Food and Drug Law Commons^™

Getting A Handle On Growler Laws, Adam Star

Seattle University Law Review

This Note will begin with a brief general history of growlers in the United States and the benefits they provide to consumers, retailers, and small craft brewers. Part II will provide an overview of national alcohol distribution regulation and how the present growler law exists within this larger framework. To complete the necessary background information, Part III will provide context to the competitive landscape by way of an examination of the craft beer industry’s explosive growth. The substantive portion of the Note will follow in Part IV, beginning with an outline of the various key types of growler restrictions ...

It’S Time For The Fda To Define ‘Natural’, Jason J. Czarnezki

Pace Law Faculty Publications

The authors discusses the FDA 's recent call for comments on a definition of the term natural as it applies to food.

States Vs. Fda, Catherine M. Sharkey

New York University Public Law and Legal Theory Working Papers

In the United States, food and drug safety is regulated in two ways: a stringent ex ante, national regime led by the Food and Drug Administration (“FDA”) and a robust ex post system of state-law enforcement. This federalist structure, operating on dual regulatory levels, sets the stage for synergy and for conflict.

Two recent high-profile preemption lawsuits showcase a novel dimension of the dual regulatory structure: the role of states as competing and/or complementary actors vis-à-vis the FDA in regulating food and drug safety. In Zogenix, Inc. v. Patrick, a federal district court enjoined the Massachusetts government from enacting ...

States Vs. Fda, Catherine M. Sharkey

New York University Law and Economics Working Papers

In the United States, food and drug safety is regulated in two ways: a stringent ex ante, national regime led by the Food and Drug Administration (“FDA”) and a robust ex post system of state-law enforcement. This federalist structure, operating on dual regulatory levels, sets the stage for synergy and for conflict.

Two recent high-profile preemption lawsuits showcase a novel dimension of the dual regulatory structure: the role of states as competing and/or complementary actors vis-à-vis the FDA in regulating food and drug safety. In Zogenix, Inc. v. Patrick, a federal district court enjoined the Massachusetts government from enacting ...

Reflexiones Con Respecto A La Política De La Dea , Y, De Antinarcóticos En América Latina®, Daniel Fernando Gomez Tamayo

Daniel Fernando Gómez Tamayo. PhD Canon Law

The Patented Medicines (Notice Of Compliance) Regulations: An Examination Of The Decision Making Patterns In These Cases At The Supreme Court Of Canada, Jason D. Newman

Electronic Thesis and Dissertation Repository

Abstract

Generic drug approval cases involving Canada’s Patented Medicines (Notice of Compliance) Regulations are adjudicated at the Federal Court through the judicial review process. The European Union alleges that this abbreviated process is unfair to litigants who hold patents on medicines, since it does not encompass all of the features of a trial, nor is it an actual suit for patent infringement. In addition, the process has unequal appeal rights for the patent holder and the patent challenger, where the generic challenger can appeal a decision at Federal Court, but the patent holder cannot.

When examining the pattern of ...

An Unsealed Package: The Ninth Circuit Creates A Circuit Split When Interpreting Fda Regulations On Food Label Nutrient Content Claims In Reid V. Johnson & Johnson, Danielle M. Haikal

Boston College Law Review

On March 13, 2015, in Reid v. Johnson & Johnson, the U.S. Court of Appeals for the Ninth Circuit held that the statement “No Trans Fat” on the label of Benecol, a food that contains between 0 and 0.5 grams of trans fat, was not a permitted nutrient content claim. The court held that such a statement made on the label was false or misleading and was therefore not authorized by Food and Drug Administration (“FDA”) regulations. The court came to this conclusion despite the Third Circuit reaching the opposite conclusion in 2013, in Young v. Johnson & Johnson, regarding ...

The Insufficiency Of The Law Surrounding Food Allergies, Aimee Nienstadt

Pace Law Review

This paper proceeds in five parts. First, I will give an overview of food allergies. The second section will discuss legal protections at the federal level, including the ADA and other specific federal laws that are aimed at food allergies. The third section will discuss legal protections at the state level, including state laws directed at school districts and state laws directed at restaurants. The fourth section will discuss actions by the private/non-profit sector. The final section of my paper will discuss further necessary legislative changes for people with food allergies.

Recent Developments And Future Prospects Of The Common Market, Michael Waelbroeck

Georgia Journal of International & Comparative Law

No abstract provided.

Newsroom: Horwitz On Legalizing Marijuana 04-10-2016, Andrew Horwitz, Peter Kilmartin

Life of the Law School (1993- )

No abstract provided.

When Tuna Still Isn’T Always Tuna: Federal Food Safety Regulatory Regime Continues To Inadequately Address Seafood Fraud, Stephen Wagner

Ocean and Coastal Law Journal

In 2012 alone, Americans consumed approximately 4.5 billion pounds of seafood, over 90% of which was imported. Simply put, Americans eat a lot of seafood, with upwards of 500 different species available to satiate the demand. Consequently, imported and domestic seafood in the United States is a thriving 80.2 billion dollar market, with certain highly desired species of fish fetching steep prices.

One fundamental assumption of the consumer-driven market is that the label on the seafood correctly identifies the species of seafood, thereby, among other things, justifying the market price. It is increasingly clear, however, that this assumption ...

The Challenge Of Adverse Selection To Domestic Seafood Markets In Vietnam: Assessing Consumer Demand And Supply-Side Policy Options, Eliot Martin

Independent Study Project (ISP) Collection

The Vietnamese seafood industry has grown rapidly over the past few decades, largely rallying behind huge foreign demand. Institutions surrounding the production and processing of seafood for export have supported efforts to implement reliable regulations and eco-label certifications in line with demand for safe, environmentally friendly, and otherwise high quality products. No comparable efforts exist in the domestic market. Adverse selection is identified as the core problem with the lack of higher end goods on the domestic market, resulting from asymmetric information between producers and consumers, as well as moral hazard between actors in the supply chain. This study finds ...

Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price

Law & Economics Working Papers

Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological ...

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Evan R. Youngstrom

Congress Puts The Usda’S Cool Enforcement On Ice, Golden Gate University School Of Law

GGU Law Review Blog

It is more important that Americans have safer food than to know if their steak is “single‑origin”. Especially in the wake of major E. coli outbreaks at mega chains like Chipotle, food safety in the United States should take priority over pseudo‑protectionist policymaking and food transparency.

A Potential Liability Scenario For "Non-Gmo" Labeling, David Wallace

David L Wallace

(Mis)Perceptions Of Law In Consumer Markets, Oren Bar-Gill, Kevin E. Davis

New York University Law and Economics Working Papers

There are good reasons to believe that consumers’ behavior is sometimes influenced by systematic misperceptions of legal norms that govern product quality. Consumers might misperceive specific rules, such as those found in food safety regulations, as well as more general standards, such as the unconscionability doctrine or limitations on waivers of default substantive or procedural rights. When demand is affected by systematic misperceptions of legal norms, lawmakers may be able to maximize welfare by deviating from the legal standard that would be optimal in the absence of misperception. We use a formal model to characterize these optimal deviations under different ...

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 ...

A Liberal Dilemma: Respecting Autonomy While Also Protecting Inchoate Children From Prenatal Substance Abuse., Andrew J. Weisberg, Frank E. Vandervort

Articles

Substance abuse is a significant social problem in America. It is estimated that some eighteen million Americans have an alcohol abuse problem and that almost five million have a drug abuse problem. According to the National Institute on Drug Abuse, substance abuse costs some $700 billion per year Substance abuse is a major contributor to child maltreatment. It is estimated that between one- and two-thirds of cases in which children enter foster care are linked to parental substance abuse. Unfortunately, this may be an underestimate as recent research suggests that many cases, particularly cases in which children have been exposed ...

Underbanked: Cooperative Banking As A Potential Solution To The Marijuana-Banking Problem, Patrick A. Tighe

Michigan Law Review

Numerous states have recently legalized recreational marijuana, which has created a burgeoning marijuana industry needing and demanding access to a variety of banking and financial services. Due, however, to the interplay between the federal criminalization of marijuana and federal anti-money laundering laws, U.S. financial institutions cannot handle legally the proceeds from marijuana activity. As a result, most financial institutions are unwilling to flout federal anti-money laundering laws, and so too few marijuana-related businesses can access banking services. This Note argues that the most viable policy option for resolving this “underbanking” problem is a financial cooperative approach such as a ...