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Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.

I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various …

Did The Fda Properly Assess The Safety Of Olestra As A Food Additive?, Leah Lebel

The Science Journal of the Lander College of Arts and Sciences

The following is an excerpt of the introduction to this article: Olestra, a fat-substitute comprised of sucrose that has been esterified with fatty acids (Blume 1995), has been the subject of much controversy ever since its creation. Olestra is not absorbed (Mattson and Nolen 1972) because it cannot be hydrolyzed by pancreatic lipases (Mattson and Volpenhein 1972) or taken up across the enterocyte microvillus membrane (Freston et al. 1997), and thus, cannot be utilized for energy. Olestra has physical and organoleptic properties similar to those of traditional triglycerides (Jandacek and Webb 1978) and is emulsified together with triglyceride (Freston et …