SILVER SPRING, Md. — The Food and Drug Administration (FDA) gave Swedish Match the go-ahead to market eight new snus smokeless tobacco products under the General brand name. This move by the agency is the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. This action permits the tobacco products to be sold in the United States.
"The law is clear. Companies must apply to the FDA first, and then the FDA uses a rigorous scientific review to determine if new tobacco products should come to market under this pathway. 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, director of the FDA’s Center for Tobacco Products.
"As other manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law," he added.
Under the PMTA pathway, manufacturers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be appropriate for the protection of the public health. This standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
The FDA's evaluation includes reviewing a tobacco product’s components, ingredients, additives and health risks, as well as how the product is manufactured, packaged and labeled. The review also takes into account the increased or decreased likelihood that existing tobacco product users will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using them.
According to the agency, the marketing orders issued for the eight Swedish Match snus smokeless tobacco products reflect evidence showing that these products — marketed as described in the manufacturer’s application — would result in a low likelihood of new initiation, delayed cessation or relapse. The FDA's review also determined that these products would likely provide less toxic options if current adult smokeless tobacco users used them exclusively.
The marketing orders are product-specific and do not apply to other tobacco products, the FDA noted.