SILVER SPRING, Md. -- Could softening the warning label on a smokeless tobacco product prove beneficial to Americans? One Swedish tobacco company thinks so.
Swedish Match North America (SMNA) met with the FDA's Tobacco Products Scientific Advisory Committee here on Thursday to discuss an application that would allow it to rewrite its label. The company argued that changing the warning label for snus, a popular Swedish tobacco product that is also sold in the U.S., would positively impact Americans' health.
The Swedes want to remove this label language, "Warning: This product is not a safe alternative to cigarettes" and replace it with this statement, "Warning: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes."
The company also wants FDA permission to drop label warnings that smokeless products cause gum disease, loss of teeth, and mouth cancer.
In all, Swedish Match is asking for label revisions for 10 products, all of which it said are justified based on "extensive, product-specific evidence related to the health effects of snus."
The company did, however, agree that snus should carry a warning that the product is addictive.
The FDA advisory committee will meet today to vote on its recommendations for the label. The FDA is not required to follow the advice of the committee, but it often does. The agency intends to make a final decision on the sponsor's application by June 15.
Swedish Match is, in part, basing its claim to benefit population health on the historical evidence of the product's use in the firm's home country.
In comparison with other Western countries, men in Sweden and Norway who use tobacco primarily use snus. As a result, these men don't suffer from health effects of traditional smokers, explained Jim Solyst, the vice president of federal regulatory affairs for Swedish Match North America.
In the U.S., where there isn't a strong history of snus use, the message that snus is less harmful than smoking is not well understood, Solyst added. "[A]t least if we make the label change then maybe citizens of the U.S., particularly smokers, will be aware that there are other alternatives to smoking, and that's really the motivation behind our application," Solyst said.
An FDA representative was unconvinced that the company's data supported the safety of snus.
Hannah Day, PhD, an epidemiologist in the FDA's Office of Science said that 11 of the 12 studies were cross-sectional -- a design that makes determining cause and effect challenging. Half focused on adults under 25, and many tobacco-related diseases don't surface until after age 40. And most of the studies used small sample sizes. Only three included more that 50 snus users.
"In addition, the applicant does not provide an argument as to why it is biologically plausible that effects of snus on gum disease and tooth loss would be significantly different from other smokeless tobacco products," Day said.
Regarding the association between snus and oral cancer, the FDA did not find "strong and consistent" evidence of a relationship. However, FDA's technical experts were concerned by positive findings in two of the six studies the applicant submitted and therefore were "unable to rule out the possibility of an association."
As for the "overall risks to health" of snus, based on the SMNA's application, the FDA's technical experts agreed that snus were not likely to be associated with lung cancer, chronic obstructive pulmonary disorder, and chronic respiratory disease.
However, FDA reviewers said the application did not provide evidence to refute claims of an association with other diseases such as esophageal, stomach and pancreatic cancers, cardiovascular disease, stroke and all cause mortality. There are also known health risks to pregnant women.
In addition to deciding whether snus will significantly reduce harm, the committee will weigh the sponsor's claim of population health benefits.
One of the questions the FDA has asked the committee to address is the generalizability of the Swedish tobacco use to behavior among Americans. Snus is far less popular in the U.S.: National Adult Tobacco Survey data indicate that only about 5% of Americans have ever tried them and, among those ever-users, fewer than 5% currently use them regularly.
If the FDA does approve Swedish Match's application, the product's status will be time-limited and must undergo renewal after a specified period. The company will also be required to perform post-market surveillance.