You are here
WINSTON-SALEM, N.C. — Reynolds American Inc.'s R.J. Reynolds Tobacco Co. (RJRT) subsidiary has submitted Modified Risk Tobacco Product (MRTP) applications to the Food and Drug Administration (FDA) covering six styles of Camel Snus.
The pouched, smokeless tobacco product was introduced in 2006 and marketed nationwide.
To support the applications, RJRT provided the FDA more than 450,000 pages of documentation, according to the No. 2 tobacco company.
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.
In the next step, the agency will review the applications to determine whether they are accepted for substantive review. RJRT "looks forward to working with the agency as the process moves forward," the company said.
RAI, based in Winston-Salem, is the parent company of RJRT; Santa Fe Natural Tobacco Co. Inc.; American Snuff Co. LLC; Niconovum USA Inc.; Niconovum AB; and R.J. Reynolds Vapor Co. Its brands include Newport, Camel, Natural American Spirit, Grizzly, ZONNIC and VUSE.