For the first time, advertisements for one brand of snus can say that using the smokeless tobacco product "instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."
The US Food and Drug Administration announced on Tuesday it was allowing the marketing through the modified risk tobacco product pathway. It's the first time the agency has allowed product marketing of this type.
What that means is that there are now eight Swedish Match USA Inc. snus products sold under the General brand name that will be able to market with a claim that the products are essentially less harmful than traditional cigarettes.
Snus looks like small tea bags that contain moist snuff. Users place the pouches between their cheek or teeth and gums, and the nicotine releases over time. It's less messy that some other forms of smokeless tobacco, because the user doesn't have to spit the used tobacco out. The product has been popular in Sweden since the 1600s and some smokers have quit regular cigarettes by switching to snus, studies have found.
Swedish Match USA has been allowed to sell and market its products in the United States, but until now wasn't allowed to use this specific health claim.
In the FDA announcement on Tuesday, the agency said that just because there is a modified risk claim, it doesn't mean snus is FDA approved.
"All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from their use," the FDA said.
FDA to continue monitoring product
The FDA said it made the decision after reviewing scientific evidence submitted by the company. It had to show that snus wouldn't encourage people who don't use tobacco products to start using them. The company also had to demonstrate that people who intended to quit smoking altogether didn't instead switch to snus.
The FDA said the company met these standards and "the modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole."
Epidemiological studies show that exclusive use of snus, compared to cigarette smoking, poses a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis, according to the FDA.
The FDA also added that there is no evidence that there is "significant youth initiation of these products."
The modified risk orders have a five-year time limit. The FDA will continue to monitor the product.
"In addition to stringent restrictions to limit youth access and exposure to advertising, this time-limited authorization comes with a number of postmarket requirements that will allow us to keep a close watch on the marketplace," said Acting FDA Commissioner Dr. Ned Sharpless in an agency release. "Should any information lead us to determine that the marketing of these products as posing less risk no longer benefits the health of the population as a whole, the agency would consider withdrawing this authorization."
Organizations argued against the change
The American Lung Association, along with several other health advocacy organizations including the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids submitted testimony to the FDA in May arguing against allowing the companies to make these claims.
The organizations argued that there was insufficient evidence on the impact of the marketing of General snus with modified risk claims on the increased likelihood of tobacco use initiation by non-users, particularly by kids.
"Although there are obvious distinctions between e-cigarettes like JUUL and smokeless tobacco products like General snus, the fact that another kind of highly-addictive 'reduced risk' product is proving so appealing to young people, in part because it can be used discreetly, should cause FDA to closely scrutinize the potential impact of modified risk claims for General snus on youth initiation," the letter to the FDA said.
There is also concern that adults wouldn't quit cigarettes, and instead would use snus in addition to cigarettes.
"The Lung Association is disappointed with FDA's announcement today," said Erika Sward, the assistant vice president of national advocacy at the American Lung Association. "The FDA seems to fundamentally not understand that their consumer and top priority is the public health -- not the tobacco industry."