FDA Affirms Snus as Harm Reduction. Does This Signal Hope for Vaping?

October 22, 2019

Despite contributing to the vaping panic rolling across the country, the US Food and Drug Administration (FDA) has taken a key step towards institutionally recognizing tobacco harm reduction.

On October 22, a handful of snus products—smokeless tobacco pouches that are placed under the lip to allow absorption of nicotine—were approved to be marketed as bearing reduced risks in comparison to combustible cigarettes. It’s the first time the regulatory agency has ever permitted this.

The FDA has given Swedish Match, a company that makes and sells snus, the go-ahead to begin amending its marketing materials and product packaging to include the following 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.”

Some international public health experts have welcomed the move. Dr. Konstantinos Farsalinos, a leading tobacco harm reduction researcher at the Onassis Cardiac Surgery Center in Greece, called it a “positive development.” Yet he added that it happened much too slowly. “It took the FDA too long to acknowledge the overwhelming evidence from long-term epidemiological studies on snus,” he told Filter. “It should have happened years ago.”

In Sweden, where cultural acceptance of snus has seen large numbers of smokers switching over, lung cancer rates have fallen to dramatically lower levels than in other European countries. Yet a study published in March showed that most American smokers incorrectly continue to believe that snus is as harmful as cigarettes. The FDA’s move may help to address that health information gap.

As you’d expect, Gerry Roerty, vice president and general counsel for Swedish Match’s US arm, sees the success of the company’s bid to have its products recognized for harm reduction as a win. The decision comes after a nearly four-year-long process, which ended in a “compromise” between the company’s belief that snus is “unquestionably safer” than cigarettes and the FDA’s hesitancy to “quantify” the exact extent of the risk reduction, as Roerty told Filter.

The FDA agrees with Swedish Match that its products “significantly reduce harm and the risk of tobacco-related disease,” as the agency stated in a press release. But the initially proposed phrase, “substantially reduce,” was dismissed by the FDA in favor of “lower”—a decision that came down to the FDA concluding that the company’s “applications did not support the specific request to revise the warning, but that the evidence may support other claims about relative health risks compared to cigarettes,” as an FDA spokesperson told Filter.

FDA recommended that any new claim should be more precisely tailored to the evidence, carefully constructed, and adequately tested so as to ensure that the products meet the modified risk standards.

Tobacco harm reduction advocate Clive Bates, former director of Action on Smoking and Health (ASH), is concerned by this compromise, fearing that the harm-reducing qualities of snus are being unduly downplayed in the approved language, reducing its capacity to encourage smokers to switch.

“What will users perceive ‘lower risk’ to mean?” he asked in an email discussion with other advocates. “Am I alone in thinking the permitted […] claim on General Snus offers the consumer no useful information whatsoever and is likely to be more misleading and off-putting than saying nothing at all?”

Above all, it seems like the FDA is invested in underscoring the risks of any tobacco product. “Although exclusive use of these General Snus products poses lower risk of certain specific health outcomes, as described in the claim, compared to cigarette smoking,” said the FDA spokesperson, “they are not ‘safe’ and still pose increased health risks compared to not using tobacco.”

Although the newly approved language is not the ideal in the eyes of advocates or manufacturers, it comes “at least with an acknowledgement that there are products on the lower risk continuums,” said Roerty.

As state-level bans on flavored vaping products, a known harm reduction tool for smokers, proliferate, federal recognition of the existence of tobacco harm reduction could help people rethink their perception of other smokeless options.

Photo of an open snus container; courtesy of Swedish Match
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