The U.S. Food and Drug Administration has denied a request from the manufacturer of several "snus" smokeless tobacco brands seeking modified risk tobacco product (MRTP) status to remove a key warning label from its products, and put off a decision on the company's other requests.
The agency told Swedish Match North America that its snus products must continue to carry a warning about gum disease and tooth loss.
But it deferred ruling on whether to remove a warning linking use of the smokeless tobacco products to mouth cancer and whether to allow the company to claim that the products are less harmful than cigarettes.
Swedish Match took the FDA's announcement in stride, saying it looks forward to working with the FDA to advance the MRTP application.
"We took a major step towards our vision 'a world without cigarettes' by having the first MRTP application ever accepted by the FDA in history, and we believe it's a sign that we're moving in the right direction," said a company statement. "We will adhere to the invitation by the agency to continue our constructive dialogue in order to understand the next steps necessary for issuance of a modified risk order."
The MRTP pathway outlined in the 2009 Family Smoking Prevention and Tobacco Control Act allows companies to submit applications for the FDA to evaluate whether their tobacco product can be sold or distributed for use to reduce harm or risk related to smoking cigarettes.
The snus products marked by Swedish Match North America were approved for sale in the U.S. by the FDA just over a year ago, and the company's MRTP application has been
Swedish Match is the first tobacco company to submit a product to the FDA for modified risk status.
The packets of moist tobacco, which are placed under the upper lip, are more widely used in Sweden than cigarettes by tobacco users, and some data suggest they have had fewer adverse health effects in that country.
In addition to deferring final action on the two requests, the FDA offered the company guidance for amending its application.
"The lessons learned through these first applications provide key insights moving forward," Mitch Zeller, MD, of the FDA's Center for Tobacco Products said in a press release issued Wednesday.
"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 application if it chooses," he added.
In an interview with 51˶, Zeller noted that the FDA issued a 115-page summary of the review process, which should guide the company in revising its application.
"We have laid out for them that rather than going down the path of either eliminating a warning or modifying a warning, they might want to think about coming back to us with a request for a direct health claim along the lines of either reducing exposure or reducing risk," he said. "We pointed out the evidence in the record where that could potentially be the basis for us to consider their request for (a reduced harm) claim, as long as they do the right studies along the way."
He added that current scientific data support maintaining the current warning about risks of gum disease and tooth loss, but the scientific evidence on the link to mouth cancer is less clear.