Trade Press and Regulatory Summary

FDA layoffs reportedly included employees funded by tobacco user fees - New York Times

• The FDA laid off hundreds of employees, including scientists studying e-cigarette safety and lawyers enforcing underage tobacco sales laws, despite their salaries being funded by tobacco industry user fees rather than taxpayer dollars. These firings, part of a broader government-wide reduction, have raised concerns about weakened enforcement and regulatory oversight.

US FDA asks fired scientists to return - Health World

• After abruptly firing hundreds of employees, including those in the FDA’s tobacco regulation division, the agency is now attempting to rehire around 300 of them. The rehiring effort follows backlash over the sudden terminations, which disrupted drug, food, and tobacco product oversight.

NY lawmaker introduces bill to ban Zyn, other flavored nicotine pouches after FDA's support of product - Fox

• New York lawmakers have proposed a ban on flavored nicotine pouches, arguing they appeal to youth despite the FDA's endorsement of the products as a harm reduction tool. The bill, which aims to align regulations for nicotine pouches with those on flavored tobacco products, has sparked debate over its necessity given federal youth usage data showing minimal uptake.

Illegal U.S. vape sales worth at least $2.4 billion in 2024, data shows - Reuters

• Unauthorized flavored disposable vape sales in the U.S. reached approximately $2.4 billion in 2024, accounting for 35% of e-cigarette sales in retail outlets. The persistence of illicit vape products highlights enforcement challenges and the continued demand for flavored vaping options.

Trump to name FBI chief Patel as acting ATF director, source says - KSL

• President Trump plans to appoint Kash Patel as the acting director of the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF), despite opposition from Democrats and some Republicans. The appointment follows Attorney General Pam Bondi’s firing of the ATF’s chief counsel, signaling a shift in leadership at the agency responsible for regulating tobacco and firearms.

NIH funding freeze stalls applications on $1.5 billion in medical research funds - NPR

• The National Institutes of Health has halted the review of new grant applications, delaying decisions on $1.5 billion in funding for research on diseases such as cancer and Alzheimer’s. The funding freeze, resulting from broader government cost-cutting measures, has put thousands of medical research projects on hold.

Leading Pro-Vape Academic 'Couldn’t Stand on the Sidelines Any Longer' - Filter

• Public health professor Michael Siegel has returned to the vaping debate, challenging leading tobacco control groups for ignoring scientific evidence supporting harm reduction. He argues that misinformation about vaping persists, despite studies showing its potential benefits for smoking cessation.

Philip Morris International and Altria Presentations at CAGNY 2025

The following is a brief summary of the PMI and Altria presentations from the 2025 Consumer Analyst Group of New York (CAGNY) conference:

PMI

• Reported continued growth in the Smoke-Free category, with net revenues approaching $15 billion and 100 markets.

• Announced that IQOS is on track to overtake Marlboro in net revenues within a decade.

• ZYN achieved nearly $2 billion in U.S. net revenues.

• The company is on track to achieve its vision of becoming majority Smoke-Free by net revenue in the top-5 operating income (OI) markets by 2030.

• Total volumes (cigarettes, HTUs, oral Smoke-Free products (SFPs), and e-vapor) are estimated to grow by up to 2% in 2025, driven by the multicategory approach.

• PMI sees substantial international and U.S. growth opportunities for its Smoke-Free products, including IQOS, ZYN, and VEEV.

• The company discussed the evolving understanding of nicotine and the importance of consumer perceptions.

Altria

• Showcased its strong performance in the smokeable business, particularly in the oral tobacco segment. Doubled on! retail distribution through 2024. Launching Raspberry Lemon and Watermelon Mint internationally. FUMi oral nicotine pouches also competing internationally.

• Discussed ambitions beyond U.S. nicotine, including energy drink investment - Proper Wild

• Altria emphasized the potential for harm reduction with innovative products like Ploom and on! nicotine pouches.

• The company discussed the challenges posed by illicit e-vapor products and the need for regulatory oversight.

• CEO Billy Gifford, in response to an analyst question, noted that it is possible the company would sell the Center for Research and Technology located in Richmond, VA to Virginia Commonwealth and build new R&D facilities at another existing site.

Attorney General of New York State Sues Largest Vape Distributors

These companies are responsible for illegally distributing, marketing, and selling flavored disposable vapes – including popular brands such as Puff Bar, Elf Bar, Geek Bar, Breeze, MYLE, and more according to the complaint.

Deep Dive - Proposed Uniform Postmarket Reporting Standards Framework for Authorized Tobacco Products

This framework contemplates consistent postmarket reporting requirements for all authorized tobacco and nicotine products to ensure compliance, transparency, and public health protection. It integrates key elements from existing FDA regulations while promoting efficiency for industry stakeholders.

1. General Framework Overview

Objective:

• Standardize postmarket reporting obligations across all authorized tobacco and nicotine products.

• Enable regulatory oversight to monitor marketing impact, youth access, and public health implications.

• Establish data-driven evaluation of authorized product use patterns and compliance adherence.

Applicability:

• All tobacco and nicotine products granted a Marketing Granted Order (MGO) under the Premarket Tobacco Product Application (PMTA) process.

• Includes ENDS (electronic nicotine delivery systems), nicotine pouches, heated tobacco products, snus, and other novel nicotine products.

Submission Frequency:

• Annual Reports: Standardized format across all authorized products.

• Quarterly Compliance Updates: Only for high-risk products (e.g., those with higher youth appeal).

• Immediate Notification: For safety concerns, unauthorized marketing, or regulatory violations.

2. Core Postmarket Reporting Categories

A. Sales and Distribution Data

Objective: Assess market penetration, consumer trends, and demographic usage.

• Total Sales Volume: Reported in units, dollars, and volume per jurisdiction.

• Geographic Distribution: U.S. Census region breakdown.

• Retail vs. Online Sales Split: Include age verification methods used for online purchases.

• Demographic Data of Consumers (if available): Age, gender, tobacco/nicotine use history.

Uniform Metric: Sales data must align with pre-defined FDA templates for consistency across product categories.

B. Youth Access and Marketing Compliance

Objective: Monitor adherence to marketing restrictions and prevent youth exposure.

• Digital Media Monitoring:
  

  • Report impressions delivered by marketing channel (social media, websites, mobile apps).

  • Document corrective actions taken to mitigate youth exposure.

• Retail Compliance Audits:
  

  • Record results of undercover purchase attempts (if conducted).

  • Frequency of audits and remedial measures taken.

• Advertising and Marketing Channels:
  

  • List all advertising, sponsorships, and promotional activities.

  • Confirm compliance with 85% adult audience threshold for media placement.

Uniform Metric: Digital ad reach reporting must include data from accredited third-party tracking firms.

C. Adverse Event and Safety Monitoring

Objective: Identify potential health risks from product usage.

• Serious and Unexpected Adverse Experiences (submitted within 15 days of occurrence):
  

  • Death, hospitalization, seizures, cardiovascular/respiratory issues.

  • Documented correlation between event and product use.

• Non-Serious Adverse Reports (submitted annually):
  

  • Oral irritation, nicotine dependence symptoms, reported withdrawal effects.

• Product Quality and Safety Reports:
  

  • Contamination, mislabeling, leakage, battery malfunctions (for ENDS).

Uniform Metric: Utilize standard FDA electronic submission templates for consistency.

D. Labeling and Packaging Compliance

Objective: Ensure product labeling aligns with approved guidelines.

• Final Printed Labeling and Warnings:
  

  • Include high-resolution images of all package variations used during the reporting period.

• Changes to Labeling or Packaging:
  

  • Report modifications related to health warnings, tamper-proofing, or nicotine disclosures.

• Misleading Claims Investigation:
  

  • Any incidents where retailers misrepresent products (e.g., implying FDA approval).

Uniform Metric: Ensure all submitted materials include metadata timestamps for tracking changes over time.

E. Consumer Perception and Market Research

Objective: Evaluate consumer understanding and behavioral impact.

• Consumer Surveys & Market Trends:
  

  • Behavioral tracking of adult smokers switching to reduced-risk products.

  • Perception of product risks compared to cigarettes or other nicotine alternatives.

• Youth and Non-Smoker Appeal Studies:
  

  • If requested by FDA, conduct research assessing youth appeal risks.

Uniform Metric: Use standardized consumer study methodologies with consistent reporting variables.

F. Postmarket Compliance Monitoring and Enforcement Actions

Objective: Document corrective actions taken to address regulatory violations.

• FDA Warning Letters or Penalties Received

• Corrective Actions Taken in Response

• Retail or Distributor Violations Identified

Uniform Metric: Companies must report all compliance violations in real-time notifications within 30 days of issue resolution.

3. Reporting Format and Submission Guidelines

Standardized Reporting Template

• Each submission must follow a structured format:

  1. Executive Summary (2-3 pages summarizing key data).

  2. Sales & Distribution Data (Section A).

  3. Marketing Compliance & Youth Access (Section B).

  4. Adverse Event & Safety Reports (Section C).

  5. Labeling & Packaging Compliance (Section D).

  6. Consumer Research & Behavioral Impact (Section E).

  7. Compliance & Enforcement (Section F).

Electronic Submission via FDA CTP Portal

• Reports must be uploaded in FDA-approved electronic formats (e.g., XML, structured PDFs).

• Secure cloud-based FDA dashboard for real-time compliance tracking.

Postmarket Record Retention Requirements

• Minimum of 4 years for all sales, safety, and marketing compliance data.

• Retained data must be made available for FDA audits upon request.

4. Compliance and Penalties

Triggers for Additional FDA Scrutiny

1. Increase in Youth Use Trends (≥5% uptick in National Youth Tobacco Survey).

2. Violation of Marketing Restrictions (unapproved digital campaigns, influencer violations).

3. Failure to Submit Required Reports within deadlines.

4. Serious Adverse Events beyond expected risk profile.

FDA Enforcement Actions

• Warning Letter Issued for first-time offenses.

• Corrective Action Plan (CAP) required for repeat violations.

• Suspension of MGO if compliance is consistently ignored.

Conclusion

A uniform postmarket reporting framework enhances regulatory oversight, promotes compliance consistency, and provides valuable data to assess the public health impact of authorized tobacco products. This structured approach ensures real-time monitoring, data-driven enforcement, and a standardized reporting process across all nicotine product categories.