Week of May 12 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• On May 14, 2025, Robert F. Kennedy Jr., as U.S. Health and Human Services Secretary, testified at two congressional hearings:

House Appropriations Committee Hearing (morning): Kennedy faced questions about President Trump’s proposed $1.7 trillion budget for fiscal year 2026, which included a 26% cut to HHS funding, staff reductions, and program eliminations. He defended these cuts, discussed the U.S. measles outbreak, and addressed concerns about vaccine policies. He also responded to inquiries about artificial food dyes and HHS reorganization efforts.

Senate Health, Education, Labor, and Pensions (HELP) Committee Hearing (afternoon): Kennedy testified on the HHS budget and his overhaul of the department, including mass layoffs and program cuts. Kennedy also discussed Chinese vapes in the U.S.

• HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers - FDA

The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today (May 13) announced the launch of a public Request for Information (RFI) to identify and eliminate outdated or unnecessary regulations. The initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency, in alignment with President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation.”

Under the directive, HHS Secretary Robert F. Kennedy, Jr. has committed the Department to a "10-to-1" deregulatory policy: for every new regulation proposed, at least ten existing regulatory actions will be rescinded. The effort is designed to lower the cost of living, remove bureaucratic barriers, and allow health care providers to devote more time and resources to patient care. (see analysis below)

• Regulating in the Name of Public Health - The Regulatory Review

In a conversation with The Regulatory Review, public health expert Mitch Zeller reflects on his tenure at the U.S. Food and Drug Administration (FDA) and shares how lessons from tobacco regulation can be applied to broader public health policymaking.

The evolving marketplace for tobacco and nicotine products has been an extraordinary challenge for FDA. The regulatory framework is still intact. But the Center for Tobacco Products has had its budget capped, with no inflation adjustments, since 2019. The Center is completely funded by industry user fees. Not one dollar is collected from the e-cigarette industry even though much of the Center’s programmatic efforts are focused on that category.

I started working on FDA regulation of tobacco products in 1994. It did not become a fixture until legislation was enacted in 2009. I have been working to advance the evidence base and the policy case for nicotine reduction for almost 20 years. All we have to show for the effort is a proposed rule that is likely to be withdrawn in the second Trump Administration.

HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers - FDA CTP Proposal

• The 10-to-1 rule: For every new regulation introduced, at least ten existing regulations must be eliminated.

• Regulatory cost cap: The total cost of all new regulations in fiscal year 2025 must be significantly less than zero.

• Expanded scope: The order applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives.

• Radical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset, promoting greater transparency and accountability.

Proposed Changes to the PMTA Final Rule for Deregulation

These proposed changes support the request for information (RFI) for deregulation initiatives at FDA CTP.

Section §1114.7: Content of a PMTA

Current Requirement: Requires detailed product composition, health risk investigations, manufacturing processes, and labeling.

Proposed Change: Simplify health risk investigations to focus on critical constituents (e.g., TSNAs, HPHCs) and allow summary reports for non-critical data.

Rationale & Compliance: Reduces applicant burden and review time, aligning with the 10-to-1 rule by offsetting with rescissions of redundant guidance (e.g., “General PMTA Guidance”). Supports cost cap by lowering preparation costs.

Section §1114.41: Reporting Requirements

Current Requirement: Mandates periodic postmarket reports on sales, consumer research, advertising, and adverse experiences.

Proposed Change: Eliminate non-essential reporting (e.g., demographic breakdowns, formative research) unless tied to youth risks; reduce report frequency to annual for low-risk products.

Rationale & Compliance: Decreases reporting costs, aligning with cost cap. Rescinding detailed reporting supports the 10-to-1 rule while focusing on youth protection.

Section §1114.45: Record Retention

Current Requirement: Requires 4-year retention of PMTA and postmarket records, including study data and complaints.

Proposed Change: Shorten retention to 2 years for non-critical records (e.g., marketing communications); exempt small businesses from redundant study data retention.

Rationale & Compliance: Lowers storage costs, supporting cost cap. Rescinding redundant recordkeeping aligns with the 10-to-1 rule and expanded scope to non-regulatory documents.

Section §1114.49: Electronic Submission

Current Requirement: Mandates electronic submission via FDA’s system, with waivers for cases where electronic means are not reasonable.

Proposed Change: Expand waiver eligibility for small businesses with limited IT resources; streamline waiver application process.

Rationale & Compliance: Reduces barriers for applicants, aligning with cost cap and transparency by simplifying access. Contributes to 10-to-1 rule by rescinding complex guidance.

Section §1114.39: Postmarket Changes

Current Requirement: Requires reporting of significant postmarket changes to product composition or marketing.

Proposed Change: Narrow “significant” changes to exclude minor labeling/packaging updates unless impacting youth appeal.

Rationale & Compliance: Reduces unnecessary submissions, lowering costs and aligning with cost cap. Rescinding broad requirements supports the 10-to-1 rule.

Section §25.40: Environmental Assessment

Current Requirement: Requires an environmental assessment per 21 CFR §25.40, as cross-referenced in §1114.7(b)(10).

Proposed Change: Eliminate or streamline for low-impact products (e.g., ENDS) with a categorical exclusion.

Rationale & Compliance: Reduces applicant burden, aligning with cost cap and 10-to-1 rule by rescinding redundant environmental guidance.

Deep Dive - Food and Drug Law Institute (FDLI) Annual Conference Review

1. A Hint of Harm or Harm Reduction: Exploring the Role of Flavors in Evidence-Based Policy Making

Presenters: Dave Dobbins, Tony Abboud, Ian Jones, Rachael Schmidt (Moderator)

Overview: The discussion explores the role of flavored e-cigarettes in smoking cessation versus their perceived risk to youth. Data from studies (e.g., Study #310) show flavored vapes lead to higher cigarette cessation rates (12-22% at Month 6) compared to tobacco flavors (2%). Youth vaping rates have declined from 20% in 2019 to 5.9% in 2024 (NYTS data), with flavors ranking low (13.5% in 2021) among reasons for youth use. Benefits include significant cigarette reduction (>50%) or cessation, while risks like youth usage are mitigated by age-gating. Qualitative testimonials highlight flavors’ appeal to adult smokers and safety benefits. The presentation urges evidence-based policies balancing adult harm reduction with youth protection, challenging the narrative linking flavors to youth vaping.

2. Reducing Regulatory Uncertainty for Nicotine Products

Presenters: Clive Bates, Kellsi Booth, Ahmad El Hellani, Paige Magness, Beth Oliva (Moderator)

Overview: The discussion critiques the FDA’s slow Premarket Tobacco Product Application (PMTA) process, averaging >900 days against a 180-day mandate, with only 10 authorized vapes despite 86% of sales being unauthorized. Proposed reforms include authorizing >4,000 vapes, reducing PMTA costs ($10k-$500k), and shortening reviews to 180 days. Suggestions involve resetting the process with product standards, risk-based categorization, and robust post-market surveillance (e.g., Altria’s Underage Tobacco Use Survey). Challenges in comparing tobacco products for APPH and unintended consequences of nicotine caps (e.g., driving illicit trade) are highlighted. The goal is to crowd out illicit markets, enhance transparency, and align policies with the continuum of risk.

3. Illicit Nicotine: Enforcement, Compliance, and the New Administration

Presenters: John Verbeten, Maham Akbar, Robyn Gougelet, Kevin Schroth, LieAnn T. Van-Tull (Moderator)

Overview: The discussion addresses the prevalence of illegal e-cigarettes, with 86% of sales unauthorized and 90% of China’s exports mislabeled, evading $2.2-$2.6 billion in duties (2023-2024). FDA enforcement includes >1,400 warning letters (975 for ENDS) and novel actions like seizures via a 2024 multi-agency task force. Youth vaping has dropped to 5.9% (NYTS 2024), with disposables dominating. Policy proposals include advanced age verification, standardized marketing restrictions, a 180-day PMTA process, and interagency coordination to target illicit supply chains. The discussion emphasizes balancing enforcement with efficient authorization to support compliant businesses and protect public health.

4. The Demographic Future of the Nicotine Consumer Landscape and Regulatory Responses

Presenters: Benjamin Apelberg, Annie Kleykamp, Andrew Joyce, Jeffrey Willett

Overview: The presentation examines evolving nicotine use trends and regulatory implications, emphasizing demographic shifts. NYTS data (1999-2024) show youth e-cigarette use at 5.9% and combustible cigarette use at 1.7%, with nicotine pouch use rising (2.0% among 10th/12th graders). PATH data (Wave 1-7) indicate declining adult cigarette use, stable older adult smoking (~9%), and increased e-cigarette use among young adults. Older adults, a growing segment (3.8M smokers in 2021), face high health costs (e.g., lung cancer, COPD) but are overlooked in research (71% of SRNT abstracts focus on youth). Misconceptions about e-cigarettes’ harm and ageist biases hinder tailored policies. FDA’s APPH framework balances youth risks (e.g., flavors, marketing) against adult benefits (e.g., switching via RCTs, cohort studies). Forecasts predict sustained nicotine appeal, no youth epidemic, and a shift toward harm reduction, urging faster PMTA reviews, robust surveillance, and clinician education on risk continuum.

5. AI Policy and the New Administration

Presenters: Jessica Tierney, Barrett J. Tenbarge, Brendan O’Leary, Vernessa Pollard (Moderator)

Overview: The presentation examines the evolving role of artificial intelligence (AI) in FDA-regulated industries under the new administration, highlighting opportunities, complexities, and policy considerations. AI is defined as systems learning patterns from data to approximate human tasks, per the 2019 McCain Act and an April 3, 2025, OMB memo emphasizing broad AI applicability. Use cases include clinical application modeling, adverse event (AE) sorting, regulatory submissions generation, supplier operations, and enterprise functions like HR and compliance. AI disrupts traditional risk management, raising questions about intellectual property (IP), employee training, litigation, cybersecurity, and data governance (e.g., data provenance, model stability). The FDA’s recent AI pilot at CDRH for CMC review aims to enhance reviewer efficiency, but lacks transparency on implementation. The new administration’s pro-innovation stance contrasts with the previous focus on individual risk, though guardrails remain essential. Industry is encouraged to engage proactively with the FDA to shape AI policy, leveraging draft guidance (e.g., CDRH’s AI framework) and advocating for clear decision-making frameworks, despite uncertainties around finalization and federal funding constraints.