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Disc. Tobacco City & Lottery, Inc. v. United States - 674 F.3d 509 (6th Cir. 2012)


Under the so-called modified risk tobacco product rule, a person may only commercially market a product as a modified risk if, after application to the United States Food and Drug Administration, it is determined that the product, as it is actually used by consumers, will—(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.


On June 22, 2009, the President signed into law the Family Smoking Prevention and Tobacco Control Act (Act), which provided the United States Food and Drug Administration (FDA) with the authority to regulate tobacco products. It also sought to “promote cessation of tobacco use.” As part and parcel of this purpose, the Act regulated not only the sale of tobacco products, but also the advertising and marketing of those products. Plaintiffs, a group of manufacturers and sellers of tobacco products, brought suit against the United States of America in the district court, claiming that the challenged provisions of The Family Smoking Prevention and Tobacco Control Act violated their free speech rights under the First Amendment, constituted an unlawful taking under the Fifth Amendment, and were an infringement on their Fifth Amendment due process rights. Plaintiffs also alleged that the Act's authorization of further restrictions by federal agencies, states and Indian tribes was an unconstitutional delegation of legislative authority. Plaintiffs sought a preliminary injunction and a judgment declaring the challenged provisions unconstitutional. Both parties filed motions for summary judgment. The district court granted summary judgment to Plaintiffs on their claims that the ban on color and graphics in advertising and the ban on statements implying that tobacco products are safer due to FDA regulation violated their First Amendment speech rights. The district court granted summary judgment to the government on all other claims.


Did the “modified-risk tobacco products rule” violate the First Amendment?




The Court of Appeals for the Sixth Circuit held that the Act's requirement that tobacco packaging and advertising that includes color graphic and non-graphic warning labels, 15 U.S.C.S. §§ 1333, 4402(2)(A), satisfied the requirements of the First Amendment. Because the modified risk tobacco products rule, 21 U.S.C.S. § 387k, did not regulate non-commercial speech, and met the criteria set forth in Central Hudson for the regulation of noncommercial speech, it did not violate the First Amendment. According to the Court, in analyzing the Central Hudson factor concerning whether the regulation of commercial speech directly advanced the governmental interest asserted, the Government carried the burden of showing that the challenged regulation advanced the Government's interest in a direct and material way. That burden was not satisfied by mere speculation or conjecture; rather, a governmental body seeking to sustain a restriction on commercial speech must demonstrate that the harms it recited were real and that its restriction will in fact alleviate them to a material degree.

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