RJ Reynolds and Lorillard sue FDA

The major U.S. tobacco companies, Lorillard Inc. and RJ Reynolds Tobacco have filed lawsuits accusing two federal bodies, including the FDA of menthol cigaretteshiring members of tobacco advisory committee that have conflict of interests. The suit filed to the District of Columbia Court as well includes Department of Health and Human Services, together with its executives and the director of the Food And Drug Administration’s Center of Tobacco products.

The U.S. Food and Drug Administration was entitled with the authority to regulate tobacco industry in June 2009, under the Tobacco Control Act signed by President Obama, but it could not prohibit nicotine in tobacco products. The tobacco companies are willing to have the court stop the federal agency from getting on relying on recommendations especially regarding the menthol flavoring in cigarettes and smokeless-tobacco products, from the Tobacco Products Advisory Committee, comprised mainly of authorities with tobacco control or health care.

The issue around menthol flavoring is vital for both cigarette-makers. Lorillard makes Newport brand, the leading menthol cigarette brand in the USA, while Reynolds American has won market share recently with growing sales of cigs4us.biz/virginia-cigarette menthol cigarettes.
The advisory committee is scheduled to provide a non-obligatory recommendation on the usage of menthol flavoring in tobacco products by the end of March. “We decide to file that suit to contest the composition and the actions of the committee, not to challenge any recommendations expected by the committee,” admitted David Howard, senior communications manager for Reynolds American. “To underline our intention, we decided to file the lawsuit before the committee gives any recommendations.”

Jeff Venture, the spokesman for the FDA denied to comment about the litigation, citing the agency’s general policy.
The tobacco companies as well are willing to keep the federal agency from disclosing to the committee any confidential information until the committee is legally in place. The news about the lawsuit doesn’t surprise the industry analysts.

Even until the panel was established last March, both tobacco giants expressed their concerns on whether certain members might be open-minded regarding menthol and smokeless tobacco since they previously were against those products. The committee is also entitled to examine new tobacco products, such as dis-solvable tobacco manufactured by RJ Reynolds.

An objective examination of smokeless tobacco is vital, according to the tobacco companies, as the manufacturers of nicotine-replacement products are competing the tobacco companies for the adult smokers’ audience. Reynolds counsel Martin Holton III stated they sent several letters to the Food and Drug Administration since summer, notifying about possible conflicts of interest. Other tobacco companies, such as Philip Morris USA have sent similar letters as well.

“The Food and Drug Administration has not given a response to the certain statements in our letters,” Holton stated. “We consider the only way to have our arguments taken in consideration seriously is by means of the lawsuits..”

The tobacco companies claimed that three out of the eight voting members of the advisory committee have conflicts since they have been paid witnesses in lawsuits against tobacco companies.

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