FDA to study warnings for cigarette packaging

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The Food and Drug Administration (FDA) is planning to launch a research study to find new warning labels for cigarette packs that are constitutional.

The agency announced its proposed Experimental Study on Warning Statements for Cigarettes Graphic Health Warnings in a public notice in the Federal Register.

The voluntary online consumer study aims to assess whether potential textual warnings statements, which the FDA is revising along with graphic warnings, promote a greater public understanding of the negative health effects of smoking cigarettes.

In 2009, Congress enacted the Tobacco Control Act, which amended the Federal Cigarette Labeling and Advertising Act and required the FDA to issue “regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements.”


In June 2011, the FDA issued a final rule that required manufacturers to use one of nine images with new warning statements on product packaging and in advertisements. The agency claimed the new warnings would help current smokers quit and discourage minors and nonsmokers from picking up the habit.

But R.J. Reynolds Tobacco Co. and four other cigarette manufacturers sued, arguing that the required labels, which included textual warnings, a corresponding graphic image and the “1-800-QUIT-NOW” cessation hotline number, violated the First Amendment.

The manufacturers claimed the FDA’s new warnings were designed merely to send a message that consumers should not buy a lawful product. They claimed the American public is already “overwhelmingly aware of the risks addressed by the warnings.”

“The warnings, therefore, were not selected based on their ability to increase consumer knowledge,” the companies argued in court briefs. “Instead, they were intentionally crafted to attach ‘negative affect’ to cigarettes and convey a message to consumers that smoking is not a legitimate or acceptable personal choice.”

The U.S. Circuit Court of Appeals sided with the tobacco companies in 2012.

In a 2-1 ruling, the court said, “the First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech, but also to show that its regulation directly advances that goal.”

“FDA failed to present any data — much less the substantial evidence required under the [Administrative Procedure Act] — showing that enacting their proposed graphic warnings will accomplish the agency’s stated objective of reducing smoking rates,” Judge Janice Rogers Brown wrote in delivering the opinion of the court.

The FDA is now going back to the drawing board.

In its notice, the agency said the results of the study will help inform the agency’s development of cigarette graphic health warnings so it can implement the mandatory graphic warning label statements consistent with the Federal Cigarette Labeling and Advertising Act and the First Amendment.

The public has 30 days to comment on the proposed study.

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