US tobacco companies drop lawsuit vs FDA over labeling

Feb. 21, 2005: Cigarette butts lie in an ashtray outside a Montreal office building. (Reuters)

The three largest U.S. tobacco companies on Tuesday dropped their lawsuit accusing the U.S. Food and Drug Administration of exceeding its authority by closely monitoring the content of their product labels after the agency said it would reconsider its rules.

Altria Group Inc, Reynolds American Inc and Lorillard Inc dismissed their case after the FDA on May 29 said it would review whether to mandate advance approval for label alterations such as changes to logos and background colors, or the use of descriptors such as "premium tobacco."

In their April lawsuit filed in federal court in Washington, D.C., the companies said the 2009 Tobacco Control Act limited FDA authority to pre-approve label changes to two "narrow" circumstances: products claiming to lower tobacco-related risks, or when prior approval is required by regulation.

By expanding its oversight to cover how labels look, the FDA violated the tobacco companies' commercial speech rights under the First Amendment, the complaint said.

The plaintiffs included Altria's Philip Morris USA, Reynolds American's RJ Reynolds and Lorillard Tobacco, whose respective cigarette brands include Marlboro, Camel and Newport, and some of their smokeless tobacco units.

In its May 29 statement, the FDA said it would not act against tobacco companies that do not seek pre-approval for label changes that create "distinct" products otherwise identical to those being sold, or where the only change is the quantity in each package.

The FDA said the interim policy would remain in place while the agency decides whether to adopt new label approval procedures.

Altria spokesman Brian May said there was no need to pursue the lawsuit in light of the FDA's announcement. Reynolds American spokesman David Howard declined to comment. Lorillard did not respond to a request for comment.

FDA spokesman Michael Felberbaum declined to comment.

On May 26, Reynolds American won U.S. antitrust approval to buy Lorillard, combining the second- and third-largest U.S. cigarette companies.

The case is Philip Morris USA Inc et al v. FDA et al, U.S. District Court, District of Columbia, No. 15-00544.