Safer Alternative to Smoking Can't Call Itself a Safer Alternative to Smoking
FDA decided not to decide whether snus can be marketed as the first safer-than-cigarettes product.
Snus, a nicotine-laced-tobacco product, has been credited with helping to reduce smoking-related deaths in Sweden, where it was invented and is widely used.
In the United States, the Food and Drug Administration requires snus to carry the exact same warning labels as cigarettes, cigars, and chewing tobacco. It's been more than a year since Swedish Match, the maker of snus, asked to identify its product to Americans as what it is—as safer alternative to cigarettes—but last week the FDA said it won't be allowing that to happen anytime soon.
In a ruling issued on December 14, the FDA told Swedish Match that the company's products—snus consists of a small packet, similar to a tea bag, filled with tobacco powder and placed in the upper lip, in a manner similar to chewing tobacco but without the need for chewing or spitting—would have to continue carrying a warning about the potential for tooth loss and gum disease. The federal agency deferred a decision on whether snus could be advertised as less dangerous than cigarettes, but indicated that it would continue working with Swedish Match to advance its application.
"We took a major step towards our vision 'a world without cigarettes' by having the first [Modified Risk Tobacco Product] application ever accepted by the FDA in history and we believe it's a sign that we're moving in the right direction," said Swedish Match in a statement to Medpage Today, a trade journal.
The so-called MRTP designation was created by a 2009 law allowing the FDA to evaluate tobacco products that could be less harmful than smoking cigarettes.
In the application filed with the FDA in August 2014, Swedish Match proposed a label that says "no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."
Snus submitted an MRTP application in August 2014 and, if approved, could be the first product to gain that designation. That would be a significant marketing victory for the Swedish Match, which is still trying to break into the American market.
Still, this is about more than just marketing. Several studies have shown that snus is indeed a safer alternative to cigarettes and an effective pathway to getting smokers to quit.
A peer-reviewed study published in Tobacco Control found that snus delivers high levels of nicotine with lower concentrations of other chemicals found in cigarettes and "does not appear to cause cancer or respiratory diseases." A study conducted in Norway and published in Nicotine and Tobacco Research found that using snus was much more effective at getting smokers to quit using cigarettes than nicotine replacement products like patches and gum. Snus-ers were three times as likely to quit smoking as smokers using nicotine gum, the researchers found. They believed snus was so effective because it delivered a nose of nicotine that was almost the same as cigarettes and provided a "sensory effect that medicinal nicotine products perhaps lack" because snus smells and tastes like tobacco.
Brad Rodu and Philip Cole, researchers at the University of Alabama at Birmingham, reported in 2007 that 200,000 smoking-related deaths per year could be prevented if tobacco uses across the whole of the European Union adopted snus at the same level as Swedes. (Snus is banned in most of Europe, even though cigarettes are legal, an arrangement that Reason's Jacob Sullum has described as "banning bows and arrows as an intolerable threat to public safety while allowing a free trade in machine guns.")
As I wrote last month in questioning why the FDA hadn't yet made a decision about snus' MRTP application: Approving Swedish Match's application to pitch snus as a safer alternative to smoking would probably save American lives, but it would create more competition for Nicorette gum and other pharmaceutical stop-smoking products like Chantix. It's worth noting that Mitch Zeller, director of the FDA's Center for Tobacco Products, is a former lobbyist for GlaxoSmithKline, a major pharmaceutical company that happens to manufacture Nicorette Gum.