FDA Gives Partial Ruling to Swedish Match

Single question on snus application gets modified-risk verdict

SILVER SPRING, Md. – The FDA is starting to move on submitted applications, with Swedish Match North America recently getting a partial ruling on its modified-risk submission regarding a line of its snus products.

The U.S. Food and Drug Administration, Silver Spring, Md., recently took action on one of the first applications reviewed in its modified-risk tobacco product (MRTP) path for eight snus smokeless tobacco products from Owensboro, Ky.-based Swedish Match North America 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 warnings, the FDA deferred final action and gave the company an option to amend its applications, agency officials said in a press release.

The MRTP process outlined in the 2009 Family Smoking Prevention and Tobacco Control Act allows 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.

“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, Rockville, Md. “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.”

Officials at Swedish Match did not respond to a request for comment by press time.

In its applications, Swedish Match requested to remove two warnings that the products can cause gum disease, 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 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 gum-disease request 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 said 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, the FDA press release said. 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 Swedish Match’s Premarket Tobacco Application (PMTA) authorization issued for General snus tobacco products in November 2015, FDA officials said. That separate application pertains to the FDA’s new deeming requirements to allow companies to sell new cigars, electronic cigarettes and other tobacco products (OTP) in the U.S. market.

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