Tobacco

Menthol: 'Evidence Is Insufficient'

Menthol not shown to raise health risks of smoking, says draft of FDA TPSAC report
WASHINGTON -- Smokers do not face more risks of tobacco-related disease from menthol cigarettes than unflavored cigarettes, a U.S. advisory panel said in a draft report. "The evidence is insufficient" to conclude that menthol smokers face a different disease risk than people who use regular cigarettes, said advisers to the Food & Drug Administration (FDA), according to Bloomberg. Still, menthol may make smoking more addictive, the panelists said. The comments were posted yesterday on the FDA website in two draft chapters of a report the panel must submit by March 23.

The [image-nocss] Tobacco Products Scientific Advisory Committee (TPSAC) nonbinding report is required by a 2009 law that restricts tobacco marketing and bars cigarette makers from adding flavors such as clove or strawberry. An FDA conclusion that menthol cigarettes are more dangerous than unflavored versions may lead to a ban, the report said.

Menthol products account for about 30% of the $85 billion in annual U.S. cigarette sales. Lorillard Inc.'s Newport is the top-selling menthol brand with $5 billion a year in revenue, followed by Marlboro Menthol from Altria Group Inc. and Reynolds American Inc.'s Camel Menthol, Kool and Salem, according to data compiled by Bloomberg.

There is not enough evidence to conclude that menthol smokers inhale more smoke or are exposed to higher nicotine levels than nonmenthol smokers, according to a draft chapter titled "Effects Of Menthol on the Disease Risks of Smoking" (click here).

Still, it is "biologically plausible" that menthol flavoring makes cigarettes more addictive, the panel said in a separate draft chapter, titled "The Physiological Effects of Menthol Cigarettes" (click here).

"Menthol provides an unmistakable sensory experience--the minty taste, cooling sensation and throat irritation or impact," the panelists said. "The taste and odor are pleasurable for menthol cigarette smokers and may reinforce smoking behavior."

Disease risks also are not the only indicator of menthol cigarettes' impact on public health, panel members said in a draft of the report's first chapter.

"The availability of menthol cigarettes could have no significant effect on risk for disease outcomes, yet have a significant effect on increasing initiation or reducing the success of cessation," the panel said in its draft. "The resultant increase in the prevalence of smoking would represent a negative public health impact."

"While the market (after-hours) seemed to react positively to headlines (perhaps those related to menthol and disease risk), we believe the revelations offered by the TPSAC draft were largely in-line with the base case view," said UBS tobacco analyst Nik Modi in a research note. "While we are positive on [Lorillard] shares, we do not necessarily believe today's news materially changed the outlook for menthol or truly tipped the hand of the TPSAC's intentions. We believe the key question that still remains is: 'What will the TPSAC submit to the FDA in terms of a recommended action on menthol cigarettes?'."

Kara Henschel, a spokesperson for the FDA, emphasized for CSP Daily News that only draft chapters of the report have been shared. She suggested that readers review the "Menthol Report: What to Expect" page for details on the report release process (click here).

The TPSAC reviewed decades of published studies and FDA research, along with marketing data submitted by Altria's Philip Morris USA unit, Reynolds American and Lorillard, the three biggest U.S. tobacco companies.

Advisory panel members are scheduled to discuss the draft chapters at a meeting today, March 2.

Lorillard and Reynolds have sued the FDA to block the agency from "receiving or relying on" the advisory panel's recommendations. Three of the eight panel members have conflicts of interest, according to the complaint filed February 25 in federal court in Washington. The three panelists have served as paid witnesses in lawsuits against the tobacco industry and take money from drug companies that make smoking-cessation aids, Lorillard and Reynolds said in the complaint. Altria is not a part of the suit. (Click here for previous CSP Daily News coverage.)

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