Reynolds American has submitted two new Premarket Tobacco Product Applications (PMTAs) to the U.S. Food and Drug Administration (FDA). These applications are for Reynolds’ Vuse Vibe and Vuse Ciro vapor products and if approved would allow these products to remain on the market after the FDA’s May 12, 2020 submission deadline for PMTAs.
Reynolds’ PMTAs for its Vuse products include multiple flavors for each brand style. Reynolds included a wide range of scientific studies relating to Vuse Vibe and Vuse Ciro, including how they compare to cigarettes and associated health risks. In a press release, the company noted that while the PMTAs were considered commercially proprietary and confidential, the data and information submitted to the FDA include the results of product analyses, non-clinical health risk information and human health and population information, including the impact of use to both users and nonusers of tobacco products. Reynolds American’s overall aim is to demonstrate to the FDA how the continued marketing of Vuse Vibe and Vuse Ciro is appropriate for the protection of public health. Reynolds American is seeking marketing orders from the FDA, not modified risk designations for these products.
“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,” commented Reynolds’ executive vice president and head of scientific and regulatory affairs, Dr. James Figlar. “We are optimistic that we will receive a favorable marketing order for all of our Applications, which would enable us to provide adult tobacco consumers with multiple acceptable alternatives to cigarettes and we’re hopeful that as PMTAs move forward, the Agency prioritizes enforcement against illegally marketed tobacco products introduced after August 8, 2016.”