Author Archives: Sam Halabi

Administrative Law as Prerequisite

by Sam Halabi — Tuesday, Nov. 8, 2016

Stepping away from research interests for a post, I thought I’d pose a teaching-related question to the bloggers and readers of Notice and Comment: for which courses that you (or others you know) teach is Administrative Law a mandatory prerequisite? After two weekends spent at conferences where I had a chance to catch up with […]

This entry was tagged .

How Private Food Safety Standards Restrict Access to Markets (and the Desirability of Doing So)

by Sam Halabi — Monday, Oct. 24, 2016

In general, private food safety standards might be regarded as beneficial for both producers and consumers. If Walmart, for example, imposes a requirement on its supplier farms to use chemical fertilizers instead of manure, an important safety risk is minimized (although with other perhaps less desirable costs imposed on farmers and their environment), consumers’ food […]

This entry was tagged .

What Exactly is Global GAP and Where Did it Come From?

by Sam Halabi — Tuesday, Sept. 27, 2016

To understand how private food safety standards have emerged as competitors with regulations adopted through more conventional public law processes, it is worth understanding how the major private standard setter – Global GAP – works and where it came from. The movement for private certification of farming practices resulted from two related consumer pressures and […]

This entry was tagged .

The Battle between Public and Private Food Safety Standards

by Sam Halabi — Monday, Sept. 12, 2016

One of the many far-reaching provisions of the 2011 Food Safety Modernization Act (FSMA) authorizes a voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. FDA finalized this rule in 2015 […]

This entry was tagged .

If There’s No Such Thing as Medical Marijuana, How Do We Have Medical Marijuana?

by Sam Halabi — Friday, Aug. 12, 2016

This week, the Drug Enforcement Agency (DEA) responded to petitions requesting a redesignation of marijuana for the benefit of scientific research. The DEA refused, citing, somewhat tautologically, the fact that there are no scientifically valid and well-controlled clinical trials demonstrating benefits for certain modalities of marijuana for specific medical indications.  DEA affirmed marijuana’s continued status […]

The Predictable but Disappointing Outcome of Universal Health Services v. United States ex. rel. Escobar

by Sam Halabi — Sunday, July 3, 2016

On June 16, 2016, Justice Clarence Thomas wrote for a unanimous Supreme Court that so-called “implied certification” theories supporting False Claims Act suits were permissible under the statute but ultimately sided with the government contractor because “if the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that […]

Zika and Pregnancy-Specific Vaccines’ Regulatory Lacunae

by Sam Halabi — Friday, May 6, 2016

In my next two posts, I will investigate the relationship between regulatory approval of vaccines and the response to the global public health emergency surrounding the spread of the Zika virus. That emergency has resurrected and brought into sharper relief some of the most vexing questions surrounding the regulatory state and pregnancy: the appropriate circumstances, […]

Conti-Brown’s “Independence” and Institutional Design: Lessons from and for the FDA

by Sam Halabi — Tuesday, Apr. 5, 2016

Let me begin by echoing Daniel’s thanks to Chris, the Yale Journal on Regulation’s Notice and Comment team, and Peter for the opportunity to reach outside my scholarly comfort zone and hopefully play a useful role in illuminating the importance of Peter’s book not only for scholars of the Federal Reserve system but the legal […]

FDA’s Memoranda of Understanding, Quasi-Treaties, and their Role in the Future of Global Administrative Law

by Sam Halabi — Monday, Feb. 8, 2016

In my last post, I detailed the kinds of agreements FDA uses with regulatory partners as part of a three-post series that examines FDA through the lens on the growing literature on “global administrative law.” This final post analyzes FDA’s “steepest” commitments with regulatory partners and argues that in the process of contributing to global […]

This entry was tagged .