by Erin A. Lawrence
On November 10, FDA released 36 proposed warning labels. The images are designed to cover half of the surface area of the front and back of packs and cartons of cigarettes and to cover a fifth of cigarette advertisements. The labels contain graphic pictures and text that says, for example, "Smoking can kill you" or "Cigarettes are addictive." FDA Commissioner, Margaret Hamburg, said, "We need to make sure that anyone who is considering smoking fully appreciates the consequences of cigarette use." According to the proposed rule, cigarette manufacturers will no longer be allowed to distribute cigarettes without the graphic warnings as of October 22, 2012.
Smoking is a grave concern with striking statistics. There are about 46 million smokers in the United States--20.6 percent of adults and 19.5 percent of high school students. Approximately 443,000 people die every year from smoking-related health problems. About 49,000 people die each year because of second hand smoke. It is estimated that 30 percent of all cancer deaths are related to tobacco use. Tobacco use is the leading cause of premature and preventable death nationwide. Smoking is also a fiscal burden on the United States. According to the Center for Disease Control, the United States spends around $193 billion a year on healthcare expenses and decreased productivity and an additional $10 billion on healthcare expenses related to second-hand smoke.
Canada, Europe, and other countries already require graphic warning labels on cigarette packs and cartons. Studies suggest that graphic warnings make smokers more likely to quit and adolescents less likely to start. In Canada, graphic warnings contributed to a five percent drop in the smoking population. Smokers now account for only 13 percent of the Canadian population--down from 18 percent of the population.
FDA hired a company to survey 18,000 smokers to determine which labels would be most effective. The 36 proposed labels will be narrowed to nine by June. The tobacco companies will not be allowed to pick their preferred label--they will be required to allocate all nine warnings evenly among products.
Some cigarette companies argue that the warning label requirement infringes the companies' Constitutional rights to free speech and due process. This issue was litigated and decided on January 4, 2010 in the Western District of Kentucky in a case called Commonwealth Brands, Inc. v. United States. The court held that a blanket ban on color and graphics in tobacco labeling and advertising was overly broad and that prohibiting tobacco companies from labeling products as FDA regulated was unconstitutional. However, the court also held that Congress and FDA could constitutionally ban tobacco companies from sponsoring events, require more conspicuous labeling, ban introduction of modified-risk tobacco products without FDA approval, and ban outdoor advertising, free samples, and gifts with purchases. The case is being appealed to the Sixth Circuit.