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Full-Text Articles in Food and Drug Law

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 ...


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 ...


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 ...


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 ...


Obesity Prevention Policies At The Local Level: Tobacco's Lessons, Paul A. Diller Apr 2017

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 Apr 2017

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 Apr 2017

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 Apr 2017

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 ...


Microbeads And The Toxics Use Reduction Act: Preventing Pollution At Its Source, Davis Truslow Apr 2017

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 ...


Mercury’S Toxic Process: How Bad Science And Bad Decisions Caused A Public Health Crisis, Cameryn Mercurio Apr 2017

Mercury’S Toxic Process: How Bad Science And Bad Decisions Caused A Public Health Crisis, Cameryn Mercurio

Boston College Environmental Affairs Law Review

Since 1998, ethylmercury, a vaccine preservative, has often been confused with methylmercury, a dangerous neurotoxin, by the government and public. This confusion has led to a decrease in vaccination rates and an increase in the spread of preventable disease. Despite significant efforts to educate the public on the inaccuracy of studies linking ethylmercury to autism, the public health agencies have been unsuccessful in demonstrating to the public that the substance is safe. This Note analyzes the actions taken by the public health agencies responding to public concerns about ethylmercury’s use in vaccines and recommends that the agencies undertake a ...


The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng Apr 2017

The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng

Seattle University Law Review

Part I of this Note provides background information about the major controversies related to GM foods, including the debate about whether such foods should be labeled, and the history of GMO labeling laws in the United States. Part II compares S. 764 with H.R. 1599 and explains why a national mandatory labeling approach is superior to the voluntary labeling approach advocated by the House. Part III discusses the potential drawbacks and effect of S. 764 and finally concludes that the rulemaking process that will follow may create controversies and litigation.


The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax Mar 2017

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Joanna K Sax

No abstract provided.


State And Federal Powers Clash Over Medical Marijuana In United States V. Mcintosh, Cara E. Alsterberg Jan 2017

State And Federal Powers Clash Over Medical Marijuana In United States V. Mcintosh, Cara E. Alsterberg

Golden Gate University Law Review

The unanimous opinion in United States v. McIntosh held that a spending rider approved by Congress in 2014 and 2015 prohibits the United States Department of Justice (the Department) from prosecuting marijuana suppliers who fully comply with state laws allowing the use of marijuana for medicinal purposes. The Department argued that the rider only prohibits litigation against the states themselves, rather than prosecution of individuals who provide marijuana for medicinal purposes, because the language of the rider indicates that the Department may not use appropriated money to prevent states from implementing their medical marijuana laws.

The three-judge panel of the ...


The Cost Of High Prices: Embedding An Ethic Of Expense Into The Standard Of Care, Isaac D. Buck Jan 2017

The Cost Of High Prices: Embedding An Ethic Of Expense Into The Standard Of Care, Isaac D. Buck

Boston College Law Review

In the midst of rapid and radical change of America’s health care system, the country’s crown jewel public health insurance program, Medicare, faces an intensifying cost crisis due to a past of uncontrolled prices and a future of booming enrollment. A cost challenge garnering particular media attention is pharmaceutical drug pricing for Medicare Part B. Historically, congressional action has hamstrung Medicare’s ability to limit costs, and as a result, the program is increasingly forced to pass on drug costs—through copays and coinsurance—to its elderly beneficiaries. Public outrage has followed recent stories of pharmaceutical companies seeking ...


The Impact Of Marijuana Legalization On Youth & The Need For State Legislation On Marijuana-Specific Instruction In K–12 Schools, Amanda Harmon Cooley Jan 2017

The Impact Of Marijuana Legalization On Youth & The Need For State Legislation On Marijuana-Specific Instruction In K–12 Schools, Amanda Harmon Cooley

Pepperdine Law Review

State legalization of marijuana is a divisive and polarizing issue that has resulted in fragmentation between governments and citizens. Contrary to federal law, voters in many states have approved ballot initiatives legalizing the sale of marijuana to adults for their recreational use. This Article argues that any state that legalizes marijuana has a concomitant duty to amend its K–12 public school instructional statutes to provide for substantial marijuana education. No state has yet enacted such legislation even though current alternative educational methods fail to provide sufficient safeguards. Accordingly, this Article proposes new statutory remedies that could bridge the gap ...


Patents, Hidden Novelty, And Food Safety, Jeanette M. Roorda Jan 2017

Patents, Hidden Novelty, And Food Safety, Jeanette M. Roorda

Florida Law Review

This Note discusses how federal agency policy results in a lack of access to patent-protected genetically modified organisms (GMOs) for independent food safety testing. The U.S. GMO policy is a combination of biotechnology regulations and biotechnology intellectual property protections. Intellectual property protection for the developers of new organisms has increased as the technology has advanced from manual pollination to genetic modification methods. Initially the only protection available was in the form of trade secrets, but the protection has increased incrementally to now include full utility patent protection. This Note evaluates the interactions between U.S. Patent and Trademark Office ...


Conference Of Soviet And American Jurists On The Law Of The Sea And The Protection Of The Marine Environment, Milton Katz, Richard R. Baxter, O. V. Bogdanov, William E. Butler, Thomas M. Franck, Richard Frank, P. P. Gureev, John L. Hargrove, L. A. Ivanaschenko, Y. Kasmin, V. A. Kiselev, B. M. Klimenko, H. G. Knight, O. S. Kolbasov, A. L. Kolodkin, V. M. Koretsky, F. N. Kovalev, V. N. Kudrjavtsev, B. A. Kuvshinnikov, M. I. Lazarev, A. L. Makovsky, Charles W. Maynes, P. A. Moiseev, John N. Moore, A. P. Movchan, T. M. Starzhina, Robert E. Stein, Grigory I. Tunkin, E. T. Usenko, A. F. Vysotsky, A. K. Zhudro Jan 2017

Conference Of Soviet And American Jurists On The Law Of The Sea And The Protection Of The Marine Environment, Milton Katz, Richard R. Baxter, O. V. Bogdanov, William E. Butler, Thomas M. Franck, Richard Frank, P. P. Gureev, John L. Hargrove, L. A. Ivanaschenko, Y. Kasmin, V. A. Kiselev, B. M. Klimenko, H. G. Knight, O. S. Kolbasov, A. L. Kolodkin, V. M. Koretsky, F. N. Kovalev, V. N. Kudrjavtsev, B. A. Kuvshinnikov, M. I. Lazarev, A. L. Makovsky, Charles W. Maynes, P. A. Moiseev, John N. Moore, A. P. Movchan, T. M. Starzhina, Robert E. Stein, Grigory I. Tunkin, E. T. Usenko, A. F. Vysotsky, A. K. Zhudro

Georgia Journal of International & Comparative Law

Included in the papers for the Conference of Soviet and American Jurists on the Law of the Sea and the Protection of the Marine Environment:

Introduction by Milton Katz and Richard R. Baxter, p. 1

Freedom of Scientific Research in the World Ocean by A.F. Vysotsky, p. 7

The International Law of Scientific Research in the Oceans by Richard R. Baxter, p. 27

Responsibility and Liability for Harm to the Marine Environment by Robert E. Stein, p. 41

Liability for Marine Environment Pollution Damage in Contemporary International Sea Law by A. L. Makovsky, p. 59

Protection of the Marine ...


3d-Printed Food, Jasper L. Tran Jan 2017

3d-Printed Food, Jasper L. Tran

Jasper L. Tran

No abstract provided.


Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher Jan 2017

Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher

O'Neill Institute Papers

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be ...


Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti Jan 2017

Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti

American University Law Review

No abstract provided.


Fsma: The Future Of Food Litigation, Robert Shawn Hogue Dec 2016

Fsma: The Future Of Food Litigation, Robert Shawn Hogue

University of Miami Inter-American Law Review

No abstract provided.


Pitfalls Of The Food Safety Modernization Act: Enhanced Regulation, Minimal Consumer Benefit, And Zero Tolerance Levels For Naturally-Occurring Trace Pathogens, Lindsey Lazopoulos Friedman, Wesley Van Camp Dec 2016

Pitfalls Of The Food Safety Modernization Act: Enhanced Regulation, Minimal Consumer Benefit, And Zero Tolerance Levels For Naturally-Occurring Trace Pathogens, Lindsey Lazopoulos Friedman, Wesley Van Camp

University of Miami Inter-American Law Review

Congress enacted the Food Safety Modernization Act (“FSMA”), to regulate the fresh produce industry in the United States and increase consumer safety when handling and consuming raw produce. But FSMA risks imposing a zero tolerance policy on raw produce, even where a naturally occurring low-level pathogen, such as listeria, is found in negligible amounts. A zero tolerance policy for all naturally-occurring pathogens does not increase consumer safety, and only serves to increase the cost of raw produce for consumers. This article begins with a summary of the modern history of FSMA, including a brief overview of how the law has ...