Studies on the Evolution of PMTA and TPD

DOI: https://doi.org/10.62517/jel.202414108

Author(s)

Yidan Liang1, Jingjing Liu1, Jiali Zhu1, Ming Deng2,*, Shunlong Li2

Affiliation(s)

1China Tobacco Yunnan Import & Export CO., Ltd. Kunming 650031, Yunnan, China 2School of Economics, Yunnan University, Kunming 650091, Yunnan, China *Corresponding Author.

Abstract

The Premarket Tobacco Application (PMTA) and Tobacco Products Directive (TPD) are two regulatory frameworks for the contemporary U.S. and EU tobacco regulations respectively. In this study, the development and evolution of PMTA and TPD are studied, as well as regulatory rules and related practice cases. Based on the origin, evolution and access system of tobacco products as the main logical framework, from which we can see the trend of next generation products (NGPs) regulation. The PMTA’s attitude does not negate flavored tobacco products, but requires scientific research based on facts. TPD is working to continuously improve and revise the underlying rules and expand their application across the EU. In the U.S., very few tobacco companies have been able to meet the FDA’s strict PMTA requirements, although some companies that have not received market granted order (MGO) continue to sell products in the market, most tobacco companies, especially e-cigarette companies, have been forced to withdraw from the market. The EU is constantly tightening and refining the regulatory interpretation of TPD, so as to constrain tobacco companies with stronger regulations. Although PMTA and TPD are not consistent in terms of regulations, the evolution of the two regulations is consistent, and both are committed to gradually reducing the appeal of tobacco products to youth and non-smokers, highlighting the importance of tobacco harm reduction.

Keywords

PMTA; TPD; Tobacco Products; Regulation

References

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