Food and Drug Law Commons^™

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 …

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 …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

The Cow Has Left The Barn: Updating Standards Of Identity To Reflect Consumer Understanding Of Plant-Based Foods, Nicholas G. Miller

Journal of Food Law & Policy

Have you ever seen “tofurkey” at the supermarket and thought it was a rare, delicious cousin of the turkey? The animal based food industries, led by milk and meat producers, are claiming that the reasonable consumer might. On the other hand, the plant based food substitutes are appearing on supermarket shelves with increasingly bold names for their products that tap into our familiarity with animal-based foods, using names like “Beyond Meat.” Where do we draw the line on what plant based food can be called? And who should draw that line? This paper examines the debate surrounding the labeling of …

Man's Best Friend? Fda Adopts New Rule In Wake Of Pet Deaths, But Will It Have A Significant Impact On The Pet Food Industry?, Amanda Paige Marcum

Journal of Food Law & Policy

Eight years after the largest pet food recall in U.S. history,' pet owners are still grappling with mysterious pet illnesses and deaths associated with commercial pet food. This comment discusses a number of issues related to the Food Safety Modernization Act ("FSMA") . First, it looks at a brief history of pet food industry regulation. Second, it examines the mystery of pet deaths related to jerky treats made in China. Third, it discusses recent developments in the law in response to those pet deaths. Fourth, it considers the implications of the rule and how it will affect the standards applicable …

Preempting State Prevention: How Fda Regulation Ensures Access To Abortion Medication, Jared Shea

Mitchell Hamline Law Review

No abstract provided.

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

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 …

A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman

Seattle University Law Review

This Note suggests a better balance between allowing sunscreen innovation and protecting the public from unsafe products. Part I of this Note will review the factual background of the public’s attention to sunscreen, explain the current sunscreen issues in the news, and highlight the different actors involved in the growing discourse surrounding sunscreen. Part I will also show that the actors involved in the sunscreen industry—scientific researchers, social media influencers, and the public at large—have considerable influence on consumers’ trust in sunscreen, their buying habits, and the FDA’s approach to sunscreen regulation. Part II of this Note will outline the …

Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman

Georgia Law Review

The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard …

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook

Journal of Food Law & Policy

This update summarizes some of the significant changes and developments in food law over the first half of 2006. Not every change in food law is included; instead, this update provides a starting point for scholars, practitioners, food industry members, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates, which appear in each issue of the Journal of Food Law & Policy, also provides historical context for the development of significant food law issues over time. New developments in state law, while certainly important and deserving in …

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

The 21st Century Cures Act: A Patient's Miracle Or Demise?, Brittaney N. Edwards

Journal of the National Association of Administrative Law Judiciary

The 21st Century Cures Act is designed to expedite the FDA’s approval of pharmaceutical and medical device applications in order to increase patient access to innovative therapies. However, many experts claim that the Act’s Title III provisions promote evidentiary “‘shortcuts’” that eviscerate the safety and efficacy standards of the FDA approval process. For new drugs, Title III permits surrogate endpoints and real-world evidence in lieu of more rigorous scientific data. For new medical devices, Title III requires the FDA to exempt certain Class I and II devices from any kind of safety or efficacy evaluation. Moreover, Title III forces the …

Food Entrepreneurs And Food Safety Regulation, Nina W. Tarr

Journal of Food Law & Policy

The green wave of environmental advertising among organic food producers, distributors, and retailers begun during the 1990s has become an all-out green tsunami. The organic food market is the fastest growing segment of the American food industry. Consumers are increasingly becoming aware of the impact their purchases have on several environmental issues. As a result, those consumers are becoming more aware of their spending power and are willingly altering their buying practices to purchase from companies that emphasize environmental responsibility. In fact, some retailers' inventory is already being scanned for alternative green products by their customers' iPhones because, guess what, …

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of developments in Canadian food law and policy in 2009. This update primarily analyzes the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm. In 2009, regulatory and policy developments continue to be dominated by the 2008 Listeriosis outbreak in ready-to-eat, deli meats. Other noted activities include Canada's ongoing efforts to minimize the effects of infectious diseases related to meat production, Canada's request for a WTO panel to consider the effects of American Country of Origin Labelling, and an initiative …

Whatever Happened To Old Mac Donald's Farm… Concentrated Animal Feeding Operation, Factory Farming And The Safety Of The Nation's Food Supply, Julie Follmer, Roseann B. Termini

Journal of Food Law & Policy

Today, livestock farming is a far stretch from the nostalgic notion of animals grazing in green pastures, roaming free in the fresh country air and returning at the end of the day to a cozy barn. Simply stated, livestock farming is a large scale business, where tens of thousands of animals are swiftly raised industrial-style for maximum profit. Under the "factory farm" model, large corporate owned operations grow quantities of animals for slaughter for human consumption as food. In fact, livestock farms now raise 40% of all animials in the United States.

United States Food Law Update, A. Bryan Endres

Journal of Food Law & Policy

Michael T. Roberts and Margie Alsbrook noted in the Journal's inaugural Food Law Update that "[t]he one constancy about food law in the United States is change, especially in a rapidly-developing food industry." This observation holds true today and also augurs a change in authorship of this section of the Journal. I hope to follow my colleagues' lead and provide timely and cogent updates of the federal (and occasionally state) statutes, regulations, and judicial decisions impacting food law and policy. It is both an honor and a duty, as food and its legal implications remain in many respects "the world's …

Safe But Not Wholesome: The Troubling State Of Trans Fat Regulation, Ross Williams

Journal of Food Law & Policy

On March 7, 2007, the New York Times reported that Starbucks, the retail coffee chain which sells millions of baked goods every day from its over 8,700 U.S. stores, had asked its suppliers to eliminate all trans fats from their products by the end of the year. The big story for New York readers, though, was not that Starbucks was requiring the elimination of trans fats from its baked goods. In fact, New York City had just passed an ordinance strictly limiting the use of artificial trans fats, the type present in partially hydrogenated vegetable oil (PHVO), by virtually all …

Putting Paper To Pen: Generation Juul's Case For Harm Reduction, Liz Emanuel

Indiana Law Journal

Part I of this Note soberly explores and delineates the perceived and real threats of vaping for America’s youth, concluding with an analysis of the socioeconomic and developmental health effects of nicotine addiction. Part II delves into the federal government’s response to e-cigarettes as well as the powers and limitations of federal regulation under the Food and Drug Administration’s (FDA) “Deeming Rule” and the potential effectiveness of an increase in the national tobacco purchase age or a federal ban on flavored vaping products. Part III discusses the realistic benefits of taking a harm reduction approach to youth vaping in the …

No Ifs, Ands, Or Juuls About It: Why Influencers Must Be Held Accountable, Krystina Dorta

Catholic University Journal of Law and Technology

This article analyzes how the FTC’s Endorsement Guide regulating the advertising of e-cigarette products should be applied to social media influencers. The struggle to regulate e-cigarettes by the FDA and the FTC has led to different advertising methods, which either comply with or neglect the FTC’s Endorsement Guide. This article evaluates the federal government’s reaction to the e-cigarette health crisis, followed by a review of the FTC’s previous actions addressing Endorsement Guide violations, along with the consequences on other companies’ marketing strategies. Finally, this article reviews influencer liability standards for Endorsement Guide violations and develops recommendations to improve those standards.

The Future Of The Agricultural Industry – Is Blockchain A New Beginning?, Ryan Bisel

Seattle University Law Review

As we advance into a digital era, we begin to depend on technological innovations to rapidly help develop and update processes and methods within different industries. Blockchain technology—popularized by cryptocurrency—is slowly making its debut in the agricultural supply chain. Implementing a blockchain requirement for suppliers would be beneficial because it would allow agricultural suppliers and distributors to track their products in a more efficient manner. However, there are four potential legal issues that are foreseeable: (1) preemption, (2) overlapping regulatory authority, (3) applying current legal rules to new technology, and (4) contracting. This Note will specifically focus on issues of …

United States Food Law Update: Labeling Contoversies, Biotechnology Litigation, And The Safety Of Imporeted Food, A. Bryan Endres

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law throughout the first half of 2007. Out of necessity, not every change is included; rather, this update is limited to significant changes in national law. This series of updates provides a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates also builds an important historical context for the overall development of the discipline.

Beetles For Breakfast: What The Fda Should Be Telling You, Kaycee L. Wolf

Journal of Food Law & Policy

Imagine sitting down to breakfast and eating strawberry yogurt with a glass of grapefruit juice. You think you are eating a healthy meal, but along with vitamins, calcium, and nutrients, you are getting a side of crushed beetles. Cochineal extract and carmine, two color additives derived from the cochineal beetle, color many foods such as strawberry yogurt. When people consume products with color additives, most do not realize that they could be ingesting insects, which can also be potentially dangerous, not to mention possibly unappetizing or upsetting. Imagine that one minute you are sitting down to eat a healthy cup …

Uncapping The Bottle: A Look Inside The History, Industry, And Regulation Of Bottled Water In The United States, Joyce S. Ahn

Journal of Food Law & Policy

"Agu chupa! Agu chupa!" As we drove through the lush rolling hills of northwestern Rwanda, a crowd of young children appeared from the tea fields and repeatedly shouted these words to us. The taxi driver explained that the children wanted our "water bottes." Aware that visitors often drink bottled water, the children run alongside taxis with the hopes of obtaining the plastic bottles. Although Rwandan children typically carry their drinking water in tightly-woven baskets, the modern plastic bottles have become popular and prized possessions.

Reputation And Authority: The Fda And The Fight Over U.S. Prescription Drug Importation, Thomas J. Bollyky, Aaron S. Kesselheim

Vanderbilt Law Review

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts.

In this Article, we argue that prescription drug importation …