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FDA Advisors Undecided on Risk Status of Snus

A divided FDA advisory panel could not reach consensus Wednesday on whether “snus” smokeless tobacco products from Swedish Match should be granted “modified risk tobacco product” (MRTP) status.

Several members of the Tobacco Products Scientific Advisory Committee (TPSAC) expressed concerns about uptake of snus by youth if the product receives the MRTP designation and becomes more popular in the U.S. as a result.

But other panel members argued that if a product like snus that is demonstrably less harmful than traditional cigarettes does not qualify for MRTP status, the designation might as well not exist.

Snus are small packets of tobacco that are typically placed inside the upper lip. Although it is generally accepted that smokeless tobacco is addictive and can cause oral cancer, tooth loss, and other diseases, the fact that such products aren’t combusted or inhaled means that they aren’t a risk factor for lung cancer or other pulmonary diseases. Some epidemiological data from Sweden, where snus have been marketed for many years, support a lower overall health risk compared with cigarettes.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to designate certain products as MRTP, meaning that they can be marketed as posing a lower risk of smoking-related disease than cigarettes and other combustible tobacco products.

Swedish Match North America was the first company to submit an MRTP application to the FDA in 2014, but in December 2016 the FDA denied the company’s request to remove specific warnings about gum disease and tooth loss from its labeling.

At the time, FDA officials asked Swedish Match to summit an amended application for MRTP status for its eight General Snus products to back up its reduced-harm claims, which included new research.

TPSAC member Kenneth E. Warner, PhD, of the University of Michigan in Ann Arbor, said even though the research newly submitted by the company was, in his opinion, “not perfectly done,” it had convinced him that the risks associated with the snus products were relatively low.

“I think the health (benefits) are really clear compared to smoking — more so than for any other smokeless tobacco product,” he said. “My sense is that if this is not approved, it might be the death knell for the [MRTP] process because we would be basically saying you can’t get anything through this process.”

In a presentation to the panel, Matthew L. Myers of the anti-smoking group Campaign for Tobacco Free Kids, addressed the potential uptake of snus products by adolescents, teens, and young adults.

He noted that the fact that there is little history of young people in the U.S. using, or even being aware of, the products “should not lull this committee or FDA into complacency.

“Of particular concern is that there is no information in front of this committee to allow you to make an accurate assessment on what is being requested on youth use,” he said.

Panel member Brian King, PhD, MPH, deputy director for research translation in the CDC’s Office on Smoking and Health in Atlanta, also expressed concerns about the potential for widespread uptake of snus products among youth, and the paucity of research examining their knowledge and perceptions of the products.

“I completely reject the notion that just because [usage] is low now we have to completely dismiss what the relevance could be in the future,” he said. “My response to that is one word: Juul.”

He noted that one in 20 kids in the U.S. are already using smokeless products, and half of those are using snus.

“This continued absence of any youth data is preposterous to me,” he said.

Representatives for Swedish Match acknowledged at the meeting that the company had no data on youth knowledge or perceptions of its products, saying that it would have been considered irresponsible for the company to have included non-adults in its MRTP research.

In an interview with MedPage Today, Gerry Roerty, Swedish Match North American general counsel, said the company faced criticism in 2014 for including large numbers of adults in its early MRTP research panel.

“We were told it could be considered back-door advertising — effectively marketing to people by recruiting them for the study,” he said. “Imagine if we had included young people. There is no way we would have done that. Our motives would have been instantly called into question.”

The TPSAC is meeting again Thursday to discuss a similar application from tobacco giant Altria for its Copenhagen Snuff Fine Cut smokeless product.