Judge Blocks FDA From Requiring New Graphic Warnings for Cigarettes

U.S. District Court Judge Richard Leon on Monday issued a preliminary injunction blocking FDA from requiring new graphic cigarette warning labels, the New York Times reports.

The labels, which show images depicting the negative health risks associated with tobacco consumption, were to appear on packages by next fall (Wilson, New York Times, 11/7).

Background

Five U.S. cigarette manufacturers in August filed suit against FDA, arguing that the new labels violate their free speech rights. Commonwealth Brands, Liggett Group, Lorillard Tobacco, R.J. Reynolds Tobacco and Santa Fe Natural Tobacco Company said the labels will force them to "engage in anti-smoking advocacy" for the government.

The new warning labels, unveiled by FDA on June 20, represent the most significant changes to cigarette labels in 25 years.

The labels must be on the top half of tobacco packaging and constitute 20% of advertisements no later than fall 2012. A 2009 law mandated that cigarette packs and advertisements have larger and more visible graphic health warnings as part of an effort to educate the public about the health risks associated with smoking (California Healthline, 8/18).

Ruling Details

Leon ruled that the cigarette manufacturers "have demonstrated a substantial likelihood that they will prevail on the merits that these mandatory graphic images unconstitutionally compel speech" (Reichard, CQ HealthBeat, 11/7).

He said the labels are not factual and would require the companies to use their packages as "mini billboards" for the agency's "obvious anti-smoking agenda" (Felberbaum, AP/Washington Post, 11/7).

Leon said that the warnings are an appeal to emotion and their purpose is "not to inform, but rather to advocate a change in consumer behavior" (Baker, "Healthwatch," The Hill, 11/7).

Democrats, Anti-Tobacco Advocates Urge DOJ To Appeal

Several Democrats and anti-tobacco advocates called on the Department of Justice to appeal the preliminary injunction, CQ Today reports.

Sen. Tom Harkin (D-Iowa) said the ruling "in favor of tobacco companies and their profit margins is a disappointment, but it will not deter us in our efforts to make Americans -- particularly our young people -- aware of the dangers of this product."

Rep. Henry Waxman (D-Calif.) said the language in the law was tailored to ensure it was constitutional and under FDA's authority. "I believe that, on further judicial review, these public health protections will be affirmed and permitted to go into effect next year," he said (Ethridge, CQ Today, 11/7).

Case Could Reach Supreme Court

According to Matthew Myers, an attorney and president of the Campaign for Tobacco-Free Kids, the government was expecting the decision and will appeal. He also noted that "many of the same issues" are pending before a panel of the Sixth Circuit Court of Appeals.

In that case, Judge Joseph McKinley ruled that cigarette manufacturers could be forced to affix the labels on their packages. If Monday's ruling is appealed, it would join the Kentucky case and raise the likelihood that the case will be decided by the Supreme Court, according to the Times. DOJ is reviewing Leon's ruling, according to Charles Miller, a spokesperson for the agency (New York Times, 11/7).