Defending Menthol

Published in CSP Daily News

Tobacco industry voicing concerns over FDA examination of menthol cigarettes

GREENSBORO, N.C. -- The tobacco industry is running a full-court press ahead of a federal scientific panel's meeting to discuss how to regulate menthol cigarettes, a still-growing part of the shrinking cigarette market, said the Associated Press.

While most believe a ban is unlikely, several companies are voicing their concerns in their submissions to the federal Food & Drug Administration's (FDA) Tobacco Products Scientific Advisory Committee (TPSAC), which will hear industry presentations on how menthol is used in cigarettes, health effects, marketing efforts and impacts [image-nocss] on specific groups of people.

In their submissions to the panel, the nation's top three cigarette makers, Philip Morris USA parent Altria Group Inc., Reynolds American Inc. and Lorillard Inc. all said scientific evidence does not show that menthol cigarettes create greater health risk than non-menthol cigarettes.

Lorillard, which holds about 35% share of the U.S menthol cigarette market with its top-selling Newport brand, even launched a website late last month explaining the company's position, the science that is under review by a the committee, and the consequences of a potential ban on menthol cigarettes.

Click hereto read Richmond, Va.-based PM USA's submission.

The FDA won the authority last June to regulate tobacco, including banning certain products, limiting nicotine and blocking labels such "low tar" and "light" that could wrongly imply certain products are less harmful.

The law also banned cigarettes with flavors such as clove, chocolate or fruit, because they are believed to appeal to youth. However, menthol smokes were exempt. The FDA could order a reduction of menthol levels, bigger or more descriptive warning labels or higher mandated prices for menthol cigarettes.

The share of smokers using menthol cigarettes increased from 31% in 2004 to 33.9% in 2008, with more pronounced increases among young smokers, according to AP, citing a study released by the Substance Abuse & Mental Health Services Administration in November. It also showed that among black smokers, 82.6% used menthol cigarettes, compared with 32.3% for Hispanic smokers and 23.8% for white smokers.

But studies vary on menthol's health impacts and whether it plays a large role in enticing people to start smoking.

Greensboro, N.C.-based Lorillard Tobacco Co. released a submission to TPSAC of the FDA, urging it 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 of research and development, and the submission, including excerpted quotes from studies, are available at the Lorillard-sponsored website, www.understandingmenthol.com.

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 that 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 is scientifically invalid," Lorillard said.

A total of 13 existing epidemiological studies compare smoking-related disease outcomes between menthol and nonmenthol cigarette smokers. "Twelve of the 13 studies reported no significant differences between menthol versus nonmenthol 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."

Lorillard is the third largest manufacturer of cigarettes in the United States. Newport, Lorillard's flagship menthol-flavored premium cigarette brand, is the top-selling menthol and second-largest selling cigarette in the United States. 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.

Meanwhile, the union representing nearly 4,000 tobacco workers sent a letter to the FDA's TPSAC examining the public health effects of the minty smokes, warning that a ban could lead to "severe jobs loss" and black market cigarettes. "These are good, hardworking men and women.... They are an economic linchpin of the communities in which they live," Frank Hurt, president of the Bakery, Confectionery, Tobacco Workers & Grain Millers International Union wrote in a letter submitted late last month for the panel's second meeting Thursday.

Click hereto read the full letter.

The committee is to make its recommendations to the FDA's Center for Tobacco Products by March. The 12-member panel includes three nonvoting members representing the tobacco industry.