A Global View of the First Amendment Contraints on FDA

March 2008

63 Food and Drug Law Journal 151-216 (2008).

This article examines how recent First Amendment case law affects the food and drug regulatory system.  Since 1997, three prominent cases have demonstrated that the First Amendment limits the ability of the Food and Drug Administration (FDA) to regulate labeling, advertising, product claims, off-label promotion and other speech.

This article investigates this food and drug case law, governing First Amendment doctrine, and responses to FDA’s Request for Comment on First Amendment Issues.  In light of these relevant sources, it analyzes the constitutional propriety of the current food and drug regulatory regime and suggests reform where appropriate.


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