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Judge says FDA can't use advisory panel's 2011 report on menthol cigarettes, citing conflicts

RICHMOND, Va. - The Food and Drug Administration can't use an advisory panel's 2011 report on menthol cigarettes because its members had conflicts of interest, a federal judge ruled Monday.

While the agency has since conducted an independent review on the public health impact of menthol cigarettes, the ruling could hinder the FDA's ability to defend any future regulation of the minty smokes.

U.S. District Court Judge Richard Leon in Washington ordered the FDA on Monday to reconstitute the tobacco panel and barred the agency from using its older report on menthol cigarettes.

Cigarette makers Lorillard Inc. and Reynolds American Inc. sued the agency in 2011, alleging conflicts of interest and bias by several members of the panel tasked with advising the FDA on tobacco-related issues.

They argued that the panel failed to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest. The lawsuit specifically alleged that some committee members had conflicts of interest because they were paid expert witnesses in anti-tobacco lawsuits and had financial ties to pharmaceutical companies that make smoking-cessation products.

The agency, however, argued that the panel met federal standards and that the cigarette makers' "alleged injuries are entirely speculative."

In his order Monday, Leon said the FDA erred in determining that the members didn't have conflicts of interest and therefore, the agency's appointment of those members was "arbitrary and capricious," and tainted both the panel and its work.

"Conflicts of interest — whether actual or perceived — undermine the public's confidence in the agency's decision-making process and render its final product suspect, at best," he wrote.

Dr. Jonathan Samet is the only remaining member of the Tobacco Products Scientific Advisory Committee challenged in the lawsuit. Samet, director of the University of Southern California's Institute for Global Health and former director of the Institute for Global Tobacco Control at Johns Hopkins University, serves as the panel's chair. He did not immediately respond to a request seeking comment.

Representatives with the FDA, Lorillard and Reynolds American did not immediately provide comment following the late Monday ruling.

In 2013, the FDA's independent review concluded that menthol cigarettes likely pose a greater public health risk than regular cigarettes but did not make a recommendation on whether to limit or ban them. The agency's evaluation concluded that there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to smokers than regular cigarettes. However, there is adequate data to suggest that menthol use is likely associated with increased smoking initiation by younger people and that menthol smokers have a harder time quitting, the review said.

The 2011 FDA advisory panel report, which was mandated under the 2009 law giving the agency the authority to regulate tobacco, made many of the same findings, and said that removing menthol cigarettes from the market would benefit public health.

A menthol ban or other restriction on the flavoured cigarettes would fall heavily on Greensboro, North Carolina-based Lorillard, whose Newport brand is the top-selling menthol cigarette in the U.S., with more than 37 per cent of the market. Last week, Winston-Salem, North Carolina-based Reynolds American, the maker of Camel cigarettes, announced plans to buy Lorillard for $25 billion, creating a powerhouse in menthol cigarettes, which are becoming a bigger part of the business.

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Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum .

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