WASHINGTON -- The U.S. Food & Drug Administration (FDA) has denied a citizen petition from R.J. Reynolds Tobacco Co. and American Snuff Co. LLC on modified risk.
The petition asked the FDA to initiate a rulemaking to change one of the four smokeless tobacco warning statements currently required by the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention & Tobacco Control Act of 2009.
The FDA received the citizen petition on July 29, 2011, asking it to change the current statement, “WARNING: 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.”
The FDA denied the citizen petition, it said, after “thoroughly reviewing the available scientific evidence and public comments. The agency determined there is insufficient evidence to demonstrate that a change in the warnings would promote greater public understanding of the risks associated with the use of smokeless tobacco products.”
“R.J. Reynolds Tobacco Co. and American Snuff Co. are disappointed with the FDA’s denial of the petition; however, they will continue to engage in regulatory discussions, in the belief that open lines of communications are the most effective approach to establish a science-based regulatory framework for the tobacco industry,” David Howard, as spokesperson for RAI Services Co., Winston-Salem, N.C., told CSP Daily News.
“The companies continue to believe that the challenged warning does not accurately reflect the scientific consensus regarding the comparative risks of cigarettes and smokeless tobacco products. The scientific literature demonstrates that although no tobacco product is safe, the health risks associated with cigarettes are significantly greater than those associated with the use of smokeless tobacco products. The challenged warning is, therefore, a misleading comparison because it implies that smokeless tobacco products and cigarettes present equal risks,” he continued.
“Additionally, multiple surveys show that adult tobacco consumers believe smokeless tobacco products present the same, if not more, risk to health than cigarettes. The companies continue to believe a change in the wording to one of the smokeless tobacco warnings would promote greater public understanding of the risks associated with the use of smokeless tobacco products—a principal goal of the statute that requires warnings and authorizes the FDA to change them as warranted,” he said.
In 2012, the FDA issued draft guidance on submitting applications for modified-risk tobacco products. A manufacturer who seeks to claim that its product poses fewer risks than other tobacco products may submit a modified-risk tobacco product application with scientific evidence to support that claim, the agency said.
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