FDA takes action on applications seeking to market modified risk tobacco products
The U.S. Food and Drug Administration today took action on the first applications reviewed through the modified risk tobacco product (MRTP) pathway for eight Swedish Match North America Inc. snus smokeless tobacco products sold under the General brand name. The agency denied the company’s request to remove a currently required warning stating that the products can cause gum disease and tooth loss. With respect to the company’s other requests to remove or revise two additional currently required warnings, the agency deferred final action and issued a response that offers the company an option to amend its applications.