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Reynolds applies to FDA for premarket status for Vuse e-cigarette

Reynolds applies to FDA for premarket status for Vuse e-cigarette

R.J. Reynolds Vapor Co. entered the regulatory gauntlet with the Food and Drug Administration again on Friday with its submission for premarket approval for multiple Vuse electronic cigarette products.

The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users.

Reynolds is requesting permission to market Vuse, the No. 2-selling U.S. e-cigarette, as an electronic nicotine delivery system aimed at adult consumers.

“The application highlights key evidence demonstrating that the continued marketing of Vuse products is appropriate for the protection of the public health,” the company said in a statement.

The FDA could not be immediately reached for comment about the submission.

The FDA’s premarket application process requires tobacco manufacturers provide not only information on the composition, design and manufacturing process, but also chemistry, toxicological and behavioral studies that demonstrate the product − when used − is appropriate for the protection of the public health.

Reynolds said its submission contained more than 150,000 pages of documentation.

“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,” said James Figlar, Reynolds American Inc.’s executive vice president of scientific and regulatory affairs.

Ricardo Oberlander, Reynolds’ chief executive, said the Vuse premarket application is part of the company’s transforming tobacco initiative “to build a broad portfolio of competitive options for the adult tobacco consumer.”

“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.”

Some anti-smoking advocates question whether the FDA would approve a premarket status for Vuse given the heightened scrutiny over e-cigarette products in recent weeks. Vuse and top-selling Juul are sold mostly in closed-pod products.

The federal Centers for Disease Control and Prevention said Thursday that its latest update on vaping-related illness has exceeded 1,300 nationwide with at least 26 related deaths.

Most who got sick said they vaped open-pod products containing THC, the marijuana ingredient that causes a high, but some said they vaped only nicotine. Most of the THC vaping liquids are not currently regulated by the FDA.

“The irony (with Reynolds’ premarket application) is that the FDA’s tobacco law was designed to prevent competition for cigarettes by making any approval process exceedingly difficult,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette and health studies.

“Reynolds might succeed, but few others have such resources, and the law has thus far protected the cigarette business from disruption by low-risk alternatives for over a decade.”

In September 2018, R.J. Reynolds Tobacco Co.’s bid to market Camel Snus as a modified-risk tobacco product took a significant step when an FDA scientific advisory committee approved advancing the applications for six Camel Snus styles to the agency. The styles are Frost, Frost Large, Mellow, Mint, Robust and Winterchill.

Snus, which became popular first in Sweden, are teabag-like pouches of loose tobacco that users stick between their cheek and gum, but that don’t require spitting. They are marketed in part for use in places where smoking is prohibited.

Reynolds submitted its applications in April 2017, which included more than 450,000 pages of data and extensive scientific research.

Reynolds said in a statement the committee “recognized that the available science supports that switching completely from cigarettes to Camel Snus can significantly reduce smokers’ risk of lung cancer and respiratory disease.”

If any application is approved by the FDA, Reynolds would be able to market the snus styles as posing less risk for smokers who stop smoking and use the products in place of cigarettes.

“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,” Oberlander said.

Also in September 2018, the FDA accepted Friday for substantive scientific review a modified-risk application from U.S. Smokeless Tobacco Co., an Altria Group Inc. subsidiary, for the Copenhagen moist snuff style known as fine cut.

A modified-risk tobacco product application seeks authorization to advertise products as reduced harm or reduced risk compared to cigarettes.



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