R.J. Reynolds Tobacco Co. v. U.S. Food & Drug Admin.
| Decision Date | 07 December 2022 |
| Docket Number | 6:20-cv-00176 |
| Parties | R.J. Reynolds Tobacco Co. et al., Plaintiffs, v. U.S. Food & Drug Administration et al., Defendants. |
| Court | U.S. District Court — Eastern District of Texas |
J. CAMPBELL BARKER United States District Judge
Several motions are ready for resolution in this challenge to an FDA rule. First, the government asks the court to dismiss one plaintiff for lack of subject-matter jurisdiction and to then dismiss or transfer the case for improper venue in this district. For the reasons explained below, the government's argument as to jurisdiction is unpersuasive and the government's argument as to venue is forfeited. Accordingly, the government's motion to dismiss or transfer (Doc. 36) is denied.
Second both sides move for summary judgment and agree that no factual disputes require trial. As explained below plaintiffs are entitled to judgment on their claim that the challenged rule is invalid under the First Amendment. Accordingly, the court denies defendants' motion for summary judgment (Doc. 37) and grants in part plaintiffs' motion for summary judgment (Doc. 34).
1. Plaintiffs sue to challenge an FDA rule on cigarette health warnings. Such warnings have a long history. For over 50 years, Congress has required health warnings on cigarette packages and advertising.[1] Section 4 of the Labeling Act of 1965 is the precursor of today's regime. It required that cigarette packages state: “Caution: Cigarette Smoking May Be Hazardous to Your Health.”
Two decades later, Congress amended § 4 of the Labeling Act to require that cigarette packages and advertising include on a rotating basis, one of four “Surgeon General's warnings”:
Those warnings typically appear on the side panel of cigarette packages, as shown in the image below:[3]
(Image Omitted)
In the 1990s, the FDA tried to impose additional restrictions on cigarette sales under its existing statutory authority. The Supreme Court, however, read those statutes as withholding authority for such regulations.[4] In response, Congress passed the Family Smoking Prevention and Tobacco Control Act of 2009,[5] which gives the FDA limited authority to regulate tobacco products. The Tobacco Control Act recites Congress's understanding that “tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects.”[6] Congress expressed particular concern that more limited efforts to regulate tobacco products had “failed adequately to curb tobacco use by adolescents.”[7]
Rather than banning tobacco products-which could foster a black market-the Tobacco Control Act creates measures aimed at reducing the usage and dangers of tobacco products. Among other things, the Act approves the FDA's 1990s restrictions on cigarette marketing, finding them “substantially related to accomplishing the public health goals” of the Act.[8] Specifically, Congress found that “[r] educing the use of tobacco by minors” by half would save over three million children from premature deaths,[9]and that advertising “often misleadingly portrays the use of tobacco as socially acceptable and healthful to minors.”[10]
The Tobacco Control Act also amends § 4 of the Labeling Act to replace the Surgeon General's warnings with new warnings that have both a textual and a graphic component.[11] Congress set out nine textual warnings-called “label statements”[12]-that must be displayed with equal frequency on a rotating basis.[13] Congress then directed the Secretary of Health and Human Services to require, by rulemaking, that the label statements be accompanied by color graphics depicting the negative health consequences of smoking.[14]
Congress directed that the label statements must occupy the top half of the front and rear panels of cigarette packages.[15] And Congress directed that the label statements must occupy at least 20 percent of the area of cigarette advertising.[16]
Congress also specified type-size, format, and color requirements for the label statements.[17] But the type-size and format requirements-although not the color requirements-were made subject to adjustment by mandatory and optional rulemaking.[18]
Congress separately gave the Secretary authority to issue rules adjusting the type size, format, color graphics, and text of any label requirements “if the Secretary finds that such a change would promote greater public understanding of the risks associated with the use of tobacco products.”[19]
Those amendments to § 4 of the Labeling Act were made in subsection (a) of § 201 of the Tobacco Control Act.[20] But those amendments were not effective immediately. Rather, Congress directed that the amendments “shall take effect 15 months after the issuance of the regulations required by subsection (a)” of § 201.[21]
Read literally, that provision creates a circularity. There are no regulations required by § 201(a) until § 201(a) takes effect as law. But the parties agree that “required by” should be read as meaning something like “required by § 201(a) were it in effect.” The court agrees and adopts that reading to avoid an absurdity.
The parties also agree to another implied qualification: the 15-month countdown clock to the effectiveness of § 201(a)'s statutory amendments runs only if the contemplated regulations are not just issued but also keep their effectiveness throughout the countdown period. Thus, the parties agree that the Act's additional labeling requirements are “tied to the effective date of the graphic-warnings Rule.”[22] On that view, a court's postponement of the effective date of the FDA's regulations also postpones the 15-months-after-rulemaking effective date of (i) the Tobacco Control Act's amendment to § 4 of the Labeling Act and (ii) related Tobacco Control Act provisions.[23] The court accepts the parties' shared understanding of the effective date of the statutory provisions.
2. On June 22, 2011, the FDA issued a final rule specifying graphic health warnings.[24] The rule required that the Act's nine textual warnings be accompanied by graphics on the top half of the front and back panels of cigarette packs and the top fifth of advertisements.[25] As shown, the required graphics[26] included disembodied organs, a distressed baby, and a sutured corpse:
(Image Omitted)
(Image Omitted)
The FDA justified those graphics as reducing the consumption of cigarettes and thus improving public health:
The warnings currently in use in the United States also fail to include any graphic component, despite the evidence in the scientific literature that larger, graphic health warnings promote greater understanding of the health risks of smoking and would help to reduce consumption. In proposing this regulation and preparing this final rule, we found substantial evidence indicating that larger cigarette health warnings including a graphic component, like those being required in this rule, would offer significant health benefits over the existing warnings.[27]
That regulatory approach follows the path of countries like Australia and Canada, which require cigarette packages to carry large warnings with stark graphic and textual components.[28]
3. Before the FDA's final rule issued in 2011, five cigarette manufacturers-including R.J. Reynolds-and one cigarette retailer sued the government to enjoin enforcement of some provisions of the Tobacco Control Act, including its requirement of graphic and textual health warnings.[29] The district court rejected those plaintiffs' argument that the Act's requirement was facially invalid as an unconstitutional compulsion of and burden on private speech.[30] Graphics for the health warnings had not yet been specified by the FDA. But the court reasoned that a graphic component would not alter the neutral and uncontroversial nature of the required warnings, “at least as a general rule.”[31] The Sixth Circuit affirmed that aspect of the judgment.[32] It held that the Act's textual warnings should be judged under the free-speech standards set out by the Supreme Court in Zauderer v. Office of Disciplinary Counsel.[33] The textual warnings complied with those standards, the court held, because they were factual, uncontroversial, and reasonably related to preventing consumer deception (from past tobacco-industry deception).[34]
The Sixth Circuit then held that the Act's requirement of a graphic component to the warnings was not facially invalid. The court could imagine some set of graphics that might satisfy Zauderer, such as an illustration merely showing the warnings' text in a child's handwriting.[35] At the same time, the court noted that it was resolving only a facial challenge and that, by the time of its decision, specific images had been chosen by the FDA and were “under review elsewhere.”[36]
4. That separate review of the FDA's 2011 graphics took place in the District of Columbia. There, a group of tobacco companies sued and obtained on appeal a judgment vacating the 2011 rule.[37]
The vacatur of the 2011 rule, the parties agree, also postponed the effective date of the Tobacco Control Act's statutory amendments tied to that rulemaking.[38] That understanding leaves the Surgeon General's warnings applicable today, pursuant to the pre-Tobacco Control Act version of the Labeling Act.
The D.C. Circuit's vacatur of the...
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