R.J. Reynolds Tobacco Co. v. Food & Drug Administration
402 U.S. App. D.C. 438
| D.C. Cir. | 2012Background
- The Family Smoking Prevention and Tobacco Control Act directs FDA to require graphic warnings on cigarette packages and ads, with nine images paired to nine textual warnings.
- The Act mandates the warnings occupy the top 50% of front/rear package panels and 20% of ad space; final graphics were issued June 22, 2011, including the 1-800-QUIT-NOW hotline.
- FDA based its image selection on an 18,000-person internet study comparing text-only versus graphic warnings and salience measures (emotional impact).
- Tobacco companies RJ Reynolds, Lorillard, and Commonwealth Brands challenged the rule as First Amendment violations in district court, which granted summary judgment for the companies.
- FDA appealed; the D.C. Circuit reviews de novo; the panel vacates and remands the graphic warnings ruling, finding First Amendment violations.
- The majority ultimately concludes the graphic warnings fail Central Hudson analysis and must be set aside, with APA claims left for remand.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| What level of scrutiny applies to graphic warnings? | Companies contend Zauderer should apply (informational disclosures). | FDA argues Central Hudson intermediate scrutiny governs compelled commercial speech. | Zauderer does not apply; Central Hudson governs (intermediate scrutiny). |
| Do the graphic warnings directly advance a substantial interest? | No substantial evidence that warnings reduce smoking rates. | Warnings conceptually promote cessation and inform consumers. | FDA failed to show the warnings directly advance the goal to reduce smoking to a material degree. |
| Are the warnings narrowly tailored to the government’s interest? | The warnings are not sufficiently tailored to reduce smoking rates; data are weak. | Warnings are reasonably related to informing and deterring tobacco use. | Not narrowly tailored; the evidence does not meet Central Hudson’s requirements. |
| Does the 1-800-QUIT-NOW telephone number constitute permissible compelled speech? | Numbers are promotional and burdensome; not directly informative of health risks. | Quitline is tied to cessation and supports the health goals. | 1-800-QUIT-NOW fails Central Hudson’s fourth prong; severable from the main warnings. |
| Should the district court have applied Zauderer for the entire rule? | Zauderer applies to disclosure of factual information about health risks. | Zauderer not controlling for these graphic disclosures; Central Hudson applies. | Court applied the wrong standard; graphic warnings fail Central Hudson analysis. |
Key Cases Cited
- Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) (disclosure requirements reviewed for deception-prevention purposes)
- Central Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n, 447 U.S. 557 (1980) (intermediate scrutiny for truthful commercial speech)
- Milavetz, Gallop & Milavetz, P.A. v. United States, 130 S. Ct. 1324 (2010) (disclosure requirements directed at misleading commercial speech fall under Zauderer)
- Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001) (government interest in preventing health deception in tobacco regulation)
- Philip Morris USA Inc. v. United States, 566 F.3d 1095 (2009) (Supreme Court/DOJ line of cases on commercial speech and corrective statements)
- United States v. United Foods, 533 U.S. 405 (2001) (distinct treatment of compelled fees/ads not tied to deception-mitigation)
- Ibanez v. Florida Dept. of Bus. & Prof'l Regulation, 512 U.S. 136 (1994) (Zauderer applicability limited to deception-prevention context)
- Warner-Lambert Co. v. FTC, 562 F.2d 749 (1977) (corrective advertising and ongoing deception contexts)
- Spirit Airlines, Inc. v. U.S. Dept. of Transportation, 687 F.3d 403 (2012) (advertising pricing disclosures and total-cost requirements under scrutiny)
- Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002) (transparent pricing disclosures and the least-restrictive means inquiry)