China’s vaping giant Relx gears up for US entry – ProWellTech

China’s vaping giant Relx gears up for US entry – ProWellTech

The backlash against vaping in the US hasn’t deterred a Chinese challenger from entering the world’s largest vaping market.

Relx, one of China’s largest e-cigarette companies, is looking to submit its pre-sale application for tobacco products to the US Food and Drug Administration by the end of 2021. Following a review process that does not will take more than 180 days, the FDA will take “action”, which could be a marketing authorization, a request for further information or a refusal.

The vape startup has requested a pre-presentation meeting with the FDA and is expected to meet with the regulator in October, said Donald Graff, the two-year startup’s head of science affairs for North America, appearing in a video at a press event. this week in Shenzhen.

Graff had a short stint at Juuls Labs as his chief scientist after a 13-year streak at the Celerion clinical research company, where he oversaw tobacco studies. He is now driving Relx’s PMTA application.

PMTA is a large, meticulous and expensive bureaucratic process for vaping products to determine that they are “appropriate for public health protection” before being marketed in the United States Relx, based in the global hub of e-cigarette manufacturing Shenzhen, has established a team to work on the application process, including hiring third-party consulting services and clinical partners to generate data from the tests needed for submission.

All e-cigarette companies currently on the US market had to submit their PMTA application by September 10 this year. To date, no product has received marketing authorization from the FDA.

The high costs of PMTA prevent many small players from entering the US market, but Relx has the financial knack to bear the costs: it estimates the whole process will cost more than $ 20 million. A Nielson survey commissioned by Relx showed that the company held a nearly 70% share of the Chinese pod vaping market.

As the risks associated with e-cigarettes continue to attract the attention of regulators around the world, Relx has increased its investment in research to examine the impact of vaping on public health. At this week’s event, its CEO Kate Wang, a rare founder of a major tech company in China, and formerly CEO of Uber China, repeatedly stressed “science” as the startup’s key focus.

The Shenzhen-based company’s bioscience lab was recently unveiled, which is measuring the effects of Relx vapors through in vivo and in vitro tests, as well as conducting preclinical safety assessments.

Despite its ongoing efforts to demonstrate the benefits of switching from smoking to vaping, Relx, along with its competitors, faces regulatory uncertainties in various markets. The Trump administration banned flavored vaping products last year (Relx plans to introduce unflavoured products for PMTA review) and India banned e-cigarettes citing negative health impacts on youth.

Asked how the startup intends to address policy change, a Relx executive told the event that “the company maintains a good relationship with regulators in various countries.”

“No conclusions can be drawn about something that is still ongoing,” the executive said, referring to the early stage of the vape industry.

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