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FDA Can’t Use Panel Findings on Menthol Cigarettes, Judge Rules


A federal judge ruled this week that the Food and Drug Administration (FDA) cannot use findings from a panel report that recommended removing menthol cigarettes from the market. Three of the panel members had conflicts of interest, the judge said.

U.S. District Court Judge Richard Leon ruled in favor of Lorillard and R.J. Reynolds, the tobacco companies that challenged the 2011 FDA panel report, according to Reuters. Leon told the FDA to reconstitute the committee.

The judge’s opinion stated three of the panel’s expert doctors had worked for lawyers who were suing tobacco manufacturers, or consulted for drug companies that designed smoking-cessation medications. “The presence of conflicted members on the Committee irrevocably tainted its very composition and its work product,” Leon wrote. He said the panel’s findings and recommendations were “at a minimum suspect, and, at worst, untrustworthy.”

FDA spokeswoman Stephanie Yao told Reuters the agency is reviewing the decision to determine how to proceed.

The Family Smoking Prevention and Tobacco Control Act, which became law in 2009, gives the FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. The FDA convened the panel of outside experts to consider the public health risks of menthol cigarettes.

In March, a group of former top health officials urged tobacco companies to stop marketing and selling menthol cigarettes. The group includes all of the living former U.S. Secretaries of Health, Surgeons General, and Directors of the Centers for Disease Control and Prevention.

The group, called the Citizens’ Commission to Protect the Truth, also called on the Obama Administration to allow the FDA to ban menthol flavoring in cigarettes. In November, the attorneys general of 24 states urged the FDA to ban the sale of menthol cigarettes.

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