The U.S. Food and Drug Administration has for the first time authorized the sale of a tobacco product that it says will not significantly harm the health of the population as a whole.
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.
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)
