Dr. Jessica Zdinak, Senior Research Officer of ARAC, Delivered Keynote at 2Firsts Compliance Symposium

Jan.16.2025
Dr. Jessica Zdinak, Senior Research Officer of ARAC, Delivered Keynote at 2Firsts Compliance Symposium
2025 Global NGP Compliance Development Symposium in Shenzhen concludes successfully, emphasizing industry's adaptation to evolving regulations.

On January 9, 2025, the 2025 Global NGP Compliance Development Symposium, organized by 2Firsts, concluded successfully in Shenzhen. The seminar aimed to promote global compliance development and advocate for companies to actively embrace the new era of compliance. More than 10 renowned compliance industry experts and representatives from China and around the world delivered keynote speeches through a combination of online and offline formats, attracting nearly 200 participants from various sectors, including international tobacco companies, top Chinese e-cigarette companies, leading supply chain companies, and researchers. The conference was organized by the global leading NGP industry media —2Firsts.

 

Dr. Jessica Zdinak, Senior Research Officer of ARAC, Delivered Keynote at 2Firsts Compliance Symposium
Dr. Jessica Zdinak speaking at the event | Image source: 2

 

Dr. Jessica Zdinak, Chief Research Officer of Applied Research and Analysis Company LLC (ARAC), attended the seminar and delivered an online presentation on the topic "Challenges and Consideration Factors for Enterprises Applying for PMTA in 2025."

 

Dr. Jessica Zdinak, Senior Research Officer of ARAC, Delivered Keynote at 2Firsts Compliance Symposium
Dr. Jessica Zdinak Speech | Image Source: 2Firsts

 

In her speech, Dr. Jessica Zdinak delved into the development trajectory and future trends of the American tobacco products market, particularly emphasizing the FDA's core regulation of "protecting public health." She reviewed key turning points in the market from the dominance of combustible cigarettes to the enactment of the Tobacco Control Act, the implementation of the PMTA process, and pointed out that many manufacturers often encounter the dilemma of long delays and slow review progress after submitting PMTA scientific research and applications, resulting in application periods ranging from five to seven years.

 

Dr. Jessica Zdinak also analyzed the shortcomings of the Center for Tobacco Products (CTP), a newly established federal agency, in terms of infrastructure development and experience accumulation from 2022 to 2024, as well as the chaotic review situation that arose after receiving a large number of applications. Looking ahead to 2025, under the leadership of a Republican-dominated administration, she expects the FDA to significantly improve the efficiency of reviewing PMTA applications and increase efforts to crack down on overseas products entering the market without authorization.

 

At the 2025 Global New Year Symposium on the Development of New Tobacco Regulations, Dr. Jessica Zdinak's professional speech received widespread praise and enthusiastic response from attendees. After the speech, many participants expressed that the information helped them gain a deeper understanding of the regulatory dynamics of the American tobacco product market, the complex process of PMTA applications, and future development trends, providing guidance for strategic planning and compliance layout for businesses. At the same time, attendees also expressed sincere gratitude to the organizers of the event. They believed that the organizers had created a high-quality compliance communication platform, greatly promoting communication and interaction among various parties in the industry, and effectively driving the industry's stable development on the compliance path.

 

As a leading media and think tank in the field of Next Generation Products (NGP) globally, 2Firsts actively maintains close communication with various testing and regulatory agencies, building a strong bridge for industry resource sharing and information exchange. In the future, 2Firsts will continue to integrate resources and consolidate wisdom, working hand in hand with industry partners to promote the high-quality development of the global NGP industry, and contribute lasting strength to the industry's innovation breakthroughs and compliant advancement.

 


 

Regarding ARAC 

 

Applied Research and Analysis Company (ARAC) is a leading U.S. based behavioral science research firm that designs, executes, and presents scientifically-sound, yet customizable studies to support manufacturers, regulatory agencies, and industry consultants. Their expertise includes consumer-focused research services in product development and innovation and regulatory science supporting marketing authorization applications, with SUCCESS in U.S. product authorizations and applications.

 

ARAC specializes in MODULE 5 & 6 studies including: label/claim development and comprehension, human factors/usability testing, and clinical/behavioral studies, such as randomized experimental longitudinal, actual use, TPPI, and post-market surveillance systems.

 

“Most Outstanding Service to Industry” 2024 Golden Leaf award-winning fully staffed IN-HOUSE psychologists, behavioral scientists, statisticians, survey methodologist, and medical monitoring offering tailored research solutions with unparalleled integrity and an exceptional client experience.

 

For more infornation, click HERE to watch the presentation replay.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
PMI Global R&D Chief Meets Chinese Tobacco Regulator as China Advances Heated Cigarette Standards
Philip Morris International’s global R&D chief Michele Cattoni met Liu Sanjiang, deputy director of China’s State Tobacco Monopoly Administration, in Beijing on Aug. 27. The meeting comes as China advances mandatory standards for heated cigarettes and nicotine pouches, laying groundwork for their domestic introduction. Cattoni has held senior roles in PMI’s heated tobacco development, while China’s draft standard covers multiple heating architectures, including systems similar in principle to PMI’s IQOS ILUMA technology.
Aug.27
Imperial Brands Sees Double-Digit NGP Growth as Sixth Year of Tobacco Revenue Gains Backs £1.5 Billion Buyback
Imperial Brands Sees Double-Digit NGP Growth as Sixth Year of Tobacco Revenue Gains Backs £1.5 Billion Buyback
Imperial Brands reaffirmed its FY26 guidance in its October 8 pre-close trading update, forecasting double-digit net revenue growth in next-generation products and share gains across heated tobacco, vape and modern oral. Tobacco net revenue is expected to grow at a low-single-digit rate, marking a sixth consecutive year of growth. The company has completed its £1.45 billion FY26 share repurchase and announced a £1.5 billion buyback for FY27. Group adjusted operating profit is expected to increase 3% to 5%, while free cash flow is forecast to exceed £2.2 billion.
Oct.09
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
South Korea Fully Reviews Nicotine-Analog and Nicotine-Free Vape Liquid Imports, With Over 99% From China and Chinese Supply-Chain Documents Under Scrutiny
Korea Customs Service has tightened import controls on nicotine-analog and nicotine-free e-cigarette liquids, placing the products under 100% document review and subjecting all e-cigarette liquid import declarations to pre-clearance ingredient analysis. As of September 20, 2026, South Korea had imported about 15 metric tons of nicotine-analog liquids, 99.99% from China, and about 316 metric tons of nicotine-free liquids, including roughly 315 metric tons, or 99.7%, from China. The measures follow South Korea's April expansion of its tobacco definition to include synthetic nicotine products and include new checks on Chinese manufacturing, transaction and export documentation.
Sep.24
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
German prosecutors and customs authorities are conducting a criminal investigation into an alleged cross-border organised vape network. Authorities say that between January 2024 and March 2025, four employees of an unnamed Chinese e-cigarette manufacturer allegedly built a network of sales agents and wholesalers that brought more than 7.6 million nicotine disposable vapes into Germany, causing an estimated €33.3 million in excise-tax losses. The manufacturer has not been named. Some products visible in enforcement images have packaging resembling products from FUMOT’s portfolio. European regulatory records from 2024, FUMOT’s public overseas-sales materials and records involving German vape importer and distribution company Zamu-Pro GmbH also show FUMOT/RandM products and German distribution activity during the period covered by the investigation.
Sep.21
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
Trump Names Darrell Scott as CDC Tobacco Health Adviser, Citing Tobacco Risks and Harm-Reduction Solutions
U.S. President Donald Trump has named Pastor Darrell Scott to serve as an adviser on tobacco health issues on the Centers for Disease Control and Prevention’s Advisory Committee to the Director. Trump said Scott would focus on the burden of tobacco-related disease and help examine ways to protect Americans from dangerous tobacco products while supporting solutions that reduce harm. Scott’s public career has largely centered on faith leadership, community advocacy and politics.
Sep.02
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
FDA Revises Import Alert 98-07 Rules, Bringing May Enforcement Priorities Into Unauthorized ENDS Detentions
The U.S. Food and Drug Administration has revised the rules under Import Alert 98-07 to incorporate its May 2026 enforcement-priority policy for certain electronic nicotine delivery systems marketed without premarket authorization. The alert continues to allow detention without physical examination, or DWPE, for ENDS lacking required marketing authorization, while directing field divisions to apply the May risk-based framework. When necessary, detention or refusal decisions must also undergo review by the FDA's Center for Tobacco Products. Products including PACHA and Vuse Pro have already emerged as industry examples of the May policy, although enforcement discretion does not constitute FDA marketing authorization.
News
Sep.28 by 2Firsts Perspectives