FDA’s Authorization of the First Tobacco Product through Premarket Tobacco Application (PMTA)
November 10, 2015
Following a rigorous, science-based review, the U.S. Food and Drug Administration announced today 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 U.S., but does not mean that they are safe or “FDA approved.” All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue to abstain from doing so.
The Family Smoking Prevention and Tobacco Control Act of 2009 granted the FDA an important authority to regulate the manufacturing, marketing and distribution of tobacco products. While the law provides critical tools to enable the FDA to make tobacco-related disease and death part of America’s past, it also gave the agency the authority 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 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.”
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 FDA’s scientific 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.
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.
Now that these products have been given PMTA marketing orders, they may be introduced into interstate commerce. The company is required to report regularly to the FDA with information regarding the products on the market, including, but not limited to, advertising, sales data, information on current and new users and adverse experiences. The FDA may withdraw a marketing order if it determines that the continued marketing of a product is no longer appropriate for the protection of the public health, among other reasons.
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. Today’s PMTA actions are marketing authorizations and do not constitute MRTP authorizations.
The FDA Tobacco Product Approval Issue Presented by Public Health Law Center
Last Updated: 2015-11-09