FDA Approves Marketing of Smokeless Tobacco Products Through Premarket Process
"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, J.D., director of FDA's Center for Tobacco Products.
The U.S. Food and Drug Administration announced Nov. 10 that, for the first time, it has authorized the marketing of new tobacco products through the premarket tobacco application pathway. This allows the tobacco products to be sold in the United States but does not mean that they are safe or "FDA approved," the agency cautioned, adding that all tobacco products are potentially harmful and addictive. The marketing orders in this case are for Swedish Match North America Inc. snus smokeless tobacco products under the General brand name. Snus is term describing a moist powder tobacco product.
The Family Smoking Prevention and Tobacco Control Act of 2009 granted FDA the authority to regulate the manufacturing, marketing, and distribution of tobacco products and also to permit new tobacco products to be introduced to the U.S. market under specific circumstances. "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, J.D., director of 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."
Manufacturers using the PMTA pathway must demonstrate that marketing of the new tobacco product would be appropriate for the protection of the public health, and FDA must consider the risks and benefits to the population as a whole. FDA announced that the PMTA decisions for the Swedish Match 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" and that 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.