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

JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
JAMA Study: U.S. Vape Directories Fail to Sustainably Curb Unlisted Sales as Product Shifts May Redistribute Brand Share 2Firsts Recommended
A study by CDC Foundation researchers found no sustained decline in e-cigarette sales across Alabama, Oklahoma and Louisiana, the first three U.S. states to implement e-cigarette directory laws. Louisiana initially saw a significant sales decline, followed by a rebound and a persistent reduction in product availability. Sales also shifted from nontobacco-flavored disposables toward prefilled cartridges, with Vuse Alto driving much of the increase in menthol cartridges. By April 2025, unlisted products still accounted for more than half of e-cigarette nicotine sales in all three states.
Sep.18
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
The U.S. Court of Appeals for the Ninth Circuit upheld the FDA’s denial of MH Global LLC’s applications to market flavored electronic nicotine delivery systems (ENDS). The court ruled that FDA’s comparative-efficacy framework, which requires applicants to show that flavored products provide greater cessation or switching benefits than tobacco-flavored alternatives, is consistent with the Tobacco Control Act’s “appropriate for the protection of the public health” standard. The court also found that FDA was not required to establish the framework through notice-and-comment rulemaking.
Aug.26
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
BAT CFO Dragos Constantinescu Takes Office, Returning After Seven Years and Former Asahi Europe Leadership Role
Dragos Constantinescu has officially taken up his role as Chief Financial Officer and Executive Director at British American Tobacco (BAT). He previously spent 16 years at BAT across finance and general management roles in Europe before joining Asahi in 2019 and becoming CEO of Asahi Europe & International in 2025. His return comes as BAT continues to advance its “A Better Tomorrow” transformation.
BAT
Sep.01
China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan files patent for cellulose-free nicotine pouch scaffold to replace microcrystalline cellulose
China Tobacco Yunnan Industrial Co., Ltd. has filed a patent application for a cellulose-free scaffold material for nicotine pouches, proposing a combination of bioceramic material, polydextrose and sugar alcohols to replace conventional microcrystalline cellulose and cellulose derivatives. The filing aims to address issues including powdery mouthfeel, residue and limited release control, while also reducing reliance on existing cellulose-based patent portfolios. In patent examples, one fast-release formulation reached a nicotine release rate of 50% at 10 minutes and more than 90% at 20 minutes.
Sep.02
South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Extends Vape Rules to Unmanned Stores After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's Ministry of Gender Equality and Family said on September 14 that it plans to designate unmanned e-cigarette stores as businesses where minors are prohibited from entering or working. Operators would be required to verify customers' ages and display notices restricting access by minors. The proposal is open for public comment through October 6. The move follows an April expansion of South Korea's statutory tobacco definition that brought products made with natural or synthetic nicotine under the Tobacco Business Act. Nicotine-free liquids and products using nicotine analogues such as 6-methylnicotine, however, remain an emerging regulatory issue.
Sep.21
Malaysia Police Seize RM12.7 Million in Illegal Vapes and Cigarettes as Probe Points to Sea Shipments From China
Malaysia Police Seize RM12.7 Million in Illegal Vapes and Cigarettes as Probe Points to Sea Shipments From China
Police in Malaysia’s Selangor state seized illegal vape products and contraband cigarettes worth about RM12.7 million (approximately $3 million) in two enforcement operations. According to New Straits Times and The Star, the vape-related operation uncovered 131,036 boxes of vape products, 4,900 bottles of e-liquid and 25,510 vape devices, valued at about RM9.4 million. Police said preliminary investigations indicated that some illegal vape products entered Malaysia through sea shipments from China before moving through storage and distribution networks.
Aug.10