"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", says RAI CEO
"The FDA will now review our scientific justification and determine the appropriateness of VUSE e-cigarette products against the public health standard.
"For adult tobacco consumers seeking an alternative source of nicotine, having FDA oversight of e-cigarette products is an important step to ensure those alternatives meet strict regulatory scrutiny."
The
* Risks and benefits to the population as a whole, including both users and non-users of tobacco products;
* Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available;
* Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available; and
* The methods, facilities, and controls used to manufacture, process, and pack the new tobacco product.
Dr.
He continued: "We also 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.
"While many of the results of our studies are confidential and proprietary, we believe that our application is complete and meets the regulatory requirements laid out in
The next step in the review process is the FDA evaluation of the scientific information and data in the VUSE application. The FDA will also conduct inspections of manufacturing sites, as well as sites and entities involved in clinical and nonclinical studies, as part of this review process. Thereafter, the application may receive market clearance or denial, based on the
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