The First Amendment guarantees that Congress shall make no law abridging the freedom of speech. This protection encompasses commercial speech, which the U.S. Supreme Court said in Central Hudson Gas & Electric Corp v. Public Service Commission (1980) “assists consumers and furthers the societal interest in the fullest possible dissemination of information.”

The U.S. Food and Drug Administration (FDA) doesn’t always hear this message. When it is not aiming its enforcement efforts against false or misleading information, the agency has a history of losing First Amendment challenges. Yet the FDA continues its pursuit of speech-based conduct — from Internet promotion to dissemination of information about off-label drug uses to the color of cigarette labeling — frequently when the information conveyed is not misleading.

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