Philip Morris USA, Inc. v. U.S. Food & Drug Administration (2016)

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202 F.Supp. 3d 31 (D.D.C. 2016)

The tobacco industry challenged an FDA guidance document that changed the way that the agency administers the premarket review process.


On March 4, 2015, the FDA issued a guidance document making changes to one part of the premarket review process. For more information on this action and the implications for public health, see FDA Policy Puts Industry Interests Before Public Health. After some wrangling with major tobacco companies over the legality of the guidance, on September 8, 2015, the FDA reissued its guidance document without changing any of the underlying policies and on September 30, 2015, the industry filed a lawsuit, claiming that the proposed approach to labeling changes infringes on tobacco companies’ First Amendment Rights and that the guidance misinterpreted the Tobacco Control Act. In addition to refuting the merits of the industry’s claim, the FDA has also argued that the tobacco industry’s claims were not yet ripe for review because the industry has yet to suffer any harm based on its allegations.

Litigation Status

On August 16, 2016, a district court judge found that the portion of the FDA’s guidance related to labeling changes exceeded its statutory authority by misinterpreting the Tobacco Control Act. The judge ordered the FDA to revise its guidance accordingly. The FDA’s revised guidance on this issue now indicates that “manufacturers need not receive premarket authorization for existing products that are subject to a label change only.” The FDA did not appeal this decision.