This quarterly newsletter serves as a digest of the latest announcements and stories out of CTP. It is a complement to our Spotlight on Science newsletter and CTP News e-blasts. A 2020 Message from Former FDA Commissioner Dr. Stephen Hahn Despite the unforeseen challenges posed by the COVID-19 pandemic, it was a year of unparalleled contributions to public health at FDA. In a review of the agency's initiatives and achievements, Former FDA Commissioner Dr. Stephen Hahn offers a highlight of what was accomplished, including the Center for Tobacco Products' comprehensive, science-based approach to regulating an evolving tobacco landscape and protecting the public – especially youth – from the harms associated with tobacco product use. CTP continued to demonstrate our commitment to this mission over the last year by completing historic regulations, reviewing tobacco product premarket applications using rigorous scientific standards, enforcing the law and our regulations, and continuing our award-winning public education campaigns. Regulation and Guidance Postponed: Cigarette Health Warnings Effective Date On December 2, 2020, the U.S. District Court for the Eastern District of Texas granted a motion by the plaintiffs in the case of R.J. Reynolds Tobacco Co. et al. v. United States Food and Drug Administration et al., No. 6:20-cv-00176, to postpone the effective date of the "Required Warnings for Cigarette Packages and Advertisements" final rule by an additional 90 days. The new effective date of the final rule is January 14, 2022. Pursuant to the court order, any obligation to comply with a deadline tied to the effective date is similarly postponed. FDA strongly encourages entities to submit cigarette plans as soon as possible, and in any event by March 16, 2021. FDA has revised the "Submission of Plans for Cigarette Packages and Cigarette Advertisements" guidance and "Required Warnings for Cigarette Packages and Advertisements" small entity compliance guide to include the rule's new effective date and updated the recommended date for submission of cigarette plans. FDA Issues Guidance on Tobacco Product Perception and Intention Studies On Oct. 27, 2020, FDA issued the draft guidance, "Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies." This draft guidance describes the agency's proposed recommendations on designing and conducting tobacco product perception and intention (TPPI) studies that may be submitted as part of a tobacco product application, such as a modified risk tobacco product (MRTP) application, premarket tobacco product application (PMTA), or substantial equivalence (SE) report. FDA Updates Deeming Guidance to Reflect Recent Court Decisions On October 16, 2020, FDA posted a revised guidance to reflect recent court decisions regarding FDA's enforcement of premarket requirements for premium cigars, as well as health warning and labeling requirements for cigars and pipe tobacco. Compliance and Enforcement FDA Warns Firms to Remove Unauthorized E-liquids from Market in Letters Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline Starting in January, FDA issued warning letters to firms who have not submitted premarket applications to FDA and are continuing to sell or distribute unauthorized electronic nicotine delivery system (ENDS) products after Sept. 9, 2020. As of now, FDA has issued warning letters to 30 firms who manufacture and sell e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S. Public Health and Education Youth Use of Tobacco Products Decreased in 2020, National Survey Finds In December 2020, FDA, in partnership with CDC, released new data from the 2020 National Youth Tobacco Survey (NYTS). The data show youth use of any tobacco product declining, with an estimated 1.73 million fewer youth currently using any tobacco product in 2020 (4.47 million) compared to 2019 (6.20 million). The results showed 23.6% of high school and 6.7% of middle school students reported currently using any tobacco product in 2020. In addition, current use of any combustible tobacco products, multiple tobacco products, e-cigarettes, cigars, and smokeless tobacco decreased among both high and middle school students between 2019 and 2020. Despite these encouraging declines, the survey did not show significant decreases in the use of cigarettes, hookah, pipe tobacco, or heated tobacco products. The latest data follow previously released findings from the 2020 NYTS focused on youth use of e-cigarettes. Virtual Learning: Youth E-Cigarette Prevention Magazine, Contest and Blog Virtual Exhibit Booth Experience and Free Tobacco Education Materials FDA recently launched a virtual exhibit booth, which provides visitors an opportunity to explore CTP resources on the Exchange Lab. This virtual platform provides a "site within a site" series of carefully curated and tailored landing pages (with a unique URL) designed for several of CTP's targeted stakeholder audiences - public health practitioners, health care providers, school nurses, educators, and tobacco retailers. The Exchange Lab provides free print materials, web content and social media posts to help keep communities informed about tobacco-related issues. It offers a wide variety of science-based content focused on public health education, tobacco research, retailer information, and tobacco regulations and compliance. FDA Issues Marketing Order for IQOS 3 System Holder and Charger On Dec. 7, 2020, FDA issued a marketing order to Philip Morris Products S.A. authorizing the sale of the IQOS 3 System Holder and Charger. Compared to the previous version authorized in April 2019, the newly authorized version has minor design differences, including how the holder inserts into the charger, changes to the charging connectors and LED indicator lights, a new touch feedback feature, and an option to reduce the perceived heat from the tobacco aerosol inhaled by users. FDA Releases Updated Version of the Safety Reporting Portal's Tobacco Questionnaires FDA has made several updates to the Safety Reporting Portal (SRP) questionnaires to better capture information about affected individuals, pre-existing health conditions, and product-specific details. Did You Know… … you can request a speaker from CTP's Speakers Bureau, a centralized place to request expert speakers on CTP's regulatory actions and public education initiatives? 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 |
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