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FDA rejects change in smokeless tobacco warning labels

May 15, 2015

By Craig Palmer

Washington – The Food and Drug Administration May 11 rejected an industry petition to label smokeless tobacco products as presenting "lower" or "substantially less" risk to health than cigarettes. The Association had urged the FDA to reject the petition.

Smokeless tobacco product packages and advertising must bear one of four required warning statements in rotation:

  • "WARNING: This product can cause mouth cancer.
  • "WARNING: This product can cause gum disease and tooth loss.
  • "WARNING: This product is not a safe alternative to cigarettes.
  • "WARNING: Smokeless tobacco is addictive."

A July 28, 2011, citizen petition and subsequent supplements filed on behalf of R.J. Reynolds Tobacco Company and American Snuff Company, LLC, urged the FDA to initiate administrative rulemaking to change the warning that "This product is not a safe alternative to cigarettes" to:

  • "WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes," or alternatively
  • "WARNING: No tobacco product is safe; however, exclusive use of smokeless tobacco products presents substantially less risk to health than cigarettes."

The current health warning statements are sufficient, the Association told the FDA in commenting on the proposed changes in smokeless tobacco product warnings. These warnings are clear, concise and scientifically sound.

"As a matter of public health, we have become increasingly alarmed by attempts to market smokeless tobacco products as a healthier (or less harmful) alternative to cigarettes," said the Association comment filed April 1, 2013, for the FDA regulatory docket on the petition. "Smokeless tobacco is not a healthy alternative to cigarette smoking; both products pose health risks," the ADA said. "Suggesting one product is somehow 'safer' than the other dilutes that vital public health message."

FDA's 12-page letter rejecting the petition said that the law allows the agency to adjust the warnings through rulemaking if it finds that a change in the warning would promote greater public understanding of the risks associated with the use of smokeless tobacco products. But current scientific evidence and comments in the regulatory docket do not support a change, the FDA said.

"Based on its review, FDA does not intend to propose any changes to the smokeless tobacco warnings at this time," the letter said. "However, new developments in research may be pivotal in determining whether changes to warning statements should be made. FDA intends to monitor the warning statements on smokeless tobacco products for effectiveness and may propose changes to the smokeless tobacco warnings if there is evidence to show that such changes would promote greater public understanding of the risks associated with smokeless tobacco products."

FDA's adoption of the proposed warning would in effect give all smokeless tobacco products the status of modified risk tobacco products without the demonstrations required by the Federal Food, Drug and Cosmetic Act, including those relating to the benefit of the population as a whole, the rejection letter said.