Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, March 19, 2012

Federal Appeals Court Backs FDA Against Tobacco Companies

Seal of the United States Court of Appeals for...
Seal of the United States Court of Appeals for the Sixth Circuit. (Photo credit: Wikipedia)
In an 84-page ruling in Discount Tobacco & Lottery, Inc. et al. v. U.S. Food & Drug Administration (Docket No. 10-5234/5235), the United States Court of Appeals for the Sixth Circuit has upheld controversial FDA regulations mandating that tobacco companies display graphic warnings about the dangers of smoking on cigarette packages and advertisements.

As reported by the law blog of The Wall St. Journal, the appellate court decision written by Judge Eric Clay found the warnings "serve as disclaimers to the public regarding the incontestable health consequences of using tobacco." A half-dozen tobacco companies, including R.J. Reynolds Tobacco Co. and Lorillard Tobacco Co., allege their First Amendment speech rights are being abridged by the FDA regs, which are drawn from the 2009 Family Smoking Prevention and Tobacco Control Act [H.R. 1256].

The Sixth Circuit ruling doesn't specifically address the grisly depictions in the warnings of blackened lungs and cadavers, but rather, upheld the validity of the law requiring the warnings appear on the top 50 percent of the front and back of cigarette packs. The appeals court struck down the use of color imagery in the warnings, handing the plaintiffs a victory of sorts.


United States District Court for the District of Columbia Judge Richard Leon in R.J. Reynolds Tobacco Co. et al. v. U.S. Food & Drug Administration et al. (Case No. 1:11-cv-01482) issued a preliminary injunction preventing the FDA regs from taking effect that the government is appealing (see "TUOL" post 3/1/12). 
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Thursday, March 1, 2012

UPDATE: Tobacco Cos. Singe FDA Rule in Federal Court

FdaImage via WikipediaUnited States District Court for the District of Columbia Judge Richard J. Leon this week granted a preliminary injunction to tobacco companies challenging Food & Drug Administration regulations requiring cigarette packaging to carry graphic depictions of the health consequences of smoking.

Last August, R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., Commonwealth Brands, Inc., Liggett Group, LLC and Santa Fe Natural Tobacco Co. sued the FDA, which in June 2011, promulgated regulations, set to take effect in September 2012, based on H.R. 1256, the Family Smoking Prevention and Tobacco Control Act of 2009, that mandated cigarette packaging and related advertising include grisly images, such as a cadaver on an autopsy table and blackened lungs. (See "TUOL" post 8/17/11.)

In siding with the plaintiffs' request for a preliminary injunction in the case, R.J. Reynolds Tobacco Co. et al. v. U.S. Food & Drug Administration et al. (Case No. 1:11-cv-01482), Judge Leon wrote in his 29-page opinion: "[T]he plaintiffs have demonstrated a substantial likelihood that they will prevail on the merits of their position that these mandatory graphic images unconstitutionally compel speech, and that they will suffer irreparable harm absent injunctive relief pending a judicial review of the constitutionality of the FDA's rule."

The tobacco companies argue the FDA-imposed warnings exceed the limits of factual and neutral information and thereby, violate their First Amendment right of free speech. As reported by Ad Week, Judge Leon's Order prevents H.R. 1256 from taking effect until 15 months after the current lawsuit is resolved, which derails the September 2012, implementation.
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Wednesday, August 17, 2011

Cigarette Cos. Hack at FDA Regs with 1st Amendment Lawsuit

FdaImage via WikipediaFive tobacco companies have joined forces to file suit in the U.S. District Court for the District of Columbia to challenge the constitutionality of Food & Drug Administration regulations set to take effect in September 2012.

In R.J. Reynolds Tobacco Co. et al. v. U.S. Food & Drug Administration et al. (Case No. 1:11-cv-01482), Reynolds, Lorillard Inc., Santa Fe Natural Tobacco Co., Liggett Group LLC and Commonwealth Brands, Inc., claim their First Amendment rights would be violated by the Family Smoking Prevention and Tobacco Control Act of 2009 [H.R. 1256], which would require them to display graphic images of the health dangers of smoking in advertising and on their packaging.

First Amendment attorney Floyd Abrams, who represents the plaintiffs, told LegalTimes the FDA regs constitute anti-smoking advocacy by the government, rather than merely requiring disclosure of uncontroversial facts. Abrams told LegalTimes his clients' First Amendment rights would be infringed on if they were mandated to include information on their products urging the public not to purchase them.

Under H.R. 1256, the FDA includes nine warnings, including images of diseased lungs, a body on an autopsy table, and a quit-smoking hotline telephone number. Judge Richard J. Leon will hear the case.



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