Food and Drug Law Commons^™

Traversing The Triangulum: The Intersection Of Tobacco, Legalised Marijuana And Electronic Vaporisers In Denver, Colorado, Emily Anne Mcdonald, Lucy Popova, Pamela M. Ling

Publications and Research

Objective: To explore the intersection of tobacco, legalised marijuana and electronic vaporiser use among young adults in the ‘natural laboratory’ of Colorado, the first state with legalised retail marijuana.

Methods: We conducted semistructured interviews with 32 young adults (18–26 years old) in Denver, Colorado, in 2015 to understand the beliefs and practices related to the use of tobacco, marijuana and vaporisers.

Results: We found ambiguity about whether the phrase ‘to smoke’ refers to the use of tobacco or marijuana products. Smoking marijuana blunts (emptied cigarillo or tobacco wrap filled with marijuana) was common, but few interpreted this as tobacco use. …

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

Pediatrics Faculty Publications

No abstract provided.

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.

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

Elisabeth Haub School of 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.

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

Life of the Law School (1993- )

No abstract provided.

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 …

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 …

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.

Corporate Agricultural Investment And The Right To Food: Addressing Disparate Protections And Promoting Rights-Consistent Outcomes, Kaitlin Y. Cordes, Anna Bulman

Columbia Center on Sustainable Investment Staff Publications

Over the past decade, the world has witnessed heightened corporate interest in large-scale land-based agricultural investment. While such investments can potentially have positive effects for local communities, they also can have wide-ranging negative impacts on human rights, including through forced displacement and the loss of livelihoods. This Article examines the impact of large-scale corporate agricultural investment on the right to food, as well as on human rights more generally. It considers the protections offered by the investment and human rights legal regimes to both corporations and individuals, including recent international developments relating to transnational corporate accountability and efforts to integrate …

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 …

Lessons From Washington And Colorado: The Potential Financial Gains Of Recreational Marijuana To Canada, Nachshon Goltz, Ekaterina Bogdanov

Osgoode Legal Studies Research Paper Series

While Colorado and Washington are among the jurisdictions spearheading the global trend towards legalization of recreational Cannabis (marijuana), Canada lags behind in the regulatory process - but not in Cannabis consumption. An empirical study conducted in downtown Toronto, as well as studies done by Statistics Canada, reveal that Cannabis use is widespread among Canadians, which indicates that the current regulatory regime is not effective as a deterrent.

This paper details the results of the above-mentioned empirical study, reviews the regulatory framework of recreational Cannabis use in Colorado, Washington and Canada, and uses taxation data from Colorado to estimate the potential …

Deterring Innovation: New York V. Actavis And The Duty To Subsidize Competitors' Market Entry, Joanna Shepherd

Faculty Articles

This Article examines a relatively new business strategy in the pharmaceutical market -- "product hopping" or "product replacement" -- in which brand pharmaceutical companies shift their marketing efforts from a drug nearing the end of its patent period to a new, substitute drug with a longer patent life. In July 2015, the Second Circuit issued an opinion in the first appellate case addressing pharmaceutical product replacement, New York ex rel. Schneiderman v. Actavis PLC. This Article explains that product replacement is the predictable business response to the incentives created by patent law and state substitution laws, and withdrawing an …

The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan, Jr.

Faculty Articles and Papers

No abstract provided.

Enforcement Discretion Under Attack: Implications For Fda, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

Author's Note: On June 23, as this article was going to press, the Supreme Court deadlocked 4-4 in U.S. v. Texas, thus affirming a preliminary injunction against implementation of the Obama Administration’s deferred-action program for millions of undocumented immigrants. Because the Court’s terse per curiam decision established no precedent, the questions that the case raised regarding the permissible scope of administrative enforcement discretion remain unresolved on the national level. The Supreme Court will likely consider them again—after a decision on a permanent injunction in the same case, in a similar immigration dispute, or perhaps in another field of administrative law. …

The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post

Faculty Publications

In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …

The Role Of States In Shaping The Legal Debate On Medical Marijuana, Florence Shu-Acquaye

Faculty Scholarship

The ongoing debate in the United States about the legality and use of medical marijuana (also known as medicinal cannabis) is intriguing.

The Effects Of Allergies And Anaphylaxis On The Body And Mind: A Survey Of Opinions And Knowledge On These Disorders, Kathryn E. O'Brien

Honors Program: Student Scholarship & Creative Works

Despite common knowledge, allergies and anaphylaxis are considered disabilities. As such, these disorders affect the daily lives of those who have them, including one's mental health. In this paper, all the nuances of allergies and anaphylaxis will be discussed as the etiology and scientific aspects of allergies, anaphylaxis, and hypersensitivity are distinguished from one another. Furthermore, the findings are reported from two surveys; an assessment of how well educated and prepared teachers are for students with allergies and whether other students with food allergies have had similar experiences to the author's and those described in research by other studies concerning …

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Introducing Marijuana Law Into The Legal Writing Curriculum, Howard Bromberg, Mark K. Osbeck

Articles

Interest in marijuana law continues to grow, due in large part to the complicated and rapidly evolving landscape of marijuana laws in the United States. Nearly every day, newspapers report on new or proposed legislation and the legal controversies that have arisen with regard to this evolving landscape. There are now several marijuana-law blogs on the Internet, Congress is considering sweeping legislation that would essentially grant significant deference to the individual states, and public opinion continues to move in favor of increased legalization. For the last two years, Newsweek magazine has published special editions devoted exclusively to marijuana law and …

Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This Article explores how AIDS activists, desperate for access to potentially life-saving pharmaceuticals, permanently transformed America’s “drug constitution.” Their advocacy altered the FDA’s interpretation and application of the federal Food, Drug, and Cosmetic Act (FDCA) so as to expedite the availability of new, unproven drugs for critical illnesses, thus enhancing individual patients’ autonomy to make therapeutic choices without government interference.The FDCA is more than simple set of instructions to a federal agency — it is a source of vitally important and deeply entrenched institutional and normative frameworks. Like major civil rights, antitrust, and environmental statutes, the FDCA should be viewed …

A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks

Publications

Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …

Politically Correct Eugenics, Seema Mohapatra

Faculty Scholarship

No abstract provided.

The Right To Regulate (Cooperatively), Alexia Brunet Marks

Publications

The growing number of new technologies in food production— such as nanotechnology, genetic modification, animal cloning, and irradiation—are garnering different regulatory responses around the world. Based on their threshold for tolerating risk, countries are asserting their national right to regulate at home using labeling, quarantine, and outright bans on foods. But domestic regulation has its limits in a free trade environment. Countries that are not mindful of treaty obligations could face legal liability, as seen in the recent litigation between Uruguay and Philip Morris International. In short, traditional models of international regulatory cooperation (IRC) are failing to provide countries with …

Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens

Reports & Public Policy Documents

In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend the …

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

Scholarly Works

In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.

We Built It And They Did Not Come: Using Governance Theory In The Fight For Food Justice In Low-Income Communities Of Color, Deborah N. Archer, Tamara Belinfanti

Articles & Chapters

Food deserts and food insecurity have received considerable attention from various stakeholders, such as state and local governments, community organizations, and private sector institutions. These stakeholders have sought to overcome food insecurity by turning food deserts into oases by providing “access” to fresh, healthy food. However, many of their solutions—building supermarkets and sponsoring farmers markets—have missed the mark. Residents of food deserts did not flock to grocery stores to purchase fruits andvegetables. As a result, many stakeholders blame the residents of food deserts for their own predicament, lamenting, to paraphrase Field of Dreams, “we built it but they did not …

Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich

Faculty Publications

Americans are “GRAS-fed” because of a “loophole” in the strict regime Congress provided for the regulation of food additives. Additives - and food products containing them - are exempt from this strict regime if they are accorded GRAS (Generally Recognized as Safe) status. The guidelines Congress provided for achieving that status by scientific evidence of safety are no longer observed. Most additives are determined by the producer alone to be GRAS. At the same time, Americans’ consumption of highly processed foods continues to rise, giving rise to long-term health problems that are increasingly tied to diet. The average American’s diet …

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …

Financing Local Food Factories, Stephen R. Miller

Articles

No abstract provided.