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Full-Text Articles in Food and Drug Law

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.


Bse: Risk, Uncertainty, And Policy Change, Enda Cummins, Pat Grace, Kevin Mcdonnell, Shane Ward Feb 2017

Bse: Risk, Uncertainty, And Policy Change, Enda Cummins, Pat Grace, Kevin Mcdonnell, Shane Ward

RISK: Health, Safety & Environment

The authors discuss how, in our "risk society," a range of potential risks and uncertainties are associated with new technologies and new diseases, such as BSE. These risks bring with them worries about human health, while the ability to assess and manage new health scares is an essential skill for government and related industries.


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.


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.


Pesticide Residue Regulation: Analysis Of Food Quality Protection Act Implementation, Linda-Jo Schierow Dec 2016

Pesticide Residue Regulation: Analysis Of Food Quality Protection Act Implementation, Linda-Jo Schierow

RISK: Health, Safety & Environment

Dr. Schierow discusses the effects of a recent statute on food safety.


Looking Back: Cyclamate, Allan Mazur, Kevin Jacobson Dec 2016

Looking Back: Cyclamate, Allan Mazur, Kevin Jacobson

RISK: Health, Safety & Environment

The second in a series re-evaluating hazards identified in the 1950s and 60s.


Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg Dec 2016

Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg

Brooklyn Law Review

The rapid legalization of marijuana across the United States has produced a number of novel legal issues. One of the most confounding issues is that presented by the marijuana-impaired driver. In jurisdictions that have legalized the use of marijuana, how high is too high to get behind the wheel? This note assesses the various marijuana DUI laws that states have implemented to combat marijuana-impaired driving. Many of these statutes have followed in the footsteps of the BAC-based standard used to combat drunk driving—using THC measurements to quantify a driver’s level of marijuana-based impairment. Unfortunately, unlike alcohol, the scientific ...


The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran Dec 2016

The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran

Brooklyn Law Review

Pricing prescription pharmaceuticals is a complex process that entails the consideration of a multitude of factors, not the least of which is the research and development expenditure exhausted by drug makers to gain FDA approval. While public sentiment has increasingly turned against the pharmaceutical industry due to its perceived greed as manifested in the high cost of its drugs, the intricacies of pricing such unique products is rarely discussed. A recently proposed New York state bill, the Pharmaceutical Cost Transparency Act (the NYPCTA), continues this unfortunate trend, by requiring companies to disclose the R&D costs of newly approved drugs ...


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 ...


A Trademark Holder's Hangover: Reconciling The Lanham Act With The Alcohol And Tobacco Tax And Trade Bureau's System Of Designating American Viticultural Areas, Julia Lynn Titolo Nov 2016

A Trademark Holder's Hangover: Reconciling The Lanham Act With The Alcohol And Tobacco Tax And Trade Bureau's System Of Designating American Viticultural Areas, Julia Lynn Titolo

Journal of Intellectual Property Law

No abstract provided.


Why Coca-Cola's Fictional Lawsuit Against Coke Zero For Taste Infringement Is A Losing Battle, Jessica Nicole Cox Nov 2016

Why Coca-Cola's Fictional Lawsuit Against Coke Zero For Taste Infringement Is A Losing Battle, Jessica Nicole Cox

Journal of Intellectual Property Law

No abstract provided.


Daubert's Significance, Thomas G. Field Jr., Colleen M. Keegan Nov 2016

Daubert's Significance, Thomas G. Field Jr., Colleen M. Keegan

RISK: Health, Safety & Environment

The authors review and note the limited reach of Daubert v. Merrell Dow Pharmaceuticals. They also address its implications for concerned non-lawyers.


Risk And Regulatory Calibration: Wto Compliance Review Of The U.S. Dolphin-Safe Tuna Labeling Regime, Cary Coglianese, André Sapir Nov 2016

Risk And Regulatory Calibration: Wto Compliance Review Of The U.S. Dolphin-Safe Tuna Labeling Regime, Cary Coglianese, André Sapir

Faculty Scholarship

In a series of recent disputes arising under the TBT Agreement, the Appellate Body has interpreted Article 2.1 to provide that discriminatory and trade-distortive regulation could be permissible if based upon a “legitimate regulatory distinction.” In its recent compliance decision in the US-Tuna II dispute, the AB reaffirmed its view that regulatory distinctions embedded in the U.S. dolphin-safe tuna labeling regime were not legitimate because they were not sufficiently calibrated to the risks to dolphins associated with different tuna fishing conditions. This paper analyzes the AB’s application of the notion of risk-based regulation in the US-Tuna II ...


Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer Oct 2016

Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer

Journal of Intellectual Property Law

No abstract provided.


Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton Oct 2016

Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton

RISK: Health, Safety & Environment

Mr. Hilton attempts to show why important choices presented in current proposals to amend child-resistant packaging regulations are fundamentally normative. He then argues that these choices should not be obscured by the technical issues.


Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey Sep 2016

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.


Memory And Punishment, O. Carter Snead Aug 2016

Memory And Punishment, O. Carter Snead

O. Carter Snead

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered - by the offender, by the sentencing authority, and ...


Newsroom: Horwitz On Marijuana Legalization 7/15/2016, John S. Kiernan, Roger Williams University School Of Law Jul 2016

Newsroom: Horwitz On Marijuana Legalization 7/15/2016, John S. Kiernan, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.


The Current Scientific And Legal Status Of Alternative Methods To The Ld50 Test For Botulinum Neurotoxin Potency Testing, Sarah Adler, Gerd Bicker, Hans Bigalke, Christopher Bishop, Jörg Blümel, Dirk Dressler, Joan Fitzgerald, Frank Gessler, Heide Heuschen, Birgit Kegel, Andreas Luch, Catherine Milne, Andrew Pickett, Heidemarie Ratsch, Irmela Ruhdel, Dorothea Sesardic, Martin Stephens, Gerhard Stiens, Peter D. Thornton, René Thürmer, Martin Vey, Horst Spielmann, Barbara Grune, Manfred Liebsch Jul 2016

The Current Scientific And Legal Status Of Alternative Methods To The Ld50 Test For Botulinum Neurotoxin Potency Testing, Sarah Adler, Gerd Bicker, Hans Bigalke, Christopher Bishop, Jörg Blümel, Dirk Dressler, Joan Fitzgerald, Frank Gessler, Heide Heuschen, Birgit Kegel, Andreas Luch, Catherine Milne, Andrew Pickett, Heidemarie Ratsch, Irmela Ruhdel, Dorothea Sesardic, Martin Stephens, Gerhard Stiens, Peter D. Thornton, René Thürmer, Martin Vey, Horst Spielmann, Barbara Grune, Manfred Liebsch

Martin Stephens, Ph.D.

The Expert Meeting on alternative methods for Botulinum neurotoxin (BoNT) potency testing was held at the BfR as the result of a decree from the German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), after it was informed by German state authorities about an increase in animal numbers being used in the LD50 potency test in mice for the purposes of BoNT potency testing. Ethical concerns have been raised in both Europe and the United States about the animal suffering involved in this type of testing, especially in the context of BoNT’s aesthetic applications. There had been increased ...


The Administrative State And The Common Law: Regulatory Substitutes Or Complements?, Catherine M. Sharkey Jul 2016

The Administrative State And The Common Law: Regulatory Substitutes Or Complements?, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

The modern administrative state looms larger than ever, and grows at an ever-accelerating pace. Not everyone is pleased with these developments. Four such individuals — Chief Justice Roberts, Justices Thomas, Alito, and the late Justice Scalia — have expressed their displeasure, indeed their alarm, with consistency, clarity, and vigor. They warn that the rise of administrative agencies, and the attendant ascendance of doctrines of mandatory judicial deference to agency interpretations of federal law, signals no less than the end of our government’s separation-of-powers structure, and our right to live our lives without fear of bureaucratic encroachment at every turn. Their opinions ...


Is Regulation (Ec) No 1924/2006 On Nutrition And Health Claims Applied To Commercial Communications Addressed Exclusively To The Professional Sector (B2b)?, Luis González Vaqué Jun 2016

Is Regulation (Ec) No 1924/2006 On Nutrition And Health Claims Applied To Commercial Communications Addressed Exclusively To The Professional Sector (B2b)?, Luis González Vaqué

Luis González Vaqué

See more at: http://www.blmedien.de/data/emags/blmedien/eFOOD-Lab_International_02_2016/#/22/


Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete Jun 2016

Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete

Catholic University Law Review

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a ...


International Fisheries Regulation, John P. Rivers Jun 2016

International Fisheries Regulation, John P. Rivers

Georgia Journal of International & Comparative Law

No abstract provided.


Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An Jun 2016

Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An

Minnesota Journal of Law, Science & Technology

No abstract provided.