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R.J. Reynolds Tobacco Co. v. FDA - 402 U.S. App. D.C. 438, 696 F.3d 1205 (2012)


Because commercial speech receives a lower level of protection under the First Amendment, burdens imposed on it receive a lower level of scrutiny from the courts. The bottom line is clear: the government must affirmatively demonstrate its means are narrowly tailored to achieve a substantial government goal. Where the case also involves a compelled commercial disclosure, courts apply the intermediate standard set forth in Central Hudson.


The Family Smoking Prevention and Tobacco Control Act (Act) directed the Secretary of the U.S. Department of Health and Human Services to issue regulations requiring all cigarette packages manufactured or sold in the United States to bear one of nine new textual warnings, as well as "color graphics depicting the negative health consequences of smoking. Pursuant to this authority, the Food and Drug Administration (FDA) initiated a rulemaking proceeding through which it selected the nine images that would accompany the statutorily prescribed warnings. Five tobacco companies (Tobaccos) challenged the rule, alleging that FDA's proposed graphic warnings violated the First Amendment. The district court granted Tobaccos' motion for summary judgment, concluding that the graphic warnings were not the type of purely factual and uncontroversial disclosures reviewable under the less stringent Zauderer standard. Applying strict scrutiny, the court held that FDA failed to satisfy its burden of demonstrating that the Rule is narrowly tailored to achieve a compelling government interest. On appeal, the FDA argued that the district court erred in finding the Zauderer standard inapplicable.


1) In analyzing the constitutionality of FDA’s proposed graphic warnings, did the Zauderer standard apply? 

2) Did the FDA’s promulgation of the graphic warning labels violate the First Amendment?


1) No. 2) Yes.


In light of 21 U.S.C.S. § 387k's restrictions on labeling and advertising, and absent congressional findings on the misleading nature of the packaging itself, Zauderer's lenient standard of scrutiny did not justify the graphic warnings (GW). The GW were an effort to discourage cigarette purchases, not to combat deceptive claims. The GWs were not purely factual and uncontroversial information, or accurate statements for Zauderer to apply; they were intended to evoke an emotional response, or shock a viewer into retaining the test warnings. An intermediate standard of review applied. The FDA's only explicitly asserted interest was in reducing smoking rates and there was no evidence, much less substantial evidence, showing the GWs would reduce those rates. None of the studies evaluated whether increased thoughts about stopping smoking led people to actually quit. And, the studies failed to account for smoking bans, advertising restrictions, or higher taxes and prices. The FDA's interest in effectively communicating health risks merely described how it planned to accomplish its goal of reducing smoking rates, and not an independent interest capable of sustaining the GWs.

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