By TobaccoChina Online
According to the regulations on e-cigarettes by the US Food and Drug Administration (FDA), e-cigarette enterprises that have not submitted the application for Premarket Tobacco Product Application (PMTA) by September 9, 2020, will be subject to FDA’s compliance and law enforcement actions, that is, immediately having their e-cigarette products pulled from the US market, including devices, e-liquids, pods, etc. E-cigarette brands that have submitted a PMTA within the time limit will continue to be sold for at least one year until FDA’s “Rejected” notice might be received. If the application is approved, they can continue to stay on the market.
This means that the United States, as the largest consumer of e-cigarettes, will come into the most stringent regulatory period. Its market share is over 40% in the world, and some data show that its sales account for 57% of the global e-cigarette consumption. This shows how truly important FDA’s PMTA is.
PMTA includes nine review items, such as application qualification, basic information, descriptive information, product samples, product labels, scientific research results, product attributes and production process, in vivo toxicology research, and HPHCS (harmful ingredients and potentially harmful ingredients).
As the most stringent product listing standard in the global e-cigarette industry, the PMTA application process is very complex with extremely rigorous and scientific reviews, which take about two years. It is reported that some Chinese e-cigarette enterprises have already submitted applications, and some have set the date for submitting applications.
Youme Group: Suorin
In August 2020, Youme Group officially submitted more than 50,000 pages of PMTA application materials to FDA for the Suorin brand. The group has invested a lot of manpower and material resources in product performance research, production quality process control, and other aspects. The team members include relevant pathology experts, clinical research experts, professional researchers, a legal advisory team, etc. The total investment is expected to exceed RMB100 million.
It is reported that Youme Group officially launched the PMTA project in November 2019. Through the unremitting efforts of special teams both in China and the US, it took eight months to complete the detection tests required by a PMTA, such as the hazardous substance test, a toxicological analysis, an extraction test, and a clinical trial. According to the data and conclusions drawn from the laboratory, the performance indexes of several styles of products under Suorin brand are excellent in design and production, as well as chemical and biological tests.
Smoore: Vaporesso
The private brand Vaporesso of Smoore International Holding Co., Ltd. (hereinafter referred to as Smoore) brings its innovative e-cigarette products into the PMTA regulatory framework. The company has engaged American 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.
As early as in 2016, Smoore has been actively preparing for PMTA. The company has set up a professional team, employing nearly 100 high-tech researchers with doctorate and master’s degrees. Meanwhile, it has cooperated with top overseas consulting companies and laboratories, including former employees of FDA, to assist the preparation of PMTA.
According to the latest news, Vaporesso is the first open tank e-cigarette brand in China’s e-cigarette industry that has passed the second round of PMTA. At the same time, it also means that Vaporesso entered the final stage of the PMTA process.
Smoktech
Smok submitted a PMTA in July 2020 for several products, which in August, had successfully passed the first round of PMTA audit. Smok said that FDA provided a scientific basis for e-cigarettes in the United States and indicated whether it was “appropriate to protect public health” by submitting a PMTA to assess the risks and benefits of these products to the entire population.
Boulder
The e-cigarette brand Boulder officially announced that after more than three years of preparation, it had submitted a PMTA to FDA on September 8 for six e-liquids and three devices. It is the first Chinese e-cigarette company that has submitted a PMTA for e-liquids in the US. It is said that as early as in December 2016, Boulder began to prepare a large number of experiments and data required for a PMTA. Up to now, it has spent more than RMB100 million, most of which were on e-liquids that had more difficulty.
According to the above requirements, the company carried out toxicity, addiction, and attractiveness research on e-liquids, made physical and chemical analysis on aerosols, conducted crowd experiment on consumers, and wrote hundreds of thousands of pages of materials. According to the official information, released by Boulder, the application fee for each device is RMB2 million, while that for each e-liquid is RMB20 million yuan, which is 10 times of the former.
Ji’er Technology: Voopoo
On August 28, Voopoo, a self-owned brand of Ji’er Technology, formally submitted a PMTA to FDA. On September 4, Voopoo disclosed that it had successfully passed PMTA’s first review round.
Since FDA announced the first version of the relevant provisions of PMTA in 2017, Voopoo has set up a special team to conduct in-depth project research and analysis. The team members include toxicology experts, clinical medicine experts, PMTA project experts, product analysts, r&d experts, legal consultants, marketing personnel, etc. The whole process of the project costs RMB100 million. It took 20 months from preparation to application, completing the PMTA testing requirements, such as product composition analysis, manufacturing research, as well as non-clinical and clinical human body research.
Heyuan Group
On September 4, Heyuan Group announced that on August 25, 2020, it successfully passed FDA review and completed the first round of PMTA audit. On September 8, 2020, Heyuan Group completed the second round of audit, meaning that the PMTA entered the last round of review.
Heyuan said, “in the whole application process, we need to invest huge capital, manpower and material resources. The move is not only based on the consideration of entering the US market, but also lets consumers around the world experience more reassuring products.” They also said that before entering the substantive review stage, more than one year’s efforts have been made to complete more than 100,000 pages of application materials and evidence to support their claims, and multi-dimensional test data and reports to prove that the company’s products are beneficial to public health.
Meanwhile, it is expected to continue to cooperate with FDA in the coming weeks or months, hoping that the PMTA process will bring more market orders.
Enterprises prepared to submit PMTAs
In July 2020, RELX Technology announced that it had established 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 working with four global authorities to commission completely independent safety tests and a clinical study on the products to be applied for in the United States. On July 7, RELX officially announced its PMTA application process. According to the current progress, RELX will formally submit its PMTA to FDA as early as the end of 2021. The whole application process is expected to cost about RMB150 million.
Why enterprises rush to submit PMTAs
On November 1, 2019, China issued its most severe e-cigarette warning, calling on the vape industry to stop selling and promoting e-cigarette products online. After the announcement, almost all enterprises refocused on offline channels and overseas market expansion.
The United States is the largest e-cigarette market in the world. However, the strict PMTA standards closed the doors for many small- and medium-sized enterprises. Since last year, Juul has been sued many times and its market value has also been greatly reduced. The market outlook seems unstable.
China’s vape industry has always been proud of its excellent supply chain, which guaranteed the product quality for domestic enterprises. In addition, the enterprises that have promoted the application of PMTA by the government have invested hundreds of millions of funds. It can be said that it is now a perfect opportunity to break into the US market.
The domestic market is also developing in a stable direction. Under the dual effects of last year’s ban on online e-cigarette sales and advertising and this year’s pandemic, the e-cigarette market has experienced a reshuffle. At present, the new tobacco policy in China has not yet been put in place. In addition to the demand of entering the overseas market, in order to stabilize the leading position of the industry and cope with the more stringent domestic policies, enterprises also need to endorse their own quality through the authoritative identification of PMTA.
However, the attitude of the United States to Chinese enterprises is not optimistic, and not a single e-cigarette product has passed the PMTA process yet, so the fate of Chinese enterprises in the US market remains undecided.