Food and Drug Law Commons^™

The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson

Georgia Journal of International & Comparative Law

No abstract provided.

Preventative V. Punitive: How Genetically Modified Rice Litigation Shaped Regulation And Remedy For Genetically Engineered Crops, Allison Waldrip Bragg

Journal of Food Law & Policy

As agricultural technology develops, new issues emerge. While genetically engineered crops can increase yields and productivity, they can also increase new legal concerns that had not previously existed. One such concern is the comingling of non-engineered crops with genetically engineered varieties. The corruption of plants that are not engineered is a problem not only because of the loss of that original plant itself if the entire plant population were to become comingled, but also because of the inability to sell a crop that has been intended as a non-engineered crop when it is infiltrated by genetically engineered material.

Paradise Found? Food Transportation Regulation: A Detour Through Regulatory Purgatory, William Nash

Journal of Food Law & Policy

On January 31, 2014, the Food and Drug Administration ("FDA") issued a Notice of Proposed Rulemaking ("NPRM") that would set requirements for shippers, carriers and receivers of food transported in intrastate and interstate commerce. The NPRM marks a potentially important step in a long history of the (non-)regulation of food transportation. In Parts I and II, this paper will provide some context of the history of food transportation, as well as the major incidents that placed the food transportation industry on the regulatory map. In Parts III and IV, the paper will consider the history of food transportation regulation from …

Let's Stop Worrying And Learn To Love Transparency: Food And Technology In The Information Age, Scarlettah Schaefer

Journal of Food Law & Policy

Food and technology have had a long and tempestuous relationship. Current methods of food production and processing in the industrialized world depend heavily on technological developments. However, all technologies are not created equal. Some can produce food that is safer, more sustainable, more nutritious, or longer lasting. Some can have the opposite effect: increasing opportunities for adulteration, increasing the difficulty in detecting food fraud, and contributing to both foreseeable and unforeseeable health or ecological costs. Increasingly sophisticated technologies often become less apparent to the average consumer. For example, consider irradiated meat or genetically modified foods as opposed to freezer storage …

The Hamburglar, Friend Or Foe: What Is The Best Solution For Lawsuits Alleging Obesity Caused By Fast Food Outlets When No Causal Link Between Consumption And Obesity Can Be Found?, Mary Hoshall Hodges

Journal of Food Law & Policy

When is the last time you ventured through the drive-thru of a fast food establishment? Maybe last night when it was just easier than taking the time to cook dinner, or maybe last weekend on your way home from vacation, or maybe when you were running low on funds and needed a cheap meal? Given the busy, fast-paced lives Americans lead, it is no wonder that many rely on the fast food industry, even though most would not care to admit it.

Toward A Just Food Regime: Consumption, Ideology, And Democratic Strategy, Adam B. Lichtenberger

Journal of Food Law & Policy

United States agricultural policies incentivize the growth and consumption of industrial foods. Industrial foods are linked to a host of social and ecological ills. However, agricultural policies are insulated from political criticism, in part, by the myth that consumers freely and rationally choose industrial foods. This neoliberal myth is congruous with the American preferences for "stealth democracy." That is, the neoliberal myth is an elegant, but ultimately erroneous, reconciliation of conflicting political preferences: Americans do not want to be involved in politics, but they also do not want the political process to be used by special interests or politicians to …

Who's Swallowing The "Bitter Pill"?: Reforming Write-Offs In The State Of Washington, Lauren M. Martin

Seattle University Law Review

Washington’s application of the collateral source rule permits recovery for medical expenses that were never incurred and have no relationship to their market value. This application is set forth in Hayes v. Wieber Enterprises, Inc., where the plaintiff sued a restaurant for injuries she sustained from falling down the restaurant’s basement stairs. Why should the collateral source rule compel the defendant in Hayes to pay the original amount billed, $5,800, when the physician accepted $3,300 as payment in full? Is not $3,300 the reasonable or market value of the medical services provided to the plaintiff? This Comment discusses whether Washington …

International Trade - Possible Undermining Of U.S. Pesticide And Food Safety Laws By The Draft Text Of The Uruguay Round Of Gatt Negotiations, Beth Sanders

Georgia Journal of International & Comparative Law

No abstract provided.

The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley

Catholic University Law Review

Informal regulations defining nature, natural, and organic have proliferated across diverse fields of law from patents to agriculture, from taxation to gemstones. The unwritten jurisprudence of defining nature is primarily a story of the struggle to isolate mankind’s manipulations and interventions, creating a man-nature dichotomy that frustrates more than it explicates. This failure to define nature continues with the Supreme Court’s recent Myriad decision, which struggles to define the law of nature exception to patentability, highlighting the challenge of measuring levels of human intervention and manipulation. Our dichotomous definitions do not generate neat, binary answers, but rather complicated scales of …

African Aids Crisis: Implications From The Rise Of Managed Care In South Africa, J. Christopher Driver

Georgia Journal of International & Comparative Law

No abstract provided.

Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget

Seattle University Law Review

Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …

World Trade Organization Adjudication Of The European Union-United States Dispute Over The Moratorium On The Introduction Of New Genetically Modified Foods To The European Common Market: A Hypothetical Opinion Of The Dispute Panel, Charles W. Smitherman Iii

Georgia Journal of International & Comparative Law

No abstract provided.

Raging Hormones: A Discussion Of The World Trade Organization's Decision In The European Union-United States Beef Dispute, George H. Rountree

Georgia Journal of International & Comparative Law

No abstract provided.

Depressing Diagnosis: Stringent Particularity Requirement Of The Rule 9(B) Pleading Standard As A Critical Bar To Off-Label Promotion Fraud Whistleblowers, Emily T. Chen

Cardozo Law Review

No abstract provided.

Gene Patents In The Wake Of Association For Molecular Pathology V. Myriad Genetics, Inc.: An International Perspective On Pharmacogenomics, Stephanie S. Lim

Cardozo Journal of International and Comparative Law

Now that the Supreme Court of the United States has held that isolated DNA fragments are not patentable subject matter under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, Inc., thousands of existing isolated gene patents can be invalidated. In the European Union, by contrast, patent protection for human genetic sequences has always been strong and the BRCA gene patents at issue in Myriad are still valid in the European Union. It remains to be seen how the differential gene patent protection regimes in these developed nations will affect the biotechnology industry.

This Note poses that question …

Brew Free Or Die? A Comparative Analysis Of U.S. And E.U. Craft Beer Regulations, Tammy Lam

Cardozo Journal of International and Comparative Law

The note examines the challenges faced by craft beer brewers and small alcohol producers in the United States and the European Union under current regulatory frameworks, particularly the U.S. three-tier system. It critiques the system for constraining small producer growth while favoring large brewers and suggests that adopting elements of the E.U.'s regulatory approach, which prioritizes public health and advertising regulation, could foster growth and promote safe alcohol consumption. The analysis also highlights the need for cultural shifts in U.S. perceptions of alcohol to support smaller producers

International Trade Law And The U.S.-Eu Gmo Debate: Can Africa Weather This Storm?, Michelle K. Mcdonald

Georgia Journal of International & Comparative Law

No abstract provided.

A Tale Of Two Appellations: A Comparative Study Of International Agreements And Prevailing Law Impacting The Availability Of Seasonal Employees For The Wine-Grape Harvest In California's Napa Valley And France's Bordeaux Appellation, Michael K. Edmonson

Georgia Journal of International & Comparative Law

No abstract provided.

"Where You Stand Depends On Where You Sit": Should The United States' Fda Have Followed The Lead Of Great Britain's Mhra In Banning Antidepressant Drug Use In Children And Adolescents?, Jennifer Dorminey

Georgia Journal of International & Comparative Law

No abstract provided.

B.Y.O. Heroin: Will Canada Finally Recognize The Fundamental Rights Of Injection Drug Users By Providing Access To Safe Injection Facilities?, Robert Marston

Georgia Journal of International & Comparative Law

No abstract provided.

Beer, Liquor, Or A Little Bit Of Both? Getting To The Bottom Of Properly Classifying Flavored Malt Beverages In The United States And Australia, Bryan A. Schivera

Georgia Journal of International & Comparative Law

No abstract provided.

High Time For Medical Marijuana Or Buzz-Kill?: The Controlled Substances Act And The Sherman Antitrust Act May Cause Florida's Compassionate Medical Cannabis Act To Go Up In Smoke, Thu Pham

Florida A & M University Law Review

Florida is the latest state to jump into the arena of medical marijuana with the passage of SBI030 on June 16, 2014. The law, named The Compassionate Medical Cannabis Act of 2014,' allows low-THC cannabis to be prescribed to patients suffering from cancer or physical medical conditions that chronically produce symptoms of seizures or severe and persistent muscle spasms.

A Proposed Reconciliation Of Stakeholder Interests In The Ge Soybean Industry And Role Of Earth Jurisprudence Principles, Kristen N. King Jaiven

Florida A & M University Law Review

The historical art of seed saving ensured farmers would have enough quality seeds for the following season. Traditional and indigenous farmers mastered seed saving techniques, saving the healthiest and strongest seeds to ensure preservation of seed diversity and adequate crop yields. To provide adequate protection and meet maximum sustainability for all interested parties, it is essential that laws governing the soybean industry consider the soybean as a stakeholder.

Prosser's Bait-And-Switch: How Food Safety Was Sacrificed In The Battle For Tort's Empire, Denis W. Stearns

Nevada Law Journal

No abstract provided.

The Prohibition Of Moonshine: A Consumer Protection Analysis Of Raw Milk In Interstate Commerce, Whitney R. Morgan

West Virginia Law Review

No abstract provided.

New York: Public Health Implications Of The 'Soda Ban' Ruling, Andrew Geltman

Homeland Security Publications

No abstract provided.

If Hard Drugs Were Legalized, Would More People Use Them?, David Borden

Cardozo Public Law, Policy & Ethics Journal

The article argues that criminal prohibition of drugs, including heroin, cocaine, and marijuana, causes significant harms such as public health crises, violent criminal activity, and civil liberties violations. It challenges predictions that legalization would lead to greatly increased drug use or harm, citing evidence that other factors, such as availability and social stigma, play a larger role in drug use decisions. The author advocates for ending prohibition and replacing it with regulation and public health programs tailored to each drug, emphasizing that legalization could reduce both individual and societal harm.

Restructuring Local School Wellness Policies: Amending The Kids Act To Fight Childhood Obesity, Rebecca Edwalds

University of Michigan Journal of Law Reform

Childhood obesity is a major problem plaguing the United States. Over one-third of children are overweight, and there is little indication that this trend will reverse in the near future. The federal government has attempted to combat childhood obesity through the National School Lunch Act, which regulates the quality of foods federally subsidized schools may serve to children, and provides broad goals for physical activity. These basic goals leave extensive room for states to implement different standards, and they are not sufficient to effectively confront the childhood obesity problem. This Note proposes amendments to the National School Lunch Act that …

Food Deprivation: A Basis For Refugee Status?, James C. Hathaway

Articles

It is commonplace to speak of those in flight from famine, or otherwise migrating in search of food, as “refugees.” Over the past decade alone, millions of persons have abandoned their homes in countries such as North Korea, Sudan, Ethiopia, Congo, and Somalia, hoping that by moving they could find the nourishment needed to survive. In a colloquial sense, these people are refugees: they are on the move not by choice, but rather because their own desperation compels them to pursue a survival strategy away from the desperation confronting their home communities.

The question addressed here is whether persons in …

E-Cigarettes, Vaping, And Youth, Lawrence O. Gostin, Aliza Y. Glasner

Georgetown Law Faculty Publications and Other Works

E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle.

In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. …