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Thursday, Dec 15 2016

Full Issue

FDA Refuses To Remove Warnings On Swedish Smokeless Tobacco Product

Agency officials reject a request from Swedish Match North America Inc. to remove gum disease and tooth loss warnings from packaging on its tobacco pouches, called snus. The company can reapply for modifications to other language, like the risk of mouth cancer.

The Food and Drug Administration on Wednesday partially rejected an application by Swedish Match North America Inc. to market its tobacco pouches as being less harmful than cigarettes. Eight products in the company鈥檚 General brand of tobacco pouches, called snus, represent the first test case in a program in which the agency is considering whether to allow companies to advertise some tobacco products as safer than cigarettes. (Maloney, 12/14)

U.S. health officials have rejected an attempt by a Swedish company to remove several health warnings from its smokeless tobacco pouches, though regulators left open the possibility for other labeling changes it seeks. The Food and Drug Administration announced Wednesday that it denied the request by Swedish Match to remove warnings about gum disease and tooth loss from its chewable pouches, called snus. It's the first decision of its kind handed down by the agency since it gained authority to review the relative risks of tobacco products in 2009. (12/14)

The Food and Drug Administration (FDA)聽Wednesday聽denied a request from a Swedish tobacco company to remove health warnings from its smokeless tobacco product.聽Swedish Match North America Inc. submitted a modified risk tobacco product (MRTP)聽application for snus, a moist powder tobacco pouch that users put behind their upper lip. 聽FDA said it denied the company鈥檚 first request to remove warnings of risk for gum disease and tooth loss from labels based on scientific evidence and other data. (Wheeler, 12/14)

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