Reynolds American Inc. (RAI) has submitted two new premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration (FDA). RAI is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapor products, which would allow these products to remain on the market after the FDA’s deadline for PMTAs for electronic nicotine-delivery systems.
The applications include a range of scientific studies for Vuse Vibe and Vuse Ciro using well-known methodologies, including the comparative assessment of cigarettes and associated health risks. Though the PMTAs themselves are considered commercially proprietary and are thus confidential, the data and information submitted to the FDA include the results of product analyses, nonclinical health risk information and human health and population information, including the impact to both users and nonusers of tobacco products.
According to RAI, the results of these studies demonstrate that the continued marketing of the Vuse Vibe and Vuse Ciro products is appropriate for the protection of the public health. The FDA s expected to extend the PMTA deadline to from May 12 to Sept. 9.
“I am incredibly proud of our diverse team of scientists, researchers and regulatory experts, who have worked tirelessly together to complete these applications well ahead of the FDA’s May deadline for ENDS products,” noted Reynolds’ executive vice president and head of scientific and regulatory affairs, James Figlar.
The PMTAs for Vuse Vibe and Vuse Ciro are the second and third complete grouped PMTA applications submitted by Reynolds to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019.