Cigarette Warning Rule Stands

A federal appeals court has upheld the FDA’s authority to regulate tobacco products, including a requirement that cigarette makers emblazon their products with graphic warning images.

The U.S. Court of Appeals for the Sixth Circuit, in a 2-1 decision issued Monday, backed an earlier ruling by a lower court in Kentucky that largely affirmed the FDA’s authority to regulate tobacco products. The appeals court ruled that requiring cigarette packs to contain graphic images and text warnings of the health risks of smoking is aimed at protecting consumer health, and is therefore constitutional.

A 2009 law gave the FDA regulatory authority over tobacco products. That same law also requires that starting on Sept. 22, 2012, cigarettes sold in the U.S. must carry graphic images warning of the dangers of smoking. These images include rotting teeth, diseased lungs, a baby enveloped in smoke, and a body on an autopsy table.

Tobacco companies are suing the FDA over these requirements in two separate cases, arguing that the new regulations violate the companies’ First Amendment rights.

Although Monday’s ruling did not specifically address the nine images the FDA is proposing for use, it wrote that warning images in general are necessary because it’s clear the public doesn’t adequately understand the risks of smoking.

“Ample evidence establishes that current warnings do not effectively inform consumers of the health risks of tobacco use and that consumers do not understand these risks,” the court wrote, adding that the plaintiff’s products “literally kill users.”

“Against this backdrop, the Act requires graphic and textual warnings that convey the factual health risks of smoking to provide consumers with truthful information as they make decisions about purchasing and using tobacco products,” the court ruled.

In a dissenting opinion, one of the Sixth Circuit judges wrote the requirement that a company’s product carry a large scale color graphic warning “is simply unprecedented.”

The court also upheld the 2009 law’s provisions banning tobacco companies from marketing their products as “light;” from sponsoring social, sporting, and entertainment events; from producing clothing with cigarette logos; and from distributing free cigarettes.

Marking a small victory for tobacco companies, Monday’s ruling upheld the Kentucky court’s ruling that tobacco companies were allowed to use color in their advertising. Under the 2009 law that gave the FDA the authority to regulate tobacco products, cigarette makers were only allowed to advertise in black and white.

Monday’s ruling contradicts a ruling from earlier this month in the other lawsuit. In that case, a federal judge decided that requiring cigarette packages to carry graphic health warnings on their labels is a violation of the tobacco companies’ First Amendment rights.

That judge wrote in his opinion that the gruesome images are neither factual nor accurate; rather, they only promote the FDA’s agenda of getting people to quit smoking and thus violate the free speech rights of the tobacco companies that are suing the FDA.

The government appealed that decision, and the U.S. Court of Appeals District of Columbia will hold a hearing on the case on April 10.

Those closely following the issue expect it to ultimately end up in the Supreme Court.

In the midst of legal battles over the how cigarette companies can market their products, the FDA recently launched a new anti-smoking ad campaign featuring stark testimonials from former smokers talking about what life is like with a smoking-related disease.

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By Emily P. Walker, Washington Correspondent, MedPage Today

Provided by ArmMed Media