Open Access. Powered by Scholars. Published by Universities.®

Food and Drug Law Commons

Open Access. Powered by Scholars. Published by Universities.®

1083 Full-Text Articles 1030 Authors 432684 Downloads 101 Institutions

All Articles in Food and Drug Law

Faceted Search

1083 full-text articles. Page 1 of 30.

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

“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 2017 Notre Dame Law School

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 ...


Food Date Labels And Hunger In America, Gwen B. Thomson 2017 Concordia University School of Law

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 2017 Boston College Law School

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 2017 Boston College Law School

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 2017 University of Maine School of Law

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 ...


Obesity Prevention Policies At The Local Level: Tobacco's Lessons, Paul A. Diller 2017 University of Maine School of Law

Obesity Prevention Policies At The Local Level: Tobacco's Lessons, Paul A. Diller

Maine Law Review

For at least a decade, commentators have speculated that obesity is the next tobacco, a public health scourge that might nonetheless offer a gold mine to ambitious plaintiffs’ lawyers. Successful lawsuits, as in the tobacco context, might spur the food industry to reform its practices so as to help reduce the alarmingly high national obesity rate. The obesity narrative, however, has not played out accordingly to the same script as tobacco. Relatively quick action by most state legislatures immunized the food industry to tort lawsuits seeking obesity-related damages, and the scant judicial opinions on the issue have skeptically assessed plaintiffs ...


The Symbolic Garden: An Intersection Of The Food Movement And The First Amendment, Jaime Bouvier 2017 University of Maine School of Law

The Symbolic Garden: An Intersection Of The Food Movement And The First Amendment, Jaime Bouvier

Maine Law Review

What is communicated when a neighbor raises raspberries instead of roses on the porch trellis, grows lacinato kale rather than creeping bentgrass in the front yard, or keeps Buckeye hens rather than a bulldog? This essay asserts that these and other urban agricultural practices are expensive—that they are not just ends in themselves but are commutative acts. These acts are intended to educate neighbors, assert a viewpoint, establish identity, and area widely viewed as symbols of support for a social and political movement—what Michael Pollan has dubbed the “Food Movement.” And, as symbolic acts, they deserve protection under ...


From " Food Miles" To "Moneyball": How We Should Be Thinking Food And Climate, Bret C. Birdsong 2017 University of Maine School of Law

From " Food Miles" To "Moneyball": How We Should Be Thinking Food And Climate, Bret C. Birdsong

Maine Law Review

Since Michael Pollan polarized the push to eat local food in his bestseller, The Omnivore’s Dilemma, the concept of “food miles” has been something of a rallying cry and an organizing principle in the marketing of the local food movement. Among locavores and their sympathizers, the term seems to encapsulate all that is wrong with the food system. Fresh grapes from Chile make their way to supermarkets from Maine to Minnesota, and even California. Major food conglomerates process commodity ingredients like corn, soy, and wheat into packaged food that travels across the country and across oceans before landing on ...


Legal Institutions Of Farmland Succession: Implications For Sustainable Food Systems, Jamie Baxter 2017 University of Maine School of Law

Legal Institutions Of Farmland Succession: Implications For Sustainable Food Systems, Jamie Baxter

Maine Law Review

The legal institutions relevant to farmland succession—defined as the transfer of property in and control over farmland—are increasingly important determinants of sustainable environmental outcomes on modern farms. The history of farmland succession has been written, by and large, through extra-legal processes of transfer and inheritance between generations of close family relations. This familiar “family farm” model, however, is rapidly being replaced by succession arrangements between non-relatives, often strangers, with entrant farmers from non-agricultural backgrounds. As a growing number of current farmers retire and seek creative ways to transfer control and ownership of their farms, the availability and content ...


Colloquium: Local Food || Global Food: Do We Have What It Takes To Reinvent The U.S. Food System?, Malick W. Ghachem 2017 University of Maine School of Law

Colloquium: Local Food || Global Food: Do We Have What It Takes To Reinvent The U.S. Food System?, Malick W. Ghachem

Maine Law Review

No abstract provided.


Microbeads And The Toxics Use Reduction Act: Preventing Pollution At Its Source, Davis Truslow 2017 Boston College Law School

Microbeads And The Toxics Use Reduction Act: Preventing Pollution At Its Source, Davis Truslow

Boston College Environmental Affairs Law Review

Microbead pollution presents a significant threat to human health and the environment. As a result, Congress enacted a national ban on microbeads in 2015. This ban is a drastic, reactionary measure that fails to address the continued threat posed by already existing pollution. In addition, the ban represents a continued preference for the command-and-control regulatory framework that failed to prevent microbead pollution in the first place. In contrast, pollution prevention, an alternative regulatory technique adopted by Congress as national policy in 1990, more efficiently prevents pollution by focusing on reducing pollution at its source. In 1989, Massachusetts became the first ...


Digital Commons powered by bepress