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FDA Sued Over Menthol Cigarettes

February 28, 2011

Reynolds and Lorillard, the second- and third-biggest US cigarette makers, filed suit to block the US Food and Drug Administration (FDA) from receiving recommendations from an advisory committee that the cigarette makers claim have conflicts of interest, Reuters is reporting.

Reynolds, a unit of Winston-Salem, North Carolina-based Reynolds American Inc., makes Camel and Winston cigarettes in addition to its Kool and Salem menthol brands. Lorillard Tobacco is a unit of Lorillard Inc., based in Greensboro, North Carolina. It makes Newport, the top-selling menthol brand.

The plaintiffs seek an order preventing the FDA from receiving the report, which is thought to include recommendations on the use of menthol in cigarettes. Mentholated cigarettes make up roughly 30 percent of US annual cigarette sales of more than $83 billion, according to Euromonitor International.

The FDA was given regulatory power over tobacco products in 2009 and the legislation called on the FDA to seek advice from a panel of outside experts before determining whether menthol cigarettes should also be taken off the US market.

Filed in US District Court for the District of Columbia, the lawsuit accuses three panel members of having “severe financial and appearance conflicts of interest and associated biases,” and the suit claims these three advisers have received funding for research or consultation work from drug makers that make smoking-cessation products.

According to the suit, two others on a panel subcommittee also have biases because they have served as paid expert witnesses in lawsuits against tobacco companies. Health advocates denounced the lawsuit as a frivolous attempt to keep the FDA panel’s recommendation from coming to light.

Matthew Myers president of the Campaign for Tobacco-Free Kids, tells Reuters, “They fear that the committee, having examined the evidence, will recommend effective actions that reduce or eliminate the lucrative market for menthol cigarettes, said “Once again, they are putting profits ahead of lives and health.”

Since the FDA’s panel began holding meetings last year, all three companies have spoken out against any menthol ban. The advisers are scheduled to meet on March 2 and March 17 ahead of issuing its report. The FDA is not bound to follow its recommendations and the law did not set a deadline for any action on menthol.

“As a matter of general policy, the FDA does not comment on possible, pending or ongoing litigation,” FDA spokesman Jeff Ventura concluded.

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