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FDA Launches Study to Evaluate New, Improved Warning Labels for Cigarette Packs

— September 20, 2017

The Food and Drug Administration plans to launch a study with the intent of finding new warning labels for cigarette packs.

According to The Hill, the FDA announced its upcoming venture with a public notice in the Federal Register. Entitled the “Experimental Study on Warning Statements for Cigarettes Graphic Health Warnings,” the endeavor is seeking feedback and survey participation from the public.

The agency’s ultimate aim is find which warning statements on cigarette packets might have the effect of increasing general awareness of the dangers of tobacco.

In 2012, the FDA was forced to revise a planned rollout of graphic warning statements, which would be affixed to every package of smokes manufactured or sold in the United States.

One of the proposals previously considered by the FDA. Image via the FDA.

The warnings would have incorporated one of nine images depicting the potential ill effects of smoking, along with a statement on the dangers of tobacco. A toll-free number – 1-800-QUIT-NOW – followed.

Not surprisingly, the proposal received significant pushback from the cigarette industry, with the R.J. Reynolds Tobacco Co., along with three manufacturers, suing.

Reynolds and its allies claimed that the FDA’s attempt to warn smokers about the damage being dealt to their bodies impinged upon their First Amendment rights.

The cigarette companies effectively argued that the government was making a concerted effort to dissuade consumers from purchasing a product which is entirely lawful in all fifty states.

Moreover, 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 wrote in a court brief. “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.”

In a 2-1 ruling, the U.S. Circuit Court of Appeals opted to side with Big Tobacco over the Food and Drug Administration, saying, “The First Amendment requires the government not only to state a substantial interest justifying a regulation on commercial speech, but also to show its regulation directly advances that goal.”

“[The] 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,” wrote Judge Janice Rogers Brown in the majority opinion.

The ruling has forced the FDA to return to the drawing board, so that it can create tobacco warnings which are both effective and comply with the ruling delivered by the court.

The survey and feedback requested in its Federal Register announcement are open to the public for 30 days.


FDA tries again to find balance between corrective cigarette warnings statements and 1st Amendment

FDA to study warnings for cigarette packaging

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