Food and Drug Law Commons^™

Remediating Public Health Crises Through Litigation: Lessons From Oklahoma In The Tobacco And Opioid Epidemic Litigations, Caroline Beckworth

Oklahoma Law Review

No abstract provided.

The Interchangeable-Part Structure Of Food And Drug Law, Adam I. Muchmore

FIU Law Review

This Article demonstrates that nested tiers of interchangeable parts serve as the foundation for the regulatory programs administered by the U.S. Food and Drug Administration. Core interchangeable parts used in FDA-administered programs include product categories, prohibitions on adulteration and misbranding, agency-registration requirements, current good manufacturing practices, product standards, marketing authorization requirements, postmarket requirements, and user fees. In each of these areas, Congress or the FDA has engaged in interchangeable-part lawmaking (IPL). IPL occurs when a government takes a portion of its law in one subject area and uses it as a model for its own law in another subject area. …

The Hunger Games: Food As A Right, Not A Privilege, Camesha F. Little

FIU Law Review

Despite the United Nations' explicit declaration that all humans have a right to food, food insecurity and hunger remain persistent problems in the United States and around the globe. The dystopian landscapes depicted in novels such as The Hunger Games and Parable of the Sower—societies crippled by poverty, oppression, and pervasive starvation—resonate with sobering contemporary realities. This Article examines existing food laws, food rights, and the current protections safeguarding the United States food supply from a humanitarian perspective. Ultimately, this Article argues that the human right to food must expand to encompass a right to healthy or natural food, and …

Revisiting Patent Linkage, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Alfred Engelberg’s article of a quarter-century ago, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, raised a provocative question that retains currency today. The special provisions that Hatch-Waxman established, and Engelberg addressed, have come to be known as patent linkage. Following the principle of linkage, the Food and Drug Administration (FDA) cannot approve generic drugs for marketing if they would infringe a patent.

Hatch-Waxman’s complex patent provisions aspire towards multiple salutary purposes, including encouraging the prompt availability of generic drugs, improving public notice of pharmaceutical patents, and accelerating dispute resolution proceedings. Congress also attempted to ameliorate perceived …

An Integrated Approach Can Improve China’S Food Additives Security, Qian Li, Jingru Hou, Jennifer S. Stevenson, Cihui Liu

Faculty Articles

In China, the development of food additives remains a critical challenge in food additives security research. We discuss an integrated approach that can improve China’s food additives security, including technical management, standards implementation, and punitive damages regime. Through this integration, we identify that technical management, standards implementation, and punitive damages regime are each complementary to each other. Technical management helps reduce the inherent risks of food additives beforehand. Standards implementation helps prevent and control risks of food additives use halfway. Punitive damages regime helps relieve secondary risks arising from food additives use. Crucially, this integration enhances the suitability of food …

The 340b Drug Pricing Program: Administration, Litigation, And Reform, Ryan P. Knox, Ameet Sarpatwari

Oklahoma Law Review

No abstract provided.

A Spoonful Of Sugar Won’T Help This Medicine Go Down: The Inflation Reduction Act’S Failure To Address Pharmaceutical Evergreening, Megan E.A. Davis

Oklahoma Law Review

No abstract provided.

Transitioning To Regenerative Agriculture: One "Net-Zero" Pledge At A Time, Alexia Brunet Marks

Publications

As climate change intensifies, food sector multinational companies (MNCs), like Nestlé; Mars, Inc.; Unilever; PepsiCo; and Danone, face increasing pressure to reach net-zero by 2050, whereby they would reduce and ultimately eliminate carbon dioxide emissions from their supply chains by 2050. Carbon dioxide emissions are a major business liability, decreasing a firm’s value an average of $212,000 for every one thousand metric tons produced. As companies seek to align their pledges with regional, national, and subnational climate goals, they are legally required to comply with a growing number of disclosure rules for foods entering the United States and the European …