Food and Drug Law Commons^™

Opening A Federal Reserve Account, Julie Andersen Hill

Articles

To open bank accounts, new customers provide personal information and make a deposit. Within a few minutes (or perhaps a few days), new customers get access to payment services. For many years, the process financial institutions used to open accounts at FederalReserve Banks was similar. Eligible banks filled out a one-page form and within a week received an account allowing them access to the FederalReserve's payment systems. Recently, however, Federal Reserve Banks have spent years considering account requests from novel banks.

This Article examines the Federal Reserve's process for evaluating requests for accounts. Using interviews, court documents, and other sources, …

Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Faculty Scholarship

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

All Faculty Scholarship

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a $40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter.

Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under …

Off-Label Speech, David A. Simon

Emory Law Journal

This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or …

The Immigration Implications Of Presidential Pot Pardons, Jason A. Cade

Scholarly Works

This Essay examines the immigration implications of President Joe Biden’s Proclamation on October 6, 2022, pardoning most federal and D.C. offenders who committed the offense of simple marijuana possession. A late twentieth century interpretive shift by the Board of Immigration Appeals holds that pardons only prevent deportation for certain criminal history categories, which do not include controlled substance offenses, and thus far lower federal courts have deferred to the agency’s approach.Nevertheless, according to the analysis I offer, President Biden’s cannabis pardons should be deemed fully effective to eliminate all immigration penalties. All of the immigrant pardon cases to reach the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Investment Bankers And Inclusive Corporate Leadership, Afra Afsharipour

Seattle University Law Review

Few major deals happen without the engagement and advice of investment bankers. Whether a company is undertaking an initial public offering or engaging in a large merger or acquisition deal, investment bankers play a central role in advising corporate executives. Successful investment bankers are devoted to cultivating relationships with executives. And these relationships place bankers in a position to earn tens of millions in fees for their advisory and service roles in connection with corporate dealmaking. Investment bankers’ constant endeavors to nurture relationships with executives, while also maximizing their own ability to enhance fees, commonly leads to allegations of double-dealing, …

Beyond The Business Case: Moving From Transactional To Transformational Inclusion, Jamillah Bowman Williams

Seattle University Law Review

While workplace diversity is a hot topic, the extent to which the diversity management movement has effectively improved intergroup relations and reduced racial inequality remains unclear.1 Despite large investments in diversity and inclusion training and other company wide initiatives, historically excluded groups remain vastly underrepresented in leadership and the most lucrative careers, such as finance, law, and technology. This calls the efficacy of diversity, equity, and inclusion (DEI) efforts into question, particularly with respect to reducing racial inequality in the workplace.

This Article explains why it is time for organizational leaders to move beyond the transactional case for diversity and …

Reframing The Dei Case, Veronica Root Martinez

Seattle University Law Review

Corporate firms have long expressed their support for the idea that their organizations should become more demographically diverse while creating a culture that is inclusive of all members of the firm. These firms have traditionally, however, not been successful at improving demographic diversity and true inclusion within the upper echelons of their organizations. The status quo seemed unlikely to move, but expectations for corporate firms were upended after the #MeToo Movement of 2017 and 2018, which was followed by corporate support of the #BlackLivesMatter Movement in 2020. These two social movements, while distinct in many ways, forced firms to rethink …

Women In Shareholder Activism, Sarah C. Haan

Seattle University Law Review

Even a cursory review of the history of American environmental, social, and corporate governance (ESG) shareholder activism reveals the presence of women leaders. This Article sketches some of this history and interrogates the role of women in the shareholder activism movement. That movement typically has involved claims by minority shareholders to corporate power; activists are nearly always on the margins of power, though minority shareholders may, collectively, represent a majority interest. This Article ascribes women’s leadership in shareholder activism to their longstanding position as outsiders to corporate organization. Women’s participation in shaping corporate policy—even from the margins—has provided women with …

How Firms Turn Middle Managers Into Diversity Leaders, Alexandra Kalev, Frank Dobbin

Seattle University Law Review

In 2007, the Conference Board published a piece calling middle managers “the biggest roadblock to diversity and inclusion” for standing in the way of change efforts. Today, many chief diversity officers report that they have failed both to diversify middle management and to get middle managers involved in promoting inclusion. We explore popular diversity programs that create “paper” or “symbolic” principles for achieving diversity (diversity policy statements and guidelines for hiring, promotion, and discharge), as well as programs that engage middle managers in promoting diversity (special recruitment and mentoring programs, and diversity task forces). “Paper” policies often fall flat, but …

Gender And The Constitutional Theory Of The Firm, Jamee K. Moudud

Seattle University Law Review

This Article adds to the literature that has linked feminist economics to foreign trade and development. It argues that two key factors need to be in place jointly if efforts to promote gender equity are to succeed. On the one hand it argues that foreign debt is an important constraint to domestic progressive social policies of all kinds as it increases the power of international creditors who generally tend to support austerity policies. On the other hand, while alleviating the burden of foreign debt via exportpromotion policies is necessary, it is by no means a sufficient condition to promote domestic …

Court’S Choice Of Law Ruling Undermines Washington Community Property Law: A Critique Of Shanghai Commercial Bank V. Chang, Brian D. Hulse

Seattle University Law Review

This Article deals with the issues that arise when Washington courts face the following scenario. One spouse enters into a contract without the joinder (and perhaps without the knowledge) of the other spouse. Both spouses are domiciled in Washington. The contract has contacts with one or more jurisdictions other than Washington and is generally governed as to validity and interpretation by the law of another jurisdiction. The contracting spouse defaults and the other party to the contract obtains a judgment on the contract. The court confronts a question about the property to which the plaintiff will have recourse to collect …

Policing For Profit: A Constitutional Analysis Of Washington State’S Civil Forfeiture Laws, Julia Doherty

Seattle University Law Review

The summer of 2020 reignited a conversation about the relationship between race and policing in the United States. While many have taken the opportunity to scrutinize the racially discriminate components of our criminal justice system, comparable aspects of civil law must be equally scrutinized. A particular area of concern pertains to racially biased policing and the concept of “policing for profits” with Black, Indigenous, and people of color communities (BIPOC), which is accomplished mainly through civil asset forfeiture at a state and federal level.

The World Moved On Without Me: Redefining Contraband In A Technology-Driven World For Youth Detained In Washington State, Stephanie A. Lowry

Seattle University Law Review

If you ask a teenager in the United States to show you one of their favorite memories, they will likely show you a picture or video on their cell phone. This is because Americans, especially teenagers, love cell phones. Ninety-seven percent of all Americans own a cell phone according to a continuously updated survey by the Pew Research Center. For teenagers aged thirteen to seventeen, the number is roughly 95%. For eighteen to twenty-nine-year-olds, the number grows to 100%. On average, eight to twelve-year-old’s use roughly five and a half hours of screen media per day, in comparison to thirteen …

“What’S Past Is Prologue”: The Story Of The Sale Of The University Of Puget Sound School Of Law To Seattle University, Annette E. Clark

Seattle University Law Review

When the Seattle University Law Review editorial staff invited me to write an updated history of the Seattle University School of Law in honor of our 50th anniversary, I planned to start the narrative with the year 1989, which was where the prior written history (authored by former Law Library Director Anita Steele and published by the Law Review) had left off. It also happens to be the year when I graduated from this law school and joined the tenure-track faculty, so 1989 seemed like a propitious place to begin. However, as I began to do the research necessary to …

A Path Forward: Litigating The Treaty-Based Claims Of Children Sexually Abused In The Indian Health Service System, Peter B. Janci, Stephen F. Crew, Zachary Pangares

Seattle University Law Review

In 1855, representatives for the United States traveled to the Great Plains with orders to seek peace with Blackfoot Nation so the westward expansion of “civilized” white settlers could continue without interruption. After weeks of negotiations, the United States plan materialized. The terms of these promises were memorialized on October 17, 1855, in a treaty between the United States government and Blackfoot Nation.

One hundred and sixty-seven years later, representatives for the United States and the Blackfoot Nation convened in Rapid City, South Dakota to discuss the U.S. government’s breach of the treaty’s terms. Eight Native men, including three from …

Army Commander’S Role—The Judge, Jury, & Prosecutor For The Article 15, Anthony Godwin

Seattle University Law Review

Service members in the armed forces are bound by a different set of rules when compared to other U.S. citizens. Some of the normal safeguards and protections that civilians enjoy are much more restrictive for military service members, and this is generally for a good reason. Such restrictions are partly due to the complex demands and needs of the United States military. Congress and the President have entrusted military commanders with special powers that enable them to handle minor violations of law without needing to go through a full judicial proceeding. Non-judicial punishments (NJP), also known as Article 15s, are …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Blood On The Tracks, Thomas D. Russell

Seattle University Law Review

Streetcars were the greatest American tortfeasors of the early twentieth century, injuring approximately one in 331 urban Americans in 1907. This empirical study presents never-before-assembled data concerning litigation involving streetcar companies in California during the early twentieth century.

This Article demonstrates the methodological folly of relying upon appellate cases to describe the world of trial court litigation. Few cases went to trial. Plaintiffs lost about half their lawsuits. When plaintiffs did win, they won very little money. Regarding the bite taken out of the street railway company, the Superior Court was a flea.

Professor Gary Schwartz and Judge Richard Posner …