The decisions were made on products for which approval was sought under a "substantial equivalence" pathway, under which manufacturers must show that the new products are similar to existing ones in terms of their public health impact.
Approved were two nonmentholated cigarettes made by Lorillard Tobacco under its Newport brand.
The four products that were rejected were not identified; it is not known whether they were cigarettes or another type of tobacco product. The four products were not e-cigarettes, since those are not currently regulated by the FDA, noted Mitchell Zeller, JD, director of the FDA's Center for Tobacco Products.
Zeller told reporters during a telephone press briefing Tuesday that the agency's confidentiality rules bar it from naming products or their sponsors when an application is denied. Similar rules apply to drug and device applications.
Congress gave the FDA authority to regulate tobacco products in 2009, although the agency is not allowed to ban them entirely.
Under regulations established since then, the FDA has designed two pathways for tobacco companies to bring new products to market.
One is the "premarket tobacco product application" or PMTA, analogous to the premarket approval pathway for novel medical devices. Under this process, companies must show, among other things, that the new product "is appropriate for the protection of public health."
Zeller said that this was intended to be the primary pathway for new tobacco products to reach the market. But, to date, the agency has "received zero applications."
Instead, manufacturers have turned to a second pathway that relies on a "substantial equivalence" standard in which the new product is compared to others already on the market. This pathway is roughly similar to the 510(k) process for devices -- not only because both rely on a substantial equivalence standard, but also because both are less rigorous than the respective premarket application pathways.
The FDA has received approximately 4,000 applications for new tobacco products through the substantial equivalence pathway, Zeller said. More than 3,500 of these are for products already on the market but for which FDA review is eventually required.
Several hundred are for products not currently marketed, and the six with decisions announced today were part of that group, Zeller said.
An FDA statement announcing the decisions said the rejected applications had failed to meet the agency's standards for a showing of substantial equivalence.
"A variety of factors contributed to the four NSE [not substantially equivalent] decisions announced today, including a lack of evidence to support that the addition of specific ingredients did not raise different questions of public health, a lack of information about the design of the product, and incomplete test data," the statement said.
The agency said it had turned away an additional 20 substantial equivalence applications without review because they did not meet the basic requirements.
During the press call, Zeller and FDA Commissioner Margaret Hamburg, MD, called the agency's actions "historic" because they mark the first time that the agency has exercised its authority to keep new tobacco products off the market.
"The day of evidence-based tobacco product regulation is here," Zeller declared. "Today is the first day that a regulatory agency anywhere in the world has made a science-based determination on a premarket basis that a product can or cannot be marketed."
He noted that companies whose substantial equivalence claims have been rejected can still go through the primary PMTA process to win approval for new products.
