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PMTA non-clinical testing laboratory

The first non-clinical testing laboratory for PMTA in China has been completed, and the head manufacturer plans to seize the rights of the global product safety system

Recently, the reporter known that Smoore Anlysis testing and safety evaluation center(refeeed to as “safety evaluation center”) has built China’s first PMTA non-clinical testing laboratory. At present, the laboratory has covered the non-clinical research requirements of PMTA, material safety, HPHCs, toxicology tests and other non-clinical items.

This is first time that a Chinese electronic cigarette factory has built a PMTA testing laboratory. It can conduct FEELM products pre-test, comprehensively improve product safety, help the brand to sucessfully pass PMTA. 

Although the global production center of e cigarette products in China, but the United Sates is the largest consumer market. The U.S. accounted for more than 55% of the total overseas global market in 2021 and will exceed 65% in 2022 (The 2022 E-Cigarette Industry Export Blue Book). Branded products manufactured by Chinese ODM/OEM factories must pass the most stringent safety inspection in the world before entering the US market.Safety testing and systematic demonstration of products used to be the weakness of Chinese technology suppliers. 

However, since the establishment of the first research laboratory in 2017, Smoore has continued to layout the world’s leading testing projects and build a sound product safety demonstration system. At present, Smoore Safety Assessment Center has established the industry’s first E&L analysis and testing laboratory, improving the material safety standard of vapor material to medical level. 

In April this year, FEELM’s customer NJOY were approved by PMTA for sale in the US market.The FDA thought NJOY products have lower levels of HPHCs than cigarettes, and that users of NJOY products are exposed to lower levels of potentially harmful ingredients and have better harm reduction than cigarettes. Logic vape products manufactured by Smoore, also passed PMTA.

Currently, there are eight products approved by the FDA, many of which are manufatured by Smoore. The factory quality management system plays a very important role in FDA’s review,and the fact that Smoore’s OEM products can pass PMTA indicates that FDA has at least tentatively recognized that OEM factory meet its quality management requirements for e cigarette factory plants.


Post time: Jul-28-2022