R.J. Reynolds Tobacco Co./Lorillard Tobacco Co. sued to block FDA TPSAC menthol recommendations..



February 26, 2011 - R.J. Reynolds Tobacco Co. (unit of Reynolds American, Inc.) and Lorillard Tobacco Co. sued to block the U.S. Food and Drug Administration (FDA) from receiving recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC) that includes members that the cigarette makers claim have conflicts of interest. (Case is Lorillard Inc. v. U.S. Food and Drug Administration, 11-cv-00440, U.S. District Court, District of Columbia (Washington).)

Reynolds and Lorillard, the second- and third-biggest U.S. cigarette makers, filed the complaint today in federal court in Washington. They seek an order preventing the FDA from receiving the report, which is to include recommendations on the use of menthol in cigarettes.
The Tobacco Products Scientific Advisory Committee (TPSAC) is currently developing a report and recommendations on the impact of the use of menthol in cigarettes on the public health. The report and recommendations are due to the Secretary of the U.S. Department of Health and Human Services (HHS) by March 23, 2011. As the due date draws near, the U.S. Food and Drug Administration (FDA) looks forward to receiving the report from the Committee. FDA also understands that members of the tobacco industry, members of public health and tobacco control organizations, as well as the general public are eager to see the report and may have questions about the actions FDA will take after receiving the report. Therefore, FDA has outlined what is to come over the next few months as the Committee finalizes the report.

There is no required deadline or timeline for the FDA to act on the recommendations provided by the Committee in the report. Any action(s) taken by the FDA that lead to sale/distribution restrictions or establishment of product standards require formal rule making that includes public notice and comment. Therefore, receipt of the report and recommendations by the FDA will not have an immediate effect on the availability of menthol cigarettes.
Menthol report what to expect??
Three of the eight committee members “have severe financial and appearance conflicts of interest and associated biases,” the companies said in their complaint. The three members serve as paid expert witnesses in lawsuits against the tobacco industry and take money from drug companies that make nicotine-replacement products and other smoking-cessation aids, according to the complaint.
Some TPSAC background information:
August 25, 2009 - The U.S. Food and Drug Administration (FDA) today announced an action regarding the implementation of the Family Smoking Prevention and Tobacco Control Act. The Agency has officially established the Tobacco Products Scientific Advisory Committee (TPSAC). (FDA Moves Forward on Implementation of Tobacco Law..)

March 1, 2010 - FDA - Roster of the Tobacco Products Scientific Advisory Committee..

JUne 27, 2010 - Commentary - the FDA CTR Scientific Advisory Committee..

August 17, 2010 - FDA CTP justification for selection of members of Scientific Advisory Committee..

September 8, 2010 - CRE states that the FDA Tobacco Advisory Committee is in violation of the Federal Advisory Committee Act ..

January 6, 2011 - The Food and Drug Administration (FDA) has lost an adviser to the Tobacco Products Scientific Advisory Committee (TPSAC) - Dr. Gregory N. Connolly..
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. (Lorillard - essentially a one-product company - Newport cigarettes..)

Jeffrey Ventura, an FDA spokesman, declined to comment on the suit.

Altria Group Inc.’s Philip Morris USA unit is the biggest U.S. cigarette maker.

References: Reynolds, Lorillard Sue to Block U.S. Panel Views on Menthol in Cigarettes by Bob Van Voris (rvanvoris@bloomberg.net), Bloomberg.com, 2/25/2011;
Tobacco companies sue to thwart federal panel, claiming bias
by the CNN Wire Staff, CNN Health, 2/25/2011

1 comments:

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