The U.S. Food and Drug Administration (FDA) had cleared for distribution the first new smokeless tobacco product to be released in the American market.
The FDA cleared for sale eight varieties of snus, loose tobacco powder in teabag-like pouches. The snus will be provided by the Stockholm-based Swedish Match under the "General" brand.
"Following a rigorous, science-based review, the [FDA] announced today that for the first time it has authorized the marketing of new tobacco products," the agency said in their press release.
Snus has been a popular product in Scandinavian market for many years and is growing popular in the U.S. tobacco market as well. It is a moist powder with less cancer causing chemicals compared to typical tobacco products. The powder is placed under the user's lip and left there as the nicotine is slowly released.
While snus is technically already available in the U.S. market from several companies, including Swedish Match, this is the first time that the product underwent the FDA's formal review and became cleared for marketing.
"The law is clear. Companies must apply to the FDA first," said Mitch Zeller, director of the FDA's Center for Tobacco Products. "Today's action demonstrates that the premarket tobacco application process is a viable pathway ... as long as the public health can be protected."
Under the formal review known as the premarket tobacco application (PMTA) pathway, manufacturers are required to prove that new tobacco products will not pose a huge risk for the health of the general public, including non-tobacco product users.
The FDA will then evaluate the product's components, active ingredients and health risks as well as the manufacturing process and the product's packaging and labeling.
Previously, the Swedish Match applied to the FDA to allow the warning label on their product to be changed to claim that the snus present "substantially" lower risk for users than cigarettes.
But while most of the panelists agree that snus may be less harmful than traditional tobacco products, the company will need to provide enough research to back these claims, particularly evidence that can rule out snus use as a risk factor for developing tooth loss or gum disease, or that Sweden's experience can be replicated among U.S. citizens.
