Food and Drug Law Commons^™

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.

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 …

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 …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Voting Matters: Materiality Considerations And The Shareholder Vote, Renee M. Jones

Seattle University Law Review

For the shareholder franchise to have meaning, shareholders must have access to relevant information to inform their voting decisions. The securities laws’ disclosure requirements play an essential role in informing the shareholder vote.

This Essay focuses on the question of the materiality of information in the context of shareholder voting. It addresses the question of whether ESG-related information is material, positioning the materiality inquiry within the context of shareholders’ voting decisions. It explores the definition of materiality with a focus on the “reasonable investor” concept embedded within the definition. The Essay argues that the implicit expectations of many commentators that …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Understanding The Big Three’S Wavering Support Of Environmental And Social Shareholder Proposals, Jeff Schwartz, Jefferson Jensen

Seattle University Law Review

Because of their substantial equity portfolios, BlackRock, Vanguard, and State Street (the Big 3) are central players in corporate governance. It is, therefore, critical to understand how they vote. One puzzle is that their support for shareholder proposals on environmental and social matters appears to waiver. In 2020, for instance, BlackRock supported 11.1% of environmental proposals at S&P 500 firms. In 2021, it seemingly reversed course, supporting 55.2%. It then flipped again, supporting 32.1% in 2022. Such statistics suggest that the Big 3 are constantly changing their views on these topics. This Article seeks to better understand whether this is …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Most-Favored-Nation Drug Pricing—How Courts Could Shape Future Health Regulation, Nicholas Bagley, Craig Garthwaite, Benedic Ippolito

Other Publications

The Trump administration recently issued an Executive Order aimed at delivering most-favored- nation (MFN) drug pricing to the US. The order instructs drug manufacturers to reduce the prices of brand-name drugs to match the lowest price among selected high-income countries. If drug makers do not make significant progress toward this goal, the administration will pursue several strategies to lower prices. Most notably, the Executive Order directs the Secretary of Health and Human Services (HHS) to propose a rule to impose MFN pricing. In all likelihood, the administration will revisit prior efforts to enact MFN pricing through the Center for Medicare …

Money Talks: The Disproportionate Influence Of Corporations On U.S. Governance Today, David C. Hayter

Lewis & Clark Law Review

Corruption: “Dishonest or illegal behavior especially by powerful people (such as government officials . . . )”; and “inducement to wrong by improper or unlawful means (such as bribery).”

What does the word “corruption” first bring to mind? For some, maybe a foreign country—where political regimes blatantly use the government as a tool to further personal agendas or gains without due consideration of the citizenry. For others, a fictional movie or TV show depicting politicians and police officers providing protections to mafia members in exchange for cash. No matter what comes to mind, many today think of corruption as manifested …

Legal Implications Of Digital Health Apps Informing Food Allergy Labeling For Consumers' Health And Privacy Protection, Kathy Keunghee Kim

Maurer Theses and Dissertations

This dissertation examines food allergy labeling’s use in a digital format. Allergy information is typically found on food packaging and containers to help consumers identify individually concerned allergens. Given the critical role that food allergy labels play in preventing unexpected allergic reactions before selecting or consuming food, it is essential to comprehend the labeling descriptions. However, current regulations and laws regarding allergy labeling often confuse consumers due to the existence of mandatory and voluntary Precautionary Allergy Labeling (PAL) categories and the absence of laws and regulations that require allergy information for restaurant meals. Technology companies have introduced digital health and …

From "Maine Law" To Model Act: Liquor Liability In Maine, William P. Shumaker

Maine Law Review

With the passage of the Maine Liquor Liability Act by the 112th Legislature, the State of Maine has completed a thorough reexamination of its public policy in the area of liability for injuries resulting from the use of alcoholic beverages. For 130 years the state's policy in this area was expressed by the statute commonly known as the dram shop act, the essential provisions of which had remained unchanged for over a century. This statute held sellers and other providers of alcoholic beverages strictly liable to any third party injured as a result of the intoxication of the recipient of …

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

Journal of Food Law & Policy

Energy drinks first rose to popularity in the 1980s after the creation of Red Bull. In addition to high caffeine amounts, energy drinks often contain herbal stimulant additives, vitamin and mineral mixtures, and sugar. There is very little information available on the long-term effects of these stimulant mixtures on the body. Although many consumers purchase energy drinks because of their caffeine content, many are left in the dark when it comes to labeling transparency and are unaware of their true contents. Energy drinks are classified as dietary supplements, meaning they are not directly regulated by the FDA before hitting store …

Forced To Weather The Storm: Reforming The Livestock Indemnity Program To Improve Farm Animal Welfare, Cameron Krier Massey

Journal of Food Law & Policy

Each year, extreme weather events put the lives and wellbeing of millions of farm animals at risk. These events can lead to injury, suffering, acute and chronic stress, decreased productivity, and loss of life. As storms increase in frequency and intensity, efforts should be made to ensure livestock are protected. This paper proposes modifications to the Livestock Indemnity Program (LIP), a federally run disaster assistance program that compensates livestock owners and growers for animal deaths and reduced value caused by eligible conditions, including extreme weather. Surprisingly, the program does not require producers to show proof and use of a disaster …

Udder Confusion: An Almond Milk Case Study To Examine The Complex Interplay Of Consumer Choices, Social Media, And Regulation, Madeline Mcculloch

Journal of Food Law & Policy

The preference for plant-based diet options has steadily increased for the American public. This is all particularly true for alternative milks. By the end of 2020, plant-based milk alternatives (“PBMA”) accounted for approximately fifteen percent of the total milk market and thirty-five percent of the overall plant-based market, making alternative milks, particularly almond, one of the most popular ways for people to dabble in a plant-based diet. Almond milk holds the gold in the U.S. plant-based milk market. It is, first, essential to examine the comprehensive context surrounding almond milks’ status on grocery shelves. This writing will attempt to do …

Legal Chefs’ Appetizing Taglines To Engage Consumers In The Age Of Social Media: The Struggle Against Trademark Genericide, Emily Mcdonald

Journal of Food Law & Policy

Many have heard the phrases “raisin bran,” “escalator,” “nylon,” and “aspirin,” all of which are “old” trademarks that have undergone genericide. Genericide occurs when a trademark has become common from the customer’s perspective concerning specific goods or services rather than associated with the source, which is usually the company that registered the trademark. In short, businesses are no longer able to use the trademark exclusively. Another common trademark phrase that became generic was “Taco Tuesday.” In light of the prolific use of social media today, recent data and statistics show that “food” has become a predominant category and trend on …

Food Identity, Mathilde Cohen

Journal of Food Law & Policy

Food identities are typically ascribed either based on medical or social definitions or chosen by individuals. But they can also be expressive dimensions of other identity traits such as race, ethnicity, religion, national origin, gender, age, body size, disability, and socio-economic status, among others. What role does the law play in supporting or undermining certain food identities? This Article makes two central contributions. First, it highlights that though U.S. law recognizes food identity as an interest to be protected in certain contexts, it does so in an unsystematized way, contributing to systemic deprivation and discrimination in relation to foodways. The …

Time To Stop Trip-Ing: The World Needs A New Geographical Indications Agreement, Evan Glatt

Brooklyn Journal of International Law

When it comes to purchasing food and alcohol, a product’s name carries weight and helps consumers make decisions. When the product’s name includes a place and establishes a certain level of quality and expectation, consumers trust that the product is what it purports to be. This concept, the reputation of a particular food product by name, is known as a geographical indication (GI). GIs cover a wide range of products, from the well-known champagne to lesser known products such as Roquefort cheese. GIs create financial value for local producers, contribute to sustainability initiatives, and raise the quality of goods for …