Food and Drug Law Commons^™

Third-Party Funding: Balancing Transparency, National Security, And Access To Justice, Victoria Shannon Sahani

Seattle University Law Review

Many lawmakers who have recently become aware of the multi-billion-dollar global third-party funding industry are raising new national security concerns that further complicate preexisting, longstanding debates about transparency, disclosure, access to justice, and the best way to regulate third-party funding. In response, this Article briefly asserts three main points relating to the question of how best to regulate third-party funding. First, this Article explains the third-party funding industry, including its global regulatory landscape and how it serves three distinct populations: consumers, businesses, and law firms. Second, this Article explains that third-party funding is one tool that can help expand access …

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

Journal of Food Law & Policy

Energy drinks first rose to popularity in the 1980s after the creation of Red Bull. In addition to high caffeine amounts, energy drinks often contain herbal stimulant additives, vitamin and mineral mixtures, and sugar. There is very little information available on the long-term effects of these stimulant mixtures on the body. Although many consumers purchase energy drinks because of their caffeine content, many are left in the dark when it comes to labeling transparency and are unaware of their true contents. Energy drinks are classified as dietary supplements, meaning they are not directly regulated by the FDA before hitting store …

The Costs Of Convenience: A Case For Regulating Online Food Marketplaces In The Public Interest, Angela Lee

Journal of Food Law & Policy

As digital platforms have become more popular, including those relating to food ordering and delivery, the range of both their positive and negative impacts have become more apparent. In response, governments in various jurisdictions have made efforts at regulating such platforms, as part of their mandate of balancing complex and often competing goals in the public interest. Unfortunately, attempts at governing digital platforms to date have largely proven ineffective at checking the power of the large corporations that are behind their growth and expansion. I argue that a critical assessment of these new forms of online food marketplace further supports …

Law School News: Rake To Plate: Rwu Law Students Dive Into The Clamming Industry 10-4-2023, Grace Boland

Life of the Law School (1993- )

No abstract provided.

A Uniform Approach To Farm Animal Welfare Laws: Thought For Our Food Instead Of Food For Our Thought, Channing Burd

Journal of Food Law & Policy

We have all seen the commercials and know “Happy Cows Come from California,” but there is a larger issue hidden inside the phrase. Why should not all farm animals be happy, regardless of which state they were raised in? Why are only the cows in California happy, but not the chickens and the hogs as well? Farm animal welfare in the United States needs regulatory overhaul, and we needed it decades ago. This article will illustrate why regulatory overhaul is needed. First, we will examine how a new system of laws, which are part of a uniform code enacted by …

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Private Farms, Public Power: Governing The Lives Of Dairy Cattle, Jessica Eisen

Journal of Food Law & Policy

It is widely assumed that laws governing dairy productioninclude substantial protection of animals’ interests—that in some way the state is regulating the treatment of farmed animals and protecting them against the worst excesses of their owners’ selfinterest. In fact, across jurisdictions in Canada and the United States, the standards governing farmed animal protection are not established by elected lawmakers or appointed regulators, but are instead primarily defined by private, interested parties, including producers themselves. As scholars of animal law have noted, this has contributed to weak and ineffectual legal protection of the interests of farmed animals. The present study will …

Why The Dea & Not The Fda? Revisiting The Regulation Of Potentially Addictive Substances, Taleed El-Sabawi

Faculty Publications

In addressing the opioid overdose crisis, Congress has explicitly questioned its historic reliance on a criminal justice approach to problem drug use and has instead adopted a more health-oriented approach. Despite Congress' rhetoric, the DEA, a criminal justice agency, continues to retain the power to make key decisions on the classification of potentially-addictive substances, thereby affecting their manufacture, distribution, and overall availability. While the DEA is statutorily required to defer to the Food and Drug Administration (“FDA”), a public health agency, at junctions of the decision-making process, the current “split enforcement” scheme laid out in the statutes has not actualized …

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 including …

Crispr: Redefining Gmos—One Edit At A Time, Eric E. Williams

University of Arkansas at Little Rock Law Review

No abstract provided.

Agricultural And Food Law—Food Labeling And Biotechnology—The Food Fight Over Labeling Genetically Engineered Foods And A Natural Solution To Protect Agricultural Biotechnology In The Natural State, Katie W. Branscum

University of Arkansas at Little Rock Law Review

No abstract provided.

Medical Cannabis: Miracle Or Myth?, Blair Henry, Arnav Agarwal, Edward Chow, Hatim A. Omar, Joav Merrick

Pediatrics Faculty Publications

No abstract provided.

"All I Do Is Win": The No-Lose Strategy Of Cafo Regulation Under The Caa, Karl J. Worsham

Journal of Food Law & Policy

Corporate farms, often known as concentrated animal feeding operations ("CAFO'), provide inexpensive animal products but do so by externalizing the cost of their operation in the form of environmental harms and risks to human health. This article explores one possible approach to mitigating CAFO-caused harms. It argues that CAFO regulation under any one of three Clean Air Act ("CAA ") programs will result in net benefits, not just for air quality, but also for other CAFO-caused harms and thus, that CAA regulation of CAFOs is a no-lose strategy. The article then goes further to conclude that, while regulation under any …

Regulating The Food Truck Industry: An Illustration Of Proximity And Sanitation Regulations, Nicholas Alvarez

Journal of Food Law & Policy

Manny Hernandez, a Chicago food truck owner, would wake up in the middle of the night and slowly travel by foot around downtown Chicago carrying a 200-foot rope. The rope was used to measure the distance from the doors of brick-and-mortar restaurants to possible parking locations for his food truck. A Chicago ordinance prohibited food trucks from operating within 200 feet of the front door of any brick-and-mortar restaurant. Furthermore, Manny could not just find one spot; he needed to find many spots because Chicago law also stated that food trucks were only allowed to park at one location for …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

Articles

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

Regulating Ambiguous Risks: The Less Than Rational Regulation Of Pharmaceuticals, W. Kip Viscusi, Richard J. Zeckhauser

Vanderbilt Law School Faculty Publications

The US Food and Drug Administration (FDA) balances risks and benefits before approving pharmaceuticals. But powerful behavioral biases that lead to the mishandling of uncertainty also influence its approval process. The FDA places inordinate emphasis on errors of commission versus those of omission, a bias that is compounded by its desire to avoid blame should risks eventuate. Despite extensive testing, uncertainties inevitably remain. We often learn about the risks of drugs after they are on the market. And there are off-label uses of drugs, which are not part of the initial testing. The FDA shows a strong aversion to ambiguous …

From The Lab To The Supermarket: In Vitro Meat As A Viable Alternative To Traditional Meat Production, Trae Norton

Journal of Food Law & Policy

In 1932, Winston Churchill predicted that 50 years in the future "we shall escape the absurdity of growing a whole chicken in order to eat the breast or wing by growing these parts separately under a suitable medium." Although Churchill's prediction is about 30 years off, in August of 2013, the first ever meat patty grown in vitro was consumed in London, England. With this historic scientific achievement, many are predicting that in vitro meat will be a viable solution to the problems associated with industrial meat production, such as animal cruelty, inefficient natural resource consumption, and pollution. Analysts predict …

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.

Food Labeling Litigation: Exposing Gaps In The Fda's Resources And Regulatory Authority, Nicole Negowetti

Law Faculty Publications

No abstract provided.

Let My Brewers Go! A Look At Home Brewing In The U.S., Hannah Jeppsen

Journal of Food Law & Policy

In mid-August of 2012, a group of Americans stormed the White House, demanding transparency on a subject many Americans may find surprising: beer. More specifically, Americans requested White House home brew recipes, a presidential secret until Barack Obama's administration released them on September 1, 2012. Not only does Obama enjoy a good home brew, he is also the first president to brew in the White House and even take beer on the campaign trail. However, it was the August petition that garnered home brewing national media attention.

A Cost-Benefit Analysis Of Sugary Drink Regulation In New York City, Shi-Ling Hsu

Journal of Food Law & Policy

New York City Mayor Bill de Blasio spent much of his time during his successful 2013 campaign positioning himself as the populist candidate, pointedly contrasting himself with the outgoing mayor, billionaire Michael Bloomberg. There is one Bloomberg initiative, however, that de Blasio has committed to carry forward: the city-wide size restriction on sales of "sugary drinks," most commonly, carbonated sodas. On city public health issues such as the sugary drink policy, the populist de Blasio and the billionaire Bloomberg would appear to have much in common. "People are dying every day, this is not a joke," remarked Bloomberg in striking …

Health And Welfare Preempted: How National Meat Association V. Harris Undermines Federalism, Food Safety, And Animal Protection, Marya Torrez

Journal of Food Law & Policy

In 2008, the Humane Society of the United States (HSUS) released an undercover video filmed at the Hallmark Meat Packing Company and Westland Meat Company (Hallmark/Westland) in Chino, California. "The footage depicted nonambulatory cows being kicked, dragged, electrocuted, jammed with forklifts and sprayed in the nostrils with water to simulate drowning - in an effort to get them to stand up and walk to their slaughter." At least five inspectors from the U.S. Department of Agriculture (USDA) - the federal agency tasked with ensuring that food safety and animal welfare guidelines are followed - were present at the time. The …

The Market For Drug-Free Poultry: Why Robust Regulation Of Animal Raising Claims Is The Right Prescription To Combat Antibiotic Resistance, Dorinda L. Peacock

Journal of Food Law & Policy

Since their introduction in the mid-twentieth century, antibiotics have become a mainstay of poultry production for purposes ranging from growth promotion to disease treatment and control. Nevertheless, for almost as long, there have been concerns about the role that these agricultural uses play in the development of antibiotic resistant bacteria. The issue of antibiotic resistance in general is fast becoming a public health crisis and scrutiny of agriculture as a contributing cause continues. Nevertheless, to date, neither regulatory efforts to curb agricultural usage nor private sector actions in response to consumer demand and public-interest campaigns have led to significant changes …

The Forgotten Half Of Food System Reform: Using Food And Agricultural Law To Foster Healthy Food Production, Emily Broad Leib

Journal of Food Law & Policy

America is facing widespread problems with its food system, including environmental harms due to externalities from industrial farms; the increasing amount of "food _miles" traveled by the products that make up our daily meals; and the growing size and complexity of recent outbreaks of foodborne illnesses. Indeed, the entire system that covers the life cycle of food, through production, processing, distribution, consumption, and food waste management, is in crisis. One of the most disturbing of these well-documented problems with the industrial food system is the increase in rates of obesity and diet-related illnesses. Obesity rates in the U.S. have more …

Locally Grown Food: Examining The Ambiguity Of The Term 'Local' In Food Marketing, Brad Rose

Journal of Food Law & Policy

Locally grown food products are becoming increasingly popular among consumers. In response, many food retailers are devoting more space to locally grown products. The locally grown label is part of a marketing strategy designed to take advantage of consumer desires for fresh and safe products that support local farmers and help the environment. Many consumers believe that locally grown food is "fresher, has fewer chemicals, and comes from smaller, less corporate farms.' This increased demand from consumers has led to an "explosion of the use of the word 'local' in food marketing." However, there is no single definition of "local" …

The Special Supplemental Nutrition Program For Women, Infants, And Children (Wic) And The Supplemental Nutrition Assistance Program (Snap): Comparing Policies And Suggesting Changes, Regina T. Cucurullo

Journal of Food Law & Policy

National concerns, such as obesity, should be addressed through national efforts. Considering the national reach of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and the Supplemental Nutrition Assistance Program (SNAP) and their ability to influence the diets of a significant amount of the nation's population, changes to these programs should be made to encourage healthy nutrition.

Food Sovereignty In The United States: Supporting Local And Regional Food Systems, Allison Condra

Journal of Food Law & Policy

Today, perhaps more than ever, an increasing portion of U.S. society is paying attention to and asking questions about our food and agricultural system. We are recognizing the immense consequences of the agricultural "efficiencies" we valued and wrote into our policies in the seventies-for example, growing corn "fence row to fence row" and the ease of microwaved meals and prepackaged foods. 3 The increasingly global nature of our food system and its consequences are becoming more apparent. Food safety concerns-prompted by a growing number of foodborne illness outbreaks and the government's response in the 2009 Food Safety Modernization Act-loom large …

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of developments in Canadian food law and policy in 2010. This update primarily analyzes the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm.

Food Entrepreneurs And Food Safety Regulation, Nina W. Tarr

Journal of Food Law & Policy

It is a bucolic scene: local food growers and producers chatting with consumers who come back each week to participate in a direct and continuing conversation about food with someone they know, and to engage in commerce. This illusion of simplicity masks the ever-growing morass of conflicting, complicated, and expensive regulatory oversight that undermines the local food movement by creating barriers between producers and consumers. Those creating and implementing food policy in the United States are facing a fundamental dilemma of how to reconcile the local food movement with regulations designed to address concerns about food safety.

This article will …

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …