Rulemaking:

Request for Comment on First Amendment Issues

Stated Purpose:

"In several instances the FDA's methods in protecting the consumer from information have fallen afoul of the First Amendment provision: 'Congress shall make no law ... abridging the freedom of speech.' In light of recent case history, the FDA has requested public comment on whether FDA regulations chill speech and ways in which the FDA could protect consumers' interest without violating the First Amendment."

Summary of RSP Comment:

The FDA was created at the turn of the last century with the directive to protect consumers from fraud. In order to fulfill this mission, the FDA has maintained that it must filter the information that reaches the consumers: FDA has historically employed its authority to ensure, to the extent possible, that health care professionals and consumers receive accurate and complete information. The manner and substantive content of FDA's regulation of speech has important implications for public health. False or misleading claims concerning foods, drugs, biologics, medical devices, cosmetics, or veterinary medicines may harm individuals who rely on those claims. Truthful claims, by contrast, may improve public health. However, in several instances the FDA's methods in protecting the consumer from information have fallen afoul of the First Amendment provision: "Congress shall make no law ... abridging the freedom of speech." In light of recent case history, the FDA has requested public comment on whether FDA regulations chill speech and ways in which the FDA could protect consumers' interest without violating the First Amendment. The FDA posed nine questions to guide those wishing to comment, three of which this comment addresses. They are: 1) "Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority?" 2) "What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels?" 3) "Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech?" This comment addresses these questions by giving a brief overview of case law, followed by a discussion of how advertising and labeling practices affect the consumer, and the FDA's handling of the trans fat labeling regulation, concluding with the recommendation of how the FDA should approach consumer protection in the 21st century.