FDA Hands Swedish Match Partial Lose on Modified Risk Bid

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FDA Hands Swedish Match Partial Lose on Modified Risk Bid

12/14/2016

SILVER SPRING, Md. — The Food and Drug Administration (FDA) has turned down Swedish Match North America Inc.'s modified risk tobacco product (MRTP) application for its General snus brand.

The tobacco company sought the MRTP designation in June 2014. However, now two and half years later, the agency has denied Swedish Match's request to remove a required warning stating that the smokeless tobacco 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, according to the FDA.

Swedish Match was the first tobacco company to submit an MRTP application under the The Family Smoking Prevention and Tobacco Control Act of 2009.

The measures outlines a pathway for companies to submit applications for the FDA to evaluate whether a tobacco product may be sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.

"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, 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," he added.

In its applications, Swedish Match 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, according to the agency. 

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.

The actions on these MRTP applications do not affect the premarket tobacco application (PMTA) authorizations issued for General snus tobacco products in November 2015.

Under the PMTA pathway, manufacturers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health. This standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

Swedish Match's corporate headquarters are located in Stockholm and its U.S. division is in Richmond, Va.