WASHINGTON -- Swedish Match U.S. won the FDA's coveted modified risk tobacco product (MRTP) designation for eight of its General-brand "snus" smokeless tobacco products, the .
Snus are small packets of tobacco that users place between their upper lip and gum. As a smokeless product, they do not pose direct risks of lung cancer or other pulmonary diseases, although oral cancer is a definite risk. They are the first tobacco product of any kind to receive MRTP status.
"Today's action further authorizes the manufacturer to market these specific products with the claim 'Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis,'" the FDA said.
But they will still need to carry the same applied to all smokeless tobacco products. These list risks of mouth cancer, gum disease, and tooth loss, and emphasize that smokeless tobacco is addictive and not a safe alternative to cigarettes.
Also, snus cannot be marketed as "FDA approved," the agency noted, since technically they are merely "authorized for sale." As well, the MRTP designation expires after 5 years; renewal requires a new application.
Tuesday's decision comes after an FDA advisory committee in February failed to agree on whether snus deserved MRTP status. Several members of the panel worried that, despite the FDA's disclaimers, allowing snus to be marketed as lower-risk will be seen as a form of approval, thus spurring greater use, especially among youth. And that meeting came long before the reports of severe lung injury and death from e-cigarette use.
Nevertheless, the agency determined that "consumers [will] understand the claim and appropriately perceive the relative risk of these products compared to cigarettes, and that the modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole."
Even risk of oral cancer is lower with snus, when used exclusively, than with regular cigarettes, the FDA said. And the agency accepted Swedish Match's evidence that "youth initiation" is rare with snus and that MRTP status will not affect it.