FDA Says Menthol Cigarettes Likely Have Health Impact

Lorillard Inc. (LO), Altria Group Inc. (MO) and other tobacco companies may face limits on selling menthol cigarettes in the U.S. after regulators determined the minty flavoring may encourage people to start smoking.

The Food and Drug Administration, in a preliminary evaluation today, stopped short of proposing a ban. The FDA is instead asking for input on whether to set standards prohibiting or limiting menthol in cigarettes. A panel of advisers to the FDA determined in 2011 that ending menthol sales would benefit public health because the flavor lures people to start smoking.

Menthol makes up about 30 percent of the cigarette market, Lorillard, the largest U.S. maker of such products, said on its “Understanding Menthol” website. Greensboro, North Carolina-based Lorillard makes the Newport brand of menthol cigarettes, while Altria’s Philip Morris USA unit sells menthol versions of Marlboro. Reynolds American Inc. (RAI) makes Camel, Kool and Salem.

“Menthol cigarettes raise critical public health questions,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said on a conference call. “We need more information on outcomes and we are honestly soliciting comment in response to the questions about regulatory outcomes.”

He declined to comment on when the agency may take regulatory action.

Lorillard fell 4.5 percent to $44.08 at 4 p.m. New York time. Reynolds lost 2 percent to $50.80, while Richmond, Virginia-based Altria declined 2.4 percent to $35.99.

Softer Tone

The softer tone of today’s FDA evaluation compared to the 2011 advisory panel report suggests “a ban is very unlikely,” Bonnie Herzog, an analyst at Wells Fargo & Co. in New York, wrote today in a note. She recommends buying Lorillard shares and said, “it could still be a long time until some type of final resolution is ultimately reached.”

The FDA’s evaluation was expected for some time, Murray Kessler, Lorillard’s chief executive officer, said in an e-mailed statement. Lorillard is encouraged by the comments “reiterating FDA’s science-based approach and the commitment and need to conduct rigorous research to ensure that FDA’s actions, if any, are based on sound science,” Kessler said.

Companies have been waiting on a menthol determination from the FDA since the agency was given authority by Congress to regulate the cigarette flavoring under a 2009 law covering tobacco products. The industry argued in a March 2011 report the science doesn’t support any claim menthol cigarettes have a disproportionate impact on public health.

Black Smokers

Altria Chief Executive Officer Martin Barrington told analysts today on a conference call that he hadn’t reviewed the FDA report and declined to comment. Reynolds will respond to the FDA’s notice after reviewing the documents, Maura Payne, a company spokeswoman, said in an e-mail. If the FDA decides to regulate menthol in cigarettes, Reynolds doesn’t expect “any impact on the marketplace in the short term” because of the length of the regulatory process, she said.

Menthol cigarettes probably are associated with increased dependence and reduced success in smoking cessation, especially among black smokers, the FDA said in the preliminary evaluation. The ingredient itself isn’t a danger.

“From the available studies, the weight of evidence supports the conclusion that menthol in cigarettes is not associated with an increase in disease risk to the user compared to non-menthol cigarette smokers,” the FDA said.

The FDA plans to research menthol levels in cigarettes and assess the different effect minty smokes have on quitting compared to non-flavored versions. The agency also will study genetic differences in taste perceptions that may explain why more black smokers prefer menthols and toxin exposure created by both types of cigarettes, Zeller said.

“Any decision on menthol under my watch will be based on rigorous science,” Zeller said.

The 2009 law also gave the FDA the authority to determine which current tobacco products can remain on the market and which new ones can be introduced. Lorillard won the first two clearances from the FDA in June to market new tobacco products among 500 requests. The agency cleared two non-menthol Gold Box cigarettes from the tobacco company for sale.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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