FDA deflects challenge from Reynolds, Lorillard, others..

October 2, 2009 - Marketing restrictions in the law giving the U.S. Food & Drug Administration (FDA) authority over tobacco do not violate free speech and serve a greater public health interest, the government said in a response to a legal challenge by two of the nation's largest tobacco companies, reported the Associated Press. (R.J. Reynolds, Lorillard, others file suit claiming law restricts communication..

Meanwhile, the FDA on Thursday began collecting millions in fees from the nation's tobacco companies to help fund the agency's newly granted authority to regulate the industry. The user fees, which will be collected quarterly, are based on each company's share of the U.S. tobacco market. (FDA - began collecting fees from nations tobacco companies..)

R.J. Reynolds Tobacco Co., maker of Camel cigarettes, and Lorillard Inc., which sells the Newport menthol brand, filed the federal lawsuit with several other tobacco companies in August to block those marketing restrictions, claiming the provisions violate their right to free speech and restrict their ability to communicate with consumers. It is the first major challenge of the legislation passed and enacted in June. The lawsuit, which named the FDA, the government and individual officials as defendants, does not challenge the decision to give the FDA authority over tobacco products.

The government gave a full-throated defense of the public health interest in the regulations. "The health risks associated with tobacco use and nicotine addiction are overwhelming and incontrovertible," the government wrote in its response. "Tobacco use is not only deadly but also addictive."

Eleven public health and consumer advocacy groups on Wednesday, October 1st also asked the federal court (UNITED STATES DISTRICT COURT FOR THE WESTERN DISTRICT OF KENTUCKY BOWLING GREEN DIVISION) to reject the lawsuit, saying the provisions are narrowly tailored to satisfy First Amendment constitutional requirements and is designed to end "decades of false health claims that have misled millions of smokers." Information submitted to the federal court: MEMORANDUM OF AMICI CURIAE.. (Amicus curiae (friend of the court), that refers to someone, not a party to a case, who volunteers to offer information on a point of law or some other aspect of the case to assist the court in deciding a matter before it. The information may be a legal opinion in the form of a brief, a testimony that has not been solicited by any of the parties, or a learned treatise on a matter that bears on the case. The decision whether to admit the information lies with the discretion of the court.)

The law that started to take effect last month gives the FDA authority over tobacco for the first time and lets the agency reduce nicotine in tobacco products, ban candy flavorings and block labels such "low tar" and "light." Tobacco companies also must put large graphic warnings over any carton images.

The companies said in their lawsuit that the law, which takes full effect in three years, prohibits them from using "color lettering, trademarks, logos or any other imagery in most advertisements, including virtually all point-of-sale and direct-mail advertisements." The complaint also says the law prohibits tobacco companies from "making truthful statements about their products in scientific, public policy and political debates."

The tobacco makers say the new mandated health warnings for cigarettes would relegate the companies' branding to the bottom half of the cigarette packaging, making it "difficult, if not impossible, to see."

Joining in the suit filed in U.S. District Court in Bowling Green, Ky., are National Tobacco Co., Discount Tobacco City & Lottery Inc., and Kentucky-based Commonwealth Brands, which is owned by Britain's Imperial Tobacco Group PLC.

Reference: FDA Deflects Challenge Says new tobacco regulation does not violate free speech; begins collecting fees, Convenience Stores / Petroleum (CSP) Daily News, 10/2/2009.

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