No Disproportionate Impact on Public Health
This website provides scientific information about menthol and its use in cigarettes. Your host is William R. True, Ph.D., Senior Vice President of Research and Development for Lorillard Tobacco Company. Dr. True joined Lorillard Tobacco Company in 2002. Earlier in his career, he worked in executive and scientific positions for major U.S. corporations. He has a doctorate in organic chemistry from Vanderbilt University, Nashville, Tenn.
In 2009, a new federal law - the Family Smoking Prevention and Tobacco Control Act - set in motion a science-based process to evaluate the impact on public health of menthol as an additive in cigarettes.
The U.S. Food and Drug Administration (FDA) is currently reviewing comments to a preliminary scientific evaluation of menthol cigarettes that it issued in 2013 to meet its obligations under the law. FDA also is in an information-seeking mode, awaiting results of several additional studies it commissioned in 2013, some of which are long-term studies, as well as reviewing comments submitted in response to questions FDA asked in its Advanced Notice of Proposed Rulemaking in 2013.
On July 21, 2014, nearly one year after FDA issued its preliminary scientific evaluation, U.S. District Judge Richard J. Leon found several members of the Tobacco Products Scientific Advisory Committee (TPSAC), a committee appointed by FDA that reviewed scientific research and issued a nonbinding advisory report on menthol cigarettes in 2011, had conflicts of interest that fatally tainted its composition and work.
Judge Leon ordered FDA to "reconstitute the TPSAC membership so that it complies with the applicable ethics laws" and barred FDA from "using or relying on [TPSAC's 2011] Menthol Report in any manner." (See timeline below for more detail.)
Ultimately, we believe sound regulatory science will show there is no justification for regulating menthol cigarettes any differently than nonmenthol cigarettes.
Timeline and Key Documents
2011.In March 2011, the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) provided a non-binding report and recommendation on menthol to FDA.
At the same time, Lorillard and other industry stakeholders submitted to FDA "The Industry Menthol Report," which summarized scientific evidence. It demonstrated that "there is no scientific basis to support the regulation of menthol cigarettes any differently than nonmenthol cigarettes."
The Industry Report also showed the potential countervailing effects of any restriction in availability, including the likelihood of exacerbating the current illegal market in cigarettes, which would have adverse public health effects.
2013.FDA issued a scientific assessment in July 2013 and also issued an Advance Notice of Proposed Rulemaking. At the same time FDA announced that it was funding new studies related to menthol in cigarettes, acknowledging that current evidence is insufficient to support disproportionate regulation on menthol cigarettes.
The period to comment on the two FDA documents closed in November 2013. Lorillard commented on the advance notice and in addition FDA received more than 200,000 comments from individuals, groups, public officials and others, the vast majority of which opposed disproportionate rules for menthol cigarettes.
2014.In his July 21, 2014 opinion, Judge Leon said FDA erred in determining that three challenged members of TPSAC did not have financial and appearance conflicts of interest. Their appointment was "arbitrary and capricious," he said, and "fatally tainted the composition of the TPSAC and its work product, including the Menthol Report."
He added: "Here, the presence of conflicted members on the Committee irrevocably tainted its very composition and its work product. In turn, the Committee's findings and recommendations, including reports such as the Menthol Report, are, at a minimum, suspect, and, at worst, untrustworthy."
He remanded the case "for the appointment of a newly-constituted, interest free, TPSAC panel of authorities consistent with the applicable ethics laws." In a separate order, Judge Leon enjoined FDA "from using or relying on the Menthol Report in any manner."