Food and Drug Law Commons^™

Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

After providing a brief overview of regulation in each area, Part I of this Article identifies three types of discordance between produce safety and environmental protection on farms. First, because of limited resources, farmers will have to choose between implementing food safety practices and implementing environmental practices. Second, indirect trade-offs between the two regulatory goals result in damaging collateral consequences for the environment. Food safety regulation may exacerbate a range of existing environmental harms. Third, there is at least one direct clash that may make compliance with food safety law incompatible with participation in certain environmental programs. Part I also …

Creating Order Amidst Food Eco-Label Chaos, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Eco-labels, certifications, and seals of approval serve a variety of functions including communicating to businesses and consumers the environmental attributes of a particular product and incentivizing improvements in production. Eco-labels also provide a basis for companies to set measurable sustainability goals for sourcing, improvements, and transparency. As they gain greater traction in the marketplace, however, there has been a massive proliferation of labels, certifications, and green seals of approval. This has led to consumer confusion, inaccurate and misleading claims, and inconsistent standards. A 2009 survey identified about 600 labels that denote some definition of “environmentally friendly” worldwide, including more than …

Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane

Michigan Telecommunications & Technology Law Review

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …

Michigan Craft Beer Legislation, Kincaid C. Brown

Law Librarian Scholarship

Michigan is currently in the midst of a craft beer boom. The Michigan Brewers Guild’s member list includes more than 150 breweries and brewpubs brewing craft beer. Michigan’s craft beer industry is boosting the state’s economy. According to an analysis by the Brewers Association customized by the Michigan Brewers Guild, the craft beer industry is directly responsible for more than 5,000 Michigan jobs and contributes more than $277 million to the state’s economy and more than $144 million in wages.

Regulating The Underground: Secret Supper Clubs, Pop-Up Restaurants And The Role O F Law, Sarah B. Schindler

Faculty Publications

Instagram pictures of elegantly plated dinners, long farmstyle tables, and well-to-do people laughing in what looks like a loft apartment are followed by commenters asking, “Where is this?” This is the world of underground dining. Aspiring and established chefs invite strangers into their homes (or their friends’ stores after hours, or the empty warehouse at the edge of town, or the nearest farm) for a night of food and revelry in exchange for cash. Although decidedly antiestablishment, these secret suppers and pop-up restaurants are popular—there are websites to help people locate them, and many respected publications have penned stories about …

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

Sprung From Night Into The Sun: An Examination Of Colorado's Marijuana Regulatory Framework Since Legalization, Robert T. Hoban, Raushanah A. Patterson

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation, Jennifer Thurswell Radis

Loyola University Chicago Law Journal

POM Wonderful sued Coca-Cola under the Lanham Act claiming that it suffered losses due to the misleading label on Coca-Cola’s Minute Maid brand’s Pomegranate Blueberry juice blend. Reversing the Ninth Circuit’s decision in June 2014, the Supreme Court found that POM’s claim was not precluded even though the label was regulated by the FDCA. In fact, the Court acknowledged the complementary nature of private enforcement with FDA regulation, as it did in Wyeth v. Levine in 2009. This Article submits that POM exemplifies the Court’s willingness to strengthen the Lanham Act’s protections against misleading labeling, as it did the same …

From Silicon Valley To The Kitchen Table: Innovative Online Agriculture & Food Start-Ups And The Law, Matthew A. Forcum

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

A Practitioner's Guide To Defending "Natural" Food Labeling Litigation, Lauren E. Handel

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Mad Cow Disease: Is There An App For That?, Sara Gonzalez-Rothi Kronenthal

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Aged Distilled Spirits Competitiveness Act: Increasing Kentucky's Economic Output While Leveling The Playing Field For Kentucky Distilleries, Drake Staples

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Taking "The War On Drugs" To The Fields: The Importance Of Agriculture In Reforming International Law On The Illegal Drug Market, Terra Rivera

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Independent Drug Testing To Ensure Drug Safety And Efficacy, Marc A. Rodwin

Journal of Health Care Law and Policy

This Article explores a proposal that would preclude biased drug testing by removing all drug sponsor influence on the design and conduct of clinical trials for new drug applications (“NDAs”), a reform that would address the root of institutional corruption. Recently advocated by leading scholars, the idea has a long history, yet was neglected for over half a century due to pharmaceutical industry opposition.

Tort As Democracy: Lessons From The Food Wars, Melissa Mortazavi

Faculty Articles

This Article develops alternative emerging theories regarding the function of tort in American civil society. Often, scholars and policymakers evaluate the tort system in terms of compensation, loss allocation, and risk management. This focus overlooks an important modern function of tort; in the context of the modern administrative state, tort is a vital player in the democratic deliberative process. Tort suits bring forth new ideas, force fact-finding, and increase communication amongst public and private institutional actors to develop sound and legitimate law and policy. Perhaps nowhere is this more obvious today than with the current boom of food litigation. Lawsuits …

The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role, Sam F. Halabi

Faculty Publications

Section 305 of the FDA Food Safety Modernization Act specifically calls for FDA to develop recommendations on whether and how to harmonize requirements under the Codex Alimentarius Commission (“Codex”), an international organization charged with developing food standards, guidelines, codes of practice and “other recommendations to ensure fair practices in food trade and protect[ion of] the health of consumers.” FDA’s International Food Safety Capacity-Building Plan is largely supportive and deferential to Codex, concluding that “the use of Codex standards helps assure a safe global food supply.” To be sure, Codex’s stated mission and policies should create and facilitate adoption of universal …

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

Cool Story: Country Of Origin Labeling And The First Amendment, Rebecca Tushnet

Georgetown Law Faculty Publications and Other Works

Country of origin labeling (COOL) requirements have long been part of government regulation of commerce. While one might ordinarily think of mandatory COOL as part of trade policy--or even as a means of encouraging individual citizens to engage in country-specific buying that would be disallowed as protectionism if carried out by their governments -- the most robust legal challenges to mandatory COOL now come from the First Amendment, not from free trade principles. This reliance on free speech claims offers a stark example of the charismatic force of the First Amendment. Objections having little to do with free speech at …

Why Healthy Behavior Is The Hard Choice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Our society is structured to encourage unhealthy diets and physically inactive lifestyles, which are key risk factors for chronic diseases including diabetes, heart diseases, and cancers. We are bombarded with advertisements for hyperprocessed foods laden with saturated fat, salt, sugar, and refined carbohydrates, “low-fat” foods often contain high amounts of sugar and salt, and parks and recreation spaces are often inaccessible or unsafe.

Four simple ideas - taxes on unhealthy products, product reformulation, improving the informational environment, and increasing healthy food accessibility - could make healthy behaviors the “default” choice for most consumers. First, taxes on unhealthy products, such as …