the FDA (the Food and Drug Administration) has issued marketing granted orders to NJOY Ace and its tobacco-flavored e-liquid pods on April 26. It is the first e-cigarette authorized by the FDA that is equipped with ceramic coils and manufactured by FEELM, the flagship atomization tech brand belonging to SMOORE.
NJOY has partnered with SMOORE since 2009. NJOY Ace was launched in 2018 and is powered by FEELM inside, the world’s first black ceramic atomization coil with metallic film. As the first ceramic coil e-cigarette and pod vape authorized by the FDA, NJOY Ace's approval for sale fully showcases the harm reduction potential of FEELM ceramic coil. According to the FDA, NJOY Ace is authorized for sale because "chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke."
Based on PMTA requirements, SMOORE has established a comprehensive analytical testing and safety assessment system, including the vaping industry's first corporate toxicology laboratory, which explores the health impacts of exposure to e-cigarette vapor by means of cytotoxicity test, evaluating the reaction of living cells to different components of e-cigarette vapor. The company has also developed the third generation of in-house safety standards SMOORE 3.0, which covers all of the PMTA tests and HPHCs (Harmful and Potentially Harmful Constituents) listed by the FDA.
“The principle of PMTA is to scientifically and systematically substantiate harm reduction performance of the vaping product and show it is appropriate for the protection of the public health (APPH)”, said Dr. Long, Director of SMOORE Analytical Testing and Safety Assessment Center. "The manufacturer must demonstrate the product's potential to switch adult smokers while preventing youth and non-smokers from nicotine addiction," which could explain that all the FDA-authorized vaping products are tobacco-flavored, and popular flavored products have been issued Marketing Denial Orders. It also indicates that vaping manufacturers shall focus on tobacco flavor reproduction and improve harm reduction performance, in order to be approved under the PMTA pathway.
According to Nielsen, for the two weeks ended April 9, 2022, Vuse has surpassed Juul and become the No.1 in the U.S e-cigarette sales, with a market share of 35%. Its flagship product Vuse Alto is also equipped with FEELM ceramic coils. As the No.3 player in the U.S, NJOY accounts for approximately 3.1% market share. Moreover, a federal judge has required the FDA to provide progress reports on PMTAs submitted by major vaping brands. It is expected that more major vaping brands, such as Vuse and Juul, will receive their FDA status reports soon.