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UNITED STATES

VUSE submitted for substantive review by FDA

03 Dec 2019. Reynolds American Inc., a member of the British American Tobacco group, has applied to the FDA for a substantive review of its VUSE products, according to a company press release.

A successful review would mean RAI’s VUSE product moving one step further towards being made available to the general public. Ricardo Oberlander, CEO of RAI, stated, “This is a first-of-its-kind application for VUSE products, and it puts VUSE one step closer to gaining a marketing order from the FDA. FDA will now review our scientific justification and determine the appropriateness of VUSE e-cigarette products against the public health standard.”

The VUSE application amounts to more than 150,000 pages of research and data, which will be scientifically reviewed by the FDA. This will be the next stage in the approval process, which comes 6 weeks after VUSE’s initial submission. The FDA will examine multiple aspects of the proposed products, including whether those who currently use tobacco products would be more or less likely to stop, were the reviewed products made available, and whether those who do not currently use tobacco products would be more or less likely to start using them if this product were available. The FDA will also examine the potential risks and benefits to the general population as well as the methods and facilities used to manufacture, process, and pack the new product.