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FDA denies Swedish Match request on tobacco warning label changes

In its first action on so-called modified-risk tobacco products, the U.S. Food and Drug Administration on Wednesday rejected a company’s request to remove some health warning labels from a smokeless product called snus.

Swedish Match, a Swedish-based tobacco company with its North American headquarters in Richmond, applied to the FDA in 2014 to have its snus product designated as modified risk, meaning it could be less risky to health.

Snus (pronounced snoos), is a smokeless tobacco sold in small pouches that the user places between the cheek and gum.

It has been popular in Scandinavian countries for many years, and Swedish Match, which sells snus under the brand name General in the United States, argued in its application to the FDA that it is a less-risky alternative to cigarettes and other tobacco products.

The company said it submitted about 120,000 pages of documents to the FDA to back that claim, including scientific and consumer studies conducted over the past 30 years in Norway and Sweden.

The company wanted to remove mandatory, rotating warning labels on snus packages that say it can cause gum disease, tooth loss and mouth cancer.

It also wanted to change the wording on a warning label that says snus is “not a safe alternative to cigarettes.” The company wanted it to read: “No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

The company did not seek to change a warning that says smokeless tobacco is addictive.

The FDA said it denied the request to remove the gum disease and tooth loss warnings because, based on the scientific evidence, “the products can cause gum disease and tooth loss.”

However, the agency deferred a final decision on the mouth cancer warning and the wording change, giving Swedish Match up to two years to amend its application. The FDA said the application “could be amended to support issuance of modified-risk orders.”

Under a 2009 federal law that gave the FDA authority to regulate tobacco products, companies can apply to the agency to market novel products as modified risk if there is evidence they are less risky to health.

The FDA has not yet authorized any tobacco products as modified risk. In reviewing such requests, the agency has to consider a product’s potential impact on both individual users and the population as a whole.

“The lessons learned through these first applications provide key insights moving forward,” said Mitch Zeller, director for the FDA’s Center for Tobacco Products, in a statement. “For example, companies should carefully consider how they plan to present and substantiate a modified-risk claim.”

“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,” Zeller said.

Swedish Match called the FDA decision encouraging and noted that the agency previously found that snus contains “significantly lower levels of harmful constituents compared to over 97 percent of the smokeless products on the U.S. market.”

The FDA decision leaves open the possibility that other warning label changes could be approved for snus products eventually, or that Swedish Match could propose other ways of communicating the lower risks of the product, said Jim Solyst, Swedish Match’s vice president for federal regulatory affairs.

“I think there are various ways of looking at this decision,” Solyst said. “Certainly, there are positive elements to the correspondence we received from the FDA. They would like to continue the dialogue. They have given us more guidance as to what is possible.”

Some public health and tobacco-control groups opposed changing the warning labels on snus. For instance, during the FDA’s review of Swedish Match’s application, the American Dental Association urged the agency to make no changes to warning labels without more research on whether smokeless tobacco is “a gateway” to cigarette smoking.

The FDA is considering other applications for modified-risk tobacco products.

Earlier this month, tobacco company Philip Morris International said it submitted an application to the FDA to market a new type of cigarette that heats tobacco instead of burning it as potentially less harmful than conventional cigarettes.

If the product, called iQOS, gets clearance, Henrico County-based Altria Group Inc. — parent of top U.S. tobacco company Philip Morris USA — would have exclusive rights to sell it in the United States under a licensing agreement between the companies.

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