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Reynolds Enters FDA Modified-risk Tobacco Gauntlet With Camel Snus Styles Source from: Winston-Salem Journal 12/20/2017 ![]() Monday, six styles of Camel Snus became the first Reynolds American Inc. tobacco products to enter the Food and Drug Administration review process for gaining modified-risk status. Reynolds submitted modified-risk tobacco product applications April 3. The FDA has filed modified risk applications for substantive review for 18 Camel Snus styles and the process could take up to a year to complete. The styles are Frost, Frost Large, Mellow, Mint, Robust and Winterchill. The FDA review process will include a public-comment period, starting today on www.regulations.gov under file FDA-2017-N-4678. The process also includes going before the FDA’s Tobacco Products Scientific Advisory committee. If any one of the applications 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. Snus 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. Camel Snus has been the dominant snus product in the U.S. since its 2006 debut. The FDA’s decision to move forward with the applications “is an important step forward in fulfilling Reynolds’ commitment to collaborative leadership in the transformation of the tobacco industry,” said James Figlar, senior vice president for scientific and regulatory affairs with RAI Services Co. “We believe the science and our proposed advertising to be compelling and accurate,” Figlar said. Dr. Scott Gottlieb, the FDA commissioner, called in July for a sweeping regulatory “road map” on tobacco and nicotine products. That included easing some regulations for product innovations, and extending the application deadline for FDA regulatory review for new products, such as e-cigs and vaporizers, from late 2018 to as far out as August 2022. R.J. Reynolds Tobacco Co. confirmed in October it is attempting another go with Eclipse, its groundbreaking heat-not-burn traditional cigarette. British American Tobacco Plc, which spent $54.5 billion in July to completely take 100 percent ownership of Reynolds, has plans for a substantial equivalence filing in 2018 for its heat-not-burn traditional cigarette brand, glo, as well as a modified-risk application in 2020. A substantial-equivalence filing is for products that either have the same characteristics as those marketed on/before Feb. 15, 2007, or have different characteristics but do not raise different questions of public health. “Our next-generation product business has real momentum, and our confidence is reflected in the financial objectives we have set out,” Nicandro Durante, BAT’s chief executive, said in September. BAT projects generating $662.5 million in revenue this year from “next generation” products. The forecast is for more than $1.32 billion in fiscal 2018 and for $6.63 billion in fiscal 2022. “We expect the next-generation product business to be breaking even by the end of 2018 and to deliver substantial profit by 2022,” BAT said. BAT’s main rival for global next-generation product sales is Philip Morris International, which has submitted a modified-risk application for its heat-not-burn cigarette product iQOs. Altria Group Inc. said in November it would file in the first quarter a modified-risk application for Copenhagen moist snuff. It also said that by the end of 2018, it would file premarket tobacco applications for smokeless chewable products under the Verve brand, and for MarkTen, its main electronic cigarette brand. “The true test here is whether the FDA is able to follow through on its commissioner’s proclamation of the importance of moving smokers to the low risk end of nicotine’s continuum of risk,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several electronic-cigarette studies. “The success of product substitution with snus in Sweden, vaping in the UK, and now the dramatic success of heat-not-burn products in driving down cigarette sales in Japan could be not just replicated but accentuated in the United States.” Enditem |