Reynolds American has submitted two new Premarket Tobacco Product Applications (PMTAs) to the US Food and Drug Administration (FDA), the company reported.

Reynolds American is seeking marketing orders for its Vuse Vibe and Vuse Ciro vapour products, which would allow these products to remain on the market after the FDA’s May 12, 2020 deadline for PMTA applications for Electronic Nicotine Delivery Systems (ENDS). The PMTAs include multiple flavour variants for each brand style, according to the press release.
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. “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,” Reynolds’ Executive Vice President and Head of Scientific and Regulatory Affairs, Dr. James Figlar was quoted as saying.
The PMTAs for Vuse Vibe and Vuse Ciro are the second and third complete grouped PMTA applications submitted by Reynolds American to the FDA for review, following the initial PMTA applications for Vuse Solo submitted in October 2019. The PMTA process allows the FDA to evaluate whether the marketing of certain ENDS products is appropriate for the protection of the public health.