Tobacco Firms Sue FDA Over Warning Label Requirement

Not surprisingly, tobacco giants R.J. Reynolds Tobacco Co. and Lorillard Inc. are suing the U.S. Food and Drug Administration (FDA) over graphic labeling scheduled to be included on cigarette packs next year.

The lawsuit was filed yesterday in U.S. District Court in Washington and is also being filed by cigarette makers Commonwealth Brands Inc., and Liggett Group LLC, said the Winston-Salem Journal. The graphic labeling is intended to cover one-half of the cigarette pack and nine labels are planned including, said the Winston-Salem Journal, one with cigarette smoke surrounding a baby, one depicting sick lungs and gums, and one of a post-autopsy body; all were selected by the FDA this June and are scheduled for release in September 2012.

The cigarette makers question the labels’ constitutionality—which is also planned on being used in the upper 20 percent of advertisement pieces—and have asked for a preliminary injunction banning use of the labeling, said the Winston-Salem Journal.

General Counsel for Reynolds claims that the labeling does not consider principals at the heart of the constitution the Winston-Salem Journal reported.

Kathleen Sebelius, secretary of the U.S. Health and Human Services Department disagrees. “These labels are frank, honest, and powerful depictions of the health risks of smoking, and they will help encourage smokers to quit and prevent children from smoking,” she said, wrote the Winston-Salem Journal.

In March, Lorillard Inc and R.J. Reynolds Tobacco Co. filed another lawsuit against the FDA, who alleged that “conflicts of interest and bias” existed on an advisory panel charged with making a recommendation about potentially banning menthol cigarettes. In 2009, some cigarette makers sued the FDA saying they were attempting to “protect their First Amendment right to communicate with adult tobacco consumers about their products,” reported the Winston-Salem Journal.

In January 2010 filing, industry called the anti-cigarette message “idealogical” and argued that larger warnings adversely impact the strength of branding and trademark messages.

Smoking remains the leading preventable cause of death in America and is linked to some 443,000 deaths and $100 billion in healthcare costs annually.

Second-hand smoke has been connected to a variety of serious health issues; contains over 4,000 substances, including over 50 known or suspected carcinogens; and is a culprit in many diseases in adults and children, such as sudden infant death syndrome, acute respiratory infections, middle ear disease, asthma, coronary heart disease, lung and sinus cancers, sinus problems, mental problems, and hearing loss.

Smoking has also recently been associated with colorectal cancer, creating damage in the body just minutes after inhaling for the first time, increasing risks for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) and significantly increasing arterial stiffness in people as young as 18 to 30.