 Latest News
National Survey Shows Drop in E-Cigarette Use Among High School Students
In November, FDA and the Centers for Disease Control and Prevention (CDC), released data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
Among U.S. high school students, current use of any tobacco product declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10.0%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Although a decrease in e-cigarette use was observed among high school students, there was an increase in current use of any tobacco product (4.5% to 6.6%) and multiple (≥2) tobacco product use (1.5% to 2.5%) among middle school students. However, among middle school students overall, no significant change was observed during 2022-2023 for current use of any individual tobacco product type, including e-cigarettes.
Funding Awards Announced for Tobacco Centers of Regulatory Science
In September, the FDA’s Center for Tobacco Products (CTP) and National Institutes of Health (NIH) announced funding awards for seven organizations within Tobacco Centers of Regulatory Science (TCORS).
These new funding awards are the third round of TCORS, a long-standing component of the Tobacco Regulatory Science Program, or TRSP, a trans-HHS collaborative research effort between NIH and FDA that fosters regulatory research.
Retailers Warned to Stop Selling Illegal E-Cigarettes Resembling Youth-Appealing Characters, School Supplies, Toys, and Drinks
In August and November, FDA issued warning letters to 22 online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like youth-appealing characters, school supplies, toys, and drinks. Since the appearance of these illegal products can be deceiving, the agency is also seeking to raise awareness among parents, teachers, and other adults.
FDA Warns Companies Selling Illegal E-cigarettes with Emerging Popularity Among Youth
In September, FDA issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold an e-cigarette product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech.
FDA Seeks Fines Against Retailers for Selling Illegal Youth-Appealing E-Cigarettes
In September and November, FDA issued complaints for civil money penalties (CMPs) against a total of 42 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand. The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products. During follow-up inspections, the FDA observed that the retailers had not corrected the violations, which resulted in these civil money penalty actions.
CTP’s Progress Addressing Recommendations from the Reagan-Udall Evaluation
In October, CTP Director Brian King published a statement summarizing the center’s continued efforts to address the evaluation of CTP by an independent expert panel facilitated by the Reagan-Udall Foundation (RUF). Since CTP’s June 2023 progress update, the center has continued to make significant progress in putting plans into action to address each recommendation.
Premarket Tobacco Application Efforts
Over the last several months, CTP has provided several mechanisms to update industry on best practices for tobacco product applications. CTP held a two-day public meeting on FDA’s premarket tobacco product application process on Oct. 23 and 24.
Additionally, CTP launched new resources to help applicants navigate the FDA tobacco product application process. Specifically, CTP is offering a new webpage with more in-depth information on how to complete the three required premarket tobacco product application (PMTA) forms to submit and amend pending applications.
CTP also launched the Product Form Validator Tool for Form FDA 4057b, “Premarket Tobacco Product Application Grouping Spreadsheet.”
FDA continues to make decisions on PMTAs, including the following:
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October 12, 2023: Marketing Denial Orders, R.J. Reynolds Vapor Company (3 Vuse Alto menthol-flavored and 3 Vuse Alto mixed berry-flavored products, each in three nicotine strengths)
Population Assessment of Tobacco and Health (PATH) Study Updates
In September, FDA’s Center for Tobacco Products (CTP) and NIH’s National Institute on Drug Abuse (NIDA) announced the availability of the Wave 6 Public-Use File (PUF) from the Population Assessment of Tobacco and Health (PATH) Study. These Wave 6 files contain questionnaire data collected from March 2021 to November 2021. In addition, Wave 5.5 Ever/Never Special Collection Public-Use Files (SCPUF) are now available along with updated Master Linkage Files (MLF).
More About CTP Research
Current Funding Opportunities
- FY24 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science (FDABAA-24-00123)
- NIH Tobacco Regulatory Science Program (TRSP) Notices of Funding Opportunities
- Public Health Communication Messaging about the Continuum of Risk for Tobacco Products (U01; RFA-OD-23-021)
- Mentored Research Scientist Career Development Award in Tobacco Regulatory Research (K01): RFA-OD-22-023 (non-clinical trial) or RFA-OD-22-024(clinical trial)
- Pathway to Independence Award in Tobacco Regulatory Research (K99/R00): RFA-OD-22-025 (non-clinical trial) or RFA-OD-22-026(clinical trial)
- Tobacco Regulatory Science (R01 Clinical Trial Optional): RFA-OD-23-017
Recent Publications by CTP Researchers
This newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our CTP Connect newsletter and CTP News e-blasts.
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