FDA Questions Tobacco Industry Response On Menthol Requests

First Published Thursday, 1 January 1970 12:01 am – © 2010 Dow Jones

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- A Food and Drug Administration official Thursday questioned the responsiveness of the tobacco industry in providing information about menthol cigarettes.

During a tobacco products scientific advisory committee meeting, Corinne Husten, a senior medical advisor at the FDA’s Center for Tobacco products, said the industry didn’t respond by an Aug. 26 deadline for an agency request to provide information on the quantities of menthol and nicotine by brand from 2000 to 2010.

But the information request on menthol levels is considered voluntary. It was included in a broader, mostly mandatory, request sent to more than 100 tobacco firms in May that sought information about the impact of menthol on tobacco dependence and the marketing of menthol products, among other things.

Jonathan Daniel Heck, a panel member representing industry who also works for Lorillard Tobacco Company, said he had believed the industry had responded to all of FDA’s requests including providing both the mandatory and voluntary information.

Later Thursday, Husten clarified what had been received and said that as of Oct. 6 some companies provided “brief summaries” and others chose not to respond to the requests for voluntary menthol information. She said the companies didn’t provide “health and research” documents on things like menthol levels.

William True, the senior vice president for research and development at Lorillard Tobacco Company, spoke during the open public hearing portion of the panel meeting. He explained that Lorillard provided information in a format it thought would be most useful to the FDA such as providing charts showing nicotine and menthol levels in its products.

Lorillard is one of largest manufacturers of menthol-flavored cigarettes. Menthol cigarettes account for roughly one-third of the $70 billion U.S. cigarette market, according to industry figures.

A representative for Altria Group Inc. (MO), the parent company for Philip Morris USA, said Philip Morris provided both the mandatory and the voluntary information about menthol in cigarettes to FDA.

The FDA was given the authority to regulate tobacco products as part of a new law last year. All tobacco flavorings except for menthol were banned on concerns the flavors enticed children and adolescents to start smoking.

The FDA is considering what, if anything, to do about menthol and has charged its tobacco products scientific advisory committee with writing a report about the public health impact of menthol.

The menthol report is due next March and the tobacco panel is holding a serious of meetings as it considers what information to include in the report.

One question is whether menthol masks the harshness of tobacco and makes it easier to smokes cigarettes and harder to quit.

The tobacco industry has said there is no evidence that menthol in cigarettes makes it more likely people will start smoking compared to regular cigarettes.

The FDA could limit the amount of menthol used in cigarettes or ban its use altogether. One concern is whether a ban would create an illegal black market for menthol products given their widespread use.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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