Lorillard calls upon FDA TPSAC to employ dispassionate science in evaluation of menthol in cigarettes

Data is Overwhelming and Consistent

With the words of Food and Drug Commissioner Margaret Hamburg on the screen beside him, a Lorillard Tobacco Company (NYSE: LO) scientist today called upon the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) to employ a "truly science-based, data-driven" process in its evaluation of menthol in cigarettes.  Earlier this week Hamburg made headlines when she told an FDA science panel to "Follow the science wherever it leads and the rest will fall into place."

"The data is overwhelming and consistent – menthol has no effect on the health risks of smoking," Dr. William R. True, senior vice president, research and development, said in a presentation at the conclusion of two days of committee hearings.

The process of evaluating the health effects of menthol "seems to have begun with an underlying presumption by several Committee members that menthol must have some adverse effect and, despite all the evidence to the contrary, the Committee members keep searching for some data that might support their presumption,"  True said.

"Science has to be dispassionate," he said.  "When the data doesn't support the hypothesis, the hypothesis must be abandoned.  That is the scientific method; that is sound science."

Legislation signed into law last year authorized the Food and Drug Administration (FDA) to regulate cigarettes and other tobacco products. One provision of the law mandated the creation of TPSAC, which will submit a report and recommendation on the use of menthol in cigarettes to the FDA.

The full statement as delivered by Dr. True:

"Extensive and conclusive data on the health effects of menthol in cigarettes already exists.  The major manufacturers have done their best to provide the information requested by the Committee, not only through the presentations over the past two days, but also with hundreds and perhaps thousands of pages of submissions and extensive bibliographies of relevant published studies.

"In addition, an extensive document production has already been made to FDA – and another will be made in August – and all the detailed product information has been provided to the FDA.

"The Committee says it needs more data.

"Thirteen epidemiology studies – the gold standard of evaluating disease risk.  

"The largest cigarette biomarker study ever conducted – Phillip Morris' study with 3,600 smokers, over ten times the number of smokers in any study.

"Three of the four national surveys show no effect of menthol on initiation, dependence or cessation.

"The data is overwhelming and consistent – menthol has no effect on the health risks of smoking.  

"Or, is the Committee adopting a standard that requires more than thirteen epidemiology studies and biomarkers studies of more than 3,600 participants to come to any conclusion on any health issue related to cigarettes?

"The process of evaluating the health effects of menthol seems to have begun with an underlying presumption by several Committee members that menthol must have some adverse effect and, despite all of the evidence to the contrary, these Committee members keep searching for some data that might support their presumption.

"The undercurrent of this notion appears to be preventing this evaluation process from being truly science-based and data-driven.  Science has to be dispassionate.  When the data doesn't support the hypothesis, the hypothesis must be abandoned.  That is the scientific method; that is sound science."