FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers On April 29, FDA announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products – the leading cause of preventable death in the U.S. FDA is working toward issuing proposed product standards within the next year: one to ban menthol as a characterizing flavor in cigarettes and another to ban all characterizing flavors (including menthol) in cigars. The authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency. The decision to advance these product standards is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009. Regulation and Guidance New Cigarette Health Warnings Effective Date On March 2, 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 April 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 required by 21 CFR 1141.10(g)) as soon as possible, and in any event by June 14, 2021. FDA intends to revise its relevant guidance documents related to the rule with the new effective date. Compliance and Enforcement FDA Warns Additional Firms for Making and Selling Unauthorized E-Liquids From Feb. 26 through the end of March, FDA issued warning letters to 49 firms respectively who manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal, and therefore they cannot be sold or distributed in the U.S. The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline. FDA Requires Information on Social Media Practices of E-Cigarette Brands On March 17, FDA issued letters to four companies requesting information about their use of social media marketing and influencer marketing related to their electronic nicotine delivery system (ENDS) brands: Aspire, Joyetech, Vaporesso, and Voopoo. FDA has authority under Section 904(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to solicit this information. Resources & Training: Retail Sales of Tobacco Products Tobacco retailers play a direct role in protecting kids from nicotine addiction and the deadly effects of tobacco use. FDA offers free resources and training to help tobacco retailers comply with the rules designed to prevent our nation's youth from becoming the next generation of Americans to die prematurely from tobacco-related disease. Click below to explore FDA's offerings, including retail compliance webinars, "This is Our Watch" materials, age calculator app, guidance, and more. Public Health and Education How to Discuss E-Cigarettes & Nicotine Addiction with Youth FDA and Scholastic continue working together to develop youth e-cigarette prevention resources. According to the 2020 National Youth Tobacco Survey, more than 3.6 million teens used e-cigarettes in the last 30 days, and nearly a quarter of high-school aged users report daily use. In this new blog post from Kathy Crosby, Director of Communications at FDA's Center for Tobacco Products, get tips on how to start a conversation with your child about e-cigarettes, learn to recognize the warning signs of nicotine addiction, and find resources pediatricians recommend to help youth quit vaping. New FDA & AAP Video Series: Pediatricians Discuss Youth E-Cigarette Use Parents and educators play an active role in fighting tobacco use among youth. National Youth Tobacco Survey data shows that youth e-cigarette use remains a public health concern and teens do not fully understand the health consequences. FDA and the American Academy of Pediatrics (AAP) recently collaborated to develop a video series featuring pediatricians answering common questions about youth e-cigarette use. FDA also created a new webpage that includes tobacco education resources for parents and educators. Parents and teachers can use these resources to learn more and to start an honest conversation with youth about the dangers of tobacco use. Looking for Teen Smoking Cessation Tools? The National Cancer Institute's SmokeFree.gov website provides quit tools tailored to several demographics, including teens. If you need to reach teens with smoking cessation messages to help them quit, SmokeFree.gov has information on becoming smokefree, the risks of tobacco, tobacco triggers, and quitting vaping. In addition to articles, the website provides tools to put teens on the path to becoming smokefree. Did You Know… …SmokefreeTXT is a text messaging program that gives 24/7 encouragement, advice, and tips for becoming smoke-free? Learn more and sign up here. This 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. |
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