MRTPs for Camel Snus

R.J. Reynolds Tobacco Co. (RJRT) 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 in the U.S.

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
• 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.

The company says it looks forward to working with the agency as the process moves forward.