The U.S. Food and Drug Administration (FDA) has filed for substantive scientific review the premarket tobacco product applications (PMTA) that was recently submitted by Reynolds American Inc. (RAI) for Vuse vapor products.
“This is a first-of-its-kind application for Vuse products, and it puts Vuse one step closer to gaining a marketing order from the FDA,” said RAI CEO Ricardo Oberlander.
“FDA will now review our scientific justification and determine the appropriateness of Vuse e-cigarette products against the public health standard.”
The Vuse application comprises more than 150,000 pages of research and data, according to RAI.
According to RAI Executive Vice President James Figlar, the company surveyed current tobacco users to understand product use behavior and demographics, conducted behavioral studies of current and non-users of tobacco to gauge consumer understanding of risks and interest in product use, and performed statistical population modeling to project the effect on the population as a whole.
In addition, the RAI conducted clinical studies that looked at the abuse potential of Vuse products, which included examining nicotine pharmacokinetics, as well as conducted several studies to examine the aerosol properties of the products and the temperature during use.