favoring larger companies. The authorization of a limited number of products, primarily in tobacco and menthol flavors, may be influencing consumer preferences and product development.

While enforcement actions have achieved some success in curbing the illicit e-cigarette market, challenges remain. Illicit products are still widely available, and the FDA's focus on retailers may be less effective than targeting manufacturers and distributors higher up the supply chain. The emergence of new illicit brands and products necessitates ongoing and adaptive enforcement strategies.

The potential policy shifts under the new administration could have significant implications for the e-cigarette market and public health. Easing restrictions on e-cigarettes may lead to increased youth use and nicotine addiction, potentially undermining public health efforts to reduce tobacco use. The uncertainty surrounding future regulations may create challenges for industry planning and investment.

Overall, the U.S. nicotine and tobacco industry is poised for continued evolution in the coming years. The industry's ability to navigate the complex regulatory landscape, adapt to changing consumer preferences, and address public health concerns will determine its future success.

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