Tobacco Companies Sue FDA Over Graphic Warnings Rule

August 17, 2011

By Kurt R. Karst –      

Earlier this week, a group of five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands,  Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) filed a four-count Complaint against FDA in the U.S. District Court for the District of Columbia challenging the Agency’s June 22, 2011 final rule, promulgated pursuant to the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), requiring the display of certain health warnings and graphics on cigarette packages and in cigarette advertisements.  As we noted back in November 2010 when FDA issued its proposed rule, a court challenge seemed inevitable. 

Under the Tobacco Control Act, each cigarette package and advertisement must bear one of nine new textual warning statements.  FDA is required to issue regulations requiring accompanying color graphics that depict the negative health consequences of smoking.  FDA’s final rule specifies the nine color graphic images (see here) that must accompany each of the nine new textual warning statements, and that the Plaintiffs in their August 16th Complaint say “are designed to shock, disgust, and frighten adult consumers of cigarettes.”  The Tobacco Control Act states that the new textual and graphic warnings, among other requirements, will become effective “15 months after the issuance of” a final rule.  FDA says in its final rule that the regulations  will take effect on September 22, 2012, when cigarettes for sale or distribution in the U.S. may longer be manufactured or advertised without the new health warnings, and on October 22, 2012, when cigarette manufacturers will no longer be allowed to distribute cigarettes for sale in the U.S. unless they display the new health warnings.

The Plaintiffs allege in their Complaint that FDA’s final rule “violates the First Amendment under any standard of review.”  Not only are the warnings imposed by the final rule “not purely factual and uncontroversial commercial disclosures aimed at preventing deception of consumers,” but they “do not further any compelling governmental purpose,” and “are not the least restrictive means available to accomplish any governmental purpose,” says the Complaint.  Moreover, “[t]he warnings imposed by the Rule are unjustified because they would have few if any benefits.”  (Another lawsuit, filed in the U.S. District Court for the Western District of Kentucky in 2009 and decided in January 2010, challenged the constitutionality of other Tobacco Control Act provisions.  In that case, the district court held invalid the Tobacco Control Act’s ban on color and imagery in tobacco advertising and upheld several other provisions of the law.  That decision has been appealed U.S. Court of Appeals for the Sixth Circuit.) 

FDA’s final rule also allegedly “contravenes core requirements” of the Administrative Procedure Act (“APA”).  “In promulgating the Rule, FDA acted arbitrarily and capriciously by attempting to justify the Rule (and its rejection of alternatives to the Rule) on 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.”  Moreover, “FDA failed to provide Plaintiffs with meaningful notice as required under 5 U.S.C. § 553(b)(3), by failing to disclose key technical data, methodologies, and assumptions underlying the Rule,” according to Plaintiffs.

Noting the Tobacco Control Act’s 15-month effective date for the new textual and graphic warnings (among other requirements), Plaintiffs contend that:

Congress’s use of a single implementation date for the new textual and graphic warnings and the Related Requirements demonstrates an intent that manufacturers not be subjected to multiple, costly overhauls of their packaging and advertising.  In light of this intent, the Act must be read to tie the effective dates of all cigarette packaging and advertising changes to the “issuance” of regulations by FDA that are constitutionally and procedurally valid.  Any contrary reading would frustrate the congressional intent reflected in the Act and create the anomaly that an invalid Rule would have substantial and detrimental legal effect.

Thus, the Plaintiffs seek both declaratory and injunctive relief that the new textual and graphic warnings will become effective, and that FDA will not enforce the requirements, until 15 months after FDA issues regulations “that are permissible under the United States Constitution and federal law.”

Categories: Tobacco