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Articles 1 - 30 of 44
Full-Text Articles in Food and Drug Law
With All The Strings Attached: Analyzing Participation Of Disempowered Groups In Structuring New York’S Social Equity Cannabis Investment Fund, Nicholas Schuermann
With All The Strings Attached: Analyzing Participation Of Disempowered Groups In Structuring New York’S Social Equity Cannabis Investment Fund, Nicholas Schuermann
Journal of Law and Policy
For decades, New York’s selective enforcement of cannabis prohibition has disproportionately targeted low-income Black and brown communities, resulting in mass incarceration, decimated economic opportunity, and entrenched generational harm. In 2021, New York enacted the Marihuana Regulation and Taxation Act (“MRTA”) with an explicit reparative mandate: to redress these harms by lowering barriers to enter the new recreational cannabis market for those severely impacted by prohibition. Central to this effort is the Cannabis Social Equity Investment Fund, a $200 million program designed to provide justice-impacted entrepreneurs with turnkey retail locations, low-interest loans, and business support. In practice, however, the Fund has …
Oh, Oh, No Ozempic: The Dangers Of Ozempic’S Direct-To-Consumer Advertisements, Taylor Blicht
Oh, Oh, No Ozempic: The Dangers Of Ozempic’S Direct-To-Consumer Advertisements, Taylor Blicht
Journal of Law and Policy
On average, viewers are exposed to about nine drug advertisements a day. Direct-to-consumer pharmaceutical advertising (“DTCPA”) is when pharmaceutical companies market their prescription drugs straight to consumers. Ozempic is a weekly injection of semaglutide, developed by the pharmaceutical company Novo Nordisk in 2017 for adults with Type-2 diabetes. After people started to show signs of weight loss on Ozempic, Novo Nordisk created Wegovy in June 2021, targeting towards people with obesity. Due to the exploding weight-loss effect of Wegovy, celebrities and social media influencers started taking the medication and sharing their weight loss journeys. DTCPA can be harmful to consumers …
Wine Unwelcome: The Constitutional Contours Of Wine Regulation, Alexander Fallone
Wine Unwelcome: The Constitutional Contours Of Wine Regulation, Alexander Fallone
Brooklyn Journal of Corporate, Financial & Commercial Law
Wine retail shops face a dizzying labyrinth of state laws that severely restrict their ability to ship wine to out-of-state consumers. While the dormant Commerce Clause would normally strike down laws that impose restrictions on interstate commerce, wine (and alcoholic beverages) must contend with Section Two of the Twenty-first Amendment, which gives the states control over the importation and distribution of wine intending to be consumed within their borders. Court of Appeals cases interpreting Supreme Court precedent on the tension between the dormant Commerce Clause and Section Two have practically stripped the dormant Commerce Clause of any power. This Note …
When Poison Is On The Menu: Proposing The Adoption Of Ireland’S Stricter Allergen Regulations In America’S Food Establishments, Katherine Fitzgerald
When Poison Is On The Menu: Proposing The Adoption Of Ireland’S Stricter Allergen Regulations In America’S Food Establishments, Katherine Fitzgerald
Journal of Law and Policy
In the modern era, a growing number of children and adults have been diagnosed with deadly food allergies. For the approximately 33 million Americans who have at least one food allergy, restaurants, aside from the home, are the most likely place where deadly reactions could occur. In order to adapt to this expanding and sensitive population, the federal government should pass legislation that protects these citizens from suffering a preventable, untimely death. Luckily, the legislators of the European Union, and specifically Ireland, have already put food labeling legislation in place that serves to protect those with food allergies. This Irish …
A "One Health" Approach To Healthy Food, Katya S. Cronin
A "One Health" Approach To Healthy Food, Katya S. Cronin
Brooklyn Law Review
Diet-related diseases are the number one killer of Americans. Nutrition and food healthfulness are increasingly seen as foundational to public health. As a result, the healthy foods industry is booming, the medical community is integrating nutrition into healthcare, and even insurance companies are subsidizing food prescriptions. The federal government invests heavily in nutrition, spending more than $166 billion a year on federal programs that provide healthy food to vulnerable populations. After the Biden Administration announced its agenda to “promote a healthy diet among Americans,” the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”) sprang into …
Time To Stop Trip-Ing: The World Needs A New Geographical Indications Agreement, Evan Glatt
Time To Stop Trip-Ing: The World Needs A New Geographical Indications Agreement, Evan Glatt
Brooklyn Journal of International Law
When it comes to purchasing food and alcohol, a product’s name carries weight and helps consumers make decisions. When the product’s name includes a place and establishes a certain level of quality and expectation, consumers trust that the product is what it purports to be. This concept, the reputation of a particular food product by name, is known as a geographical indication (GI). GIs cover a wide range of products, from the well-known champagne to lesser known products such as Roquefort cheese. GIs create financial value for local producers, contribute to sustainability initiatives, and raise the quality of goods for …
I Ain't Afraid Of No Ghost…Kitchen! A New Realm Of Consumer Protection After The Inform Consumers Act, Johanna Silva
I Ain't Afraid Of No Ghost…Kitchen! A New Realm Of Consumer Protection After The Inform Consumers Act, Johanna Silva
Brooklyn Journal of Corporate, Financial & Commercial Law
The effects of the COVID-19 pandemic were pervasive, sparing none from its impact. However, the restaurant industry bore an even greater change and a heavier burden than most. At the height of the pandemic, some 110,000 restaurants shut down. QR codes replaced paper menus, street parking transformed into outdoor dining sheds, and Friday night dinners at the “great spot on the corner” became takeout orders from the couch. Reopening was an unpredictable gamble for restaurant owners, fraught with tiered plans and inconsistent regulations on safe and unsafe dining practices. The desperate search for creative solutions to stay in business propelled …
Thai Drug Offenses And Narcotic Charges: Tracing Thailand’S Drug Control And Capital Punishment History, Jonathan Hasson, Carolyn Hoyle
Thai Drug Offenses And Narcotic Charges: Tracing Thailand’S Drug Control And Capital Punishment History, Jonathan Hasson, Carolyn Hoyle
Brooklyn Journal of International Law
The Article examines Thailand's political economy of drugs and use of sanctions, including capital punishment, using a historical approach. It traces Thailand's nation building and emergence as a global hub for illicit drugs against the backdrop of European and US interventions since the colonial era. The Article reveals how Western concepts and discourses were appropriated by Thai elites to advance local agendas while suppressing democratic movements. The Article explores how the drug trade became entangled with government corruption, militarization, and extrajudicial state violence which often targeted ethnic minorities. In light of recent cannabis policy changes, the Article considers the historical …
Enough Excuses On Drug Importation: A New Transnational Paradigm For Fda Regulation And Lower Us Drug Prices, Gabriel Levitt
Enough Excuses On Drug Importation: A New Transnational Paradigm For Fda Regulation And Lower Us Drug Prices, Gabriel Levitt
Brooklyn Journal of International Law
The US Food and Drug Administration (FDA), which enforces drug safety laws, asserts that under most circumstances the importation of prescription drugs is illegal. Yet because of high drug prices in the United States, over the past couple of decades, tens of millions of Americans have imported prescription drugs for personal use. For many, this was their only way to afford them. A unique array of federal laws, regulations, and policies, including the de facto decriminalization of the practice of personal drug importation, have in effect permitted personal drug importation. The same exceptions, however, are not available for commercial drug …
America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa
America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa
Brooklyn Law Review
A resurgence in federally approved psychedelic research has spawned the Psychedelic Renaissance, and with each study it becomes increasingly clear that psychedelics have the potential to revolutionize mental health treatment. However, if Congress fails to reform the industry’s patent procedures, threats to innovation in the budding field of psychedelic medicine will manifest in their ugliest form. Psychedelics are a class of hallucinogenic drugs that primarily trigger substantially altered states of consciousness, including psychological, visual, and auditory changes. Medical research on psychedelics has produced staggering results that indicate psychedelics have the potential to be significantly more effective in treating mental illnesses …
Serving Up The Truth On America’S Failing Organic Food System, Leah M. Elefante
Serving Up The Truth On America’S Failing Organic Food System, Leah M. Elefante
Brooklyn Law Review
The organic food market in the United States has grown from a niche subset into an integral component of American food consumption. The current laws regulating the organic industry, including the recently adopted Strengthening Organic Enforcement (SOE) final rule, do not align with the average consumer’s understanding as they navigate the many options in grocery stores. This note analyzes the history and evolution of the organic food market in the United States, the process by which food producers become organic certified, and the pitfalls of the current system, which relies on definitions crafted by politicians, not scientists, and allows many …
How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard
How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard
Brooklyn Law Review
The sharply rising deaths associated with use of synthetic opioids in the United States highlight the failure of a legislative strategy focused on reducing the availability of prescription opioids. However, since synthetic opioids prescribed for pain relief have never been a major contributor to either developing opioid dependence or dying from opioid use, it is not surprising that these measures have not only failed to reduce deaths, but have also caused considerable harm to people in need of pain relief. Yet reversing them and taking a public health approach focused on preventing the most serious harms associated with synthetic opioids …
High Time For A Change: How The Relationship Between Signatory Countries And The United Nations Conventions Governing Narcotic Drugs Must Adapt To Foster A Global Shift In Cannabis Law, Alexander Clementi
Brooklyn Journal of International Law
Since the early 1970’s, the inclusion of cannabis and its byproducts in the United Nations Single Convention on Narcotic Drugs has mandated a strict prohibition on cultivation and use of the substance, which has led to a largely global practice of criminalization and imprisonment of anyone found to be in its possession. Yet recently, mostly in response to growing public health concerns, countries like Uruguay, Portugal, The Netherlands, Canada, and the United States have enacted laws which seek to decriminalize or even legalize cannabis use and possession. Yet, cannabis remains classified as a Schedule IV narcotic under the Single Convention, …
An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao
An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao
Brooklyn Journal of International Law
In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …
Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck
Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck
Brooklyn Law Review
Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …
Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino
Brooklyn Law Review
The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …
The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein
The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein
Brooklyn Law Review
In recent years, concern over the environmental, animal welfare, and human costs of animal agriculture has spurred an increased demand for nonanimal sourced protein. This has led to significant innovation in food technology. As part of this trend, food scientists have developed a process for in-vitro cultivation of meat cells to produce protein that is biologically and nutritionally identical to meat from traditionally raised and slaughtered animal sources, but that involves neither animal agriculture nor animal slaughter. This lab-grown “clean meat” represents a new era in food technology and is already having an effect on the existing meat industry. In …
The Heavy Hand Of Amazon: A Seller Not A Neutral Platform, Edward J. Janger, Aaron D. Twerski
The Heavy Hand Of Amazon: A Seller Not A Neutral Platform, Edward J. Janger, Aaron D. Twerski
Brooklyn Journal of Corporate, Financial & Commercial Law
Since the adoption of Section 402A of the Second Restatement of Torts, every party in a product’s distribution chain has been potentially liable for injuries caused by product defects. Consumers who buy from reputable sellers are almost always guaranteed to have a solvent defendant if injured by a product defect. Amazon, though responsible for a vast number of retail sales, has sought to avoid liability by claiming that it is not a seller but a neutral platform that merely facilitates third-party sales to consumers. With two significant exceptions, most courts have sided with Amazon and concluded that Amazon is not …
False Foods: Harmonizing The Eu And Us Organics Programs, Elizabeth G. Fudge
False Foods: Harmonizing The Eu And Us Organics Programs, Elizabeth G. Fudge
Brooklyn Journal of International Law
The growth of the importation and exportation of organic foods in recent years has led governments around the globe to take more aggressive approaches in overseeing and certifying such products. Currently, there is a discrepancy in how states certify and respond to non-compliance issues for imported organic products. This creates a strong need to harmonize organics programs, specifically between the EU and US programs, as they are the two largest consumers of organic products. Through auditing both the EU and US organic import programs, significant issues of non-compliance became exceedingly clear. This Note argues that the best solution for addressing …
(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein
(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein
Faculty Scholarship
No abstract provided.
Global Implementation Of Soda Taxes: Is There A Better Solution For Combatting Obesity?, Lauren Cedeno
Global Implementation Of Soda Taxes: Is There A Better Solution For Combatting Obesity?, Lauren Cedeno
Brooklyn Journal of International Law
As incidences of overweight and obese populations continue to increase around the world, countries are looking for ways to decrease the prevalence of this epidemic. Soda and SSB taxes have increased in prevalence as countries seek to address the health problems associated with consumption of soda and other sugary beverages. This Note explores the implementation of these taxes in Mexico, Europe, and the United States. In analyzing these taxes, this Note seeks to gain a greater understanding of whether these taxes have impacted overweight and obesity rates in the countries and municipalities that have enacted them. This Note argues that …
Pharmaceutical Drug Pricing: The Internet As A Solution For This Health Issue Turned Financial Issue, Thomas P. Kelly
Pharmaceutical Drug Pricing: The Internet As A Solution For This Health Issue Turned Financial Issue, Thomas P. Kelly
Brooklyn Journal of Corporate, Financial & Commercial Law
Over the course of five decades, American annual expenditure on pharmaceutical drugs has increased by more than $350 billion. This drastic increase has led many patients to struggle to afford their necessary, and potentially life-saving, medications. Today’s high pharmaceutical prices are largely due to the fact that name-brand drug manufacturers have few restrictions on how much they can charge for their products. Additionally, name-brand manufacturers are able to monopolize the manufacture of their drugs because patent laws prevent other manufacturers from using the formula of these drugs for two decades. To combat these high prices, this Note proposes a partnership …
Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert
Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert
Brooklyn Law Review
Milk is one of the most ubiquitous and heavily regulated substances on the planet—and perhaps one of the most contested. It is tied closely to notions of purity, health, and femininity, and is seen as so central to human civilization that our own galaxy—the Milky Way—is named after it. But despite its wholesome reputation, milk has long had a sinister side, being bound up with the exploitation of the (human and nonhuman) bodies it comes from and being a symbol of and tool for white dominance and superiority. The word itself, in verb form, means “to exploit.” It is also …
Lactose’S Intolerance: The Role Of Manufacturers’ Rights And Commercial Free Speech In Big Dairy’S Fight To Restrict Use Of The Term “Milk”, Kathleen Justis
Lactose’S Intolerance: The Role Of Manufacturers’ Rights And Commercial Free Speech In Big Dairy’S Fight To Restrict Use Of The Term “Milk”, Kathleen Justis
Brooklyn Law Review
This note examines the relationship between restrictions on commercial speech and manufacturers’ First Amendment right to describe their products to consumers, with a focus on the DAIRY PRIDE Act. It argues that broad, content-based restrictions of commercial speech, like that proposed in the DAIRY PRIDE Act, likely impose unconstitutional limitations on manufacturers’ First Amendment right to freedom of speech. This note recommends that both Congress and the FDA should refrain from passing a statute or promulgating a regulation like the DAIRY PRIDE Act. Rather, it proposes that adding rules to control the proportions and location of disclaimers on product labels …
Something To Wine About: What Proposed Revisions To Wine Labeling Requirements Mean For Growers, Producers, And Consumers, Deborah Soh
Brooklyn Journal of Corporate, Financial & Commercial Law
Title 27 of the Code of Federal Regulations governs the standards for the information that is printed on wine bottle labels, including the appellation of origin. Currently, however, wines are exempt from these regulations if they will not be introduced in interstate commerce. There is a proposed amendment to the Code that would bring all wines, regardless of whether they are sold interstate or solely intrastate, under the federal standards for wine labeling. Between the current system, which permits exempt wines to sidestep the regulations, and the proposal, which would exact strict standards of compliance uniformly, lies a middle-ground approach …
Direct-To-Consumer Calls To Action: Lowering The Volume Of Claims And Disclosures In Prescription Drug Broadcast Advertisements, Andrew Andrzejewski
Direct-To-Consumer Calls To Action: Lowering The Volume Of Claims And Disclosures In Prescription Drug Broadcast Advertisements, Andrew Andrzejewski
Brooklyn Law Review
Pharmaceutical companies advertise drugs directly to consumers via television and radio broadcast commercials, print advertisements, and the internet. Although broadcast advertisements are demonstrably unable to adequately convey risk information, a total ban on them would be too restrictive, and any regulation targeting these advertisements must withstand First Amendment scrutiny. The FDA’s recent attempts to modify its requirements for broadcast advertisements do not overcome these challenges. It is in the best interest of patients, doctors, the drug industry, and the government for Congress to authorize the FDA to regulate broadcast drug advertisements as limited calls to action, consisting of restricted product …
The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski
The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski
Faculty Scholarship
No abstract provided.
Swimming Upstream: The Need To Resolve Inconsistency In The Fda's Fishy Regulatory Scheme, Kelsie Kelly
Swimming Upstream: The Need To Resolve Inconsistency In The Fda's Fishy Regulatory Scheme, Kelsie Kelly
Journal of Law and Policy
The citizens of the United States rely on the federal government to maintain the safety of their food through effective regulation. As the technology used to develop food has advanced, the outermost limits of the current regulatory framework are being tested. The result has been a circuitous and ineffective attempt to regulate transgenic organisms, intended for human consumption, using multiple agencies and a patchwork of laws. The ability to incorporate DNA from nearly any organism into the genome of another provides immense potential for innovative new food products, but may also allow for unintended health and environmental consequences. Proper regulation …
Passing The Baton: The Effect Of The International Olympic Committee's Weak Anti-Doping Laws In Dealing With The 2016 Russian Olympic Team, Saroja Cuffey
Brooklyn Journal of International Law
Following the investigation of a Russian state-sponsored doping ploy prior to the Olympic Games in Rio 2016; the International Olympic Committee (IOC) decided against a blanket ban of the Russian Olympic team. Instead; it allowed athletes’ individual international federations to decide whether Russian athletes could compete. In following the various anti-doping laws in place; the IOC sought to protect and give justice to clean athletes around the world. This Note argues that they did not achieve this result; due to the anti-doping laws in place and the actors applying these laws. It suggests that there should be a universal anti-doping …
The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg
The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg
Brooklyn Law Review
The FDA has recently passed sweeping regulations, which classifies and then regulates electronic cigarettes as “tobacco products” in the same manner as traditional cigarettes. Though the agency reasons that unknowing adults and children may easily turn to e-cigarettes without fully understanding the potential health effects, there is a lack of conclusive evidence in this field to justify such a comprehensive regulatory scheme. Through the far-reaching “Deeming Rule,” e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market. The channels by which the FDA proposes manufacturers and retailers gain permission from …