WINSTON-SALEM, N.C. – April 3, 2017 – Reynolds American Inc. (NYSE: RAI) today announced that its R.J. Reynolds Tobacco Company (RJRT) subsidiary has submitted Modified Risk Tobacco Product (MRTP) applications to the U.S. Food and Drug Administration (FDA) covering six styles of Camel Snus, its premium pouched, smokeless tobacco product introduced in 2006 and marketed nationwide.
To support the applications, R.J. Reynolds has provided the FDA more than 450,000 pages of documentation. As the submission guidelines advise, the documentation covers results and discussion from an extensive suite of scientific studies, including:
- Chemistry, pre-clinical and clinical toxicology, as well as epidemiology;
- Consumer perception and understanding studies of the proposed MRTP;
- Likelihoods of use studies based on the proposed MRTP claims; and
- Population-level modeling under a scenario in which the MRTP claims are authorized for dissemination to adult smokers.
R.J. Reynolds now awaits FDA’s review of the applications to determine whether they are accepted for substantive review, and the company looks forward to working with the agency as the process moves forward.
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Reynolds American Inc. (NYSE: RAI) is the parent company of R.J. Reynolds Tobacco Company; Santa Fe Natural Tobacco Company, Inc.; American Snuff Company, LLC; Niconovum USA, Inc.; Niconovum AB; and R.J. Reynolds Vapor Company.
- R.J. Reynolds Tobacco Company is the second-largest U.S. tobacco company. R.J. Reynolds’ brands include Newport, Camel and Pall Mall.
- 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.
- Niconovum USA, Inc. and Niconovum AB market innovative nicotine replacement therapy products in the United States and Sweden, respectively, under the ZONNIC brand name.
- R.J. Reynolds Vapor Company is a marketer of digital vapor cigarettes, manufactured on its behalf by R.J. Reynolds, under the VUSE brand name in the United States.
Copies of RAI’s news releases, annual reports, SEC filings and other financial materials, including risk factors containing forward-looking information, are available at www.reynoldsamerican.com. To learn more about how Reynolds American and its operating companies are transforming the tobacco industry, visit Transforming Tobacco.