A Swedish snus manufacturer faces a daunting task in getting Food and Drug Administration approval to market its smokeless product as less harmful to consumers than combustible cigarettes, according to analysts.

Swedish Match said it has submitted eight styles of its General snus brand as a modified risk tobacco product in an application that contains more than 100,000 pages. The styles are available in more than 20,000 U.S. retail outlets.

“Swedish snus is very well scientifically documented,” Dr. Lars-Erik Rutqvist, senior vice president for scientific affairs for the company, said in a statement. “As an industry leader, we must properly apply the evidence to demonstrate the potential public health benefit of our snus tobacco products.”

Snus typically comes in a small pouch that is placed between the lip and gum. The tobacco is pasteurized, not fermented, and it contains less moisture and salt than moist snuff. It also does not require the consumer to spit.

Camel Snus, made by R.J. Reynolds Tobacco Co., dominates the U.S. market. Swedish Match has about a 10 percent share of the overall U.S. smokeless category after ramping up production in February 2012.

In April, the FDA released its long-awaited proposal on regulating electronic cigarettes and other tobacco products not already under its oversight. Congress gave the FDA industry oversight in 2009.

According to the proposal, companies can make claims of reduced risk compared with traditional cigarettes only if the FDA confirms that evidence supports the claim and marketing the product will benefit public health.

Swedish Match wants permission to remove two warning labels: “this product can cause mouth cancer,” and “this product can cause gum disease and tooth loss.”

It also would replace the warning that “this product is not a safe alternative to cigarettes” with this text: “no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

Swedish Match would retain the warning that “smokeless tobacco is addictive.”

Reynolds and American Snuff Co. filed a petition in August 2011 to change the warning in question for all smokeless tobacco products. “To date, FDA has not taken any substantive action with respect to the petition,” Reynolds spokesman David Howard said Monday.

Howard said Reynolds considers as proprietary any information related to FDA filings.

Swedish Match cited in its application “an abundance of Swedish and international evidence on the health effects of snus -- evidence that stretches over three decades and includes governmental cohort studies and clinical trial results.

FDA officials did not provide a timeline for implementing the approved regulations; it could take as long as two years, analysts said.

Another option for FDA review is smokeless tobacco products must be “substantially equivalent to a product already on the market as of Feb. 15, 2007. Swedish Match began selling snus in the U.S. in 2006.

“This process, for those companies brave, patient and wealthy enough to undertake it, is expected to consume years and millions of dollars, for an uncertain outcome,” according to a statement from the American Council on Health and Science. The council supports smokeless tobacco and e-cigs as a less-harmful option to cigarettes.

“(Snus) has been proven effective against smoking in the best possible way: Swedish men have the highest level of smokeless tobacco use in the world, and also the lowest smoking rates in the western world,” the council said.

“They have the lowest rates of smoking-related diseases, thanks to their devotion to snus.”

Brad Rodu, a professor of medicine at the University of Louisville and a smokeless-tobacco advocate, said “numerous studies document that the three targeted warnings have essentially no scientific basis.”

“The not-a-safe-alternative warning is particularly egregious. The purpose of this 1986 warning was to deceive smokers into believing that smokeless tobacco was just as dangerous as smoking.”

“The welcome filing by Swedish Match could dramatically alter the landscape for tobacco harm reduction,” Rodu said.

John Spangler, a professor of family and community medicine at Wake Forest University School of Medicine, said “there might be a reduced risk of oral cancer with snus, although some research conflicts with this conclusion.”

“It has recently been shown that snus may be associated with poorer survival of cancer, and there is still concern about the increased risk of heart disease and fatal heart attacks compared to non-fatal heart attacks among snus users.

“We do not know what the effect will be on tobacco initiation (both smoked and smokeless), especially among youth, when you label any tobacco product reduced risk, e.g., safer.”

rcraver@wsjournal.com (336) 727-7376

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