PMTA, referred to as Premarket Tobacco Product Application, is an application that tobacco products must put in for before marketing in the US. On July 7th 2017, FDA made such requirement that all tobacco products in market now should apply for PMTA before the deadline of September 9th 2020.
As the strictest and the most sophisticated product list standard among global electronic cigarette industry, PMTA has extremely prudent and scientific examination, the whole process of which, assessed by related institutions, needs about 2 years to finish.
Till now, there is 9 days left to put in for PMTA. According to the information available, some Chinese e-cigarette companies have already submited applications, and some have set deadlines for filing applications.
By approximately 10-year exploits and accumulation in global markets, SIGELEI has gradually formed 6 world’s leading brands - SIGELEI、SNOWWOLF、 FUCHAI、VCIGO、KAOS and COMPAK, with its products prevailing in the US, German, Netherlands, Canada, Australia, Russia, and regions in the Middle East and Southeast Asia.
Many a e-cigarette product produced before has all become the bellwether of the industry. In Aug. 2017, company is listed on the New OTC(Over the Counter) Market, stock code: 871818.oc.
It is anecdotally reported that SIGELEI has already submitted its PMTA in Aug. 2020.
Youme Group Corporation's Subordinate Brand: Suorin
Suorin has officially handed in all over 50,000-page PMTA application materials to FDA in August 2020. Youme Group has invested a lot of manpower, material resources and financial resources to apply for PMTA in many aspects like product performance study and production quality process control. The team members cover experts and pundits from pathology, clinical research, law and other fields. The whole expenses is expected to exceed $14 million.
It is understood that Youme Group officially launched PMTA project in November 2019, and through the endeavor with PMTA team in the US, it completed all tests such as "harmful substance test", "toxicological analysis", "extraction test" and "clinical test" required by PMTA. According to the data and conclusions obtained by the laboratory, many products of Suorin brand have excellent performance indexes in the design and production, chemical test and biological test.
Smoore Corporation’s Subordinate Brand: VAPORESSO
On August 20th, the subordinate brand of Smoore Corporation VAPORESSO was said to have received a file that the first round of PMTA was being processed by FDA.
Since the promulgation of the accreditation rules in May 2016, vaporesso has been fully prepared to bring its innovative e-cigarette products into the FDA's PMTA regulatory framework. The company has engaged us professional service providers to work closely with their own in-house teams with different backgrounds and expertise, and is further supported by a strong R & D team from leading Smoore laboratories and basic research institutions.
Boulder Technology Co.
On July 8, Boulder officially announced that after more than three years of preparation, Boulder will submit a PMTA application to the US FDA at the latest in the fourth quarter of 2020. This time, the PMTA application of Boulder is mainly based on vape juice and supplemented by hardware.
Boulder has been preparing amounts of experiments and data for applying PMTA since Dec. 2016. Up to now, the whole expenses for application have exceeded $14 million.
VOOPOO Technology Co.
On Aug. 28th, VOOPOO officially submitted application to FDA for PMTA.
Since the first edition of PMTA rules was promulgated in 2017, VOOPOO has set up the team made by toxicology experts, clinical specialists, PMTA program specialists,etc. The whole process costs more than $10 million and lasts 20 months, finishing the required studies and tests, such as product ingredients analysis, manufacture study, etc.
RELX Technology Co.
On July 7, RELX officially announced its PMTA application process. According to the current progress, RELX will formally submit a PMTA application to the US Food and Drug Administration (FDA) as early as the end of 2021. The entire application process is expected to cost more than $20 million.
It is understood that in September 2019, RELX launched the US PMTA certification project. Up to now, RELX has set up a professional PMTA team in the United States, led by Dr. Donald Graff, head of North American Scientific Affairs, who joined the company at the beginning of this year. In addition, RELX is cooperating with four global authorities to commission them to conduct completely independent safety testing and clinical research on the products to be applied for in the United States.