Revised FDA Guidance Documents Related to Required Warning for Cigarette Packs and Ads

The Food and Drug Administration (FDA) recently issued revised guidance documents related to the “Required Warnings for Cigarette Packages and Advertisements” final rule. On December 2, 2020, the U.S. District Court for the Eastern District of Texas granted a motion 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. On February 25, FDA issued two revised guidance documents to include the rule’s new effective date and updated the recommended date for submission of cigarette plans, specifically “Submission of Plans for Cigarette Packages and Cigarette Advertisements” guidance and Required Warnings for Cigarette Packages and Advertisements” small entity compliance guide.

To read the full guidance documents, please click here.
Join the Save Our Lungs Team

Are you interested in advocating for tobacco control and other lung health issues at the federal level? Sign up to be a member of the American Lung Association's Save Our Lungs Team! As a member, you will join the ranks of others who have made a commitment to help protect and defend lung health by calling your representatives to weigh in on important real-time issues. The Save Our Lungs Team fights back and sends a strong message to Congress, letting key decision makers know how important it is to fight back against tobacco companies and stand up for lung health for everyone.

To learn more about the Save Our Lung Team, please click here
New Report Details Tobacco Industry’s Predatory Marketing of Menthol Cigarettes to Black Americans and the Devastating Health Impact

The Campaign for Tobacco-Free Kids announced the release of a new report detailing the tobacco industry’s decades-long targeting of Black communities, especially kids, with marketing for menthol cigarettes and the devastating impact on the health and lives of Black Americans. The report documents how menthol cigarettes are a major reason why tobacco use is the number one cause of preventable death among Black Americans and Black Americans die at disproportionately high rates from tobacco-related diseases such as cancer, heart disease and stroke. The release comes amid growing efforts at the federal, state and local levels to prohibit menthol cigarettes and other flavored tobacco products in order to stop the tobacco industry’s deadly targeting of Black communities, kids and other groups. FDA currently faces an April 29 deadline to decide whether to ban menthol cigarettes, following lawsuits by several public health and medical organizations.

To continue reading, please click here.
The Tobacco Control Act’s PMTA and MRTP Provisions Mean to Protect the USA from Any New Tobacco Products That Will Not Reduce Health Harms—But FDA Isn’t Cooperating

The Journal of Health Care Law & Policy recently published a review of FDA’s Premarket Tobacco Product Application (PMTA) and Modified Risk Tobacco Product (MRTP) provisions. After carefully reviewing the available documentation relating to FDA's evaluation of the PMTAs for the Swedish Match snus, Altria/PM's IQOS, and 22nd Century's low-nicotine cigarettes and the agency's evaluation of the MRTP application for IQOS and the related final orders granting the applications, the article concludes that FDA has failed to adequately protect the public health and violated both the Tobacco Control Act and the Administrative Procedures Act. According to the author, FDA did not evaluate the PMTA and MRTP applications diligently or comprehensively enough to make a determination that issuing the related orders to allow the products or claims would be appropriate for the protection of the public health; and FDA failed to include in its final PMTA and MRTP orders readily available restrictions and requirements relating to the products and their packaging, labeling, marketing, and sale and related to the delivery of the reduced-exposure claim that would have reduced unnecessary health harms and risks caused by allowing the products to be marketed or allowing the reduced-exposure claims to be made.

To read the full article, 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
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