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On December 18, 2023 FDA Center for Tobacco Product (CTP) released its 5-Year Strategic Plan focusing on the the following goals:
Goal 1: Develop, Advance, and Communicate Comprehensive and Impactful Tobacco Regulations and Guidance
Goal 2: Ensure Timely, Clear, and Consistent Product Application Review
Goal 3: Strengthen Compliance of Regulated Industry Utilizing All Available Tools, Including Robust Enforcement Actions
Goal 4: Enhance Knowledge and Understanding of the Risks Associated With Tobacco Product Use
Goal 5: Advance Operational Excellence
Timeline Leading up to the Strategic Plan Release:
The Reagan-Udall Foundation (RUF) released their Operational Evaluation Report of Certain Components of FDA’s Tobacco Program in December 2022. This report addressed the function of several of CTP’s programs after a 3-month evaluation.
CTP responded to this report in February 2023 with a commitment to address the 15 recommendations put forth by the Foundation.
In May 2023 FDA held a Tobacco Products Scientific Advisory Committee Meeting on the Tobacco Product Manufacturing Practice (TPMP) proposed regulation as a response to the report in an effort to increase transparency central to premarket evaluation.
In October 2023 CTP held a listening session, (transcript also here) providing stakeholders an opportunity to engage with CTP on a variety of topics related to premarket applications. The request for comments in advance of this meeting was opened in July 2023. Several stakeholders provided comments on the proposed strategic goals used to develop CTP’s Strategic Plan. Select comments from the docket from stakeholders were collected below.
Analysis of comments to the docket:
Comments to Docket ID FDA-2023-N-2873
Prohibitionary policies fail to change behavior and lead to significant unintended consequences
Define the key term “appropriate for the protection of the public health”
Clarify what the data in an application must demonstrate and how much of that data is sufficient
Use post-market surveillance authority to guard against unintended consequences, rather than delaying or denying PMTA authorizations based on the precautionary principle
A well-functioning regulatory program must have clear and coherent compliance frameworks in place to maximize good behavior while minimizing the need for enforcement.
Many offending manufacturers are reaching consumers through distributors and retailers that are willing to skirt the system and are unphased by the only risk they seem to be taking—a potential FDA warning letter.
The lack of a functional framework for compliance coupled with sufficient enforcement threatens the long-term viability of a well-regulated tobacco product market, and, without such a framework, the accompanying benefits of reduced underage use and increased harm reduction for adult smokers will be unattainable.
FDA should develop a meaningful, interactive framework to address the form and content of premarket applications and, in particular, the design and conduct of clinical studies to investigate tobacco products.
Third, FDA should make available current information concerning its review of tobacco product applications.
Physicians Committee for Responsible Medicine
For Logic’s ENDS and comparator combustible cigarettes, we received reports of five 14-day and eleven 90-day inhalation toxicity studies in which a total of 2,393 rats were used; however, for NJOY’s ENDS, we received only reports of the in vitro tests. That such similar products were granted marketing orders, some with animal testing and others without, immediately raises the question of why these animal tests are conducted for any.
TPL reviews are available for only 23 PMTAs for ENDS and 22 PMTAs for other tobacco products. Beyond identifying and summary information, virtually nothing is available for the remaining 6.7 million PMTAs for ENDS that CTP has accepted for review, nor for the 19.6 million PMTAs for all tobacco products that it has refused to accept.
Recommend the Agency establish a communication channel for application review progress with a proposed frequency of quarterly application review progress/queue rank/status updates to the applicant(s). An emphasis on a timely review process is particularly crucial; marketing application applicants have experienced application review periods that span multiple years without much communication from the Agency, with some applications remaining under review for almost 3 years.
Chemular proposes introducing a 16th item for Reagan-Udall's Foundation report : "Trust Deficit." There appears to be a prevailing sentiment of mistrust between the FDA's Center for Tobacco Products and its stakeholders, primarily the Tobacco industry. The Agency views the industry's communications with skepticism, often doubts its authenticity. As of September 2021, mutual distrust has reached an equal footing between FDA’s CTP and the industry.
The SE process fails to capture the innovation brought forth by the numerous tobacco harm reduction products introduced after February 15, 2007.
Scientific data required is too complex as the PMTA process itself demands a high level of data and evidence on product characteristics, safety, addictiveness, and the potential health impacts.
In reviewing applications and determining any products’ appropriateness for the protection of public health, the FDA should prioritize products on both the basis of reduced harms and the likelihood of youth usage of such products.
Summary:
The consistent theme expressed throughout these comments is a desire for more transparency and accountability from CTP with regard to decision-making process. This would include releasing more CTP reviewer memos, further defining what “appropriate for the protection of public health” (APPH) actually looks like from a quantifiable science and evidence standpoint and creating a viable (and streamlined) authorization pathway in order to minimize noncompliance.
The Goal → Outcomes → Objectives construct of this plan remains less prescriptive than some would have preferred but based on the outputs from the October 2023 premarket application listening session, it seems like many of the stakeholder comments were, in fact, considered analyzed and subsequently presented by CTP in a way that will allow actionable tactics to be implemented.
✅ In 2023 there is ample ENDS product-specific science being published on a weekly basis, perhaps 40-50 articles per week that is being leveraged in applications through bridging PMTA data and next-generation product development.
✅ Hundreds of FOIA requests have been fulfilled in the past several years, providing job aids and reviewer guides to manufacturers for SE, PMTA as well as checklists for RTA and RTF. Despite the changing regulatory landscape and potential obsolescence of certain frameworks, generally these work tools should be made widely available to all stakeholders to align on more consistent and predictable review processes.
✅ The Tobacco Implementation Guide (TIG) v1.0 is scheduled to be released in May 2024 which will hopefully improve data standards for more efficient application review.
It's very easy to be discouraged with what has been happening in this space but I believe there is enough knowledge, enthusiasm and capital to change the direction. Perseverance in the face of challenges is key to making a meaningful impact.
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