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In This Issue…
FDA posts the list of deemed new tobacco products for which a premarket application was submitted and withdraws a premium cigar notice from the Unified Agenda. Learn more in this latest issue of Spotlight on Science, a quarterly research and science digest from FDA’s Center for Tobacco Products (CTP).
- FDA Posts PMTA List and Updates Progress Metrics
- FDA Withdraws Regulatory Notice Related to Premium Cigars from the Unified Agenda
- Article Describes E-Cigarette Use Behavior Among Youth
- Submit Comments on MRTP Application for IQOS 3 System Holder and Charger
- Watch the Video of the June 11 Virtual Meeting with CTP’s Office of Science
- Watch the Video of the FDA Science Forum with Keynote Dr. Anthony Fauci
- More About CTP Research
List of Deemed New Tobacco Products
On May 20, 2021, FDA posted the list of deemed new tobacco products for which a premarket application was submitted to FDA via the Premarket Tobacco Product Application (PMTA) pathway by Sept. 9, 2020. The list includes over 6 million products.
In February, FDA posted the list of deemed new tobacco products with timely applications submitted to FDA via the Substantial Equivalence (SE) and Exemption from SE Request (EX REQ) pathways. At the time, the PMTA list was still being compiled due to the large number of applications, size of applications, and other factors. FDA also had to ensure that the development and posting of the list was done in accordance with applicable laws; for example, FDA needed to contact each individual applicant to request the dates of initial marketing and current marketing status of each product for which an application was submitted by the Sept. 9, 2020 deadline. FDA used this information to determine if the existence of the pending application could be disclosed to the public.
Please note that FDA has not independently verified the information provided by applicants about the current marketing status of their products.
The process is now complete for the deemed new tobacco products with timely applications submitted through the PMTA pathway, and updates to the SE and EX REQ lists have been made to reflect final actions taken since their initial posting. Now, all lists of deemed new tobacco products with timely submitted applications are available. It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement. The agency will be updating these lists regularly as positive or negative actions are issued on these products.
Progress on Tobacco Product Application Review
The Agency continues to review tobacco product applications received by the Sept. 9, 2020 deadline through all three pathways and provide updates on its progress through the Tobacco Product Applications: Metrics And Reporting webpage. FDA has posted the latest metrics charts related to the review of all tobacco products applications. The charts include data as of June 1, 2021 for the applications submitted through the SE, EX REQ, and PMTA pathways. However, there are a number of important factors and context that need to be considered when reviewing this data.
On June 11, FDA announced the withdrawal of the Unified Agenda entry pertaining to the advance notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018, as well as a related request for information (RFI). The agency has posted a web statement that includes background information on the ANPRM and RFI as well as FDA’s rationale for this action.
FDA expects to update the public in spring of 2022 following the completion of an ongoing review being conducted by the National Academies of Sciences, Engineering, and Medicine (NASEM) under contract with FDA. The study findings are expected to further inform the agency’s regulatory policy.
JAMA Network Open published an article on June 7, 2021 entitled Characteristics of e-Cigarette Use Behaviors Among US Youth, 2020. This article was coauthored by CTP’s Eunice Park-Lee, Chunfeng Ren, and Karen Cullen, along with colleagues at the Centers for Disease Control and Prevention (CDC). The article analyzed data from the 2020 National Youth Tobacco Survey. Highlights include:
- In 2020, 19.6 percent of high school students and 4.7 percent of middle school students reported current e-cigarette use.
- Among them, 38.9 percent of high school users and 20.0 percent of middle school users reported e-cigarette use on 20 to 30 days within the past 30 days.
- Among current users, JUUL was the most commonly reported usual brand (high school: 25.4 percent; middle school: 35.1 percent).
- Among current users, the most common source of obtaining e-cigarettes was from a friend (high school: 57.1 percent; middle school: 58.9 percent).
- Among high school students who were current e-cigarette users, 84.7 percent reported flavored e-cigarette use. Among those, approximately three-quarters (73.1 percent) reported using fruit flavored, more than half (55.8 percent) reported using mint flavored and more than one-third (37 percent) reported using menthol flavored e-cigarettes.
- Among middle school students who were current e-cigarette users, 73.9 percent reported flavored e-cigarette use. Among those, about three-quarters (75.6 percent) reported using fruit flavored, about half (43.6 percent) reported mint flavored, and about a quarter (26.3 percent) reported using menthol flavored e-cigarettes.
FDA recently posted more materials from the MRTP application submitted by Philip Morris Products S.A. (PMPSA) for the IQOS 3 System Holder & Charger. Public comments on these materials should be submitted to FDA-2021-N-0408-0001. Currently, there is no deadline for public comments. Once all materials from this MRTP application, including amendments, are posted, FDA will announce the closing date for the comment period, which will be at least 30 days from the date the last application materials are posted.
The application materials, redacted in accordance with applicable laws, can be read on the FDA website. FDA takes into consideration all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC), before making a final determination on an MRTP application.
Please sign up to receive email alerts when materials from any MRTP application under scientific review have been posted or check our PMPSA MRTP application webpage regularly for updates specific to that application.
On June 11, 2021, CTP’s Office of Science held a live, virtual meeting discussing the scientific review of applications received by Sept. 9, 2020. The meeting focused on the application intake process, review progress, and allocation of review resources. It featured a presentation from CTP Office of Science Director Matt Holman and included a question and answer session with Office of Science staff.
The 2021 FDA Science Forum was held virtually on Wednesday and Thursday, May 26 and 27, 2021. The theme of the event was Science as the Foundation for Protecting and Promoting Public Health. The keynote speaker was NIAID Director Dr. Anthony Fauci.
Did You Know…
… you can request a speaker from CTP’s Speakers Bureau, a centralized place to request expert speakers on CTP’s research efforts and science-based regulatory actions?
To request a speaker from CTP’s Speakers Bureau, submit the following to CTPSpeakerRequests@fda.hhs.gov:
- A completed speaker request form;
- A formal invitation on organization letterhead, and;
- A program agenda with all invited speakers and topics.
For more information, please visit our Speakers Bureau webpage or contact us at CTPSpeakerRequests@fda.hhs.gov.
Recent Publications by CTP Researchers
- Characteristics of e-Cigarette Use Behaviors Among US Youth, 2020. JAMA Netw Open. 2021 Jun 1;4(6):e2111336. doi: 10.1001/jamanetworkopen.2021.11336.
- Integration of transcriptome analysis with pathophysiological endpoints to evaluate cigarette smoke toxicity in an in vitro human airway tissue model. Arch Toxicol. 2021 May;95(5):1739-1761. doi: 10.1007/s00204-021-03008-0. Epub 2021 Mar 3.
- Toxicokinetic and Genotoxicity Study of NNK in Male Sprague-Dawley Rats Following Nose-Only Inhalation Exposure, Intraperitoneal Injection, and Oral Gavage. Toxicol Sci. 2021 May 3;kfab049. doi: 10.1093/toxsci/kfab049. Online ahead of print.
- Biomarkers of Potential Harm among Adult Cigarette and Smokeless Tobacco Users in the PATH Study Wave 1 (2013-2014): A Cross-sectional Analysis. Cancer Epidemiol Biomarkers Prev. 2021 May 4. doi: 10.1158/1055-9965.EPI-20-1544. Online ahead of print.
- Exposure to Nicotine and Toxicants Among Dual Users of Tobacco Cigarettes and E-Cigarettes: Population Assessment of Tobacco and Health (PATH) Study, 2013-2014. Nicotine Tob Res. 2021 May 4;23(5):790-797. doi: 10.1093/ntr/ntaa252.
- Aquatic toxicity of waterpipe wastewater chemicals. Environ Res. 2021 Jun;197:111206. doi: 10.1016/j.envres.2021.111206. Epub 2021 Apr 28.
Research Opportunities to Explore
In support of its mission to develop regulation rooted in science, CTP seeks new research to address key areas of tobacco regulatory science such as toxicity, addiction, health effects, behavior, communications, marketing influences, and impact analysis of regulatory actions.
CTP encourages research studies to include, where appropriate to the research question, populations of special relevance, including (but not limited to): youth, socioeconomically disadvantaged populations, racial/ethnic minorities, underserved rural populations, people with co-morbid mental health conditions and/or substance use disorders, military/veteran populations, pregnant women or women of reproductive age, and sexual and gender minorities.
- Tobacco Regulatory Science Program: FDA’s partnership with NIH to foster tobacco regulatory research, offers funding for scientists whose research can inform CTP’s regulatory activities.
- Current Funding Opportunities
Spotlight on Science is a quarterly science and research digest from FDA’s Center for Tobacco Products.
Note: The contents of publications discussed in this newsletter are the responsibility of their authors alone, and findings and conclusions are those of the authors and do not necessarily represent the views of FDA.