Five Tobacco Companies File Suit Challenging FDA’s New Warnings Rule

Aug 25, 2011   
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On August 16, 2011, five tobacco companies filed a complaint against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the District of Columbia challenging the Agency’s rule requiring new textual and graphic warning labels on cigarette packaging and advertisements. As we reported here earlier this year, the FDA issued a final rule pursuant to the Family Smoking Prevention and Tobacco Control Act (the “Act”) that requires each cigarette package and advertisement to bear one of nine new textual warning statements and an accompanying graphic image (see FDA’s approved images here).  The final rule explained that the requirements for the new textual and graphic warning labels would go into effect 15 months after the FDA’s issuance of a final rule.

The five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) seek a declaratory judgment that the FDA’s final rule violates the First Amendment and Administrative Procedure Act (APA), and declarative and injunctive relief that the new textual and graphic warnings will not become effective until 15 months after FDA issues regulations “that are permissible under the United States Constitution and federal laws.”

The Plaintiffs allege that the FDA’s final rule regarding textual and graphic warnings requires them “to become a mouthpiece for the Government’s emotionally-charged anti-smoking message.” The Petitioners argue that the requirement to essentially advocate against the purchase of their own lawful products “is precisely the type of compelled speech that the First Amendment prohibits” because the Government cannot compel corporations to “use their private property as a ‘mobile billboard’ for the State’s ideological message.” The Plaintiffs also contend that the FDA’s warnings are unjustified and unduly burdensome, as they do not further any compelling governmental purpose and are “unlikely to have any material impact on consumer understanding of smoking risks, consumer intentions regarding smoking, or actual consumer smoking decisions.” The FDA’s final rule, according to the Plaintiffs, “violates the First Amendment under any standard of review.”

In addition, the Plaintiffs argue that the FDA acted arbitrarily and capriciously “by attempting to justify the Ruleon grounds that were illogical, contradictory, and without support in the regulatory record, and by employing different standards of analysis to comments supporting the Rule than to comments opposing the rule.”  As a result, the Plaintiffs allege that the FDA’s final rule “contravenes core requirements” of the APA.

Lastly, the Plaintiffs assert that the FDA has not issued a legally valid rule and, therefore, the 15-month effective date for the new textual and graphic warnings cannot come into effect until the FDA complies accordingly. The Plaintiffs contend that Congress’s single implementation date for the new warnings and related requirements “demonstrates an intent that manufacturers not be subjected to multiple, costly overhauls of their packaging and advertising.” Further, the Plaintiffs state that to avoid an invalidation of the Rule, the Act must be read to “tie the effective dates of all cigarette packaging and advertising changes to the ‘issuance’ of regulations by FDA.” In furtherance of that goal, the Plaintiffs request the court to grant declaratory and injunctive relief that the Act not become effective until 15 months after the FDA issues a rule that is permissible under the U.S. Constitution and federal law.
Fuerst Ittleman will continue to monitor the progress of this lawsuit and the FDA’s regulation of tobacco products and advertising. For more information, please contact us at