FDA Denies Request to Change Smokeless Tobacco Product Warning Label

The Food and Drug Administration (FDA) this week denied a request from two subsidiaries of the tobacco company Reynolds American to change the warning label of smokeless tobacco products to indicate they are less risky than traditional cigarettes.

The subsidiaries filed a citizen petition in 2011, asking the FDA to change one of the four warning statements used on smokeless tobacco products. The warning statements, required by the FDA, are used on a rotating basis. The labels warn the products can cause mouth cancer, as well as gum disease and tooth loss, that they are not a safe alternative to cigarettes, and that smokeless tobacco is addictive.

The companies argued the label that warns smokeless tobacco is not a safe alternative to cigarettes is misleading to users of snus, moist snuff, chewing tobacco and plug tobacco, the Winston-Salem Journal reports.

Instead, they wanted the label to be changed to “Warning: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” They also suggested “No tobacco product is safe; however, exclusive use of smokeless tobacco products presents substantially less risk to health than cigarettes.”

The FDA said it denied the petition “after thoroughly reviewing the available scientific evidence and public comments.”

Swedish Match, the manufacturer of the smokeless tobacco product snus, has asked the FDA to consider whether their product is less harmful than cigarettes. At a hearing in April, government scientists questioned a proposal to modify cancer warning language on the product’s packaging.

Swedish Match has requested that its General brand of snus be certified as “modified risk.” The company wants to be able to claim snus products are addictive but much less risky than smoking. Swedish Match wants to be able to remove one of the required health warning labels about oral cancer.