Week of January 20 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• "Federal Appeals Court Denies FDA, Cigar Industry Wins Premium Cigar Lawsuit Again" - The cigar industry has secured another victory in its lawsuit over premium cigars, pending any Supreme Court appeal.

• "New Administration Withdraws FDA's Menthol Ban Bid" - The Trump administration has withdrawn the FDA's proposed menthol cigarette ban.

• "U.K. Vape Market on the Rise" - The UK e-cigarette market is projected to grow by $1.47 billion from 2025-2029.

• “HHS Tables Nicotine Limits, Tobacco Manufacturing Standards Proposals” - In addition to halting the plans to ban the sales of menthol cigarettes and flavored cigars, the new Trump administration has halted two other major proposed tobacco regulations from the U.S. Food & Drug Administration (FDA).

Publications Summary:

• "Evidence update on e-cigarette dependence: A systematic review and meta-analysis" - New systematic review examining the latest evidence on e-cigarette addiction and dependence. Addict Behav. 2025 Jan 16;163:108243

• "Prevalence of Popular Smoking Cessation Aids in England and Associations With Quit Success" - Study examining the effectiveness of different smoking cessation methods in England.JAMA Netw Open. 2025 Jan 2;8(1):e2454962.

• "England's disposable vape ban: An inadequate solution to youth vaping" - Analysis arguing that England's disposable vape ban may have limitations in addressing youth vaping. Addiction. 2025 Jan 16. doi: 10.1111/add.16756.

• "Chemical Transformation of Vaping Emissions under Indoor Atmospheric Aging Processes" - Research examining how vaping emissions change chemically in indoor environments. Chem Res Toxicol. 2025 Jan 20. doi: 10.1021/acs.chemrestox.4c00402.

• "Electronic cigarette use among adolescents in Saudi Arabia: A national study, 2022" - National study examining e-cigarette use patterns among Saudi Arabian youth. Tob Induc Dis. 2025 Jan 21;23. doi: 10.18332/tid/197410.

Clinical Trials Summary:

• "Communicating About Nicotine Reduction in Cigarettes" - Study on messaging strategies regarding very low nicotine cigarettes. NCT06787937

• "Native Spirit: Significant Aim 3: Intervention" - Trial focused on substance use prevention among youth. NCT06785311

• "Investigating the Periodontal Status of Traditional and Heated Tobacco Product Users" - Study examining oral health impacts of different tobacco products. NCT06784817

Brief on FDA v. RJ Reynolds Vapor Company (23-1187)- SCOTUS Jurisdiction Arguments - January 21, 2025

In the FDA v. RJ Reynolds Vapor Company (23-1187) hearing held on January 21, 2025, the Supreme Court examined whether retailers can challenge FDA Marketing Denial Orders (MDOs) and whether venue rules under the Tobacco Control Act (TCA) were circumvented by filing in the Fifth Circuit. The FDA argued that only applicants, not retailers, are entitled to judicial review of MDOs and accused RJ Reynolds of engaging in forum shopping to exploit favorable rulings in the Fifth Circuit. Retailers countered that they are directly harmed by MDOs, as they face significant business losses and enforcement penalties, placing them within the statutory definition of “adversely affected persons.” Justice Thomas questioned the practicality of the government’s concerns, asking, “Why is it inconvenient for the government to litigate in one circuit versus another? It seems like it’s convenient for you.” This highlighted skepticism about the FDA’s claim that venue manipulation undermines congressional intent. Ultimately, the case centers on statutory interpretation of the TCA, balancing procedural safeguards against the practical realities of the tobacco product supply chain.

Potential Impact FDA Victory: Restricting challenges to denials would centralize judicial review with applicants, limiting multi-party petitions and ensuring Congress’s intent to reduce forum shopping is upheld.

Reynolds Victory: Expanding the scope of “adversely affected” would allow retailers to protect their business interests and could increase litigation in circuits viewed as favorable to industry.

This case hinges on the interpretation of “adversely affected,” the intent of Congress in structuring venue provisions, and the practical impact of marketing denial orders on downstream parties. Justice Thomas’s and Justice Jackson’s pointed questions highlight skepticism about the consistency of Congress’s treatment of denials and withdrawals, while Justice Kagan and Justice Sotomayor challenge the textual and structural interpretations offered by both sides.

FDA Moves Several Rules to Long-Term Action Stage

The five long-term actions related to tobacco and nicotine in the referenced document to be published in the Federal Register on February 12, 2025:

1. Requirements for Tobacco Product Manufacturing Practice (RIN 0910-AH91):

-This rule aims to establish comprehensive tobacco product manufacturing practices to prevent contamination and non-conformity, ensuring public health protection.

2. Tobacco Product Standard for Characterizing Flavors in Cigars (RIN 0910-AI28):

-Proposes banning characterizing flavors in cigars to address the appeal of flavored tobacco products, particularly among youth, and reduce tobacco-related harm.

3. Tobacco Product Standard for Menthol in Cigarettes (RIN 0910-AI60):

-Aims to prohibit menthol as a characterizing flavor in cigarettes to curb smoking initiation and enhance cessation efforts, especially in vulnerable populations.

4. Tobacco Product Standard for Nicotine Level of Certain Tobacco Products (RIN 0910-AI76):

-Proposes setting a maximum nicotine level in cigarettes and certain other tobacco products to reduce nicotine addiction and encourage cessation.

5. Nicotine Toxicity Warnings (RIN 0910-AH24):

-Focuses on implementing acute nicotine toxicity warnings for liquid nicotine and nicotine-containing e-liquids to improve consumer awareness and reduce accidental nicotine poisoning.

Potential Reasons for Moving to Long-Term Actions:

These actions were previously further along in the regulatory process (e.g., proposed or final rule stages) but have moved to long-term actions due to:

• Regulatory Delays: Lengthy public comment periods, stakeholder consultations, and technical challenges in drafting comprehensive standards may delay finalization.

• Scientific Data Requirements: The need for additional scientific evidence or data analysis to support regulatory decisions can lead to postponements.

• Legal and Administrative Hurdles: Challenges in resolving potential legal disputes or administrative bottlenecks within the agency can extend timelines.

• Policy Shifts or Prioritization: Changes in administrative priorities or focus on other urgent public health matters may result in these rules being deprioritized.

The Administrative Detention of Tobacco Products rule (RIN 0910-AI05) is currently at the Proposed Rule Stage according to the regulatory agenda. The proposed rule is scheduled for publication as a Notice of Proposed Rulemaking (NPRM) in June 2025. The rule would establish requirements for the administrative detention of tobacco products encountered during FDA inspections. This would allow FDA to detain tobacco products temporarily when there is reason to believe they are adulterated or misbranded. The rule is still in the development phase, awaiting the NPRM publication. Once published, there will be an open public comment period during which stakeholders can provide input.

FDA Artificial Intelligence Initiatives in 2024

Based on a review of the 27 AI projects in various phases of deployment, FDA seems to be implementing AI as a human-centric assistive tool rather than a replacement for human judgment. Almost all projects are designed with "Human-in-the-Loop" principles. These AI systems are positioned as decision support tools that augment rather than replace human expertise. For example, the FAR Review tool provides "risk-based intelligence and insights" but final decisions remain with human reviewers.

Operational Phase

Implementation Phase

Acquisition Phase