British American Tobacco’s U.S. subsidiary submits vapour Premarket Tobacco Application to U.S. FDA for VUSE products
11 October 2019
British American Tobacco’s U.S. subsidiary, Reynolds American Inc. (“Reynolds”) today announced submission of a Premarket Tobacco Product Application (“PMTA”) to the U.S. Food and Drug Administration (FDA) seeking orders authorising the marketing of VUSE Electronic Nicotine Delivery Systems (ENDS) products.
VUSE products offer a cartridge-based vapor system intended for adult tobacco consumers, and the application highlights key evidence demonstrating that the continued marketing of VUSE products is appropriate for the protection of the public health.
FDA has issued guidance explaining criteria for PMTA submissions, which make clear that manufacturers must provide not only information on the composition, design and manufacturing process associated with the product, but also chemistry, toxicological and behavioral studies that demonstrate the product − when used − is appropriate for the protection of the public health. To support the applications and meet this guidance, Reynolds’ submission to FDA includes more than 150,000 pages of documentation.
Reynolds’ Vuse portfolio is well-positioned in the FDA’s PMTA process, in which all vapor products must be submitted for review by 11th May 2020, to remain on the market.
“Today’s application marks the culmination of years of hard work across multiple teams, involving more than 100 individuals, including dozens of Ph.D. team members collaborating every day, with a substantial financial investment,” noted Dr. James Figlar, Executive Vice President of Scientific and Regulatory Affairs at Reynolds. “This is an important first step in a long process for the millions of adult cigarette smokers who may want a legal alternative to combustible cigarettes, thus we look forward working with the agency as the process moves forward.”
Ricardo Oberlander, CEO of Reynolds added: “We have long worked to build a broad portfolio of competitive options for the adult tobacco consumer, and today’s application is a strong next step for us in that journey. We continue to support the FDA’s efforts to create, implement and enforce a science and rule-based regulatory regime to protect the public health. Our regulatory applications, including those submitted for Camel Snus along with other future submissions for products in our Modern Oral Portfolio like VELO, are positioned to transform the market through a range of dynamic alternatives to traditional combustible cigarettes.”
Reynolds now awaits FDA’s review of the applications to determine whether they are accepted for filing and substantive review.
This is a release by British American Tobacco p.l.c. Associate companies are excluded. References to ‘British American Tobacco’, ‘BAT’, ‘we’, ‘us’ and ‘our’ when denoting opinion refer to British American Tobacco p.l.c. (the Company, and together with its subsidiaries, the “Group”), and when denoting tobacco business activity refer to Group operating companies, collectively or individually as the case may be. This release contains certain forward-looking statements, made within the meaning of Section 21E of the United States Securities Exchange Act of 1934, regarding our intentions, beliefs or current expectations reflecting knowledge and information available at the time of preparation and concerning, amongst other things, prospects, growth and strategies. BAT undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
These statements are often, but not always, made through the use of words or phrases such as “believe,” “anticipate,” “could,” “may,” “would,” “should,” “intend,” “plan,” “potential,” “predict,” “will,” “estimate,” “strategy” and similar expressions. It is believed that the expectations reflected in this release are reasonable but they may be affected by a wide range of variables that could cause actual results to differ materially from those currently anticipated.