Lorillard Urges Science-based Regulatory Process in Submission on Menthol Review

GREENSBORO, N.C., July 13 /PRNewswire/ -- Lorillard Tobacco Company (NYSE: LO) today released a submission to the Tobacco Products Scientific Advisory Committee (TPSAC) of the Food and Drug Administration, urging TPSAC to use objectivity and a single scientific standard in considering all worthy studies on the health effects of menthol in cigarettes rather than cherry picking studies and misrepresenting findings.

The submission presented findings of scientific studies about the impact of menthol to clarify presentations made by FDA staff members to TPSAC members in March that contained significant omissions and inaccurate reports.  The best available science "demonstrates that menthol in cigarettes has no meaningful effect on public health," Lorillard said in the submission. "And the overwhelming body of epidemiology shows that smoking-related disease risk is not increased by the presence of menthol."  TPSAC is developing a report and recommendation for the FDA on the use of menthol in cigarettes.

"Some presentations failed to include important available published scientific studies on menthol in cigarettes and made only passing mention of, or entirely omitted, worthy studies that have not found menthol to be associated with meaningful adverse health effects," the submission said.  "In some instances, the presentations delivered to the TPSAC included interpretations that were contradictory to those of the authors of the cited published papers."

A cover letter from William R. True, Ph.D., senior vice president, research and development, and the submission, including excerpted quotes from studies, are available at the Lorillard-sponsored website, www.understandingmenthol.com.

As one example, the Lorillard submission said FDA presentations omitted five smoking topography studies that are inconsistent with an assertion that menthol in cigarettes may increase smoking intensity.  Omitting those studies, Lorillard said, "is exemplary of the bias evident in the FDA staff briefings that were represented to the TPSAC as objective summaries of published scientific literature."

The submission also cited a presentation on tobacco-related diseases that attempted to cast doubt on the overwhelming body of epidemiology data which shows that menthol does not increase smokers' disease risk by stating that the findings "…may not be so straightforward..."  Any suggestion that the results of menthol epidemiology "are equivocal or mixed are scientifically invalid," Lorillard said.

Thirteen existing epidemiological studies compare smoking-related disease outcomes between menthol and non-menthol cigarette smokers.  "Twelve of the thirteen studies reported no significant differences between menthol versus non-menthol smokers for any of the health outcomes evaluated," the submission said.  "The overwhelming findings of these studies demonstrate that menthol in cigarettes plays no role in the inherent disease risks of smoking."

About Lorillard, Inc.

Lorillard, Inc. (NYSE: LO) is the third largest manufacturer of cigarettes in the United States. Founded in 1760, Lorillard is the oldest continuously operating tobacco company in the U.S. Newport, Lorillard's flagship menthol-flavored premium cigarette brand, is the top selling menthol and second largest selling cigarette in the U.S. In addition to Newport, the Lorillard product line has five additional brand families marketed under the Kent, True, Maverick, Old Gold and Max brand names. These six brands include 41 different product offerings which vary in price, taste, flavor, length and packaging. Lorillard maintains its headquarters and manufactures all of its products in Greensboro, North Carolina.

Forward-Looking Statements

Certain statements made in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, or the Reform Act. Forward-looking statements include, without limitation, any statement that may project, indicate or imply future results, events, performance or achievements, and may contain the words "expect," "intend," "plan," "anticipate," "estimate," "believe," "may," "will be," "will continue," "will likely result" and similar expressions. In addition, any statement that may be provided by management concerning future financial performance (including future revenues, earnings or growth rates), ongoing business strategies or prospects and possible actions by Lorillard, Inc. are also forward-looking statements as defined by the Reform Act.

Forward-looking statements are based on current expectations and projections about future events and are inherently subject to a variety of risks and uncertainties, many of which are beyond our control, that could cause actual results to differ materially from those anticipated or projected. Information describing factors that could cause actual results to differ materially from those in forward-looking statements is available in Lorillard, Inc.'s filings with the Securities and Exchange Commission (the "SEC"), including but not limited to, our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These filings are available from the SEC over the Internet or in hard copy, and are available on our website at www.lorillard.com. Forward-looking statements speak only as of the time they are made, and we expressly disclaim any obligation or undertaking to update these statements to reflect any change in expectations or beliefs or any change in events, conditions or circumstances on which any forward-looking statement is based.

Contact: Gregg Perry, (401) 886-7200, [email protected]

SOURCE Lorillard, Inc.