VUSE Premarket Tobacco Product Application Filed for Substantive Review by the FDA
First-of-its-Kind Filing for VUSE Products
N.C. – Nov. 27, 2019 – Today, Reynolds American Inc. (“RAI”) announced that the
recently-submitted Premarket Tobacco Product Application (“PMTA”) for VUSE
vapor products has been filed by the Food and Drug Administration (“FDA”) for
substantive scientific review, moving the application one step further through
the review process.
“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. FDA will now review our
scientific justification and determine the appropriateness of VUSE e-cigarette
products against the public health standard,” notes RAI CEO Ricardo Oberlander.
“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 FDA’s scientific review of the VUSE application – which totals more than 150,000
pages of research and data – comes just over six weeks after its initial
submission to the FDA. The FDA, per its earlier-issued guidance, considers the
following issues, among others:
Risks and benefits to the population as a whole,
including both users and nonusers 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. James Figlar, Executive Vice President within the RAI Group, explained the science
behind the application, stating that "We compiled both the data and
clinical information necessary for predicting the effect of continued marketing
of VUSE products on the public health. We 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.”
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 FDA’s guidance, and we will work with the Agency to address any questions
they may have about our products throughout the review process."
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 FDA’s
evaluation of the application and evidence.
About Reynolds American Inc.
Reynolds American Inc. is an indirect, wholly owned subsidiary of British American
Tobacco p.l.c., and the U.S. parent company of R. J. Reynolds Tobacco Company;
Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; R. J.
Reynolds Vapor Company; and Kentucky BioProcessing, Inc.
R. J. Reynolds Tobacco Company (RJRT) is the
second-largest U.S. tobacco company. RJRT’s brands include Newport, Camel and
Santa Fe Natural Tobacco Company, Inc. manufactures
and markets Natural American Spirit products in the United States.
American Snuff Company, LLC is the nation’s
second-largest manufacturer of smokeless tobacco products. Its leading brands
are Grizzly and Kodiak.
R. J. Reynolds Vapor Company (RJRV) markets
vapor products and modern oral products, including VUSE, VELO and REVEL.
Kentucky BioProcessing, Inc. conducts research
and development related to protein expression and extraction from tobacco