Law Commons^™

Paradise Found? Food Transportation Regulation: A Detour Through Regulatory Purgatory, William Nash

Journal of Food Law & Policy

On January 31, 2014, the Food and Drug Administration ("FDA") issued a Notice of Proposed Rulemaking ("NPRM") that would set requirements for shippers, carriers and receivers of food transported in intrastate and interstate commerce. The NPRM marks a potentially important step in a long history of the (non-)regulation of food transportation. In Parts I and II, this paper will provide some context of the history of food transportation, as well as the major incidents that placed the food transportation industry on the regulatory map. In Parts III and IV, the paper will consider the history of food transportation regulation from …

The California Cannabis Industry: The Complexities Since Recreational Legalization, Talia Lux

The Journal of Business, Entrepreneurship & the Law

This comment will first provide a look into the history and legality of cannabis in the United States, followed by a look into California’s cannabis industry. There will be a discussion on both medical and recreational legality in California and the provisions surrounding both types of legality. Next, the complexities of the cannabis industries will be discussed in terms of opening and operating a cannabis business, the different cannabis business types and the requirements for starting them, and state and local limitations. Immediately following, there will be a federal illegality discussion and how federal illegality conflicts with California law in …

Safe Consumption Sites And The Perverse Dynamics Of Federalism In The Aftermath Of The War On Drugs, Deborah Ahrens

Dickinson Law Review (2017-Present)

In this Article, I explore the complicated regulatory and federalism issues posed by creating safe consumption sites for drug users—an effort which would regulate drugs through use of a public health paradigm. This Article details the difficulties that localities pursuing such sites and other non-criminal-law responses have faced as a result of both federal and state interference. It contrasts those difficulties with the carte blanche local and state officials typically receive from federal regulators when creatively adopting new punitive policies to combat drugs. In so doing, this Article identifies systemic asymmetries of federalism that threaten drug policy reform. While traditional …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Going Hemp Wild: Understanding The Challenges And Opportunities For Fda Regulation Of Cbd In Food Products, Hannah Catt

Journal of Food Law & Policy

After the passage of the 2018 Farm Bill, champions of hemp began to tout opportunities for farmers and businesses involved with the crop. The industry has rallied around one of hemp’s major byproducts, cannabidiol, or CBD. However, the demand for CBD has left the Food and Drug Administration (“FDA”) playing catch-up. This article explains what CBD is, how it is derived, current FDA-approved uses, and a current path forward for the FDA in creating guidance for industry and consumers.

Cannabis Legalization In State Legislatures: Public Health Opportunity And Risk, Daniel G. Orenstein, Stanton A. Glantz

Marquette Law Review

Cannabis is widely used in the United States and internationally despite its illicit status, but that illicit status is changing. In the United States, thirty-three states and the District of Columbia have legalized medical cannabis, and eleven states and D.C. have legalized adult use cannabis. A majority of state medical cannabis laws and all but two state adult use laws are the result of citizen ballot initiatives, but state legislatures are beginning to seriously consider adult use legislation. From a public health perspective, cannabis legalization presents a mix of potential risks and benefits, but a legislative approach offers an opportunity …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

The Gm Food Debate: An Evaluation Of The Nationalbioengineered Food Disclosure Standard Andrecommendations For The United States Based On Foodjustice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Ryan B. Stoa

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and …

Marijuana Appellations: The Case For Cannabicultural Designations Of Origin, Ryan Stoa

Ryan B. Stoa

An appellation is a certified designation of origin that may also require that certain quality or stylistic standards be met. Appellations are most commonly associated with the wine industry, but they can be applied to any agricultural product for which the geographic origin carries importance. The MMRSA [California Medical Marijuana Regulation and Safety Act] … may have far-ranging effects on the marijuana industry in the United States. [A provision of the act permits the state Bureau of Medical Marijuana Regulation to ‘establish appellations of origin for marijuana grown in California.’] As the most populous state in the Union and the …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Stephanie Bair

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

Localism, Labels, And Animal Welfare, Samuel R. Wiseman

Northwestern Journal of Law & Social Policy

The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanely-raised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …

Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd

Faculty Publications

Scholars and other commentators have identified failures in the regulation of cosmetics-which depends heavily on voluntary industry self- regulation-and called for more stringent regulation of these products. Yet these calls have largely neglected an important dimension of the problem: the current laissez-faire approach to the regulation of cosmetics disproportionally places women, and particularly women who are members of other excluded groups, at risk. This Article examines federal cosmetics law and regulation through a feminist lens. It argues that cosmetics law and regulation have lagged behind that of the other major product categories regulated by the Food and Drug Administration under …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck

Seattle University Law Review

This Note seeks to address the issues concerning the FDA’s approval of genetically modified salmon for consumption, arguing that the FDA did not properly vet AquAdvantage salmon, as well as relied on inappropriate criteria in their approval of its market use. Part I provides a brief history of AquAdvantage salmon’s introduction to U.S. markets and the legal actions taken in response to the FDA ruling. Part II discusses the statutes and regulations fundamentally relevant to GE products, as well as a critique of the way each regulation was used to approve AquAdvantage. Part III offers a comparison to the European …

An Examination Of Trans Fat Labeling: Splitting The Third & Ninth Circuit, Jack Gainey

Washington and Lee Journal of Civil Rights and Social Justice

At first glance, consumer claims alleging misleading labeling would seem to find a simple resolution. Under 21 U.S.C. § 343, which governs misbranded food, a food product is misbranded if “its labeling is false or misleading.” However, controversial interpretation of seemingly straightforward statutory language, together with evolving case law, have blurred a once clear picture. Disagreement over the federal preemption of consumer claims regarding trans fat, underscored by a dispute regarding standing, have combined to create a divergence of opinions between courts across the country.

In 2011, the United States District Court for the Northern District of California considered a …

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …