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 Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
PMI Launches Fourth IQOS Convenience-Store Discount of 2026 for Black Friday in Japan, Cutting ILUMA i ONE to About $19 After Ploom AURA Fell to About $9
Philip Morris Japan launched its fourth confirmed nationwide convenience-store discount campaign for IQOS ILUMA i devices in 2026 on October 26, cutting three models by as much as ¥2,000, or about $12.70. The campaign began one day after JT ended a promotion that reduced Ploom AURA to ¥1,480, or about $9.40. JT says Ploom's share of Japan's heated-products category rose from 10.9% in January 2024 to 18.3% in June 2026, a gain of 7.4 percentage points, while PMI says IQOS still held about 68% category share in the third quarter. At the same time, Japan's two-stage heated-tobacco tax adjustment has pushed stick prices higher, leaving device discounts as an increasingly important tool for lowering the upfront cost of customer acquisition.
Market
Oct.28
North Carolina Tightens Vape Product Directory Enforcement, Expands State and Local Powers as Violators Face Fines, Product Seizures and License Suspension or Revocation
North Carolina Tightens Vape Product Directory Enforcement, Expands State and Local Powers as Violators Face Fines, Product Seizures and License Suspension or Revocation
North Carolina has expanded enforcement of its vapor product directory rules, authorizing more state and local law enforcement participation and establishing a task force led by the State Bureau of Investigation. The legislation requires at least one unannounced compliance inspection annually for retailers, distributors and wholesalers handling covered products. Penalties effective October 1, 2026, include civil fines of $500–$750 for a first violation and $1,000–$1,500 for repeated violations within 12 months, along with potential license suspension or revocation. Manufacturers may face penalties of $10,000 per unlisted product. The measures strengthen the product directory system established in 2024.
Regulations
Oct.28
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain Cigarette Volumes Fall 5.2% in August, BAT Drops 14.5%, JTI Gains Share; France Down 8.3% on Adjusted Basis
Spain's cigarette volumes declined 5.2% year over year in August 2026, according to government data cited by UBS and reported by Investing.com on October 7. British American Tobacco's volumes fell 14.5%, followed by Imperial Brands at 8.8%, Philip Morris International at 6.6% and Japan Tobacco at 4.6%. JTI was the only one of the four companies to gain cigarette market share, rising six basis points to 26.7%. In France, official customs data showed an unadjusted 3.7% decline in cigarette deliveries. Adjusting for the difference in delivery days produces a decline of approximately 8.3%, consistent with the UBS figure. The bank also estimated the earnings exposure of major tobacco companies to both markets.
Market
Oct.13
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea Imports 12,126 Kg of Nicotine Analogues From April to August After Bringing Synthetic Nicotine Under Tobacco Law
South Korea's liquid-vape market is showing changes across raw-material imports, product types and sales channels after synthetic nicotine came under the Tobacco Business Act on April 24. Customs data show nicotine-analogue imports totaled 12,126 kilograms from April through August, while synthetic-nicotine imports over the same five months totaled 231,663 kilograms, just 39.3% of the amount imported in March alone. Physical liquid-vape stores tracked in Seoul and Gyeonggi Province fell 9.9%, unmanned outlets edged higher and online sales listings increased from 27,774 to 42,437. Government testing of 105 liquid inhalation products promoted as nicotine-free separately found nicotine in 13 and 6-methylnicotine in 12.
Sep.22
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
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
Cliff Douglas, a veteran U.S. tobacco-control and public health policy figure, told NAS 2026 that the “continuum of risk” should play a central role in tobacco policy. He called for clearer market pathways, stronger risk communication, differentiated regulation and enforcement, and said possible FDA reforms to PMTA reviews could be a “welcome correction” if they create a more efficient, predictable route for scientifically substantiated lower-risk products. Read 2Firsts’ on-site coverage.
Sep.26