Tobacco companies file free speech lawsuit to derail FDA restrictions

A lawsuit by a group of tobacco companies is the opening salvo against a new federal law giving the Food and Drug Administration the authority to regulate the industry. The legal maneuver prompted harsh criticism from the medical community and public health organizations that strongly backed the Family Smoking Prevention and Tobacco Control Act, signed by President Obama in June.

The federal statute for the first time gives the FDA the power to regulate the sale and distribution of tobacco products. While the law does not allow the agency to ban tobacco sales, it does give the FDA the authority to reduce nicotine levels, require new warning labels and bar certain marketing tactics, especially those aimed at children.

The lawsuit -- filed Aug. 31 by two of the nation's largest cigarette makers, R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co., and several smaller manufacturers and retailers -- does not challenge the congressional decision to give the FDA oversight of the industry. Rather, the companies charge that certain marketing and advertising restrictions in the law violate their constitutional rights to free speech, according to the complaint filed against the FDA in the U.S. District Court for the Western District of Kentucky.

Legal experts expect the case to reach the U.S. Supreme Court. It's not the first time tobacco companies have asserted such legal arguments, having fought numerous state tobacco-related restrictions in court with mixed outcomes. The Litigation Center of the American Medical Association and State Medical Societies has participated in several of those cases in support of stricter tobacco regulation.

"This law is a public health victory for the American people -- protecting against aggressive tobacco advertising that leads to smoking-related illnesses and deaths," AMA Board Chair Rebecca J. Patchin, MD, said in a statement. "It is truly shameful that Big Tobacco continues to protect its profits, even at the expense of American lives, through this lawsuit." The AMA is not involved in the most recent case, Commonwealth Brands Inc. v. U.S.

American Public Health Assn. Executive Director Georges C. Benjamin, MD, said that because the federal law has yet to be fully implemented, the FDA must continue "full speed ahead" on its regulation effort rather than await the outcome of the lawsuit. "Tobacco is the leading preventable cause of death in the country, so millions of people will die if we don't have the authority to regulate it."

The FDA declined to comment, citing the pending litigation.

First Amendment challenge

The plaintiff tobacco companies said they don't dispute the federal government's right to prevent minors' access to tobacco. But other limitations in the law restrict the firms' rights to communicate with adult consumers about their products, including less harmful, or modified-risk, products, said Floyd Abrams, a First Amendment lawyer representing Lorillard.

Tobacco products "remain lawful to be sold, and Congress has gone so far in limiting the manner in which they may be sold to adults -- who have a right to purchase them -- that it violates the First Amendment," he said. "Even if it's true that [some] products are less dangerous, those statements cannot be made unless the FDA determines it will serve the public as a whole."

The companies specifically contest provisions in the statute that:

• Limit print tobacco advertising to black-and-white ads.
• Require larger warning labels on packaging.
• Prohibit the sale of modified-risk tobacco products without prior FDA approval.
• Ban outdoor advertising and event sponsorship or other promotions.

"The obvious purpose of this is to force plaintiffs to stigmatize their own products through their own packaging," the complaint states.

R.J. Reynolds Senior Vice President and General Counsel Martin L. Holton III said in a statement that the provisions "severely restrict the few remaining channels we have to communicate with adult tobacco consumers" and "chill our ability to participate in the broader public policy dialogue over the future of tobacco products."

But the tobacco companies said they plan to work with the FDA on the remaining, undisputed provisions in the law.

Road to the high court?

Legal experts say the case likely will turn on a 2001 U.S. Supreme Court precedent established in Lorillard v. Reilly, which struck down certain Massachusetts regulations barring tobacco advertising near public playgrounds and schools. The high court concluded that some of the provisions violated tobacco companies' free speech rights, but justices upheld other provisions.

The ban at question in that case, however, went well beyond the new FDA regulations, said Richard A. Daynard. He is president of the Public Health Advocacy Institute, a legal research center in Boston that focuses on tobacco liability and other public health issues. The Lorillard decision also centered on the Massachusetts attorney general's lack of authority to regulate tobacco.

"But because Congress, by a substantial majority and many years of consideration, has adopted this [federal law] and indicated in its findings of fact that these provisions were necessary to save hundreds of thousands of lives a year, the Supreme Court is not likely to view it that way and can easily distinguish these findings" from prior rulings, said Daynard, a law professor at Northeastern University School of Law.

He also noted that other federal laws have banned cigarette advertising on television and radio for more than 40 years without legal threat.

Daynard suggested it was no accident that the latest case was filed in Kentucky, which has the nation's highest smoking rate. While the move could help the plaintiffs delay the FDA regulations early in the litigation, he predicted a long legal fight leading to the U.S. Supreme Court, where the law ultimately would stand.

Federal lawmakers appear to have crafted the new law with such constitutional challenges in mind. Language in the statute calls for FDA regulations in accordance with First Amendment case law and the Lorillard decision.

Absent from the lawsuit is Altria Group, the parent company of the nation's largest cigarette maker, Philip Morris USA. The company supported the statute's passage. An Altria spokesman said the company was reviewing the lawsuit but declined to comment further.

R.J. Reynolds and Lorillard -- the country's second- and third-largest tobacco manufacturers -- opposed the bill and said in the lawsuit that the advertising limitations would threaten their market shares.