FDA rejects request to remove tobacco warnings from smokeless product

FDA rejects request to remove tobacco warnings from smokeless product
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The Food and Drug Administration (FDA) Wednesday denied a request from a Swedish tobacco company to remove health warnings from its smokeless tobacco product. 

Swedish Match North America Inc. submitted a modified risk tobacco product (MRTP) application for snus, a moist powder tobacco pouch that users put behind their upper lip.  

FDA said it denied the company’s first request to remove warnings of risk for gum disease and tooth loss from labels based on scientific evidence and other data.


Swedish Match also asked the FDA if it could remove the warning that the product causes mouth cancer and revise a third warning to say the product presents a “substantially lower risks to health than cigarettes.”

FDA deferred action on the other two requests, but told the company that the applications could be amended within the next two years to support their modified risk claims.

The applications are the first modified risk tobacco product applications the agency has received. 

Under the Family Smoking Prevention and Tobacco Control Act, companies can submit MRTP applications that ask the FDA to evaluate whether a tobacco product can be sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. 

In a statement, Swedish Match Vice President of Regulatory Affairs Fredrik Peyron called being the first company to submit a MRTP application a "major achievement." 

“Our goal has been to work to communicate truthfully to consumers about our snus products and that snus is a less harmful alternative to cigarette smoking,” he said.

“We took a major step towards our vision ‘a world without cigarettes’ by having the first MRTP (Modified Risk Tobacco Product) application ever accepted by FDA in history, and we believe it's a sign that we're moving in the right direction.”