Tobacco firms lose round in court over ad restrictions

In a victory for public health advocates, a federal trial court in Kentucky dealt a major setback to tobacco companies in their attempt to undo key provisions of a new federal law giving the Food and Drug Administration the power to regulate the industry.

While the Family Smoking Prevention and Tobacco Control Act did not allow the agency to ban tobacco sales outright, it did give the FDA the authority to reduce nicotine levels, require new warning labels and bar certain marketing tactics.

Two of the nation's largest cigarette makers -- R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co. -- charged in a recent lawsuit that certain advertising restrictions in the law violated their constitutional rights to free speech. The companies, joined by other manufacturers and retailers, asked the U.S. District Court for the Western District of Kentucky to suspend a provision prohibiting the distribution of modified-risk, or "light," tobacco products without prior FDA approval while the case against the FDA is being litigated. That restriction went into effect immediately following the passage of the law in June. Other parts of the statute have yet to be enforced.

But the court rejected the request in a Nov. 5 decision that some experts say could be an indication of where the case is headed.

District Judge Joseph H. McKinley Jr., backed the government's position that "given the significant health risks associated with the use of tobacco products and the history of marketing 'low tar' and 'light' cigarettes, it has a substantial interest in protecting consumers from misleading tobacco industry claims."

At the same time, the court rebuked the tobacco companies' argument that less-onerous measures could have been taken -- such as stronger enforcement of consumer protection laws -- without restricting their ability to make truthful claims about their products.

"It is noted that other less-restrictive means had been tried and found wanting, primarily because of the industry's success in evading regulation," McKinley wrote.

The FDA in a statement praised the court's support for what the agency called "crucial public health legislation."

R.J. Reynolds said it is considering appeal options but declined to comment further due to the pending litigation. Calls to other lead plaintiffs, Lorillard and Commonwealth Brands Inc., were not returned.

At this article's deadline, no other hearing dates had been set.

An uphill climb for tobacco

The ruling is a good sign that the government has a strong likelihood of ultimately prevailing in the case, said Edward L. Sweda Jr., senior attorney with the Tobacco Products Liability Project at Northeastern University School of Law in Boston.

"It's clear that the plaintiffs are facing a rather steep uphill climb," he said. "And it wasn't that close of a call, so it's a very encouraging ruling for the interests of the government and others in upholding the statute."

The court also "seemed to be well aware of the public health concerns that underlie the case" and the statute itself, said attorney Allison M. Zieve, director of Public Citizen Litigation Group. She helped file a friend-of-the-court brief in the case on behalf of the consumer advocacy group and 10 other medical and public health organizations.

Although the order represents the first step in the case, it was a significant one toward preserving public health and safety, said AMA Board of Trustees member David O. Barbe, MD, a Missouri family physician. The Litigation Center of the American Medical Association and State Medical Societies signed onto the brief.

"The unsubstantiated claims of the tobacco industry misled tobacco users and were responsible for millions of preventable diseases and premature deaths," Dr. Barbe said. "Based on the tobacco industry's history of misrepresentation, there can be no legitimate dispute that the government has a substantial interest in protecting the public health."

The tobacco companies stressed in their lawsuit that they are not challenging the FDA's authority to regulate tobacco, nor the entire law. Other than the modified-risk prohibitions, they are contesting specific provisions that require larger warning labels; place limitations on print advertising; and ban certain product promotions.

Despite the lawsuit's limited scope, however, the provisions at issue "are pretty big ones," Zieve said. If the tobacco industry is successful, "it really guts the law in a big way and greatly decreases its effectiveness."

Some observers say the ultimate test could come before the U.S. Supreme Court.

The high court has ruled on both sides of the issue before, noted Gregory N. Connolly, MPH, director of the Tobacco Control Research Program at the Harvard School of Public Health in Boston.

But the message in some of those decisions was that the justices "don't want to deal with this issue -- Congress has to fix it," he said. "So we have a pretty good sign we are going to trust Congress on this one, and if FDA acts in a reasonable, scientific manner, we're going to see [the federal statute] go forth."