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 Pushes Smoke-Free Business in Latin America as Argentina Lifts Heated Tobacco Ban, Mexico City Share Tops 7%
PMI Pushes Smoke-Free Business in Latin America as Argentina Lifts Heated Tobacco Ban, Mexico City Share Tops 7%
Philip Morris International (PMI) showcased IQOS heated tobacco systems and nicotine pouch products at Technovation 2026 in Buenos Aires on October 7–8, presenting research on consumer attitudes, regulatory developments and illicit cigarette trade across Latin America. PMI Chief Global Growth Officer Stefano Volpetti said smoke-free products accounted for more than 7% of the Mexico City market. Argentina repealed its heated tobacco ban in May 2026 and introduced registration requirements for tobacco and nicotine products, while local media reported nicotine pouch sales in Mendoza. A PMI-commissioned survey found that only 8% of respondents across four Latin American countries were familiar with nicotine pouches. A separate KPMG study estimated illicit cigarette consumption at 77 billion sticks across 11 markets in Latin America and Canada in 2025.
PMI
Oct.13
Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia Adds 6-Methylnicotine to Schedule 9 Prohibited Substances, Effective October 1
Australia's Therapeutic Goods Administration published a final decision on September 25 to classify 6-methylnicotine as a Schedule 9 prohibited substance under the Poisons Standard, effective October 1, 2026. TGA said the chemical has been reported in e-cigarette liquids sold in Australia and marketed as nicotine-free or nicotine alternatives, while evidence also indicates its use in preparations such as oral pouches. The government originally proposed a Schedule 7 classification but ultimately adopted the stricter Schedule 9 designation, citing acute toxicity, dependence risk, use in unapproved consumer products and misleading marketing.
News
Sep.29 by 2Firsts Perspectives
Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
Zhang Xiaotang Appointed Deputy Director of China’s Tobacco Regulator, Adding Another Finance-Background Official to Top Leadership
China’s State Council has appointed Zhang Xiaotang as deputy director of the State Tobacco Monopoly Administration, with the regulator’s official website now listing him as a Party leadership group member and deputy director. Zhang previously led Hebei China Tobacco and earlier headed the STMA’s finance and audit department. His appointment follows the elevation earlier this year of former tax official Yao Laiying to head the STMA, adding another senior official with a strong fiscal or financial-management background to China Tobacco’s top leadership in 2026.
News
Sep.20
Wall Street Journal: U.S. FDA Plans Faster Vape and Nicotine Pouch Reviews, Revisit of 2021 PMTA Rule
Wall Street Journal: U.S. FDA Plans Faster Vape and Nicotine Pouch Reviews, Revisit of 2021 PMTA Rule
The Trump administration is preparing changes intended to accelerate FDA market authorization reviews for e-cigarettes and nicotine pouches, according to The Wall Street Journal. The FDA is expected to revisit its 2021 PMTA rule and may simplify some scientific study requirements and shorten review times. The agency has not formally announced the changes. Over the past year, the FDA has already accelerated nicotine-pouch reviews, expanded ENDS authorizations and upgraded its CTP Portal NextGen application system. As of August 2026, 43 nicotine pouch products and 48 e-cigarette products had received FDA marketing authorization.
Sep.24
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As Regulators Focus on Nicotine Pouch Child Safety, Safeguard Pursues an External Packaging Route
As regulators pay closer attention to child safety in nicotine pouches, manufacturers face a practical challenge: how to strengthen child-resistant packaging without unnecessarily reworking products, production lines and regulatory submissions already in place. In a written interview with 2Firsts, Chemular detailed Safeguard’s external packaging approach, its customer-specific testing requirements and possible PMTA pathways. The model remains early-stage, but it offers a new way to think about an increasingly important regulatory and manufacturing issue.
Industry Insight
Sep.19
China’s Vape-Related Exports Rose 4.5% in Q3 2026 as 21.6% Growth in Shipments to the UK Offset a Decline in Shipments to the US
China’s Vape-Related Exports Rose 4.5% in Q3 2026 as 21.6% Growth in Shipments to the UK Offset a Decline in Shipments to the US
China's vape-related exports rose 4.5% year over year to $2.86 billion in the third quarter of 2026, led by stronger shipments to the United Kingdom as exports to the United States declined. UK-bound shipments increased 21.6%, adding $81.9 million, while US exports fell 5.2%, or $53.6 million. Growth weakened through the quarter, with September exports down 6.3% globally and 37.8% to the US. Nicotine-containing vape products accounted for more than 82% of the quarterly net increase, while device exports were nearly flat. Nine-month exports totaled $7.82 billion, up 4.0%.
DATA
Oct.26