By TIM THORNBERRY Kentucky Correspondent WASHINGTON, D.C. — In June, the U.S. Food and Drug Administration (FDA) unveiled nine graphic health warnings chosen to appear on cigarette labels and in advertising as part of the Family Smoking Prevention and Tobacco Control Act. This is landmark federal legislation passed in 2009, giving the agency regulatory power over tobacco.
Last week a group of tobacco companies including R.J. Reynolds and Lorillard filed suit in U.S. District Court, trying to stop implementation of the labeling regulation, claiming a violation of their First Amendment rights. The labels contain text warnings of the dangers of smoking along with a smoking cessation telephone number and images – such as a parent holding a small child, an illustration comparing normal and diseased lungs or a depiction of a corpse.
A statement from the FDA notes the warnings “represent the most significant changes to cigarette labels in more than 25 years and will affect everything from packaging to advertisements, and are required to be placed on all cigarette packs, cartons and ads no later than September 2012.” U.S. Health and Human Services Secretary Kathleen Sebelius said the 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 taking up smoking.
Commissioner of Food and Drugs Margaret A. Hamburg, M.D. said the Tobacco Control Act requires the FDA to provide current and potential smokers with clear and truthful information about the risks of smoking, something these warnings will do.
The litigation trail between tobacco companies and the government goes back at least to the days of the Master Settlement Agreement, and this latest suit promises not to be the last concerning the regulatory action. According to a statement from Lorillard, Floyd Abrams, a noted First Amendment attorney, will represent that company.
Abrams said, “The notion that the government can require those who manufacture a lawful product to emblazon half of its package with pictures and words admittedly drafted to persuade the public not to purchase that product cannot withstand constitutional scrutiny. The government can engage in as much anti-smoking advocacy as it chooses in whatever language and with whatever pictures it chooses; it cannot force those who lawfully sell tobacco to the public to carry that message, those words and those pictures.” A press announcement from R.J. Reynolds stated, “The lawsuit cites data included in FDA’s regulations that shows the graphic warnings will have little to no effect in reducing tobacco use. In particular, FDA’s analysis of similar graphic warnings in Canada shows that the warnings would likely cause no statistically significant change in U.S. smoking rates.
“Additionally, a study of the warnings commissioned by the FDA found that the graphic warnings did not change consumers’ understanding of the health risks of smoking or their intentions to quit.”
Martin L. Holton III, executive vice president and general counsel for R.J. Reynolds, said while the company believes governments, public health officials, tobacco manufacturers and others share a responsibility to provide adult tobacco consumers with accurate information about the health risks associated with smoking, the regulation completely disregards core constitutional principles.
“Rather than inform and educate, the graphic warnings include non-factual cartoon images and controversial photographs that have been technologically manipulated to maximize an emotional response from viewers, essentially turning our cigarette packs into mini-billboards for the government’s anti-smoking message,” he added.
“The regulation of marketing of tobacco products should be consistent with constitutional protections and enhance an adult tobacco consumer’s ability to make informed choices. We believe the goal of informing the public about the risks of tobacco use can and should be accomplished consistent with the U.S. Constitution.”
These types of cigarette warning aren’t new elsewhere, and surveys have been completed in those countries to record the effectiveness of enhanced labeling. Multiple studies conclude that larger and more graphic warnings almost always gain heightened attention from both smokers and non-smokers.
The Centers for Disease Control and Prevention (CDC) Director Thomas R. Frieden, M.D., M.P.H. said, “Warning labels motivate smokers to quit and discourage non-smokers from starting, are well accepted by the public and can be effectively implemented at virtually no cost to governments.”
Language in the final rule posted on the Federal Register list many steps in calculating whether the new regulations will actually lead to a decrease in the number of smokers. The FDA emphasized it has access to very small data sets and cannot reject, in a statistical sense, the possibility that the rule will not change the U.S. smoking rate. |