The backlash against vaping in the US hasn’t stopped a Chinese challenger from entering the world’s largest vaping market.
Relx, one of the largest Chinese e-cigarette companies, plans to submit its Premarket Tobacco Product Application to the US Food and Drug Administration by the end of 2021. Upon completion of a review process, which will take no longer than 180 days, the FDA request will take “action” which could include a marketing authorization, a request for more information, or a denial.
The vaping startup has requested a pre-submission meeting with the FDA and is expected to meet with regulators in October, said Donald Graff, head of scientific affairs for the two-year startup for North America, in a video during a press event this week in Shenzhen.
PMTA is an extensive, painstaking, and costly bureaucratic process of vaporizing products to determine if they are “good for public health” before they are marketed in the US. Headquartered in the Shenzhen e-cigarette manufacturing center worldwide, Relx has a team to work on the application process, including hiring third-party advisory services and clinical partners to generate data from tests required for submission.
All e-cigarette companies currently in the US market had to file their PMTA by September 10th this year. To date, no products have received FDA approval for placing on the market.
The high cost of PMTA prevents many small businesses from entering the U.S., but Relx has the financial resources to bear the cost – it is estimated that the entire process will cost more than $ 20 million. A Nielson survey commissioned by Relx found that the company had a nearly 70% share of the Chinese pod vape market in April.
As the risks associated with e-cigarettes continue to attract the attention of regulators around the world, Relx has stepped up its research investments to study the public health effects of vaping. At this week’s event, CEO Kate Wang, a rare founder of a large tech company in China and previously CEO of Uber China, repeatedly highlighted “science” as the focus of her startup.
Recently, the company’s Shenzhen-based life science laboratory was unveiled, which measures the effects of Relx vapors through in vivo testing, in vitro testing, and performs 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 vape products last year (Relx plans to submit unflavoured products for FDA review), and India banned e-cigarettes, citing harmful effects on teenagers.
When asked how the startup intends to deal with changing guidelines, a Relx manager said at the event: “The company has good relationships with regulators from different countries.”
“You cannot draw conclusions about something that is still in the process,” the executive said, referring to the early stages of the vaping industry.