Recently, relx, a domestic e-cigarette head brand, has for the first time publicly established a new laboratory, which has attracted extensive attention and heated discussion in China, and the United States is also constantly watching the action of Yueke. After all, Yueke also disclosed that it plans to submit PMTA to FDA before the end of 2021, which means that China's top 1 brand is on the verge of entering the United States, the world's largest e-cigarette market.
After the news that Juul, an American e-cigarette giant, planned to enter the Chinese market, there was an uproar in China. Similarly, when the Chinese e-cigarette giant was ready to enter the U.S. market, it was believed that it would also arouse the close attention of American e-cigarette brands and the media's contention for coverage. A few days ago, techcrunch of the United States made a report on Yueke. The following is the full text:
America's strong opposition to e-cigarettes has not prevented Chinese challengers from entering the world's largest e-cigarette market.
Relx, one of China's largest e-cigarette companies, is seeking to submit its pre market tobacco product application to the US Food and drug administration by the end of 2021. After completing a review process of no more than 180 days, FDA will take "action", which may be marketing authorization, asking for more information or refusing.
Donald Graff, head of North American science at the two-year-old start-up, said the new start-up has requested a pre submission meeting with the FDA and is expected to meet with regulators in October.
After 13 years at celerion, a clinical research firm, Graff was chief scientist at juuls labs, where he oversaw tobacco research for a short time. He is now the PMTA head of relx.
Another scientist from juuls, Xing Chenyue, helped invent nicotine salt, which is crucial to e-cigarettes. He also joined the e-cigarette industry in China and founded his own start-up company, Myst.
PMTA is an extensive, detailed, and costly bureaucratic process for determining that products are "fit to protect public health" before being sold in the United States. Relx, based in Shenzhen, the world e-cigarette manufacturing center, has set up a team responsible for the application process, including the engagement of third-party consulting services and clinical partners to generate data from the tests required to submit the report.
All e-cigarette companies currently in the U.S. market are required to submit their PMTA by September 10 this year. So far, no product has been approved by FDA.
The high cost of PMTA prevents many small businesses from entering the United States, but relx has the ability to bear the cost, which is estimated to cost more than $20 million. According to a Nielsen survey, the company had nearly 70% of China's e-cigarette market as of April.
As the risks associated with e-cigarettes continue to draw the attention of regulators around the world, relx has increased research investment to study the impact of e-cigarettes on public health. Wang Ying, the rare female founder of a large Chinese technology company, has previously worked for Uber She has repeatedly stressed that "science" is the focus of her start-up.
The company's bioscience laboratory in Shenzhen recently unveiled, which is measuring the impact of relx e-cigarettes through in vivo and in vitro tests as well as pre clinical safety assessments.
Although relx has been trying to demonstrate the benefits of the transition from smoking to e-cigarettes, compared with its competitors, relx faces regulatory uncertainty in various markets. The Trump Administration banned the flavoring of electronic cigarettes last year (Relx plans to submit products that did not add seasoning to FDA), while India banned electronic cigarettes, which had a negative impact on the health of teenagers.
Asked how the start-up plans to respond to changing policies, a senior relx executive said at the event: "the company has a good relationship with regulators from different countries."
"You can't draw conclusions about what's still going on," the executive said of the early stages of the e-cigarette industry