Report: FDA to abandon legal battle over cigarette warnings, expected to revise labels

By Jessica M. Karmasek | Mar 20, 2013

WASHINGTON (Legal Newsline) -- The Food and Drug Administration will not appeal the decision of a federal appeals court, which ruled last year that the FDA's new rule requiring graphic images on cigarette packaging is unconstitutional.

According to The Associated Press, the FDA had until Monday to ask the U.S. Supreme Court to review the U.S. Court of Appeals for the District of Columbia Circuit's ruling in August.

The D.C. Circuit said the new rule requiring the warnings -- images such as diseased lungs and a cadaver with chest staples -- violated First Amendment free speech protections.

"In light of these circumstances, the Solicitor General has determined... not to seek Supreme Court review of the First Amendment issues at the present time," U.S. Attorney General Eric Holder wrote in a Friday letter to House Speaker John Boehner, which was obtained by the AP.

The FDA told the AP in a statement Tuesday that it would start work on revising the warning labels.

The D.C. Circuit's ruling in August conflicts with a decision in a separate case by the U.S. Court of Appeals for the Sixth Circuit -- which made an appeal to and judgment from the nation's highest court seem even more likely.

Instead, the FDA attempted to have the case heard again. In October, it filed a petition for rehearing and rehearing en banc with the D.C. Circuit.

"In sum, this case presents a question of exceptional importance," the federal government wrote in its 16-page request.

"The majority's reasoning is wrong and it conflicts with the Sixth Circuit's analysis of graphics in Discount Tobacco. We respectfully submit that the case should be reheard en banc."

In a Dec. 5 order, the D.C. Circuit denied the FDA's request to rehear the case. According to the single-page order, Judge Judith Ann Wilson Rogers was in favor of granting the petition.

In a separate order filed the same day, the federal appeals court also denied the FDA's request for a rehearing by the full court.

"Appellants' petition for rehearing en banc and the response thereto were circulated to the full court, and a vote was requested. Thereafter, a majority of the judges eligible to participate did not vote in favor of the petition," Court Clerk Mark J. Langer wrote.

"Upon consideration of the foregoing, it is ordered that the petition be denied."

Those judges in favor of a rehearing en banc included Rogers, David S. Tatel and Merrick B. Garland, according to the one-page order.

But the government's pursuit of the case stopped there.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement Tuesday that the organization was "disappointed" that the government won't seek U.S. Supreme Court review of the D.C. Circuit's ruling, calling it "wrong on the science and the law."

However, Myers said the organization welcomed the FDA's announcement that it will begin development of new warnings that comply both with legal rulings and a 2009 law that required large, graphic cigarette warnings.

The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate the manufacture and sale of tobacco products.

After new warning statements were implemented, the FDA proposed nine graphic images. In addition to the two previously mentioned, images that were included were:

- A man exhaling cigarette smoke through a tracheotomy hole in his throat;

- Cigarette smoke enveloping an infant being kissed by its mother;

- A mouth filled with cancerous lesions;

- A man breathing into an oxygen mask;

- A crying woman; and

- A man wearing a T-shirt with a "no smoking" symbol and the words "I QUIT."

The images were supposed to take up 50 percent of the front and back portions of cigarette packaging.

"The FDA should move quickly to require strong warnings that are based on the best available science and fully inform Americans about the deadly consequences of smoking," Myers said.

He contends tobacco companies are fighting the graphic warnings because they know such warnings are effective.

"As a federal judge found in a 2006 civil racketeering judgment against cigarette manufacturers, these companies have spent decades deceiving the American people and downplaying the health risks of smoking. Even today, they continue to spend billions to glamorize smoking," he said. "The graphic warnings would counter the industry's deception and tell the truth about how deadly and unglamorous smoking truly is."

Myers, pointing to the Sixth Circuit's ruling, argues that current, text-only warnings are "stale and unnoticed."

"We return to where we began -- the lack of consumer awareness of tobacco's serious health risks resulting from the decades-long deception by tobacco companies," Judge Eric Clay wrote for the Sixth Circuit. "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.

"It is beyond cavil that adolescents are a target of the marketing expertise of tobacco companies, a targeting that exists precisely because of intertwined advantages -- or for the young, disadvantages -- the coupling of immaturity of risk perception with the evidence that the vast majority of regular smokers made the decision to begin smoking as an adolescent."

Clay continued, "It bears emphasizing that the risks here include the undisputed fact that plaintiffs' products literally kill users and, often, members of the families of users: Tobacco products kill up to one-half of the people who use them as they are intended to be used.

"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."

Tobacco companies have appealed the Sixth Circuit ruling to the U.S. Supreme Court, which has not decided whether to accept the case.

From Legal Newsline: Reach Jessica Karmasek by email at

Want to get notified whenever we write about U.S. Supreme Court ?

Sign-up Next time we write about U.S. Supreme Court, we'll email you a link to the story. You may edit your settings or unsubscribe at any time.

Organizations in this Story

U.S. Supreme Court

More News

The Record Network