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WASHINGTON -- Swedish-made "snus," a smokeless tobacco product packaged in individual use portions, will be allowed for sale in the U.S., .
But for now, at least, they will sport the same warning labels stating that they are "not a safe alternative to cigarettes" currently required for other smokeless tobacco products.
The eight snus products are the first to be cleared under the FDA's premarket tobacco application (PMTA) pathway, established after Congress authorized the agency to regulate tobacco products.
The manufacturer, Swedish Match North America, presented evidence that snus are, in fact, less toxic than cigarettes and has asked for permission to revise the label warning to read, "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."
In Tuesday's announcement, the FDA said its review had indeed confirmed that snus "would likely provide less toxic options if current adult smokeless tobacco users used them exclusively."
Nevertheless, it said that Swedish Match -- and other applicants for novel tobacco products -- "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." The FDA made clear that the sale approval did not reflect any decision on the label language Swedish Match had sought.
The agency also stressed that no product approved under the PMTA pathway can be marketed as "FDA-approved."
With the PMTA approval, Swedish Match is obliged to send the FDA regular reports on sales, marketing activities, and information on users, including adverse experiences.