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 Stockholm-based Swedish Match can sell eight new products of a
smokeless tobacco known as "snus" under its "General" brand, the FDA
said on Tuesday. Snus is a moist tobacco product placed under the
upper lip that does not involve spitting or chewing.
The FDA's ruling allows Swedish Match to sell the products. It does
not allow the company to claim they are less dangerous than other
tobacco products. To make that claim the company needs separate
approval from the FDA.
Swedish Match has already been selling some of its products in the
United States. Snus has become the most popular tobacco product in
Sweden.
In granting the authorization, the FDA determined there is a low
likelihood the products will lead to increased tobacco use in the
population, prevent people from quitting or cause those who have
quit to relapse.
The products would likely provide a less toxic option for tobacco
users who use them exclusively, the agency said in a statement.
A 2009 law giving the FDA authority to regulate tobacco products
provides several ways for companies to bring new products to the
market.
One is to show they are substantially equivalent to a product on the
market as of Feb. 15, 2007, and do not raise new safety concerns.
Another is to show they are appropriate for the protection of public
health. The hurdle is higher here. A company must show the product
will not, on balance, harm the population as a whole.
Swedish Match has already applied to the FDA to alter the warning
label on its existing snus products to claim they present a
"substantially" lower risk than cigarettes.
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The agency is reviewing the application but in April an advisory
committee recommended it be rejected.
In Sweden, the rate of smoking-related diseases - especially lung
cancer, chronic obstructive pulmonary disease and heart disease -
has plummeted.
Most FDA advisory panelists agreed that snus appears less harmful
than cigarettes when used by smokers who switch. But they said the
company had not provided enough evidence to rule out an association
between snus and tooth loss or gum disease or to prove Sweden's
experience could be replicated in the United States.
(Reporting by Toni Clarke in Washington; Editing by Matthew Lewis)
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