WASHINGTON, D.C. -- 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. This action permits the tobacco products to be sold in the United States, but does not mean that they are safe or “FDA approved.”
“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. [Yesterday’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, in a press release. “As other manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law.”
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. That 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 marketing orders are for eight Swedish Match North America Inc. snus smokeless tobacco products under the General brand name. The PMTA decisions for these 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 law also makes clear that companies cannot say or imply that their products are “FDA approved,” and a company must apply for—and receive—a separate modified risk tobacco product (MRTP) authorization in order to market a product with claims of reduced exposure or reduced risk.