A Swedish maker of smokeless tobacco “snus” products will not be able for now to change U.S. labeling language that warns of health dangers from the products, although the door has been left open for possible changes at a later time. A leading researcher on smokeless tobacco says a read of he Food and Drug Administration's (FDA) lengthy report that led to last week's action suggests that the company Swedish Match faces an uphill climb in its unprecedented request that snus be considered a Modified Risk Tobacco Product (MRTP).
In denying a request that a label warning on gum disease and tooth loss be removed and in deferring final action on two other requests, including allowing the company to state that smokeless tobacco poses significantly lower health risks than cigarettes, the FDA ignored the majority of available scientific evidence, says University of Louisville professor of medicine Brad Rodu.
The company now will have to initiate new research and submit new data in order to keep its already data-rich request alive under the FDA's MRTP process, Rodu tells Addiction Professional.
“I read this as a fairly onerous request [from the FDA] that's going to take a long time and a lot of money,” he says.
But officials with Swedish Match sounded an optimistic tone publicly upon learning last week that the FDA will consider further discussion with the company on the comparative risk language, as well as on a request to remove a labeling warning about risk of mouth cancer from snus. The federal agency will not reconsider its position that the warning about gum disease and tooth loss must remain.
“We took a major step towards our vision 'a world without cigarettes' by having the first MRTP application ever accepted by FDA in history, and we believe it's a sign that we're moving in the right direction,” said Fredrik Peyron, Swedish Match's vice president of regulatory affairs. “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.”
Snus is available in the United States but is significantly more popular as an alternative to smoking in Sweden, where lung cancer rates are substantially lower than they are in other industralized nations.
Weighing the evidence
Rodu, a dentist who in 2006 authored a research review finding no significantly increased risk of mouth cancer from moist snuff (such as snus) or loose-leaf chewing tobacco, says the FDA is basing its decision-making on a minority of studies. He says, for example, that the federal agency's interpretation of mouth cancer risk has been based on one “outlier” study, whereas nearly all other research in this area has found no link with oral cancer.
While the FDA has indicated that an amended application from Swedish Match within two years could lead to the issuance of a modified risk designation, its statements this month illustrate a heavy burden of proof for the manufacturer.
“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 stated in issuing its response on Dec. 14. “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.” In essence, the FDA's statements suggest doubt over whether Sweden's experience would be repeated in the U.S.