Food and Drug Law Commons^™

The Minty Taste Of Death: State And Local Options To Regulate Menthol In Tobacco Products, Michael Freiberg

Catholic University Law Review

Explaining why the additive menthol in tobacco products creates major public health risks, this article advocates for restricting the addition of menthol in cigarettes as a way to reduce smoking-related disease and death. Author Michael Freiberg describes how the decision to regulate menthol in tobacco products, on a federal level, was historically delegated by Congress to the discretion of the U.S. FDA, outlines the U.S. FDA’s subsequent failure to regulate menthol, and surveys state and local government efforts to regulate menthol in response to the FDA’s inaction. The article proposes additional actions that these state and local governments could take …

New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson

Faculty Scholarship

As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …

Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac D. Buck

Cardozo Law Review

While the American public remains preoccupied with the lurching implementation of the Affordable Care Act, the regulation of pharmaceutical companies for their off-label marketing and promotion of drugs features a regulatory environment within the health industry that seems to be in wild flux. Following the Second Circuit's decision in United States v. Caronia, commentators and providers are unsure about the future of federal regulation in this area, with the FDA seeking to minimize the opinion and pharmaceutical companies celebrating its impact. Much of the understandably spirited reaction to the Caronia case has omitted a discussion of the relevant and …

Food And Drug Law: The Infant Formula Act Of 1980, Randal D. Shields

Akron Law Review

The Infant Formula Act of 19802 (hereinafter the Act) was a culmination of the efforts of mothers, physicians, reporters, administrators, businessmen and congressmen to provide regulations and guidelines to prevent similar tragic episodes in the future. This comment will focus on the Act, as well as the events leading up to its promulgation. The examination will begin with the remarkable discovery in infants of the rare affliction known as metabolic alkalosis and the subsequent research which has established a direct correlation between the defective formulas and the infants' conditions. Despite an expedient voluntary recall of the formulas, controversy raged in …

Protecting Patients: A Proposal For Codifying The Reasonable Innovation Rule, Stephanie M. Mehle

Akron Law Review

Part II of this Comment will examine the history of human experimentation and how the current regime of experimenting developed then explore the gap between experimentation approved by an Institutional Review Board (“IRB”) and FDA oversight. Part III will consider the competing interests of individual patient protection and medical innovation in general and whether informed consent appropriately balances those interests. Part IV will evaluate the inadequacies of current reliance on informed consent by using two case studies, both involving novel microbial procedures, and discuss how codification of the reasonable innovation rule would address those inadequacies. Ultimately, this Comment will argue …

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

The Pharmaceutical Access And Prudent Purchasing Act Of 1990: Federal Law Shifts The Duty To Warn From The Physician To The Pharmacist, Michael J. Holleran R.Ph.

Akron Law Review

This article will first discuss the legislation recently enacted as part of the budget reduction package passed by Congress in late 1990 and how that legislation will affect pharmacists' liability. Second, the article will address the applicable statutes of limitation regarding pharmacists in particular and within the general area of malpractice. Third, the applicable standard of care will be explored as it pertains to pharmacists as well as physicians. Coupled with the standard of care discussion is an overview of the various theories of liability which physicians and pharmacists currently face and how these may change under the Act. Finally, …

An International Sos (Save Our Sharks): How The International Legal Framework Should Be Used To Save Our Sharks, Crystal Green

Pace International Law Review

The purpose of this Article is to shed light on the plight on sharks in international and domestic waters. An estimated 100 million sharks are killed every year. The cruel and wasteful practice of shark finning is responsible for a large portion of those killings. Shark fins are the most valuable part of the shark, because they are used as the key ingredient – and namesake – in an Asian delicacy known as “shark fin soup.” This Article opens with background information on the dire situation sharks are facing in our oceans, and how the depletion of these top predators …

Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole E. Negowetti

Seattle University Law Review

Over the past several decades, as the agricultural system became increasingly industrialized and the steps from farm to plate multiplied, consumers became farther removed from the sources of their food. Until recently, most consumers in America were content to eat their processed, cheap, and filling foods without giving a second thought to how these foods were produced. The tides are changing. Increasingly, consumers are calling for more transparency in the food system. Repulsed by images of animal cruelty and shocked by unsavory food production practices, consumers want the food industry’s veil lifted and are demanding changes in food production. The …

Re-Tooling Marine Food Supply Resilience In A Climate Change Era: Some Needed Reforms, Robin Kundis Craig

Seattle University Law Review

Ocean fisheries and marine aquaculture are an important but often overlooked component of world food security. For example, of the seven billion (and counting) people on the planet, over one billion depend on fish as their primary source of protein, and fish is a primary source of protein (30 percent or more of protein consumed) in many countries around the world, including Japan, Greenland, Taiwan, Indonesia, several countries in Africa, and several South Pacific island nations. Marine fisheries and marine aquaculture have been subject to a number of stressors that can undermine world food security, including overfishing, habitat destruction, and …

Keynote Remarks: Re-Tooling Law And Legal Education For Food System Reform: Food Law And Policy In Practice, Emily M. Broad Leib

Seattle University Law Review

Thank you for the opportunity to be with you today and to take part in this symposium on the important role law schools and lawyers can play in changing our food system. Food preferences and food choices are incredibly personal, but the way we produce and consume food, and its impacts on our environment, public health, and the safety of ourselves and others, make it a pressing societal issue as well.

Scuttling Iuu Fishing And Rewarding Sustainable Fishing: Enhancing The Effectiveness Of The Port State Measures Agreement With Trade-Related Measures, Anastasia Telesetsky

Seattle University Law Review

Illegal, unreported, and unregulated fishing (IUU fishing) is a substantial threat to global food security and a recurring problem for global fishery managers already facing difficult baseline situations exacerbated by climate change, including warming oceans and increasing acidification. There is nothing historically new about IUU fishing; there have always been poachers who take advantage of operating in the shadows of legal commercial fishing. What is new is the extent to which marine poaching has industrialized. It is estimated that 19% of the worldwide value of marine catches are unlawful. The problem is not limited to developing states. For example, even …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Seattle University Law Review

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right. The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Ag Gag Past, Present, And Future, Justin F. Marceau

Seattle University Law Review

While the animal rights and food justice movements are relatively young, their political unpopularity has generated a steady onslaught of legislation designed to curtail their effectiveness. At each stage of their nascent development, these movements have confronted a new wave of criminal or civil sanctions carefully tailored to combat the previous successes the movements had achieved.

Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns

Seattle University Law Review

Despite knowledge that commerce in food is a profit-driven enterprise, the public has consistently put great faith in the wholesomeness and safety of the food being purchased. To some extent, such faith is necessary, even if not always justified. In making the decision to put a bite of food in one’s own mouth, or the mouth of a friend or family member, a form of faith or trust must accompany the act of eating. For who would knowingly eat food suspected to be unsafe? But that is precisely what millions of people do every year, with a great many of …

The Medical Liability Exemption: A Path To Affordable Pharmaceuticals, Carrie E. Rosato

Florida State University Law Review

Patent monopolies are tolerated because we believe they promote progress that benefits society. What should be done when these monopolies actually increase human suffering? Drug prices in America are fifty to eighty percent higher than the rest of the world, meaning many cannot afford drugs that will improve or even save their lives. When striking a balance between the interests of the patent holder and that of the public, it is important to bear in mind that the rewards granted to patentees are secondary to the public benefit derived from their labors. The ideal solution would come from Congress creating …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

Faculty Publications By Year

No abstract provided.

Keeping Up With New Legal Titles, Franklin L. Runge

Law Faculty Scholarly Articles

In this book review, Franklin L. Runge discusses In Food We Trust: The Politics of Purity in American Food Regulation by Courtney I. P. Thomas.