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The United States does not allow the sale of electronic cigarettes, how long can China continue to sell them?

The United States does not allow the sale of electronic cigarettes, how long can China continue to sell them?

2022-06-28

In the field of electronic cigarettes, China and the United States coincide and are strengthening supervision. On June 23, local time, the U.S. Food and Drug Administration (FDA) issued a "marketing denial order" to the e-cigarette company Juul Labs Inc. (hereinafter referred to as: Juul), saying that Juul's e-cigarette products did not pass the pre-marketing of tobacco products. Filing (PMTA), the company must stop selling and distributing all products in the U.S. or risk administrative penalties.


The FDA's decision shocked the global e-cigarette community.


Juul is 35% owned by Altria, the owner of the cigarette brand Marlboro. Third-party data shows that Juul leads the U.S. e-cigarette market with a market share of 35.7%, while 90% of the company’s revenue comes from the United States.


A person in charge of a domestic e-cigarette industry company said bluntly: This is a day worth remembering, which spurs us to reflect on our understanding of this industry. The FDA has shown its attitude to practitioners in this industry with practical actions that quality and safety need to be focused on.

Just a few days before Juul was banned, the State Tobacco Monopoly Administration of China publicly stated that the administrative departments of tobacco monopoly at all levels will continue to strengthen market supervision in accordance with the law. Sell electronic cigarettes, do not publish electronic cigarette advertisements, etc.


"Times Finance" quoted the domestic PMTA certification expert Zheng Zhi and pointed out that, except for Juul, most of the top 5 e-cigarette brands in the U.S. market are OEM by the Chinese company Smol. good.


Regarding the FDA's decision, Juul issued a statement saying that it respects but does not agree with the findings and decisions, and will explore options to appeal. Affected by this, Altria's U.S. stocks plunged 9% on June 22, and the concept of e-cigarettes in Hong Kong stocks and Smol International rose sharply recently.


Continued sales fail to protect public safety


Since September 9, 2020, the US FDA requires all e-cigarette products sold in the US to apply for PMTA, and products that have not passed PMTA certification are not allowed to be marketed in the US.


The so-called PMTA is the Premarket Tobacco Application for tobacco products. After a company submits an application, the FDA will evaluate the product formulation, manufacturing process, health risks, and safety to individuals and groups, especially for young people.


Juul submitted a scientific and health data review, or PMTA application, to the FDA more than two years ago, including a pod and two flavors of pods, each with two nicotine concentrations of 5.0% and 3.0%, respectively. . According to Juul, they submitted as many as 125,000 pages of application materials, including scientific research and market information.


However, after the FDA evaluation, the toxicological study data of Juul products were insufficient and the results were conflicting, including data on genotoxicity and harmful chemicals released from e-liquids. In addition, Juul prevented the FDA from doing a full toxicological risk assessment of its products.


The FDA therefore determined that the continued sale of Juul products would not protect public safety. Therefore, Juul products must stop selling and distributing in the United States, and existing products on the market must be removed from the shelves, otherwise they will face legal risks. Retailers should contact Juul to handle inventory. However, there are no penalties for personal possession and use of Juul products.


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