Reynolds American submits Vuse electronic cigarette PMTA to FDA
On October 13, British American Tobacco‘s Reynolds American Inc. said on Friday that it had submitted an application for review of its Vuse e-cigarettes to the U.S. Food and Drug Administration (FDA), making it ahead of its main competitor, Juul labs.
According to Reuters, the FDA has set a may 2020 deadline for e-cigarette manufacturers to try to curb the use of e-cigarettes by teenagers.
Vuse electronic cigarette delivers nicotine based on the pod system. The company said it has provided up to 150000 pages of supporting documents to FDA personnel, including information and data on product composition, design, manufacturing process, and safety.
Ricardo Oberlander, CEO of Reynolds American, said: ‘we will continue to support FDA’s efforts to establish, implement and enforce a scientific and rule-based regulatory system to protect public health.
FDA has issued guidelines that explain the criteria for the submission of pre market applications for tobacco products, which clearly state that manufacturers must provide information about the ingredients, design and manufacturing processes associated with the product, as well as the chemical, toxicological and behavioral studies that demonstrate that the product is suitable for the protection of public health when used.
According to Reynolds American, today’s application marks the culmination of years of efforts by multiple teams, involving more than 100 people, including dozens of Ph.D. team members, who collaborate extensively every day. “This is an important first step for thousands of adult smokers who may want to legally replace combustible cigarettes, so we look forward to working with the agency as the process progresses.”
Currently, Reynolds American is waiting for FDA to review the application to determine whether it is subject to application and substantive review.