Food and Drug Law Commons^™

Mandatory Labeling Of Bioengineered Foods, Andrew Williams

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Weeding Out Social Welfare Organizations And The Public Policy Doctrine, Jake R. Miller

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Avoiding The Chaos Of Maryjane - A Conventional Approach To Intellectual Property Protection Of Marijuana, 17 J. Marshall Rev. Intell. Prop. L. 278 (2017), Kaylee Willis

UIC Review of Intellectual Property Law

Whether you are considering the ever-popular recreational use, or recent medicinal developments, marijuana is a highly discussed controversial substance. With revenue from marijuana into the billions of dollars, it is no wonder it has been trying to reach into the intellectual property arena. This comment specifically looks into the patent arena and the obstacles that come with an attempt to seek, and enforce protection of marijuana-based patent applications. With the USPTO’s plant and utility patent options, there is perhaps more than one way to pass marijuana-based substances as patent-eligible subject matter. The largest obstacle for this type of intellectual property …

Much Ado About The Tpp’S Effect On Pharmaceuticals, Emily Michiko Morris

SMU Science and Technology Law Review

No abstract provided.

Regulating Milk: Women And Cows In France, Mathilde Cohen

Faculty Articles and Papers

Animal milk, most commonly cow’s milk, is one of the most heavily regulated commodities in both France and the United States. With the increasing popularity of breastfeeding and the possibility of pumping, freezing, and storing breast milk, a cottage industry has emerged for people wishing to buy, sell, or donate milk produced by humans. Yet the legal landscape for human milk remains inchoate, prompting public health officials and medical professionals to call for tighter regulation. Animal and human milk are typically viewed as two distinct substances with little in common beyond a name. In contrast, this Article highlights the analogies …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

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 …

Regulatory Obstacles To Harm Reduction: The Case Of Smoking, Jonathan H. Adler

Faculty Publications

The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. In surveys, a majority of smokers express concern for their health and a desire to kick the habit.

Electronic cigarettes (“e-cigarettes” or “e-cigs”) appear to be the most promising smoking alternative to enter the market to date. E-cigarettes have the potential to satisfy smokers’ craving for nicotine in a less dangerous way. The available evidence suggests e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible …

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

Faculty Publications & Other Works

No abstract provided.

Moving In Opposite Directions? Exploring Trends In Consumer Demand And Agricultural Production, Susan A. Schneider

Mitchell Hamline Law Review

No abstract provided.

Pasture To Package: Ensuring Food Safety Compliance And Animal Welfare Integrity In Grass-Fed Beef Production, Lauren Manning

Mitchell Hamline Law Review

No abstract provided.

Unburdening The Farm: A Dormant Commerce Clause Challenge To Conflicting Standards In Agricultural Production, Bethany Gullman

Mitchell Hamline Law Review

No abstract provided.

A Little Less Regulation: Why Federal Pain Management Laws Are Hurting State Efforts To Combat The Opioid Epidemic, Michael Waldrop

Mitchell Hamline Law Review

No abstract provided.

The Craft Brewing Boom And Minnesota's Three-Tier System: The Case For Change, Jeffrey C. O'Brien

Mitchell Hamline Law Review

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 …

12 Angry Men V. The Agency: Why Preemption Should Resolve This Conflict In Drug Labeling Litigation, Michelle L. Richards

Marquette Law Review

The Supreme Court has found in favor of preemption in tort liability cases involving matters of heavy federal regulation in which Congress has delegated implementation of a statute involving technical subject matter to the agency. It has not been the case, however, in matters concerning the labeling of prescription drugs, despite the fact that the FDA has exclusively regulated drug labeling for more than a century. In fact, the current state of affairs now allows a jury to substitute the judgment of the FDA in approving a label on a name-brand drug for their own in state law failure to …

Is It Time To Pay Attention? Critiquing The Cognitive Enhancement Drug Policies And Appeals Process In United States Collegiate Sports, David Swiedler

Cardozo Journal of Conflict Resolution

This Note examines PED use in college sports, focusing primarily on cognitive enhancing drugs as an example of a common lethal PED, and the current NCAA drug-testing regulations and disciplinary process to explore its efficiency and fairness. Then, the Note proposes changes to the NCAA protocol, specifically changes to the appeals process for student-athletes who fail drug tests for PED use and request a review of the disciplinary actions taken against them by the NCAA.

Criminal Law—When Apples Tatse Like Oranges, You Cannot Judge A Book By Its Cover: How To Fight Emerging Synthetic "Designer" Drugs Of Abuse, Andrew Payne Norwood

University of Arkansas at Little Rock Law Review

No abstract provided.

Tax Treatment Of A Marijuana Business, Douglas A. Kahn, Howard Bromberg

Articles

Currently, twenty-eight states and the District of Columbia allow the use of marijuana for medical purposes and permit the conduct of a business marketing of marijuana for that purpose. Eight of those states and the District of Columbia permit the recreational use of marijuana. There is reason to believe that more states will decriminalize the marketing of marijuana. However, marijuana is listed in Schedule 1 of the federal Controlled Substances Act of 1970 (CSA) which makes it illegal under federal law to manufacture or distribute marijuana even when it is legal to do so under local state law. In a …

Abilify, Brintellix, Champix: The Abcs Of Fda Proprietary Name Disputes, M. Dinora Smith

Cardozo Arts & Entertainment Law Journal

No abstract provided.