Mitch Zeller's Reflections on His Experiences as CTP Director

Mitch Zeller’s FDA career first began in the 90’s. Then, three decades into his public health career, Zeller joined the Center for Tobacco Products as Center Director in March 2013. During an impressive nine-year tenure, he led FDA’s efforts to reduce disease and death from tobacco use and brought previously unavailable information about its dangers to light.

In preparation for his retirement from public service in April 2022, Zeller reflected on the time he spent helping to make tobacco-related disease and death part of America’s past, not America’s future, and, by doing so, ensuring a healthier life for every American family.

What’s it been like working for the Center for Tobacco Products (CTP) these past nine years?

I can only describe these past just over nine years as the Director of the CTP as a labor of love. It’s been hard but it’s also been incredibly rewarding professionally. I’ve had the opportunity to work with the best, hardest working people in the world and we’ve gotten a lot done, so my time here has been a joy. I’m going to miss the people, as well as the issues.

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SE and PMTA Submission Forms

FDA published two forms for the submission of Substantial Equivalence (SE) Reports and three forms for the submission of Premarket Tobacco Product Applications (PMTAs). The respective forms can be found on the SE and PMTA webpages. These forms are effective immediately to help ensure applications contain sufficient information for FDA’s evaluation of new tobacco product applications. The PMTA forms include the Product Grouping Spreadsheet, which will assist both FDA and industry in identifying the products of submissions where an applicant groups multiple PMTAs into a single submission.

Requirements for Products Made with Non-Tobacco Nicotine Took Effect April 14

New federal legislation making clear that FDA can regulate tobacco products containing nicotine from any source has taken effect. As of April 14, 2022, manufacturers, distributors, importers and retailers of products containing non-tobacco nicotine (NTN)—that is, nicotine not made or derived from tobacco, such as synthetic nicotine—must ensure compliance with applicable requirements under the (FD&C Act).

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Request to Co-Brand FDA’s New, FREE Smoking Cessation Education Posters

FDA released new smoking cessation education posters in English and Spanish as part of the agency’s ongoing efforts to reduce the enormous public health burden of tobacco use. The posters use a positive, motivational tone to support adult smokers on their journey to quit cigarettes, while underscoring the health benefits of quitting. Posters are available in English and Spanish for diverse audiences, including LGBTQ+ smokers. Check out the posters and learn how you can request to co-brand them with your organization’s logo.

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In Case You Missed It: Recent CTP News

• New Law Clarifies FDA Authority to Regulate Synthetic Nicotine
• FDA on Track to Take Actions to Address Tobacco-Related Health Disparities
• Watch Webinar Recording on FDA’s Two Planned Product Standards
• FDA Issues Decisions on Additional E-Cigarette Products
• FDA Issues Marketing Denial Orders to Fontem US for myblu Products
• 2021 NYTS Findings on Youth Use of All Tobacco Products
• National Academies Releases Report on Premium Cigars Health Effects
• FDA Authorizes Reduced Exposure Claim for IQOS 3 System Holder and Charger
• FDA Posts Amendments on Copenhagen Snuff MRTP Application, Re-opens Public Comment Period
• Civil Money Penalty Amounts for Tobacco Retailers Adjusted for Inflation
• Postponed: Cigarette Health Warnings Final Rule Effective Date Now Apr. 9, 2023
• Latest Spotlight on Science Newsletter
• FDA’s Exchange Lab Is Now the Tobacco Education Resource Library

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