FDA defends against cigarettes makers challenge of law

RICHMOND, Va. - Marketing restrictions in the law giving the U.S. Food and Drug Administration 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.

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, doesn’t 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 goverment wrote in its response. “Tobacco use is not only deadly but also addictive.”

Eleven public health and consumer advocacy groups on Wenesday also asked the federal court to reject the lawsuit, saying the provisons 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.”

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.

Richmond, Va.-based Altria Group Inc., parent company of the nation’s largest tobacco maker, Philip Morris USA, supported the bill and has not joined the lawsuit.

Altria’s chief rivals - No. 2 Reynolds American Inc., parent company of R.J. Reynolds, and No. 3 Lorillard, both based in North Carolina - opposed the bill, saying FDA restrictions on new products would lock in Altria’s share of the market. Altria’s brands include Marlboro, the top-selling brand in the U.S.


By MICHAEL FELBERBAUM

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