SHENZHEN, China–(BUSINESS WIRE)–SMOORE, the world’s largest vaping manufacturer, today announced the opening of China’s first large-scale non-clinical testing laboratory for pre-market tobacco product applications (PMTA).
A PMTA is an application that must be reviewed and approved by the Food and Drug Administration (FDA) before a new nicotine product can be legally marketed in the United States. It must also provide scientific data demonstrating that a product is appropriate for the protection of public health.
The laboratory, opened and operated by SMOORE’s Safety Analysis, Testing and Evaluation Center, provides all the non-clinical evidence needed to bring a new nicotine product to market, including materials safety, HPHC (Hazardous Ingredients and Potentially Hazardous Ingredients) and toxicology testing.
This is the first PMTA test lab to open in China, and will allow SMOORE and its flagship brand FEELM, the world’s leading provider of closed vaping system solutions, to further improve the safety of their products and helping the brands they work with successfully pass PMT Certification.
Before SMOORE opened its new lab, any vaping company that wanted to enter the United States had to rely on third-party partners to perform their PMTA testing, which can be a time-consuming and expensive process. With the new factory in China, FEELM’s partner brands can more easily complete their PMTA certification and improve their accessibility to the American market.
Dr Long, Director of SMOORE’s new Safety Assessment Center, said:
“The FDA is very concerned about HPHCs and has established a list of 33 substances that must be tested.
“Our new lab can do all of this and more, and has the capacity to test 37 substances; we are the only facility in China whose testing capabilities cover the full range of HPHC substances.
The lab tests against a new global HPHC database, developed by SMOORE and derived from international toxicity databases, including the US Environmental Protection Agency (EPA).
Advanced computational toxicology software is also used to predict unknown and potentially harmful ingredients not included in these databases, further increasing SMOORE’s safety ratings.
Since establishing its first research institute in 2017, SMOORE has continued to lead the industry in evidence-based research. Its Safety Assessment Center has raised safety standards to medical level and strives to continuously review product safety.
A total of eight products have been approved for marketing by the FDA, many of which are manufactured by SMOORE, demonstrating that the FDA approves the processes and testing mechanisms deployed in SMOORE’s new laboratory in China.
SMOORE is now working with its brand partners and FEELM customers to expand its testing and provide better product design support and release relevant safety reports.
SMOORE is determined to become the driving force behind supporting brands in their engagement with the FDA and other regulatory agencies, enabling them to access more overseas markets.
NOTES FOR EDITORS
For more information on the PMTA process: fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications
As a flagship technology brand owned by SMOORE, FEELM is the world’s leading provider of closed vaping system solutions. Based on the world’s leading ceramic coil heating technology, FEELM combines authentic flavor reproduction technology with innovative electronic technology, bringing the ultimate feel and premium vaping experience.
SMOORE is a global leader in providing vaping technology solutions, including manufacturing vaping devices and vaping components for HNB products on ODM basis, with advanced R&D technology, strong manufacturing capability , a broad-spectrum product portfolio and a diverse customer base.
According to Frost & Sullivan, SMOORE is the world’s largest vaping device manufacturer by revenue, accounting for 22.8% of the total global market share in 2021. Its global market share is greater than the sum of those listed from #2 to #5.
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