TPSAC Accepts Menthol Report Changes

Committee reiterates recommendation after editorial changes and discussion

ROCKVILLE, Md. -- The Tobacco Products Scientific Advisory Committee (TPSAC) voted unanimously (8-0) at a meeting last week to accept its menthol report reflecting editorial changes. But not everyone was in agreement about the report's recommendation.

The report, initially released in March, concluded that the "removal of menthol cigarettes from the marketplace would benefit public health in the United States."

TPSAC members at last week's meeting said they continue to agree with the recommendation. "No matter what you say, there is a clear biological plausibility [image-nocss] that menthol is responsible for some people smoking who would not otherwise smoke," said committee member Neal Benowitz. Other reasons cited by committee members included youth and African-American propensity toward menthol.

On the other side of the issue, industry comments included concerns about the science base used in the report, a lack of compelling evidence that menthol cigarettes are more harmful than non-menthol cigarettes and concerns about contraband.

The tobacco industry also weighed in on the report with public submissions:

"The evidence is suggestive of no causal relationship between the use of menthol in cigarettes and changes in the inherent toxicity of smoke; changes in average daily smoke exposure; changes in the health risks from smoking; dependence; cessation-related outcomes; smoking prevalence," according to a report from Altria Group Inc.

And according to Lorillard Inc. documentation: "Overall, Lorillard has serious concerns about the rigor and reliability of the TPSAC report. Further, Lorillard strongly disagrees with the conclusions and recommendations of the report."

Prior to the vote, Jonathan Sahmet, TPSAC chair, said, "Because there's been so much comment about what we said and what we didn't say, we didn't use the word 'ban.'" He pointed out that the recommendation reads 'removal,' and that the FDA has a variety of mechanisms to consider. He wanted to remind everyone "that in making this recommendation and addressing the question of adverse public health impact, we did not explore one or another potential scenario that might be pursued with regard to addressing menthol cigarettes."

The FDA is expected to submit its draft independent review of the science related to the impact of menthol in cigarettes on public health to an external peer review panel. The agency then will make the results of the peer review and the preliminary scientific assessment available for public comment in the Federal Register.

The TPSAC meeting also included initial discussions about dissolvable tobacco products. The committee plans to submit a report on its findings on dissolvables by March 23rd, 2012.

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