Currently, more than half of the pharmaceuticals distributed in the U.S. are manufactured abroad, and only approximately 11 percent of active pharmaceutical ingredient (API) manufacturers for FDA-approved products are located domestically. Recent supply chain disruptions have underscored the vulnerability of this arrangement and the need for a more robust domestic manufacturing base.

Program Structure

The program will leverage a two-phase approach to facilitate the introduction of new pharmaceutical manufacturing facilities in the U.S.

Facility Readiness Phase

The first stage of FDA PreCheck is designed to give manufacturers more direct access to the agency during the earliest and most critical stages of facility development – design, construction and preproduction. The FDA will provide more frequent opportunities for communication and feedback, helping companies identify and address potential compliance issues before they become costly delays.

Manufacturers are encouraged to submit comprehensive, facility-specific information that can be referenced later in drug applications. This may include detailed site layouts, descriptions of manufacturing operations, elements of the facility’s pharmaceutical quality system, and quality management maturity practices. The FDA recommends that this information be submitted through a Type V Drug Master File (DMF). By consolidating facility data into a DMF, companies can streamline later submissions and reduce redundancy in application materials.

Application Submission Phase

The second stage focuses on the Chemistry, Manufacturing, and Controls (CMC) portion of a drug application. The FDA will offer pre-application meetings and provide early feedback on anticipated data needs, facility readiness and inspection planning. This early engagement allows the agency to front-load certain quality assessments and coordinate inspections in a way that shortens review timelines. The goal is to ensure that, by the time an application is filed, both the facility and the supporting documentation are already well-positioned for approval.

Industry Next Steps

Companies considering domestic expansion should review the program’s requirements, assess potential benefits and evaluate whether early engagement with the FDA would be advantageous. The FDA will host a public meeting, Onshoring Manufacturing of Drugs and Biological Products, on Sept. 30, 2025, at the agency’s White Oak Campus in Silver Spring, Maryland, with virtual participation available. Please contact Winston S. Kirton and Laura Macherelli for help with next steps.

Artificial Intelligence

• The Trump administration rescinded a major executive order from President Joe Biden regarding the responsible use of artificial intelligence (AI) in healthcare.
• During the final days of the Biden administration, the U.S. Department of Health and Human Services (HHS) published its AI Strategic Plan, though its weight is called into question with the arrival of the new administration.
• The U.S. Food and Drug Administration published draft guidance on incorporating AI into premarket submissions.

Impact of Trump Administration’s Executive Order on Artificial Intelligence

The Trump administration rescinded the Biden administration’s Executive Order 14110 (Biden AI EO), which was the impetus for healthcare organizations to agree to fair, appropriate, valid, effective and safe (FAVES) principles in the use AI and called for a coordinated government effort to establish guardrails around the use of AI in healthcare.

In its place, Trump issued a short executive order on AI (Trump AI EO) that does not contain its own principles on AI but instead directs various officials to review orders and actions to ensure they adhere to Section 2 of the Trump AI EO, which states, “It is the policy of the United States to sustain and enhance America’s global AI dominance in order to promote human flourishing, economic competitiveness, and national security.” The Trump AI EO also requires, within 60 days of the date the order was issued, the Office of Management and Budget director to revise certain memoranda on federal AI governance and federal AI acquisition to ensure they are consistent with the above policy, and within 180 days, certain positions and agencies within the administration must submit an action plan to achieve the policy in Section 2.

The FAVES principles, as well as the HTI-1 Final Rule that requires transparency by certified health IT developers in the use of AI, previously analyzed here, could be impacted by the rescission. It remains to be seen what impact the Trump AI EO will have on the policies and actions taken in response to the Biden AI EO to implement, safeguard and adopt AI within the healthcare industry.

HHS Strategic Plan for Use of Artificial Intelligence

On Jan. 10, in one of the final moves before Biden left office, HHS published its Strategic Plan for the Use of Artificial Intelligence in Health, Human Services, and Public Health (Strategic Plan), which set forth the goals of HHS — one of the top governmental users of AI — in fostering and guiding the use of AI in the healthcare system, including insight on HHS’ plan for encouraging the establishment of guardrails around the quickly evolving healthcare technology landscape, as well as its priorities regarding the ever-evolving adoption of AI.

The Strategic Plan is focused on four key goals across seven domains:

1. Catalyzing health AI innovation and adoption to unlock new ways to improve people’s lives
2. Promoting trustworthy AI development and ethical and responsible use of AI to avoid potential harm
3. Democratizing AI technologies and resources to promote access
4. Cultivating AI-empowered workforces and organizational cultures to effectively and safely use AI.

Key aspects of the Strategic Plan include the following already implemented or future goals of HHS:

• Increasing funding for and supporting the adoption of AI and the development of AI for medical products
• Issuing guidance and regulations for, as well as clarity on, the use of AI in federal agencies
• Democratizing AI technologies and resources by promoting collaborative engagement with the public and aligning data standards across industries
• Continuing rulemaking to incorporate AI technology into existing and future regulations
• Promoting the safe and responsible use of AI by state, local, tribal and territorial governments
• Identifying and utilizing pathways for using AI to benefit public health, including improving threat detection, optimizing allocation of limited resources, improving efficiencies for public health operations and enhancing health equity among underserved populations, including via the use of generative AI
• Addressing cybersecurity risks imposed by the adoption of AI, supporting the standardization and alignment of best practices with regard to cybersecurity governance (including developing guidelines on maintaining operations after an AI system is compromised), encouraging developers to implement privacy by design, and developing guidelines for balancing privacy and security goals with the inclusion of AI models.  

At this time, it Is unclear how the Strategic Plan as published will be implemented or whether HHS will shift direction. As of Jan. 20, the former assistant secretary for technology policy and national coordinator for health information technology (ASTP), who implemented regulations and guidance on the use of AI during the Biden administration, including the Strategic Plan, is no longer in that position (no other ASTP has been named). On Feb. 13, Robert F. Kennedy Jr. was confirmed as HHS secretary, and it remains to be seen what impact this will have on HHS’ AI objectives. Finally, as of this writing, the Strategic Plan is no longer listed on the ASTP website, but it has not been formally rescinded.

FDA Draft Guidance on AI-Enabled Devices and Marketing Submission Recommendations

On Jan. 7, the U.S. Food and Drug Administration (FDA) issued a draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, which provides recommendations for AI-enabled devices throughout the total product life cycle. Specifically, the document gives clarity on which devices the FDA considers to be “AI-enabled devices” and provides sponsors with guidance on how the FDA plans to regulate these devices by addressing the types of information to include in a premarket submission.

The draft guidance provides details on what information sponsors should include in an AI-enabled device marketing submission, why the specific information should be included and where sponsors should provide the information within a marketing submission. The FDA recommends including the following information:

• Device Description: Sponsors should provide a detailed device description that includes a statement that AI is used in the device, the device inputs and outputs, an explanation of how AI is used to achieve the device’s intended use, a description of the device’s intended users and environment, and any installation and maintenance procedures.
• User Interface: Sponsors should provide a clear description of the device workflow, including the information provided to users and how the information is presented to users through a graphic representation, written description, demonstration video or overview of the operational sequence of the device.
• Labeling: Sponsors should follow appropriate labeling requirements for the specific device and ensure information is provided to users in an appropriate format and reading level.
• Risk Assessment: Sponsors should provide a comprehensive risk assessment in their submission, which includes a risk management plan that addresses risks that occur throughout the life cycle of the device, including installation, maintenance and any other risks associated with user interpretation of the results of a device.
• Data Management: Sponsors should include a description of how data were collected, limitations of the dataset, the data-cleaning process, a description of the reference standard (if used), data annotation, data storage and how the data is representative of the intended use population.
• Model Description and Development: Sponsors should include information on the AI model’s design, which includes a description of the model architecture and features and how the model was trained.
• Performance Validation: Sponsors should provide objective information to characterize the model’s performance based on its intended use. A submission should include the model’s validation methods, study protocols and study results.
• Device Performance Monitoring: Sponsors should provide information regarding their performance-monitoring plans, which may include a description of data collection and analysis methods, a description of the software life cycle process, a plan for deploying updates and corrective actions, and any procedures for communicating the results of performance monitoring with users.
• Cybersecurity: Sponsors should include any considerations unique to AI cybersecurity, an explanation of how cybersecurity testing is appropriate to address the risk associated with the model and a description of controls implemented to address data vulnerability.
• Public Submission Summary: Sponsors should include specific information describing the characteristics of the devices to support public understanding of the AI-enabled devices, including a statement that AI is used in the device, how AI is used as part of the device’s intended use, a description of the class of model, a description of the development and validation of datasets, a description of statistic obedience prediction, and a description of how the model will be updated and maintained over time.

In addition, the FDA discusses strategies to address transparency and bias throughout the life cycle of AI-enabled devices. The FDA is requesting public comments to the draft guidance by April 7. However, this guidance is subject to review under the Trump AI EO, which requires a review of all existing AI policies, directives, regulations and actions taken by the Biden administration.^[1]

Telehealth

Tales from the Never-Ending Telehealth Cliff

As noted in the BakerHostetler Health Care Year in Review, Congress in late December again extended, through March 31, many of the Medicare telehealth flexibilities initially implemented during the height of the COVID-19 pandemic in 2020. Without the extension, many regulatory flexibilities that have enabled the provision of care via telehealth since the COVID-19 pandemic would have expired, impacting access to care for patients and digital operations for healthcare providers.

Though the extension ostensibly indicates a level of bipartisan support, with a new administration and such a tight deadline, it’s not clear whether the telehealth flexibilities will eventually be made permanent. If not made permanent (or extended again), Medicare telehealth coverage will revert to much more restrictive conditions that limited the reach of care that had increased during the pandemic. Industry stakeholders continue to advocate for making such telehealth flexibilities permanent.

Drug Enforcement Agency Issues a Trio of Telemedicine Prescribing Rules

As we previously reported, the United States Drug Enforcement Administration (DEA) issued a third extension to enable telemedicine prescribing flexibilities to remain in place through 2025. On Jan. 17, the DEA issued two final rules and also a proposed rule addressing issuing prescriptions for controlled substances via telemedicine. One finalized rule permits remote prescription via telehealth, including via audio-only visits, for a six-month buprenorphine supply. The other finalized rule allows Department of Veterans Affairs (VA) practitioners to prescribe controlled substances over telemedicine for VA patients without in-person exams so long as another VA practitioner had, at any time, previously evaluated the patient in person. Notably, the DEA announced on Feb. 19 that, as a result of the Trump administration’s Regulatory Freeze Pending Review, the effective date for both rules is delayed to March 21.

The proposed rule would establish a long-gestating “special registration” system for permitting the prescription of controlled substances via telemedicine without an in-person evaluation. At this time, it is unclear where the Trump administration stands on telemedicine policy. However, the American Telemedicine Association has urged Trump to immediately withdraw the DEA proposed rule over concerns that as proposed it would create an unworkable framework that could not be operationalized.

New Updates to the Information Blocking Rule

We previously analyzed the Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability proposed rule, which would have codified a nonexhaustive list of practices that would constitute information blocking and made several changes and additions to the exceptions to the Information Blocking Rule (IBR). However, the Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement final rule largely did not address the IBR and focused on final changes to the Trusted Exchange Framework and Common Agreement. On Dec. 17, 2024, the Health Data, Technology, and Interoperability: Protecting Care Access final rule was published but again did not address many proposals and comments regarding the IBR; instead, it made minor modifications to the existing Privacy and Infeasibility exceptions to the IBR and finalized the new Protecting Care Access exception, which is aimed at protecting decisions not to disclose health information to avoid the risk of exposing a patient, provider or facilitator of lawful reproductive healthcare to potential legal action.

We will continue to monitor major legislative and regulatory changes impacting the healthcare industry.

[1] Exec. Order No. 14179, Removing Barriers to American Leadership In Artificial Intelligence (Jan. 23), https://www.whitehouse.gov/presidential-actions/2025/01/removing-barriers-to-american-leadership-in-artificial-intelligence.

The FDA’s Standards for Approval

To grant marketing authorization, the FDA requires comprehensive evidence that a product provides more benefits than risks to public health. In the case of Zyn, regulators determined that the pouches carry significantly lower health risks compared with cigarettes and smokeless tobacco. Unlike traditional smokeless tobacco, Zyn products deliver nicotine in powdered form that dissolves in the user’s mouth.

Under Section 910 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, the FDA must determine that a product meets the “appropriate for the protection of the public health” (APPH) standard. This determination involves evaluating risks and benefits for the entire population, including both users and nonusers of tobacco products. The FDA balances potential negative impacts, such as youth initiation, against positive outcomes, such as helping adult smokers switch to less harmful products. A product can only be authorized if the overall benefits outweigh the risks.

Key Findings Supporting Zyn’s Authorization

The FDA’s decision to authorize Zyn was informed by data on user behavior, product perception and consumer intentions. Zyn’s PMTA included a 10-week study tracking product usage, which revealed that nearly 25 percent of participants transitioned entirely from other tobacco products to exclusive Zyn use. Additional surveys showed a decline in cigarette and moist snuff usage among participants who adopted Zyn. Notably, these patterns were consistent across different flavors, demonstrating that flavor variety did not disproportionately influence usage.

Consumer perception data also played a vital role in the FDA’s analysis. Research indicated that adults over the age of 24 who smoked cigarettes and intended to quit were the most likely to use and purchase Zyn products. Many former and non-tobacco users found the products unappealing, reducing concerns about unintended uptake among these groups.

While the FDA recognized Zyn’s potential to benefit adult smokers, the agency remained cautious about the possibility of youth usage. To mitigate these risks, the FDA imposed strict marketing restrictions on Zyn, requiring the company to ensure its advertisements and promotions are targeted exclusively to adults. The agency has also committed to closely monitoring the product’s impact and will take enforcement action if youth usage rises or if compliance issues emerge. Such measures are intended to strike a balance between providing harm-reduction tools for adults and preventing unintended consequences among younger populations.

The FDA’s authorization demonstrates that companies can meet the APPH standard without comparing flavored products directly to tobacco-flavored alternatives. Despite ongoing legal debates about whether such comparative studies are required, the FDA determined that sufficient evidence existed without this additional analysis. This approach may have implications for future applications from other nicotine pouch manufacturers.

Implications for the Tobacco Industry

The authorization of Zyn represents a significant milestone in tobacco harm-reduction efforts and highlights a shift in the industry toward alternative products. With cigarette sales continuing to decline, companies are focusing on new nicotine delivery methods to meet consumer demand. While rising in popularity, Zyn has faced criticism from lawmakers and public health advocates over concerns about youth appeal and marketing practices, but Philip Morris has stated that it will not engage in influencer marketing or strategies targeting younger users. Instead, the company emphasizes that Zyn is designed for adults seeking to transition away from more harmful tobacco products.

By authorizing Zyn, the agency has acknowledged the role nicotine pouches can play in reducing harm for adult smokers. The FDA’s approach to regulating this category will likely set important precedents for future applications as the nicotine pouch market continues to grow. For now, Zyn’s authorization signals a new chapter in the evolving landscape of tobacco harm reduction.

What’s New in the Definition of Healthy?

Under the updated rule, foods can carry the healthy label only if they meet stringent criteria based on food group equivalents and nutrient limits. Specifically, products must:

• Contain a minimum amount of food from at least one key group (e.g., fruits, vegetables, whole grains or low-fat dairy) and
• Stay within specific thresholds for saturated fat, sodium and added sugars.

For example, cereals labeled as healthy must include a certain amount of whole grains and meet the limits for saturated fat, sodium and added sugars. Foods including nuts, seeds, salmon and certain oils, previously excluded, can now qualify. Manufacturers have until February 2028 to comply but may adopt the new criteria sooner.

The FDA’s Goals

The FDA intends the new definition to help consumers quickly identify foods that support healthier dietary patterns. By updating the criteria, the agency hopes to reduce diet-related chronic diseases, such as heart disease and diabetes, and address health inequities experienced by certain racial and socioeconomic groups.

Industry Concerns

While the updated definition seeks to provide clarity, it has raised concerns in the food industry. Many industry representatives argue that the criteria are overly restrictive, potentially disqualifying nutrient-dense packaged foods from bearing the healthy label. For example, some whole-wheat bread and yogurt products – long considered staples of a balanced diet – may now fail to meet the thresholds for added sugars or sodium.

Critics also warn that the complexity of the new standards might hinder innovation in creating new products. Furthermore, compliance costs for reformulating existing products could pose economic challenges for manufacturers, potentially driving up prices for consumers.

Moreover, the FDA’s rule emphasizes its reliance on current nutrition science. However, critics have questioned the validity and uniformity of the evidence used to establish these guidelines. Nutrition science evolves rapidly, and some argue that rigid definitions could quickly become outdated, especially as personalized nutrition gains prominence.

The new rule also faces criticism on First Amendment grounds. Stakeholders commented in response to the proposed rule that restricting the use of the term healthy infringes on manufacturers’ ability to communicate truthful information about their products. The FDA maintains that the rule aligns with its statutory mandate to prevent misleading labeling, but ongoing debates suggest this issue may not be resolved anytime soon.

Lastly, there are concerns surrounding consumer impact. While the rule aims to guide healthier choices, its practical impact on consumer behavior remains uncertain. Critics worry that disqualifying familiar products from carrying the healthy label could confuse rather than enlighten consumers. Additionally, the economic burden of reformulation might lead to higher prices, potentially limiting access to healthier options for lower-income families.

Conclusion

The FDA’s updated definition of healthy represents a well-intentioned effort to improve public health and reduce chronic diseases. However, the concerns about its economic, scientific and constitutional implications cannot be ignored. As the food industry adapts, it remains to be seen whether these changes will empower consumers or create unintended challenges.

For now, both manufacturers and consumers will need to navigate this evolving landscape carefully. The FDA may issue additional guidance to clarify the implementation of the new standards, which are set to become effective in February 2028. However, impending political shifts add uncertainty to the future of this rule, including potential withdrawal of this rule by the new administration. With continued dialogue and potential refinements, the FDA’s initiative could strike the right balance between clarity and flexibility, benefiting public health without unduly burdening the food industry.

Public health advocates have praised the proposal, describing it as a milestone in tobacco regulation. Organizations like the American Lung Association have emphasized the rule’s potential to reduce smoking-related deaths and diseases, which disproportionately affect marginalized communities. Tobacco use remains the leading cause of preventable death in the United States, with over 480,000 premature deaths annually linked to smoking. Many view the proposal as an opportunity to address these long-standing health inequities. Despite the decline in smoking rates over recent decades, approximately 28.3 million adults in the United States are still smokers, with nicotine’s addictive properties being a major barrier to quitting. Public health experts assert that reducing nicotine content could help more smokers quit successfully and prevent young people from becoming addicted in the first place.

However, the proposal has also sparked significant opposition from the tobacco industry, which argues the measure could drastically reduce the appeal of cigarettes to consumers, potentially impacting their market viability. Tobacco companies have raised concerns that such restrictions might violate federal tobacco control laws and lead to unintended consequences, such as an increase in black-market sales. Industry representatives argue that harm-reduction strategies, such as promoting electronic cigarettes or nicotine pouches, would be more effective in helping smokers transition to less harmful products. Additionally, some critics have questioned the economic impact of the rule, citing potential losses to the $80 billion U.S. tobacco market and its associated tax revenues.

Political dynamics add further complexity to the proposal’s future. The tobacco industry has a history of influencing policymaking through campaign contributions, and the incoming administration could play a critical role in determining whether the rule advances. During the recent election cycle, Reynolds American, one of the nation’s largest tobacco companies, donated millions to pro-Trump political action committees, prompting questions about the influence of such contributions on regulatory decisions.

The FDA’s proposal also faces procedural and legal hurdles. OMB’s review process can take months, and tobacco companies are expected to challenge the rule in court, arguing that it oversteps the agency’s authority. Additionally, it remains unclear whether the proposal will address nicotine levels in other tobacco products such as cigars, hookahs and e-cigarettes, leaving open questions about its broader impact.

While the proposal has been celebrated by many public health advocates, some remain cautious about its implementation and long-term success. Califf has acknowledged the challenges of bringing such measures to fruition, particularly in light of political transitions and the strong opposition from the tobacco industry. Nonetheless, proponents view the rule as a transformative opportunity to reduce the health burden of smoking and curb the deadly consequences of nicotine addiction. As the proposal moves through the regulatory process, its ultimate impact will depend on the commitment of policymakers and public health leaders to prioritize the well-being of millions over industry interests.

The Tobacco Control Act, enacted in 2009, granted the FDA extensive authority to regulate the manufacture, marketing and distribution of tobacco products. It also required cigarette packaging and advertisements to display one of nine specific health warnings outlined in the law. In an effort to modernize these warnings, the FDA issued a final rule in 2020 introducing 11 new cigarette health warnings. Each warning featured unique text paired with graphic imagery designed to illustrate the severe health risks of smoking, including bladder, head and neck cancer; fatal lung disease; stunted fetal growth during pregnancy; cataracts; and Type 2 diabetes. The FDA justified the updates as necessary to foster “greater public understanding” of the health risks associated with smoking. Despite the FDA’s efforts, the rule remains unenforced due to ongoing legal challenges from the tobacco industry.

In 2020, R.J. Reynolds, ITG Brands and Liggett Group first sued the FDA, claiming the rule violated First Amendment rights. Barker initially ruled in favor of the tobacco companies on constitutional grounds, but that decision was overturned by the Fifth Circuit Court of Appeals. The Supreme Court then declined to review the case, allowing the Fifth Circuit’s decision to stand. The current ruling shifts the focus from constitutional authority to the FDA’s statutory authority, with the cigarette makers arguing the agency acted arbitrarily, capriciously and beyond the scope of its discretion in adopting the rule.

Barker concluded that the FDA’s rule exceeded the authority granted by Congress. He stated that the Tobacco Control Act permits the FDA to modify the format, type or text of the nine specified warnings but does not give the agency authority to add new ones. The judge also highlighted that the FDA used the exact language mandated by Congress for only two of the 11 proposed warnings, further underscoring the agency’s overreach. Notably, he emphasized that agencies must adhere to the boundaries set by Congress and cannot unilaterally expand their powers.

This injunction delays the rule’s implementation, originally set for February 2026, and raises broader questions about the limits of regulatory authority. As the case continues, it highlights the ongoing tension between public health advocacy and the legal boundaries of regulatory agencies. The outcome could shape not only the future of tobacco regulation but also how courts interpret agency authority in public health policymaking.

As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. Our team’s insights and dedication to staying at the forefront of developments allows us to provide that are as intricate and dynamic as the healthcare industry is today.

We hope this overview of the key trends that have defined healthcare this year will empower our clients to make informed decisions in this ever changing and uncertain environment.

Download our Healthcare Industry Team 2024 Year in Review.

The guidance emphasizes the need for robust validation of analytical methods to ensure their accuracy, precision, sensitivity, and reliability. Validation involves a systematic evaluation of methods to confirm that they are suitable for their intended purpose, and the FDA recommends using total error probability to assess the reliability of test results. In addition to validation, the document outlines the importance of verification to demonstrate that previously validated methods remain applicable when applied to new products, formulations, or conditions. Verification typically involves ensuring accuracy and selectivity, often through techniques such as spike-and-recovery assessments.

To support method validation and verification, the FDA recommends the use of certified reference standards, such as those for nicotine or other harmful and potentially harmful constituents (HPHCs). These standards are essential for ensuring consistency, reliability, and traceability in analytical testing. The guidance also highlights the critical role of analytical sampling and measurement procedures, which must address potential variability and provide consistent, reliable results. These procedures should align with recognized standards, such as ISO 17025, to ensure their scientific rigor.

By standardizing the approach to method validation and verification, the FDA aims to improve the reliability of data used in regulatory submissions, enabling more efficient reviews and promoting public health. For manufacturers, adhering to this guidance is crucial not only for regulatory compliance but also for maintaining the credibility of their submissions.

The guidance also reflects the FDA’s broader mission to ensure the safety and transparency of tobacco products, particularly in the context of evolving regulatory challenges. For stakeholders, this underscores the importance of investing in robust analytical capabilities and maintaining a proactive approach to compliance. In an industry where data integrity is paramount, this guidance serves as both a roadmap and a benchmark for quality and reliability.

As the regulatory landscape for tobacco products continues to evolve, this guidance represents a critical step in fostering consistency and accountability in the evaluation of these products. Stakeholders that align their practices with the FDA’s recommendations will be better positioned to navigate regulatory complexities and contribute to public health objectives.

Background on FDA Regulation of E-Cigarettes

Under the Family Smoking Prevention and Tobacco Control Act of 2009, any company seeking to market a new tobacco product must demonstrate that doing so would be “appropriate for the protection of the public health.”[1] This involves weighing the potential for a product to help current smokers quit against the risk of encouraging new tobacco use, particularly among young people. Since the FDA assumed regulatory authority over e-cigarettes in 2016, the agency has rejected over 1 million applications for flavored products, citing strong evidence that flavors disproportionately attract minors. The FDA contends that flavors pose a “known and substantial risk” to public health by increasing the likelihood young people will use e-cigarette products and subsequently smoke cigarettes.

The Supreme Court Case: Regulatory ‘Switcheroo’?

This case arose after two companies, Triton Distribution and Vapetasia, sought to market e-cigarette liquids with the names “Jimmy the Juice Man Peachy Strawberry,” “Suicide Bunny Mother’s Milk and Cookies,” “Iced Pineapple Express” and “Killer Kustard Blueberry” in 2020. The FDA rejected the applications, citing a lack of sufficient evidence demonstrating the products’ potential benefits (helping users quit smoking) outweighing the risks (attracting new nicotine users). The companies challenged the FDA’s rejection of their applications in the Fifth U.S. Circuit Court of Appeals alleging the FDA shifted its approval standards midstream, making it impossible for their applications to succeed. The Fifth Circuit sided with the companies, calling the FDA’s actions a “regulatory switcheroo,”[2] and remanded the case for further consideration. The FDA subsequently appealed to the Supreme Court.

During oral arguments, the justices examined whether the FDA had fairly communicated its standards. Representing the companies, attorney Eric Heyer argued that the FDA’s change in evidentiary requirements for approval amounted to a “massive sea change.”[3] He argued that the FDA demanded the companies provide longitudinal studies, contradicting earlier guidance that indicated such specific studies were not necessary for premarket tobacco applications. He claimed this violated procedural fairness under the Administrative Procedure Act and the Federal Food, Drug, and Cosmetic Act by ignoring the notice-and-comment process.

A Divided Bench

The justices offered a range of perspectives during the oral arguments, revealing differing priorities in assessing the FDA’s actions and highlighting the complexity of balancing public health priorities with regulatory accountability.

The Court’s more liberal justices supported the FDA’s position, emphasizing that the risks posed to youth by flavored products were well documented and should have been clear to the applicants from the start. But some of the Court’s conservative justices, including Justice Clarence Thomas, questioned whether the FDA had adequately communicated its standards or had shifted its requirements midstream, creating an unfair disadvantage to the companies.

Justice Brett Kavanaugh, in a surprising turn for the FDA, appeared to acknowledge the agency’s reasoning, emphasizing that if the FDA determines the risks outweigh the benefits, that effectively concludes the statutory inquiry. At the same time, he sought clarity on whether the FDA had altered its evidentiary requirements during the application process, reflecting a balanced approach that recognized the agency’s discretion while probing procedural fairness. Kavanaugh expressed skepticism about the practical impact of a ruling in the companies’ favor, pointing out that they could reapply for authorization to sell the e-cigarette liquids. He questioned how reapplying would differ from what the companies were seeking through the current legal challenge.

Broader Implications: Public Health vs. Regulatory Overreach

This case has significant implications for public health and regulatory practice. Public health officials have lauded the FDA’s stance on flavored e-cigarettes as a necessary step to curb youth nicotine addiction. Data shows a significant decline in youth vaping since its peak in 2019, though an estimated 1.6 million minors still use e-cigarettes – a statistic cited by anti-vaping advocates as evidence of the need for continued strict regulation.

On the other hand, the vaping industry and some experts argue that flavored products play a vital role in helping adult smokers transition away from combustible cigarettes. They contend that the FDA’s denial of such products is based on incomplete or outdated data and that a more collaborative approach could balance youth protection with harm reduction for adults.

What’s Next?

The Supreme Court’s decision, expected by summer 2025, will not only determine the fate of Triton Distribution’s and Vapetasia’s products but could also set a precedent for how the FDA regulates emerging tobacco and nicotine products. If the Court upholds the Fifth Circuit’s ruling, the FDA may face stricter scrutiny in its approval processes, potentially forcing the agency to revise its regulatory approach.

Of course, that’s if the Court decides the case. With a new administration taking office on January 20, long before a decision might be issued, the FDA’s view on the merits may change. If the agency’s new leaders decide that reconsideration of the denials is warranted, that could spell the end of the current litigation, especially if the FDA and the companies at issue agree that the agency should have another bite at the apple. 

For now, the vaping industry, public health advocates and federal regulators await a decision that could reshape the landscape of tobacco regulation and determine how far agencies can go in protecting public health without overstepping procedural boundaries.

[1] Family Smoking Prevention and Tobacco Control Act of 2009.

[2] Wages and White Lion Investments v. FDA, Case Nos. 21-60766 and 21-60800, U.S. Court of Appeals for the Fifth Circuit.

[3] Amy Howe, Justices hear FDA case on flavored vapes, SCOTUSblog (Dec. 2, 2024, 3:49 p.m.), https://www.scotusblog.com/2024/12/justices-hear-fda-case-on-flavored-vapes/.

1. Shifting Stances on Nonbinding Guidance and Policy

Much of the FDA’s policy framework relies on nonbinding guidance documents, which are easier to alter than formal regulations. A second Trump administration might focus on revising these guidance policies in areas not directly established in law, such as nutrition standards and, notably, tobacco control. While the Federal Food, Drug, and Cosmetic Act and Tobacco Control Act protect the FDA’s core responsibilities, changes to guidance could subtly shift the agency’s regulatory focus. For instance, altering guidance on vaping product approvals or advertising regulations could effectively ease certain industry restrictions without repealing laws.

In his first term, Trump took a mixed approach to tobacco regulation. He surprised both supporters and critics by endorsing public health measures like raising the federal age for tobacco purchases from 18 to 21 and placing limits on flavored vaping products. Yet he stopped short of banning menthol and tobacco-flavored e-cigarettes, a decision that public health advocates argued had a negative impact on youth safety and health.

2. ‘Saving Vaping Again’: Trump’s Pledge to Protect the Vaping Industry

Trump recently met with the head of the Vapor Technology Association and later posted on Truth Social that he would “save vaping again,” signaling renewed support for the industry. Although he enacted certain restrictions on flavored vapes in 2019, his recent remarks suggest a more protective stance, especially given the industry’s backing.

This shift aligns with a broader, industry-friendly position that could relax existing restrictions, particularly on menthol flavors that were previously excluded. For e-cigarette and vaping companies, a regulatory environment more supportive of their interests could promote growth, allowing them to innovate and expand product lines. For smaller manufacturers and retailers, many of whom were affected by the 2019 restrictions, this stance could stimulate competition and support economic stability in the vaping sector. While industry advocates argue that relaxed regulations could promote freedom of choice and help smokers switch to alternatives, public health groups worry that looser controls could result in increased youth vaping.

3. The Financial Influence of Reynolds American

One possible reason behind Trump’s recent support for the tobacco industry is the financial backing of Reynolds American. According to a recent report from The Washington Post, Reynolds’ subsidiary, RAI Services Company, contributed $8.5 million to Trump’s main super PAC, Make America Great Again Inc., making it the PAC’s largest corporate donor.[1]

This investment is significant, signaling that Big Tobacco sees Trump as a potential ally, particularly in juxtaposition to regulatory challenges like menthol bans from the Biden administration. Reynolds’ support, along with other industry contributions, suggests that corporate interests are counting on Trump’s flexible policy stance, with campaign contributions possibly shaping his approach to future tobacco regulation.

4. Potential Removal of FDA Oversight of Tobacco

In his first term, Trump proposed moving tobacco regulation out of the FDA and into a new agency within the Department of Health and Human Services, arguing that a dedicated agency could better manage the complexity of tobacco products. This change claimed to streamline oversight, potentially reducing delays and regulatory hurdles for the industry.

Having been reelected, Trump might revive this proposal, which could reduce regulatory pressures that have long frustrated the tobacco industry. However, some public health advocates argue that removing tobacco oversight from the FDA could weaken protections, particularly for youth and other vulnerable groups.

Conclusion

A second Trump term offers the tobacco industry both opportunities and risks. On one hand, a more deregulatory approach could open markets and reduce restrictions on products like menthol cigarettes and e-cigarettes. On the other, the unpredictable nature of Trump’s policymaking leaves much up in the air — especially if Big Tobacco’s interests conflict with his past willingness to enact restrictions.

With Reynolds American and other industry giants placing their bets on Trump, the stakes are high — not just for the industry but also for public health advocates concerned about undoing recent progress in reducing youth vaping and smoking rates. Whether Trump’s promise to “save vaping again” will ultimately benefit the industry or lead to regulatory backlash remains uncertain, but the tobacco industry’s major players appear willing to take the risk.

[1] https://www.washingtonpost.com/politics/2024/09/18/menthol-cigarette-ban-trump-biden/