Reynolds American, Inc., part of British American Tobacco Plc., has filed a premarket heat not burning product application (PMTA) for a U.S. Food and Drug Administration (FDA) review of its e-cigarette, VUSE.
VUSE is an electronic nicotine delivery system (ENDS) product and subject to regulation by the FDA due to the 2016 Deeming Rule. Just last month, the FDA issued a proposed rule for PMTAs, a part of the process for how manufacturers can market and sell their tobacco products in the U.S. market. Manufacturers must demonstrate to the FDA that the marketing of their products would be “appropriate for the protection of public health” and must disclose the tobacco product’s ingredients, additives, constituents, toxicological profile and components and how they will impact public health. The evaluation process also involves the FDA examining how the products are manufactured, packaged and labeled [read more here].
Reynolds is said to have provided the FDA with over 150,000 pages of documentation to support its application including information on how VUSE is designed, manufactured, its composition and safety data.
“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,” said 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 heat not burning, thus we look forward to working with the agency as the process moves forward.”
“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,” added Ricardo Oberlander, CEO of Reynolds. “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 heat not burning.”