2025 H. Thomas Austern Writing Competition Award Winners 

We are pleased to announce the winners of the 46th H. Thomas Austern Writing Competition. Hosted by the Food and Drug Law Institute (FDLI), this annual competition supports and encourages law students in their academic scholarship surrounding FDA-regulated industries. The awards honor H. Thomas Austern, known as the “Dean of the Food and Drug Bar,” for his role in drafting and negotiating the Federal Food, Drug, and Cosmetic Act (FDCA). In addition to his contributions in the field, Austern was a strong supporter of FDLI. He helped found the Food and Drug Law Institute in 1949 and served on the Editorial Advisory Board of the Food and Drug Law Journal from its creation until his passing in 1984. 

We received dozens of submissions from students across the country. The review committee, consisting of practicing attorneys, spent the summer and fall reviewing the papers and participating in multiple rounds of discussions. The top three papers were chosen based on the depth of legal analysis, originality, and the ability to compose a unique and compelling argument.  

Please join us in congratulating the following authors for their winning papers in this year’s writing competition.  

First Place 
Hayden Davis, Harvard Law School (2025), “Defending the Constitutionality of Mandatory Disclosures on Food and Drug Labels.” 

What inspired you to choose your topic? 

A healthy economy relies on consumers having the information necessary to make informed decisions. Government has a role to play in compelling companies to disclose important facts and warnings that makes this informed decision-making possible. For decades, through the Supreme Court’s decision in Zauderer v. Office of Disciplinary Counsel, the courts have struck a careful balance between protecting the public’s interest in transparency with the need for safeguards to ensure government does not abuse its power to compel speech. 

But over the last few years, we have seen companies—especially in the tobacco industry—try to use ambiguities in the Zauderer opinion to disrupt this balance, stretching the First Amendment far beyond its intended purpose, to avoid complying with basic disclosure laws designed to keep the public safe. 

In response to these legal attacks, I wanted to defend government’s power to compel disclosures to protect public health, while providing a roadmap for what regulators should do to stay on the right side of the First Amendment. 

Why do you feel it is an important topic in food and drug law? 

Mandatory disclosures constitute some of our most significant food and drug regulations, including those most visible to the public. The constitutionality of factual mandatory disclosures underlies many crucial regulatory regimes, from food ingredient labeling to “black box” warnings on pharmaceutical products—designed to help Americans make informed choices about what we put in our bodies. 

The line between when compelled commercial speech is and is not permissible is also at the center of significant food and drug labeling issues currently being litigated, from cigarette warnings to mandated labeling of genetically modified products. 

While compelled speech doctrine has implications in many industries, food and drug labeling are some of the oldest and most important applications of mandatory disclosures, making it the perfect issue area to approach this First Amendment question from. 

 

Second Place 
Ana Lentini, Columbia Law School (2025), “A Food, Drug, or Neither? The Regulatory Concerns with the Dietary Supplement Industry.” 

What inspired you to choose your topic? 

I was introduced to the criticism surrounding dietary supplement regulation in my Food and Drug Law class at Columbia Law School. I knew quickly that I wanted to continue researching the topic.  

Why do you feel it is an important topic in food and drug law? 

Dietary supplements are a multi-billion-dollar industry and readily accessible to American consumers. As the line between medicine and wellness continues to blur, it is important to examine the supplement industry closely and with scrutiny.  

 

Third Place 
Jessica Samuels, Harvard Law School (2025), “Rehabbing Reproductive Health in Future Cosmetic Regulations.” 

What inspired you to choose your topic? 

My interest in this topic emerged from the growing body of evidence indicating that so-called “forever chemicals” pose significant risks to consumer health through their endocrine-disrupting effects, including impacts on reproductive health. When I learned that nearly a century had passed since Congress last enacted meaningful cosmetic regulation, it became clear that the statute offered a unique opportunity for reform. As an avid cosmetics consumer, I was motivated by the possibility that updated regulations could ultimately support improved reproductive and overall health outcomes for all consumers. 

Why do you feel it is an important topic in food and drug law? 

Despite rising public concern, relatively little is known about the extent to which endocrine-disrupting chemicals in cosmetics contribute to adverse health effects. Companies have capitalized on the movement toward “clean” beauty, yet the scientific evidence remains limited, in part because robust safety testing has never been required. For food and drug law practitioners and regulators, this gap presents a critical challenge: consumers cannot make informed decisions without reliable, evidence-based information. The recent legislative reforms create the first meaningful opportunity for adequate safety assessments, opening the door to improved data, stronger regulatory oversight, and better long-term health outcomes. 

 

FDLI is a nonprofit membership organization that offers education, training, publications, and professional networking opportunities in the field of food and drug law. As a neutral convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation. Articles and any other material published in Update represent the opinions of the author(s) and should not be construed to reflect the opinions of FDLI, its staff, or its members. The factual accuracy of all statements in the articles and other materials is the sole responsibility of the authors.