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 that demonstrates a product is appropriate for the protection of public health.
The laboratory, opened and operated by SMOORE’s Analysis, Testing and Safety Assessment Center, provides all non-clinical evidence required to bring a new nicotine product to market, including material safety, HPHCs (hazardous components and potentially hazardous components), and toxicology testing.
This is the first PMTA testing laboratory to open in China, and will allow SMOORE and its flagship brand FEELM, the world’s leading closed vape system solution provider, to further improve the safety of their products, and help the brands they work with to successfully pass PMTA certification.
Prior to SMOORE opening its new laboratory, any vaping companies that wanted to enter the US would need to use third-party partners to complete their PMTA testing, which can be a costly and time-consuming process. With the new China facility, FEELM’s brand partners can more easily complete their PMTA certification and improve their accessibility to the US market.
Dr Long, the director of SMOORE’s new Safety Assessment Center, said:
"The FDA is very concerned about HPHCs and has set out a list of 33 substances which must be tested for.
"Our new laboratory can do all this and more, and has the capacity to test for 37 substances; we are the only facility in China whose testing capabilities covers the full range of HPHCs substances."
The laboratory tests against a world-leading new database of HPHCs, 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 for unknown and potentially hazardous ingredients not included in these databases, further increasing SMOORE’s safety assessments.
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 grade, and works to constantly 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 of the processes and testing mechanisms deployed in SMOORE’s new laboratory in China.
SMOORE is now working with its brand partners and FEELM clients to expand its testing and to provide greater support for product design and is issuing the relevant safety reports.
SMOORE is determined to become the driving force behind supporting brands in their engagement with the FDA and other regulatory agencies, empowering them to enter 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 tech brand belonging to SMOORE, FEELM is the world’s leading closed vape system solution provider. Based on the world's leading Ceramic Coil Heating Technology, FEELM combines authentic Flavor Reproduction Technology with innovative electronics technology, bringing ultimate sensation and premium vaping experience.
SMOORE is a global leader in offering vaping technology solutions, including manufacturing vaping devices, and vaping components for HNB products on an ODM basis, with advanced R&D technology, strong manufacturing capacity, wide-spectrum product portfolio and diverse customer base.
According to Frost & Sullivan, SMOORE is the world’s largest vaping device manufacturer in terms of revenue, accounting for 22.8% of the total global market share in 2021. Its global market share is bigger than the sum of those listed from No.2 to No.5.