Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline

On February 16, the Food and Drug Administration (FDA) published a detailed perspective on the progress made on the processing and review of the premarket applications for new tobacco products. Following the September 9 premarket application deadline for certain new electronic nicotine delivery systems (ENDS) and other “deemed” new tobacco products on the market as of August 8, 2016, FDA’s job is to process, review, and take action on a massive number of applications for products that are currently on the market. FDA confirmed it completed the Processing step of all Substantial Equivalence (SE) Reports and all Exemption from Substantial Equivalence Requests (EX REQ) submitted by the September deadline. The agency is continuing to process Premarket Tobacco Product Applications (PMTA) submitted by the September deadline and aims to share the final PMTA numbers as soon as possible.

To continue reading, please click here.
FDA Warns Additional Firms for Making and Selling Unauthorized E-Liquids

On February 12, the Food and Drug Administration (FDA) issued another round of warning letters to 11 firms who manufacture and sell unauthorized e-liquids. The letter advise the companies that selling products which lack premarket authorization is illegal, and therefore they cannot be sold or distributed in the U.S. None of the firms submitted a premarket tobacco product application (PMTA) by the September 9, 2020 deadline. While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 150,000 products with the FDA. In line with the agency’s stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application. FDA previously issued warning letters to 19 additional firms.

To read the full warning letters, please click here
Master Settlement Agreement Funding Update Webinars

In case you missed it, PACT and TRU recently shared recorded webinars to launch their 2021 funding campaigns and provide comprehensive advocacy resources and technical assistance to PA adult and youth advocates, respectively.

The PACT campaign webinar can viewed here. TRU advisors and others interested in youth advocacy are encouraged to watch the TRU webinar recording. The slides for both the PACT and TRU webinars are also available for advocates to reference and share.

Both webinars provide an overview of the:
  • Master Settlement Agreement & its impact in Pennsylvania
  • Importance of tobacco prevention & control funding
  • 2021 Tobacco Prevention & Control Funding Campaign
  • Resources to help you advocate on this issue
Erie School District to Join Others In Suing Juul, Claiming Vaping Company Targeted Minors

The Erie School District is joining scores of public school districts and other government entities nationwide in taking legal action over underage vaping. The Erie School Board has authorized the district to sue Juul Labs Inc., claiming the nation's largest electronic cigarette company wrongfully marketed its products — with their streamlined designs and fruity flavors — to youth, spurring a vaping epidemic among students, harming their health and adding to the district's costs. Superintendent Brian Polito said the Erie School District has had to spend money as it tries to stop vaping at its schools. He said teachers have also had to address students in health classes to "raise awareness of the dangers of vaping." The Erie School District's case, if filed in federal court in Erie, would be transferred to federal court for the Northern District of California, which includes San Francisco, where Juul is based. Federal courts nationwide have transferred hundreds of cases against Juul to that district, where the suits have been consolidated in multidistrict litigation.

To read the full article, please click here
Nominations Now Open for C. Everett Koop Unsung Hero Award

The American Lung Association is seeking nominations for the C. Everett Koop Unsung Heroes Award. Every year the Lung Association presents the C. Everett Koop Unsung Hero Award to an individual who works to change policy to prevent kids from using tobacco and help smokers quit. These individuals work tirelessly to make a tobacco-free future possible by working to end the tobacco epidemic. The Lung Association invites you to recognize your colleagues, friends and heroes who work in tobacco policy by nominating them for the Unsung Heroes’ Award. Nominations will be accepted through April 30, 2021.

To learn more about the award, please click here
Upcoming Events
Asthma Educator Institute Virtual Course
The next virtual Asthma Educator Institute course will be taking place in March. The virtual Asthma Educator Institute™ (AEI) is a three half-day preparatory course for individuals that want to implement asthma guidelines-based care and those qualified to take the National Asthma Educator Certification Board (NAECB) examination. The curriculum aligns with the National Asthma Educator Certification (NAECB) Candidate Handbook and includes case reviews, hands-on skills demonstrations and practice. The program will run approximately 12 p.m. - 5:30 p.m. CT each day. For questions related to the course, please email asthmaeducatorinstitute@lung.org

March 9, 10 & 12
12 p.m. CT
Register here
Virtual Day at the Capitol 2021
Join advocates from across Pennsylvania as we come together virtually to meet with legislators to advocate for crucial tobacco control issues throughout the Commonwealth. During this virtual event, youth & adult lung health advocates will unite to educate state legislators on the Master Settlement Agreement (MSA) funding and why it is so essential to tobacco cessation & prevention programs, as well as the importance of clean indoor air especially during the pandemic. Register today to receive the latest updates on the event, as well as an invitation to our annual Logistics Training webinar with additional information you will need for event day. The registration deadline is April 20.

Tuesday, May 4, 2021
9 a.m. - 2 p.m.**

Register here

Questions? Contact Molly.Pisciottano@Lung.org

**Subject to change. Legislative visits will take place in the morning, followed by a virtual Town Hall in the early afternoon. Virtual activities will be available throughout the day
Email Lauren.Chappel@Lung.org to feature news in your region!
Health Promotion Resources

Resource Hub for Effective Tobacco Cessation Coverage and Health Systems Change - Key resources, webcasts, and toolkits to help states and the tobacco control community improve tobacco cessation coverage and integration into health systems

E-Cigarettes: Talk to Youth About the Risks - CDC data, guidance and resources to help parents, teachers, and health care providers talk to youth about the dangers of e-cigarettes

Tobacco Resistance Unit (TRU) - Statewide movement to help youth, ages 12 to 18, stay tobacco-free

Ask, Advise, Refer to Quit Don’t Switch - One-hour tobacco brief intervention training for healthcare professionals
Quick Links
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