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Full-Text Articles in Health Law and Policy

A Drug By Any Other Name ... ? Paradoxes In Dietary Supplement Risk Regulation, Lars Noah, Barbara A. Noah Jan 2006

A Drug By Any Other Name ... ? Paradoxes In Dietary Supplement Risk Regulation, Lars Noah, Barbara A. Noah

Faculty Scholarship

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute.


The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn Jan 2006

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Scholarship

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this ...


Abortion, Equality, And Administrative Regulation, Gillian E. Metzger Jan 2006

Abortion, Equality, And Administrative Regulation, Gillian E. Metzger

Faculty Scholarship

This symposium essay argues that administrative regulation of abortion and reproductive rights deserve closer study. Administrative regulation of abortion is overwhelmingly health regulation; the focus is on abortion as a medical procedure, and the government's only stated interest is protecting the health of women obtaining abortions. Such regulation is becoming increasingly common, and is worthy of greater attention on that ground alone. But in addition, and of particular relevance to this symposium on reproductive rights and equality, administrative abortion regulation demonstrates the difficulty in successfully challenging abortion restrictions as unconstitutional gender discrimination. Given general medical agreement that early abortions ...