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FDA opens door to reduced risk claim for Swedish Match snus tobacco
December 14, 2016 / 3:09 PM / 10 months ago

FDA opens door to reduced risk claim for Swedish Match snus tobacco

(Reuters) - The U.S. Food and Drug Administration left open the door on Wednesday for Swedish Match AB to claim its snus smokeless tobacco products represent a substantially lower risk to health than cigarettes.

The agency said the company could not remove a warning that the products may cause gum disease and tooth loss. But it deferred a decision on whether to allow the company to claim the products cause less harm than cigarettes.

It also deferred a decision on whether to allow removal of a warning that the products may cause mouth cancer. Snus is a moist tobacco product placed under the upper lip that does not involve spitting or chewing.

The FDA said evidence showed the products could cause gum disease and tooth loss. But it deferred action on the other requests, saying it believed the applications “could be amended to support issuance of modified risk orders.”

Dr. Lars-Erik Rutqvist, senior vice president of scientific affairs at Swedish Match, said he was encouraged by the FDA’s response.

“There doesn’t seem to be a disagreement between the company and the FDA as to whether snus is a modified risk product,” he said. “The disagreement seems to be the way to communicate this to the general public.”

Rutqvist said there may be other ways to communicate a reduced harm message than altering the label. He said he expected the company to meet with the FDA soon.

Snus has been used for decades in Sweden and has overtaken cigarettes as the country’s most popular tobacco product. Swedish smoking rates have plummeted as snus use has risen.

Last year, an advisory committee to the FDA recommended the company not be allowed to alter the label to claim the products are less harmful than cigarettes. They said the company had not shown the Swedish experience would be replicated in the United States.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, a public health group, said in a statement that the FDA had no choice but to reject the company’s application since it asked for the removal of statutory warning labels.

“A properly prepared application could well have received a different result,” he said.

Swedish Match was the first to have a modified risk application accepted for review by the FDA. Earlier this month, Philip Morris International Inc filed a modified risk application for an electronic product that heats rather than burns tobacco.

Reporting by Toni Clarke in Washington; Additional reporting by Ankur Banerjee in Bengaluru; Editing by David Gregorio and Peter Cooney

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