The Belated Approval of a Harm-Reduction Claim for Smokeless Tobacco Highlights the Potentially Deadly Impact of FDA Censorship
The FDA finally has agreed to allow a mild statement about the relative hazards of snus and cigarettes.
This week the Food and Drug Administration (FDA) finally granted a snus manufacturer permission to tell the truth about this Swedish version of oral snuff, which is far less hazardous than cigarettes and contains lower levels of carcinogens than other forms of smokeless tobacco. The Stockholm-based company Swedish Match will henceforth be allowed to display the following statement on packages of its General brand snus sold in the United States: "Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."
In the decade since Congress gave the FDA authority over tobacco, this is the first time the agency has allowed such a "modified risk" claim for any product. The FDA says its approval of Swedish Match's claim "demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers." But the arduous process leading to that decision also demonstrates the potentially deadly consequences of the FDA's censorship.
"Adult smokers deserve the full truth about these products and other reduced-risk tobacco and nicotine products," says Gregory Conley, president of the American Vaping Association. "The FDA's claim that this pathway is viable should come with a giant asterisk explaining just how much time and how many millions of dollars Swedish Match had to spend to get permission to tell the truth to consumers."
It has been clear for decades that smokers can dramatically reduce the health risks they face by switching from cigarettes to smokeless tobacco. The oral pathologist Brad Rodu, now a professor of medicine at the University of Louisville, published a book making that case back in 1995.
Rodu estimates that "modern smokeless products" are "98 percent less harmful than cigarettes." Snus, which unlike most American smokeless tobacco products is steam-pasteurized rather than flue-cured, is especially appealing as a harm-reducing alternative to cigarettes. The FDA notes that "the levels of two potent carcinogens in smokeless tobacco products called NNN and NNK are lower in these General snus products than [in] the vast majority of smokeless tobacco products on the U.S. market."
Until this week, however, Swedish Match was not allowed to promote its products as less dangerous than cigarettes in the United States, and even now the FDA-approved claim understates the health advantages of snus. Rodu notes that the statement "refers to 'lower' risk of disease, which implies that risks are still present, when, in fact, snus has no risk for mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis."
Why did this modest step take so long? Notwithstanding the First Amendment, even truthful, nonmisleading statements about the relative hazards of tobacco products are illegal until they have the FDA's blessing. And under the Family Smoking Prevention and Tobacco Control Act, the 2009 law that charged the FDA with regulating tobacco products, manufacturers have to persuade the agency that a modified-risk claim is not only accurate but will "benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products."
That "population as a whole" standard means it's not enough to demonstrate that a product is significantly less dangerous than cigarettes. The FDA is also supposed to consider factors such as whether a modified-risk claim might prolong tobacco use among people who otherwise would have quit entirely or encourage consumption by people who otherwise never would have used tobacco.
All that pondering takes time and requires additional evidence, beyond a straightforward comparison of health risks. "The available evidence does not demonstrate significant youth initiation of these products," the FDA says, "and evidence submitted by the company also found low levels of intentions to buy the product among non-users of tobacco (including young adults) and, importantly, found that the inclusion of the modified risk claim did not affect these intentions."
Swedish Match submitted modified-risk applications for 10 varieties of its snus in June 2014. Even getting to that point required a great deal of work: The original applications consisted of 813 files totaling 1.7 gigabytes of data. In July 2015 the company filed amendments to its applications totaling another 1.4 GB. It responded to FDA inquiries with further amendments in September 2018, November 2018, and January 2019. And now, more than five years after the original applications, Swedish Match is legally allowed to say something that Brad Rodu has been pointing out for decades: Snus poses "a lower risk" than cigarettes.
I asked Patrik Hildingsson, vice president for communication and public affairs at Swedish Match, how much this process cost in terms of money and man-hours. "I have also been thinking about the resources put into this process, human capital and monetary cost etc.," he wrote in an email. "But the truth is that it has not been tracked in a way that makes a fair assessment possible."
That's an admirably honest reply. But it seems fair to say that the cost of complying with the FDA's requirements would deter many applicants without the resources of Swedish Match, which reported revenue of nearly 13 billion Swedish krona (about $1.3 billion) last year. Where does that leave, say, a small or medium-sized vaping company that wants to accurately advertise its products as less dangerous than conventional cigarettes?
The cost of obtaining the FDA's permission to tell the truth can be measured in lives as well as dollars. Data compiled by Swedish Match show that Sweden, the only country in the European Union where snus is legally available, has by far the lowest smoking rate in the E.U. as well as the highest prevalence of ex-smokers and the lowest prevalence of tobacco-attributed mortality. Snus has been displacing cigarettes in Sweden since the late 1980s.
Norway, a non-E.U. country where snus is also legal, likewise has low rates of smoking and tobacco-related deaths. According to Swedish Match, snus accounted for 37 percent of Norway's nicotine market in 2014, up from 5 percent in 1985. "During the last 15-20 years," Hildingsson says, "Swedes used snus to quit smoking." In Norway, he says, "they are not only quitting; they start with snus and do not move to cigarettes." As a result, "the smoking drop rate is very, very fast." Hildingsson predicts that "Norway will outperform Sweden in 3-4 years' time."
Americans may not take to snus quite like the Swedes and Norwegians have. But it's inexcusable that the U.S. government has been actively obstructing these harm-reducing trends by suppressing accurate information about the relative hazards of snus and cigarettes. To the extent that such censorship has discouraged smokers from considering snus, the upshot has been more smoking-related disease and death, all in the name of promoting public health.