FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products 

On January 19, the Food and Drug Administration (FDA) finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA. “The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn, M.D.

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FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers

On January 15, the Food and Drug Administration (FDA) issued its first set of warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically 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. The firms did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline. Per court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by the FDA on the application.

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Lawsuit Alleges Collaboration Between Philip Morris International and the Supposedly Independent Foundation for a Smoke-Free World

A lawsuit filed on January 13 by a former employee of the Foundation for a Smoke-Free World alleges that -- far from being the independent, health-focused organization it claims to be – the Foundation coordinates its activities with some of the world’s biggest tobacco companies including Philip Morris International (PMI) and Altria. Further, the lawsuit alleges that the Foundation goes so far as to promote the tobacco companies’ addictive products such as electronic cigarettes and reinforces the tobacco companies’ marketing themes. For these reasons the plaintiff alleges the Foundation violates the conditions of its tax-exempt status in the United States, and that she was wrongfully fired from the Foundation when she questioned these activities. If proven to be true, the allegations are consistent with what health authorities and tobacco control advocates around the world have claimed since the Foundation was first announced by global tobacco company Philip Morris International, its sole funder: The Foundation for a Smoke-free World is nothing more than a smokescreen to promote the company’s products and its misleading claims to be concerned with health.

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A Comprehensive Approach to Increase Adult Tobacco Cessation

The CDC’s Office on Smoking and Health published an editorial in The Journal of the American Medical Association (JAMA) on increasing adult tobacco cessation through a comprehensive, interdisciplinary, and equitable approach. According to the authors, helping people recover from tobacco use and dependence requires the partnership of the public health community and health care professionals from all specialties and across disciplines to deliver comprehensive support through interventions at individual, system, and population levels. Moving forward together, health care and public heath can comprehensively support tobacco cessation and achieve greater health for all. In the same issue of JAMA, the U.S. Preventive Services Task Force (USPSTF) presented its updated recommendations and supporting evidence review on the screening and treatment of tobacco use and reaffirmed the importance of clinician action in the prevention of tobacco-related disease.

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Upcoming Events
Save the Date: Day at the Capitol 2021
This year’s Day at the Capitol event will take place virtually to ensure advocates across Pennsylvania can safely come together and meet with legislators to provide education on important tobacco control issues throughout the commonwealth.

Please mark your calendars and share with community partners.

If you have questions, please contact Molly.Pisciottano@Lung.org.

Date: Tuesday, May 4, 2021
Location: Online
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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