Food and Drug Law Commons^™

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

Closing The Gaps: Reforming Maryland Controls On Veterinary Antimicrobial Distribution, Samantha Capaldo, Kerry Mcclaughry

Journal of Food Law & Policy

Antimicrobials have been used in livestock and other food animals in the United States (“U.S.”) since the late 1940s. An antimicrobial is “[a]ny natural, synthetic, or semisynthetic substance that can eradicate or prevent the growth of microbes,” including “[a]ntibacterial, antifungal, antiparasitic, and antiviral medications.” Antimicrobial use in food animals is subject to a complex statutory and regulatory framework at both the state and federal levels. Antimicrobial use in food animals has been widely criticized for contributing to antimicrobial-resistant bacterial infections in humans. In response to this criticism, the U.S. Food and Drug Administration (“FDA”) and several states, including Maryland, have …

A Model For Food Safety Regulation And Effective Enforcement: A California Case Study, Ninveh Mansour

Loyola of Los Angeles Law Review

This Note examines California’s emerging leadership in food additive regulation amid perceived federal shortcomings, particularly within the FDA’s “generally recognized as safe” (“GRAS”) framework. Using recent legislation, the California Food Safety Act (“CFSA”) and the California School Food Safety Act (“CSFSA”), as case studies, this Note explores how California has acted to ban additives still permitted under federal law, citing gaps in federal oversight and consumer protection. This Note places these laws in the broader context of California’s regulatory legacy, including Proposition 65 and the artificial trans-fat ban. It also compares enforcement mechanisms, highlighting the effectiveness of Proposition 65’s private …

The New Red Scare: The Shocking Truth Behind The Fda's Unethical Regulation Of Red 40 And Other Synthetic Food Dyes, Angelica Martuscello

Pace Law Review

For decades, the U.S. Food and Drug Administration (FDA) has allowed synthetic food dyes to remain in the American food supply, despite evidence linking them to cancer and behavioral issues in children. These additives offer no nutritional value yet remain common in everyday products. This essay scrutinizes the FDA’s failure to enforce its own legal obligations, particularly its continued approval of synthetic dyes, which were later found to be harmful to human health. Harmful dyes have been kept on the market due to weak oversight, outdated science, and industry lobbying. In 2025, the FDA finally announced a plan to phase …

Antibiotics In Animal Agriculture, The Risks To Health, And Differences In The Us And The Eu, Li-Ting Chou

Seattle Journal of Technology, Environmental, & Innovation Law

No abstract provided.

Pills, Powders, And Proprietary Blends: The Ip And Regulatory Battle Over Dietary Supplement Transparency, Anna Marie Saunders

Georgia Journal of Law & Technology

Available in the form of pills, powders, gummies, bars, and countless other options, dietary supplements have become a cornerstone of the health and wellness industry and a popular product amongst health-conscious consumers. Fueled by the rise of social media influencers and a surge in health-awareness following the COVID-19 pandemic, the supplement industry has experienced rapid growth, evolving into a multi-billion-dollar market.  While widely embraced, these products often face criticism due to labeling and marketing practices that leave  consumers with an incomplete understanding of exactly they are consuming.  This tension arises from the unique legal intersection governing dietary supplements.  These products …

The Transatlantic Clinical Trial Transparency Gap, Gabriela Lenarczyk

Georgia Journal of Law & Technology

Clinical trial data occupy a contested space between private commercial assets and public goods. While the United States Food and Drug Administration (FDA) has historically shielded these data through expansive trade-secret interpretations, the European Union (EU) has adopted a more open disclosure regime. This Article compares the two regimes and traces how the EU’s two-decade journey toward transparency has become a key reference for researchers and advocates of open data-sharing.

Focusing on EU practices—targeted redactions, time-bound access, granular disclosure guidelines—the paper shows that U.S. objections to broader transparency often rest on overstated concerns about competitive harm. A Filspari (sparsentan) case …

Why Food In The United States May (Still) Never Be Safe: A Look Back At My Over Thirty Years Thinking About Food And The Law, Denis Stearns

Journal of Food Law & Policy

This article can serve a function as a concluding section—a kind of coda—for issues addressed in greater depth by the author (Denis Stearns) before.

This article also allows Sterns to return to a central question that prompted his thought-journey in the first place: Why does the food in this country continue to be so unsafe, despite all of the laws, all of the enforcement efforts, all of the food safety advocacy, and all of the lawsuits filed to recover damages on behalf of people injured and killed year after year. What follows, then, are additional and updated conclusions that thirty …

Food Inspections: Searching For Contamination (And Solutions) In A Haystack, Abigail Schneider, Benjamin Kelly, Michael S. Sinha

Journal of Food Law & Policy

Food recalls in the United States often reveal serious mismanagement and structural issues in both government and private industry, yet they have become unremarkable and even expected in our modern world. The procedure employed by the U.S. Food and Drug Administration (“FDA”) to monitor food manufacturing is a valuable process which protects every person who lives in the United States. However, the effects of monitoring as a tool for oversight is limited if there is no efficient response when problems arise. FDA inspects pharmaceutical, cosmetic, and food manufacturing facilities both domestically and abroad. When those inspections reveal the presence of …

Brief Of 11 Narcolepsy Patients, Public Interest Orgnizations, Medical Professionals, And Professors Of Law As Amici Curiae In Support Of Defendants-Appellees, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are patients, organizations, medical professionals, and legal scholars who share a common interest in advancing the law toward better patient health and welfare. New, clinically superior drug products for treating rare diseases and conditions tremendously benefit patients and society, because those products offer choice, competition, and improved patient care. In filing this brief, amici hope to make this Court aware of the broad real-world implications of this case, both for narcolepsy patients and for the public interest generally. Generation Patient is a nonprofit organization that represents young adults with chronic and rare conditions across the United States. Created …

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

An Integrated Approach Can Improve China’S Food Additives Security, Qian Li, Jingru Hou, Jennifer S. Stevenson, Cihui Liu

Faculty Articles

In China, the development of food additives remains a critical challenge in food additives security research. We discuss an integrated approach that can improve China’s food additives security, including technical management, standards implementation, and punitive damages regime. Through this integration, we identify that technical management, standards implementation, and punitive damages regime are each complementary to each other. Technical management helps reduce the inherent risks of food additives beforehand. Standards implementation helps prevent and control risks of food additives use halfway. Punitive damages regime helps relieve secondary risks arising from food additives use. Crucially, this integration enhances the suitability of food …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

Revisiting Patent Linkage, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Alfred Engelberg’s article of a quarter-century ago, Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?, raised a provocative question that retains currency today. The special provisions that Hatch-Waxman established, and Engelberg addressed, have come to be known as patent linkage. Following the principle of linkage, the Food and Drug Administration (FDA) cannot approve generic drugs for marketing if they would infringe a patent.

Hatch-Waxman’s complex patent provisions aspire towards multiple salutary purposes, including encouraging the prompt availability of generic drugs, improving public notice of pharmaceutical patents, and accelerating dispute resolution proceedings. Congress also attempted to ameliorate perceived …

Labeling Energy Drinks: Tackling A Monster Of A Problem, Meredith P. Mulhern, Michael S. Sinha

Journal of Food Law & Policy

Energy drinks first rose to popularity in the 1980s after the creation of Red Bull. In addition to high caffeine amounts, energy drinks often contain herbal stimulant additives, vitamin and mineral mixtures, and sugar. There is very little information available on the long-term effects of these stimulant mixtures on the body. Although many consumers purchase energy drinks because of their caffeine content, many are left in the dark when it comes to labeling transparency and are unaware of their true contents. Energy drinks are classified as dietary supplements, meaning they are not directly regulated by the FDA before hitting store …

Why The United States Should Change Its Standards For Food Additives, Sara Smith

Touro Law Review

Processed food products sold in the United States are vastly different than those in Europe, often containing unnecessary and potentially dangerous additives. Recently, food consumer advocacy groups and reporters are bringing attention to these differences, thereby raising awareness of the poor processed food quality in the United States. The United States should take a new and improved method to food safety that mirrors the European Union’s approach. This Note will compare the differences between food additives in the United States and Europe, and further, will propose solutions to increase regulation on food additives in the United States.

Criminalizing Transgender Care, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

Since 2021, twenty-four states, in extraordinarily quick succession, have enacted statutes banning physicians from prescribing puberty blockers and cross-sex hormones to minors for treatment of gender dysphoria. Although the Food and Drug Administration has not approved these drugs for this use, off-label prescribing is a common practice, and leading medical organizations all agree that this off-label use of puberty blockers and sex hormones is an essential component of transgender medical care. These state laws thus represent an extreme, and unprecedented, interference with the provision of standard-of-care medicine. This article, after exploring the ongoing litigation challenging these bans, argues that they …

I’M Not Lovin’ It: Re-Thinking Fast Food Advertising, Brody Shea, Michael S. Sinha

Journal of Food Law & Policy

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”). The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century. The FTC has regulatory authority over fast food advertising while the FDA regulates fast food, which creates a proverbial fork in the road. The fork in the road widens when considering the FDA has an active role in curbing the obesity epidemic through …

Confronting Cosmetic Carcinogens: A Proposal Regarding The Dangers Of Talcum Powder, Rachael Howell

Helm's School of Government Conference - 2021-2024

The Federal Government needs to stop the import, export, mining, and distribution of talcum powder in the United States. This is an issue that affects all Americans, especially active-duty military members.

Since 2013, there have been over 38,000 lawsuits against Johnson & Johnson, which allege that their talcum-based baby powder caused cancer. The plaintiffs in the very first talc case in the U.S. have died. All four of the plaintiffs from a 2019 suit have died. Yet, the 2019 case has been reversed and remanded. The FDA has redacted the names of scientist(s) that conduct “safety tests” on talc samples. …

Fda Overreach: Is Your Pet’S Health A “Major Question” To You?, Ross C. Reggio

Washington and Lee Law Review

Pharmacy compounding of drugs for companion animals and humans is as old as time. For hundreds of years, pharmacists created these drugs using active pharmaceutical ingredients, otherwise known as bulk drug substances, to address the medical needs of these patients. Congress recognized this longstanding practice when it enacted the Food, Drug, and Cosmetic Act (“FDCA”), with lawmakers then noting that while pharmacists, physicians, and veterinarians were already highly regulated by the states, mass-producing drug manufacturers were not regulated. The FDCA would regulate such manufacturers.

Thereafter, pharmacy compounding from bulk drug substances continued for decades after the FDCA’s enactment and without …

The Wild, Wild West Of Laboratory Developed Tests, John Gilmore

Washington and Lee Law Review Online

Since the 1950’s, scientists have built novel technologies to screen for genetic diseases and other biological irregularities. Recently, researchers have developed a method called “liquid biopsy” (as opposed to a standard tissue biopsy) that uses a liquid sample (e.g., blood) to non‑invasively spot biomarkers indicating different types of cancers in the patient’s body. While the U.S. Food and Drug Administration (FDA) has fully cleared a small number of liquid biopsy tests under its rigorous and expensive review process, most biotech companies have instead followed a less restrictive regulatory path through the Centers for Medicare and Medicaid Services (CMS), which label …

‘Rounding Up’ Roundup: One Last Hope For Glyphosate Regulation, Gabrielle Argimón-Cartaya

University of Miami Law Review

Since 1974, Bayer’s Roundup remains the world’s most popular herbicide and pervades United States farmland and food production. However, in 2015, Roundup landed centerstage in an international and presently unsettled debate over whether its active ingredient, glyphosate, causes cancer. Environmental groups regularly call for the de-registration of glyphosate due to the plethora of ailments, ecological harm, and weed resistance resulting from glyphosate use. Dissenting experts, however, believe that strict bans would devastate agriculture because of global dependence and the lack of any popular alternatives. Faced with mounting litigation, silence from the highest court, and unreliable regulators, Bayer continues to effect …

Petition Power, Erika Lietzan

Faculty Publications

The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law, and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is …

Preempting Red State Restrictions On The Use Of Fda-Approved Drugs In Gender-Affirming Care?, Lars Noah

UF Law Faculty Publications

Some observers recently have wondered whether actions by the U.S. Food and Drug Administration (“FDA”) could federally preempt increasingly common state restrictions on gender-affirming care, particularly prohibitions on the use of puberty blockers and cross-sex hormones in adolescent patients. In theory, such a legal strategy might sidestep the need to lodge increasingly unsuccessful challenges under the Fourteenth Amendment. The Supremacy Clause offers little assistance, however, in attempting to get around these state laws. Indeed, even if the FDA eventually approved such uses for currently marketed drugs, implied preemption doctrine as currently configured probably would not do the trick, though securing …

Petition Power, Erika Lietzan

American University Law Review

The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law, and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is …

Empirically Assessing 510(K) Device Safety, George Horvath

Akron Law Faculty Publications

Innovations in medical device technology hold the potential to improve health outcomes across the populace. Nearly half of all medical devices that enter the U.S. market each year are regulated by the Food and Drug Administration (FDA) under the 510(k) pathway. If FDA regulation of 510(k) devices stifles innovation, health outcomes will suffer over time because beneficial devices would not reach patients; on the other hand, if regulation facilitates innovation, health outcomes could improve. Most discussions of innovation under the 510(k) pathway have been either excessively reductionist (such as claims that the pathway stifles innovation) or wholly pessimistic (notably, the …

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

Journal of Food Law & Policy

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. 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 DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be proven safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. We call on Congress to amend DSHEA to …

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …

The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia

DePaul Journal of Health Care Law

Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.

What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether …