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FDA Gets Burned in Graphic Warning Label Appeal

By Robyn Hagan Cain on August 24, 2012 | Last updated on March 21, 2019

The D.C. Circuit Court of Appeals nixed new graphic warning label requirements for cigarettes on Friday, reports The Wall Street Journal.

Because the government didn’t provide evidence that the graphic warning labels would lower smoking rates, the appellate court found that the Food and Drug Administration (FDA) failed the Central Hudson intermediate scrutiny test.

The new warning label requirement mandated images -- such as photos of rotting teeth, diseased organs and a dead body -- in addition to the standard textual warning. Five tobacco companies -- R. J. Reynolds, Lorillard, Commonwealth Brands, the Liggett Group and Santa Fe Natural -- sued the FDA claiming that the new labels went beyond the "compelled commercial speech" that is permissible to protect consumers from confusion and deception, and mandated "grotesque" labels to persuade smokers to quit, reports The New York Times.

In November, District Judge Richard Leon issued a temporary injunction blocking the new warning label requirement from taking effect. Judge Leon made the injunction permanent in February.

Friday, the appellate court noted that 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.

The D.C. Circuit affirmed Judge Leon's decision on Friday, finding that the "FDA failed to present any data -- much less the substantial evidence required under the [Administrative Procedures Act] APA -- showing that enacting their proposed graphic warnings will accomplish the agency's stated objective of reducing smoking rates."

The FDA and the tobacco companies could still end up litigating the graphic warning labels again. In March, the Sixth Circuit Court of Appeals upheld the FDA's label requirements, so the Supreme Court could be asked to resolve the circuit split.

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