HEADLINE

Previously, Liu served as the Director of the Department of Quality Development under SAMR.

In response to FDA's recent memo on PMTA applications for non-tobacco flavored e-cigarettes, 2Firsts spoke with Dr. Jessica Zdinak, Chief Research Officer and CEO at ARAC. She explained the challenges in the FDA review process and stressed that while age-gating technology can help, it is not a substitute for scientific evaluation. Dr. Zdinak also urged manufacturers to increase investment in scientific research to meet FDA requirements.

On November 21, FDA released 13 scientific policy memos regarding PMTA reviews. Insights from discussions between 2Firsts and compliance experts revealed that vape products incorporating "age-gating technology" will be prioritized for review. Additionally, FDA stated that non-tobacco flavored vapes must provide evidence of "incremental benefits" for adult smokers. Applications without randomized controlled trials or long-term study data may be classified as "fatal flaw".

Following FDA's Import Alert on a product manufactured by ZHUHAI QISITECH CO., LTD, 2Firsts initiated correspondence with FDA to seek clarification. FDA emphasized that a Submission Tracking Number (STN) does not constitute product authorization and reminded exporters that only 34 e-cigarette products are currently authorized for legal sale in the United States. 2Firsts has included the full list in this article.

Cem Ozguven, a former global leader at PMI, shares with 2Firsts the journey behind IQOS - from groundbreaking technological advances and market breakthroughs to PMI's ambitious shift towards a smoke-free future.