"The lessons learned through these first applications provide key insights moving forward. For example, companies should carefully consider how they plan to present and substantiate a modified risk claim," said Mitch Zeller, J.D., director for the FDA's Center for Tobacco Products. "While the FDA is not authorizing modified risk orders for these products at this time, our guidance to the company will enable it to amend its applications if it chooses."
In its applications, Swedish Match North America requested to remove two warnings that the products can cause gum disease and tooth loss, and mouth cancer, which are currently required to be displayed on smokeless tobacco packages and in advertisements. The company also requested to revise a third currently required warning statement to say that the products present "substantially lower risks to health than cigarettes."
Based on the scientific evidence provided in the applications, as well as other available data, the agency determined that the request to remove the warning related to gum disease and tooth loss should be denied because these products can cause gum disease and tooth loss. On the other two requests, for which the FDA has deferred final action, the agency believes that the applications could be amended to support issuance of modified risk orders and has requested that the company amend the applications within two years if it chooses to proceed.
In its review, the FDA must look at whether a product, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual users and benefit the health of the population as a whole. In making this assessment, the agency must consider whether those who do not use tobacco products would start using the product or whether existing tobacco users who would have otherwise quit would switch to the modified risk product instead.
The actions on these MRTP applications do not affect the Premarket Tobacco Application authorizations issued for General snus tobacco products in November 2015.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration