SMOORE, a vape manufacturer, announced that is has opened China’s first non-clinical full-scale testing laboratory for Premarket 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 US. It must also provide scientific data that demonstrates a product is appropriate for the protection of public health.
What does the new lab mean for SMOORE’s credibility?
The lab, operated by SMOORE’s Analysis, Testing and Safety Assessment Center, offers non-clinical evidence required to bring a nicotine product to market, like material safety, HPHCs (hazardous components and potentially hazardous components), and toxicology testing.
This is the first PMTA testing lab to open in China, and will allow SMOORE and its flagship brand FEELM, the 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.
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 lab 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.”
The lab tests against a database of HPHCs, developed by SMOORE, and derived from global toxicity databases including the US Environmental Protection Agency (EPA). Advanced computational toxicology software is used to predict for unknown and potentially hazardous ingredients not included in these databases, further increasing SMOORE’s safety assessments.
What is SMOORE’s market expertise?
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 U.S. Food and Drug Administration, many of which are manufactured by SMOORE, showing that the FDA approves of the processes and testing mechanisms deployed in SMOORE’s new laboratory.
SMOORE is working with its 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.
