ENDS Device Manufacturer NJOY Receives Marketing Granted Orders from FDA
On Tuesday, April 26th, 2022, FDA Center of Tobacco Products announced they have provided marketing granted orders to ENDS manufacturer NJOY, LLC for four of the company’s vapor products from their PMTA, including one device and three tobacco flavored pods. The agency noted that microbial stability data provided in the application played a role in the approval of the products.
In their letters to David Graham, Chief Impact Officer and Executive Vice President of Regulatory Affairs for NJOY, the agency stated: “Based on our review of your PMTAs, we determined that permitting the marketing of the new tobacco products… is appropriate for the protection of public health (APPH). It should be noted that our determination that the marketing of these products is APPH is based in part on the submitted microbial stability data.”
The items that received marketing granted orders, and are now authorized for interstate commerce in the United States, are:
- NJOY ACE Device
- NJOY ACE POD Classic Tobacco 2.4%
- NJOY ACE POD Classic Tobacco 5%
- NJOY ACE POD Rich Tobacco 5%
These marketing granted orders mark NJOY as the 2nd company to get their products successfully through the PMTA process in 2022, and the 4th company to successfully complete the process overall. Logic Technology Development, LLC, received marketing granted orders in March for five of their products, including the Logic Pro and Logic Vapeleaf systems. In 2021, U.S. Smokeless Tobacco Company LLC was granted marketing for their VERVE nicotine discs and chews, and R.J. Reynolds Vapor Company received orders for their Vuse Solo device and replacement cartridges.