R.J. Reynolds Tobacco Co. v. Food and Drug Administration
Facts
The Act required cigarette packages and advertisements to carry new textual warnings and color graphics depicting the negative health consequences of smoking. FDA issued a final rule selecting nine graphic images and requiring inclusion of the "1-800-QUIT-NOW" hotline number, relying on an internet-based consumer study, public comments, and research from other countries. The tobacco companies did not challenge Congress's authority to require health warnings or the text of the warning statements, but challenged FDA's graphic warnings as unconstitutional compelled speech. FDA justified the rule primarily as a way to reduce smoking rates by discouraging initiation and encouraging cessation.
Issue
Whether FDA's rule requiring cigarette packages and advertisements to display graphic warning labels, including images and the "1-800-QUIT-NOW" number, violates the First Amendment. More specifically, the court considered whether Zauderer or Central Hudson supplied the proper level of scrutiny and whether the rule satisfied that standard.
Rule
Zauderer does not govern compelled commercial disclosures unless the government shows the disclosure is reasonably related to preventing consumer deception and consists of purely factual and uncontroversial information. Where Zauderer is inapplicable, compelled commercial disclosures are evaluated under Central Hudson, under which the government must show a substantial interest, that the regulation directly advances that interest to a material degree, and that the regulation is not more extensive than necessary; speculation and conjecture are insufficient, and the agency must supply substantial evidence under the APA.
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