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Articles 1 - 30 of 1133

Full-Text Articles in Food and Drug Law

Pharmaceutical Federalism, Patricia J. Zettler Jul 2017

Pharmaceutical Federalism, Patricia J. Zettler

Indiana Law Journal

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013, Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA ...


Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky Jun 2017

Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky

Erwin Chemerinsky

No abstract provided.


A General Theory Of Preemption: With Comments On State Decriminalization Of Marijuana, Lea Brilmayer Jun 2017

A General Theory Of Preemption: With Comments On State Decriminalization Of Marijuana, Lea Brilmayer

Boston College Law Review

Marijuana decriminalization is a hotly debated topic, which has nonetheless seen popular support in recent years. Current federal law (the Controlled Substances Act) conflicts with many state decriminalization efforts, raising the obvious question of federal preemption. The Supreme Court has failed to provide a clear answer on how much federal law preempts state marijuana decriminalization laws. This Article identifies the foundational principles of vertical and horizontal preemption, as well as various unanswered questions regarding these doctrines. It then applies these questions to marijuana decriminalization. Ultimately, it argues that there is a weak case for vertical or horizontal preemption in the ...


One Toke Too Far: The Demise Of The Dormant Commerce Clause's Extraterritoriality Doctrine Threatens The Marijuana-Legalization Experiment, Chad Deveaux Jun 2017

One Toke Too Far: The Demise Of The Dormant Commerce Clause's Extraterritoriality Doctrine Threatens The Marijuana-Legalization Experiment, Chad Deveaux

Boston College Law Review

This Article argues that the pending feuds between neighboring states over marijuana decriminalization demonstrate the need for a strict doctrine limiting a state’s regulatory authority to its own borders. Precedent recognizes that the dormant Commerce Clause (“DCC”) “precludes the application of a state statute to commerce that takes place wholly outside the State’s borders, whether or not the commerce has effects within the State.” This prohibition protects “the autonomy of the individual States within their respective spheres” by dictating that “[n]o state has the authority to tell other polities what laws they must enact or how affairs ...


Reefer Madness: How Non-Legalizing States Can Revamp Dram Shop Laws To Protect Themselves From Marijuana Spillover From Their Legalizing Neighbors, Jessica Berch Jun 2017

Reefer Madness: How Non-Legalizing States Can Revamp Dram Shop Laws To Protect Themselves From Marijuana Spillover From Their Legalizing Neighbors, Jessica Berch

Boston College Law Review

Reefer madness is sweeping the nation. Despite a federal ban on marijuana, states have begun to legalize medical and, increasingly, recreational use of the drug. As more states legalize marijuana, their non-legalizing neighbors have seen a distinct uptick in marijuana possession and use—and an attendant increase in crime and accidents. In December 2014, Nebraska and Oklahoma, non-legalizing states that border Colorado, a trail-blazer in the full-legalization movement, requested permission to file suit in the U.S. Supreme Court over their neighbor’s lax marijuana controls, which allow cannabis to come into their states. The Supreme Court denied leave to ...


Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky Jun 2017

Introduction: Marijuana Laws And Federalism, Erwin Chemerinsky

Boston College Law Review

No abstract provided.


Policy, Preemption, And Pot: Extra-Territorial Citizen Jurisdiction, Gabriel J. Chin Jun 2017

Policy, Preemption, And Pot: Extra-Territorial Citizen Jurisdiction, Gabriel J. Chin

Boston College Law Review

In contemporary America, legislators send messages about values through symbolic legislation and lawsuits. One conflict is between states where marijuana is legal and others that continue to ban it. This Article evaluates what might happen if anti-marijuana states made it illegal for their citizens to purchase or use marijuana, borrowing a page from the playbook of activists opposed to reproductive choice who propose that if Roe v. Wade is overturned, individuals could be prohibited from traveling to another state for the purpose of obtaining an abortion. Although such laws would be hard to enforce, they still present important questions of ...


Budding Conflicts: Marijuana's Impact On Unsettled Questions Of Tribal-State Relations, Katherine J. Florey Jun 2017

Budding Conflicts: Marijuana's Impact On Unsettled Questions Of Tribal-State Relations, Katherine J. Florey

Boston College Law Review

In the wake of a December 2014 decision by the Department of Justice to deprioritize enforcement of federal marijuana laws against tribes as well as states, many tribes have reevaluated their policies toward marijuana. Tribal attitudes toward marijuana are diverse; some tribes regard marijuana as a public health menace, whereas others see it as a source of economic opportunity. Where tribal policies are significantly more or less restrictive than those of the surrounding state, tribal-state relations have often suffered friction. The problem is particularly acute given the jurisdictional uncertainty that characterizes Indian country and the absence of any equivalent to ...


Marijuana, State Extraterritoriality, And Congress, Mark D. Rosen Jun 2017

Marijuana, State Extraterritoriality, And Congress, Mark D. Rosen

Boston College Law Review

The Trump administration inherits the Obama administration’s policy of under-enforcing federal marijuana laws and a nation with a patchwork of divergent state laws. Although allowing diversity and experimentation, such divergence may impose spillover costs to some states. Some states may attempt to address these costs by exercising extraterritorial regulatory powers on their citizens. Although it is unclear and a matter of dispute whether and to what extent states have such extraterritorial authority, this Article shows that it is certain that Congress has power to set the bounds of state extraterritorial regulation, subject to only limited constitutional restraints. The Article ...


Marijuana Legalization And Nosy Neighbor States, Alex Kreit Jun 2017

Marijuana Legalization And Nosy Neighbor States, Alex Kreit

Boston College Law Review

As more states proceed with marijuana legalization laws, questions have arisen about how to accommodate those states that wish to retain prohibition. For instance, in 2014, Oklahoma and Nebraska unsuccessfully sued Colorado based on the spillover effects that Colorado’s marijuana legalization law had on its neighboring states. This article asserts that there are several reasons why state marijuana legalization laws are unlikely to have a large effect on neighboring states. First, marijuana is not a previously unobtainable good being introduced into the stream of commerce, as it is already available through the black market inexpensively. Second, legalization laws have ...


Preventing A Risk/Risk Trade-Off: An Analysis Of The Measures Necessary To Increase U.S. Pollinator Numbers, Camila Acchiardo Vallejo Jun 2017

Preventing A Risk/Risk Trade-Off: An Analysis Of The Measures Necessary To Increase U.S. Pollinator Numbers, Camila Acchiardo Vallejo

Pace Environmental Law Review

This Note will proceed in four parts. Part II will discuss the importance of pollinators and the possible reasons for their declining numbers. Part III will delve into the current and proposed actions to increase pollinator populations that are taking place in the United States. Part IV will then discuss the generally desired and widely accepted solution: a ban on neonicotinoids. This Part will introduce the implementation and results of a neonicotinoid ban in the European Union, and the risk/risk trade-off presented by a neonicotinoid ban. Finally, Part V will compile the solutions discussed in Parts III and IV ...


Public Conservation Policies On Private Land: A Case Study Of The Brazilian Forest Code And Implications For The Agro-Industry Sector, Rayane Aguiar, Jody M. Endres, Caroline Taylor, Samuel Evans Jun 2017

Public Conservation Policies On Private Land: A Case Study Of The Brazilian Forest Code And Implications For The Agro-Industry Sector, Rayane Aguiar, Jody M. Endres, Caroline Taylor, Samuel Evans

Pace Environmental Law Review

The objectives of this paper are to discuss (1) a brief history of the Brazilian Forest Code (FC); (2) key aspects of the 2012 FC revisions; (3) the status of implementation, including institutional and field-level challenges, as well as economic incentives to ease compliance; and (4) the importance of the FC for the Brazilian agro-industrial sector.


A Window Of Opportunity For Gmo Regulation: Achieving Food Integrity Through Cap-And-Trade Models From Climate Policy For Gmo Regulation, Gabriela Steier Jun 2017

A Window Of Opportunity For Gmo Regulation: Achieving Food Integrity Through Cap-And-Trade Models From Climate Policy For Gmo Regulation, Gabriela Steier

Pace Environmental Law Review

GMOs are the links of our centralized food system, largely dependent on international trade. GMOs are inherently unsustainable because they reduce biodiversity, harm the environment, and empower positive feedback loops between monocultures, industrial agriculture, and biodiversity depletion, thereby jeopardizing food safety, security, and sovereignty. Conglomerates of multi-national companies, in short BigAg, shape multi-lateral food trade and flood international markets with their small array and enormous volumes of crops, while controlling large aspects of agriculture and food production world-wide. Zooming in on the trans-Atlantic dispute about GE crops, this paper uses comparative law to explore how a cap-and-trade model borrowed from ...


Food Deserts Are Ripe For Business, Ryelle Seymour Jun 2017

Food Deserts Are Ripe For Business, Ryelle Seymour

Boston College Environmental Affairs Law Review

People living in food deserts lack access to nutritious food. Although growing awareness of food deserts has prompted federal and state governments to allocate resources to combat the problem, many municipal and state governments lack the funding, personnel, and expertise necessary to develop and implement programs to address food deserts. The private sector can take advantage of federal and local governmental incentive programs to establish an enterprise to serve food desert areas. The successful food desert intiatives implemented around the country can serve as a model for future programs. Because these businesses have proved to be profitable but are created ...


Taxing Marijuana: Earmarking Tax Revenue From Legalized Marijuana, Armikka R. Bryant May 2017

Taxing Marijuana: Earmarking Tax Revenue From Legalized Marijuana, Armikka R. Bryant

Georgia State University Law Review

This Article provides an overview of the legal, political, and societal landscapes in states that have legalized marijuana and imposed taxes on its sale. The article begins by summarizing the War on Drugs’ origins, its fiscal expenditures, and the social policies that ultimately led to its failure.

Part I briefly details the history of marijuana regulation starting from the early twentieth century up to the Obama administration’s decision to permit recreational marijuana laws to stand in Washington state and Colorado. Part II dives deeper into the social costs of the War on Drugs and outlines the hardships faced by ...


“Safe Harbor” On The Rocks: Ttb Label Approval For Beer, Wine, And Spirits, And The Uncertain Status Of The “Safe Harbor” Defense, Michael Mercurio May 2017

“Safe Harbor” On The Rocks: Ttb Label Approval For Beer, Wine, And Spirits, And The Uncertain Status Of The “Safe Harbor” Defense, Michael Mercurio

Notre Dame Journal of International & Comparative Law

This Note examines the U.S. Alcohol and Tobacco Tax and Trade Bureau (TTB)’s label review process and the judicial split regarding the “safe harbor” doctrine in the context of alcoholic beverage labels. This Note observes that the judicial split is a result of the tension between two conflicting priorities stemming from the TTB’s purpose and identity: on one hand, courts apply Chevron deference to the TTB as a federal agency enforcing federal law, but on the other hand, courts aim to uphold the central purpose of the Federal Alcohol Administration (FAA) Act—protecting consumers from misinformation. Ultimately ...


Do Desperate Times Really Call For Desperate Measures? The Ethical Dilemma Behind The Regulation And Use Of Experimental Drugs, Lauren Kuehn May 2017

Do Desperate Times Really Call For Desperate Measures? The Ethical Dilemma Behind The Regulation And Use Of Experimental Drugs, Lauren Kuehn

Notre Dame Journal of International & Comparative Law

This Note will argue that, unlike what many patients believe, the U.S. Food and Drug Administration (FDA) plays an invaluable and imperative role in seeking the efficacy and safety of new treatment options and drugs. The balance of interests between those who are terminally ill, who wish to see increased access to unapproved medicines; the general public, who has an interest in preserving the drug approval process; and the FDA, who has been mandated by law to safeguard the safety of the general public, creates a tension that will continue to go unresolved. Thus, the patients who continue to ...


Comment: Prison For You. Profit For Me. Systemic Racism Effectively Bars Blacks From Participation In Newly-Legal Marijuana Industry, Elizabeth Danquah-Brobby May 2017

Comment: Prison For You. Profit For Me. Systemic Racism Effectively Bars Blacks From Participation In Newly-Legal Marijuana Industry, Elizabeth Danquah-Brobby

University of Baltimore Law Review

Historically, blacks have been prosecuted and convicted across the United States at significantly higher rates when compared to whites for marijuana-related crimes, despite the fact that studies indicate marijuana use by whites and blacks is relatively equal. Further, individuals with lower economic means were dually susceptible to conviction as a result of less vigorous legal representation.

Now, laws have legalized marijuana for medicinal purposes in twenty-six states, along with a small portion of states (seven) legalizing marijuana for recreational use. Yet retroactive ameliorative relief is not widely available to those who were convicted under circumstances that are now legal, and ...


Food Date Labels And Hunger In America, Gwen B. Thomson Apr 2017

Food Date Labels And Hunger In America, Gwen B. Thomson

Concordia Law Review

Millions of Americans go hungry, while 40% of the food in the United States is wasted. Research has shown that 43% of the waste occurs in homes and that consumers are making decisions about purchasing and throwing away food without understanding the meaning of the food date labels. One of the most cost-effective ways to begin to effect a change is to eliminate the myriad of confusing food date labels so that individuals do not throw away good food. In May 2016, the Food Date Labeling Act of 2016 was proposed in both houses of Congress. This bicameral bill was ...


The Role Of Antitrust Principles In Patent Monopolies: The Third Circuit Applies Antitrust Scrutiny To No-Ag Patent Settlements In Smithkline, Meghan Fay Apr 2017

The Role Of Antitrust Principles In Patent Monopolies: The Third Circuit Applies Antitrust Scrutiny To No-Ag Patent Settlements In Smithkline, Meghan Fay

Boston College Law Review

On June 26, 2015, in King Drug Co. of Florence v. Smithkline Beecham Corp., the U.S. Court of Appeals for the Third Circuit held that no-authorized generic agreements (“no-AG agreements”), in which a pioneer pharmaceutical manufacturer agrees not to introduce a generic drug, are subject to antitrust scrutiny under the Sherman Act. This Comment argues that the Third Circuit correctly extended the U.S. Supreme Court decision in Federal Trade Commission v. Actavis to non-cash settlement agreements. In Actavis, the Court held that a “reverse-payment settlement,” which compensates a generic manufacturer to delay market entry, creates monopolistic consequences and ...


Weaponizing Citizen Suits: Second Circuit Revises The Burden Of Proof For Proving Sham Citizen Petitions In Apotex V. Acorda Therapeutics, Franklin Liu Apr 2017

Weaponizing Citizen Suits: Second Circuit Revises The Burden Of Proof For Proving Sham Citizen Petitions In Apotex V. Acorda Therapeutics, Franklin Liu

Boston College Law Review

In 2016, in Apotex Inc. v. Acorda Therapeutics, Inc., the United States Court of Appeals for the Second Circuit held that a generic drug company could not rely solely on the timing of the Food and Drug Administration’s (“FDA’s”) disposition of a citizen suit and approval of a generic application to state a claim under the Sherman Act based on sham litigation. By contrast, in 2009, in In re DDAVP Direct Purchaser Antitrust Litigation, the Second Circuit held that precisely such evidence was sufficient to state a Sherman Act claim. This Comment argues that the Second Circuit’s ...


State V. Brown: A Test For Local Food Ordinances, Ryan Almy Apr 2017

State V. Brown: A Test For Local Food Ordinances, Ryan Almy

Maine Law Review

For many of us, adding a little milk to our morning coffee is likely one of the more insignificant tasks of the day. For Dan Brown of Blue Hill, Maine, that splash of dairy in his coffee mug is the result of his personal labor and constant, meticulous attention paid to the health and well-being of a single 1,000 pound mammal. Besides fresh raw milk, what does Brown gain from his efforts? He knows the exact source of the milk he puts in his coffee, as well as the butter his daughter spreads on her toast: Sprocket, Brown’s ...


Liberty Of Palate, Samuel R. Wiseman Apr 2017

Liberty Of Palate, Samuel R. Wiseman

Maine Law Review

As lawmakers concerned with problems as diverse as childhood obesity, animal cruelty, and listeria have increasingly focused their attention on consumers, legal issues surrounding food choice have recently attracted much broader interest. Bans on large sodas in New York City, fast food chains in South Los Angeles, and foie gras in California and Chicago have provoked national controversy, as have federal raids on raw milk sellers. In response, various groups have decried restrictions on their ability to consume the food products of their choice. A few groups have organized around the principle of what we might call liberty of palate ...


How Reliance On The Private Enforcement Of Public Regulatory Programs Undermines Food Safety In The United States: The Case Of Needled Meat, Diana R. H. Winters Apr 2017

How Reliance On The Private Enforcement Of Public Regulatory Programs Undermines Food Safety In The United States: The Case Of Needled Meat, Diana R. H. Winters

Maine Law Review

Mechanically tenderized meat is a relatively small, although persistent, food-safety problem in terms of the number of individuals affected by foodborne illness. However, the regulatory history of mechanically tenderized meat is a window into a much larger issue, that of regulatory inertia and the inadequacy of existing mechanisms to counter this stasis. This regulatory inertia does not have a simple cause, nor is it amendable to a simple solution. It cannot be reduced to a problem of agency capture, or a problem with agency incompetence, and although I will propose a couple of fixes, all of them have flaws. Telling ...


A Hungry Industry On Rolling Regulations: A Look At Food Truck Regulations In Cities Across The United States, Crystal T. Williams Apr 2017

A Hungry Industry On Rolling Regulations: A Look At Food Truck Regulations In Cities Across The United States, Crystal T. Williams

Maine Law Review

Although street vending has always been a part of the American food economy, in recent years modern food trucks have become a dining trend that is sweeping the country. With the booming popularity of food trucks, cities across the country are serving up various ways to regulate the growing number of vendors selling convenient and creative meals to patrons from mobile food units, commonly known as food trucks. Food trucks are regulated by local government agencies, which take a wide range of approaches. For example, in thirty-four of the nation’s largest cities, entire neighborhoods are off-limits to vendors, often ...


Whatever Happened To The "Fankenfish"?: The Fda's Foot-Dragging On The Transgenic Salmom, Lars Noah Apr 2017

Whatever Happened To The "Fankenfish"?: The Fda's Foot-Dragging On The Transgenic Salmom, Lars Noah

Maine Law Review

AquaBounty Technologies has genetically modified the Atlantic salmon through the introduction of a growth hormone gene from the Chinook salmon, which allows the fish to reach market size almost twice as quickly as its farmed counterparts. The research began more than two decades ago. The company secured licenses for the patents that emerged out of this research, and its plans to commercialize the transgenic salmons (branded “AquAdvantage”) took shape more than a decade ago. In late 2010, the U.S. Food and Drug Administration (FDA) appeared to be on the verge of authorizing production, but, more than two years later ...


A National "Natural" Standard For Food Labeling, Nicole E. Negowetti Apr 2017

A National "Natural" Standard For Food Labeling, Nicole E. Negowetti

Maine Law Review

What do Juicy Juice fruit punch, SunChips, Nature Valley granola bars, and Skinny Girl Margaritas have in common? These products are all branded with the term “natural.” From canned vegetables to cereals to soft drinks, the term “natural” has become one of the most common claims on food, drugs, dietary supplements, and personal care products. The word “natural on the label or in advertising brings to mind nature, and things that are pure, clean, healthy, free of artificial additives, and therefore safe, harmless, and beneficial to overall health. In 2011, “all-natural” was the second-most-used claim on the new American food ...


The New England Food System In 2060: Envisioning Tomorrow's Policy Through Today's Assessments, Margaret Sova Mccabe, Joanne Burke Phd, Rd, Ld Apr 2017

The New England Food System In 2060: Envisioning Tomorrow's Policy Through Today's Assessments, Margaret Sova Mccabe, Joanne Burke Phd, Rd, Ld

Maine Law Review

As the local food movement gains critical mass around the country, deep and important issues concerning food system policy arise. The modern American food system spans from agricultural production to food processing to food consumption, and finally, to health outcomes. The system’s components include economic, environmental, social, political, and scientific aspects that interact in ways that far outstrip any one discipline’s capacity to analyze and resolve problems. Additionally, the system is profoundly shaped by a complex architecture of laws and regulation. With much credit to the local and regional food movements, people have begun to question not only ...


Food Safety And Security In The Monsanto Era: Peering Through The Lens Of A Rights Paradigm Against An Onslaught Of Corporate Domination, Saby Ghoshray Apr 2017

Food Safety And Security In The Monsanto Era: Peering Through The Lens Of A Rights Paradigm Against An Onslaught Of Corporate Domination, Saby Ghoshray

Maine Law Review

Since our earliest ancestors’ desire for a better hunting weapon to procure food or a better storage facility to avoid spoilage, food safety and security has shaped human social and technological evolution like no other essential element. The need to procure food has shaped our civilization since the first human graced our planet. Food continues to be a pivotal force in humankind’s saga for life and death. Yet, despite stratospheric progress in scientific application surrounding food, food security and safety for all citizens continues to elude mankind. Why do some enjoy a feast, while others suffer in famine? This ...


Zoning And Land Use Controls: Beyond Agriculture, Lisa M. Feldstein Apr 2017

Zoning And Land Use Controls: Beyond Agriculture, Lisa M. Feldstein

Maine Law Review

If one were playing a word association game and were asked what comes to mind when the terms “food” and “land use” are given, chances are high that the response would be “agriculture.” Yet every stage in the food system, from being grown or raised through being consumed, is place-based. Put differently, everything that happens with our food system involves land use in some way. Even the acquisition of aquatically sourced foods requires a journey that begins from the shore, and yet it is rare to consider the profound ways in which our every interaction with food system utilizes or ...