Snus is a moist tobacco product placed under the upper lip that does not involve spitting or chewing.
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Following a rigorous, science-based review, the U.S. Food and Drug Administration announced yesterday that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. It does not allow the company to claim they are less unsafe than other tobacco products. Snus has become the most popular tobacco product in Sweden. The company requires a separate approval from the agency to make that claim.
Under a 2009 law, the FDA was granted authority to evaluate tobacco products for their health risks and to clear ones that don’t pose new or significant risks to the public health.
Swedish Match has already been selling a few of its products in the United States. The FDA cleared distribution of the product to the USA market. “Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected”, said Mitch Zeller, JD, director of FDA’s Center for Tobacco Products.
As a condition of approval, the company is required to report regularly to the FDA with information regarding the products on the market, including advertising, sales data, information on current and new users and adverse experiences.
Another is to show they are appropriate for the protection of public health. The hurdle is higher here.
The FDA reviewed the ingredients and additives of the smokeless tobacco products, as well as how they are packaged and labeled, and determined they are unlikely to attract new smokers. However, the announcement is accompanied by a warning that the decision should not be misconstrued as FDA’s vetting of the products or its view that these are safe.
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In Sweden, the rate of smoking-related diseases – especially lung cancer, chronic obstructive pulmonary disease and heart disease – has plummeted.
