FDA to review juul e-cigarettes for pre marketing application of tobacco products.html


According to vapingpost, the U.S. Food and Drug Administration (FDA) recently informed electronic cigarette company Juul labs that the agency will conduct a pre market tobacco product application (PMTA) review of its electronic cigarette equipment and nicotine cartridge, vapingpost reported.

Last month, Juul labs submitted the PMTA to the food and Drug Administration (FDA) as part of the process necessary to enable it to continue selling products in the United States. The company’s submission includes “comprehensive scientific evidence for the Juul device and the Juul cartridge in Virginia tobacco and menthol flavors at 5%, 3% tobacco concentration, and information on data-driven measures for the use of its products by minors.”

Due to the difficulties caused by the outbreak of covid-19, the deadline for PMTA has been moved to September 9, 2020.

“We will continue to follow the PMTA process and look forward to the next step as FDA begins to conduct a substantive review of the application,” Joe Murillo, chief regulatory officer of Juul labs, said in a statement Subsequently, according to the company’s announcement last Tuesday, the FDA has now informed manufacturers that it will conduct a “substantive scientific review.”.



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