Food and Drug Law Commons^™

Venturing Into Health, Rachel E. Sachs

Fordham Law Review

In recent years, the landscape of venture capital (VC) investment in healthcare technologies has been altered by the introduction of new types of VC firms: those that have emerged from hospital systems and health insurers. However, the legal literature has not yet analyzed these new VC firms, the role they may play in healthcare innovation, and how innovation law and policy ought to consider their involvement. Hospital system and health insurer VC firms operate very differently than traditional VC firms, even those that have historically developed healthcare specializations. Instead of simply investing capital into start-up firms, hospital system and health …

Rethinking Aquaculture Regulation In A Post-Chevron World, Kamaile A. N. Turčan

Fordham Environmental Law Review

After the Supreme Court overruled Chevron deference in Loper Bright v. Raimondo, commentators warned of the detriment to federal agencies resulting from the loss of judicial deference to agencies’ interpretations of the statutes they administer. This Essay takes a different approach and examines how advocates for agency authority can use this shift away from judicial deference to their advantage—by refocusing litigation strategy toward congressional delegations. Statutory interpretation arguments need no longer focus on whether an agency is intruding on the judicial prerogative to interpret the law and can now focus instead on whether a court is intruding on the …

Abortion Travel Restrictions Under The Dormant Commerce Clause After National Pork Producers Council V. Ross, Katherine Bartley

Fordham Law Review

Since Dobbs v. Jackson Women’s Health Organization, twelve states have banned abortion entirely, and seven states have banned abortion earlier in pregnancy than the standard set in Roe v. Wade. As abortion access dwindles, patients increasingly cross state lines to seek reproductive healthcare. In response, antiabortion state officials and lawmakers have made efforts to restrict interstate travel for abortion care.

This Note examines abortion travel restrictions under the “Dormant” Commerce Clause doctrine, which limits state laws that burden interstate commerce. In 2023, the U.S. Supreme Court affirmed but narrowed the judge-made doctrine in National Pork Producers Council v. …

When Prenatal Care Becomes A Crime, Casey Hunter

Fordham Law Review

For decades, pregnant women have increasingly faced criminalization for their actions and conduct during pregnancy, with Alabama emerging as a focal point due to its aggressive use of section 26-15-3.2: Chemical Endangerment of Exposing a Child to an Environment in Which Controlled Substances Are Produced or Distributed. Originally intended to protect children from the dangers of methamphetamine labs, this law has been reinterpreted to prosecute pregnant women who test positive for controlled substances. Central to these prosecutions are positive drug tests obtained from prenatal health records, causing many women to avoid prenatal care for fear of legal consequences.

This Note …

Beyond Agency Authority: Regulating Sulfur Hexafluoride Under An Enhanced Title Ii Framework Of The Clean Air Act, Matthew Gawley

Fordham Environmental Law Review

This paper explores the critical need for robust Congressional action to regulate sulfur hexafluoride (SF6), a greenhouse gas with a global warming potential more than 20,000 times greater than carbon dioxide. Recent Supreme Court decisions––in West Virginia v. EPA and Loper Bright Enterprises v. Raimondo––to restrict EPA authority and end the Chevron doctrine have curtailed federal environmental agencies’ regulatory authority, shifting the responsibility for addressing major environmental challenges back to Congress. Despite being addressed under Title I of the Clean Air Act (CAA) through the 2022 Inflation Reduction Act (IRA), current SF6 regulations prove grossly inadequate. The utilities industry––the largest …

Article Iii Standing For Cercla Private Cost Recovery Actions: How The Test's Strained Logic Belies Its Authority, Jonathan M. Palacios

Fordham Environmental Law Review

This Note examines how Article III standing doctrine applies to

private plaintiffs’ cost recovery actions under § 107(a)(4)(B) of the

Comprehensive Environmental Response, Compensation, and

Liability Act. A review of judicial decisions reveals inconsistencies

in the analysis of injury in fact and traceability, and suggests that

current Article III standing doctrine is misaligned with its purported

objectives. In response, this Note proposes a structured framework

for assessing injury in fact and a refined approach to analyzing

traceability that distinguishes between different forms of causal

uncertainty. These doctrinal adjustments should better align case

outcomes with Article III standing doctrine’s constitutional and …

Crypto & The Climate: Will Local & National Environmental Regulation Save Or Stifle The Cryptocurrency Boom?

Fordham Environmental Law Review

As cryptocurrencies continue to gain traction among mainstream investors and consumers, regulators and lobbyists are increasingly taking note of the potential environmental impacts of the industry. At its core, the process of mining new currency for virtual wallets is energy intensive, which can place strains on electrical grids and accelerate the impacts of climate change. However, these effects are felt very differently depending on what source of electricity the mining operation utilizes and the methodology behind the specific currency. These variable factors are on the minds of legislators and regulators as public pressure to better understand and regulate the industry …

A Shifting Focus: How Algal Turf Scrubbers (Ats) In Natural Waterways Can Prevent Toxic Blooms And Could Save The Algae Energy Industry

Fordham Environmental Law Review

Biofuels have generated global interest among oil companies and governments. In particular, algal biofuels are slated to be more promising than traditional biofuel feedstocks, like corn and sugarcane, which are simultaneously cultivated as food products. However, the drawbacks of harvesting algae on a large industrial scale has led to intense criticism. Most critics focus on issues of sustainability, scalability of production, and the legal and ethical concerns of genetically modified crops. New research in cyanobacteria, however, illustrates algae’s potential to produce clean electricity in addition to oil, ethanol, and gasoline. Moreover, using Algal Turf Scrubbers (“ATS”) in natural waterways offers …

Why We Need A Constitutional Right To Healthy Environment In Canada

Fordham Environmental Law Review

The increasing demand for constitutional recognition of the right to a healthy environment (‘RTHE’) has been a matter of public concern and debate in many countries, including Canada.2 This paper asks, will a constitutional RTHE within the Canadian Constitution add any value when statutes already exist to protect the environment (and thereby health)? The present environmental statutes work towards protecting the environment, and by protecting the environment, public health can be protected.3 Together, both of them form a ‘healthy environment’, ie., an environment that fosters a healthy life.4 This paper will argue that there is additional value in recognizing a …

Bridging The False Certification Gap: Why “Resulting From” In The 2010 Aks Amendment Requires But-For Causation, Alexandra Wildman

Fordham Law Review

Before 2010, violators of the Anti-Kickback Statute (AKS) could avoid False Claims Act (FCA) liability if claims for items or services borne of their kickback scheme were submitted to federal healthcare programs by a third party. In 2010, as part of the Affordable Care Act (ACA), Congress attempted to close this loophole in the FCA by amending the AKS. Under the amendment’s terms, claims submitted to federal healthcare programs for items or services “resulting from” an AKS scheme are false for the purposes of establishing FCA liability, regardless of who submitted the claims.

Although the amendment widened the FCA liability …

Regulatory Takings In Climate Change: Geo- Engineering One’S Way Around The Fifth Amendment, Noah Chase

Fordham Environmental Law Review

Picture yourself as the owner of a small business located in the downtown area of a large city; your business consists of a shop and an adjoining parking lot. A new regulation has just been passed which requires any owner of property within the city limits to paint all roofs and parking areas with a new reflective coating, in order to reduce the heat which is absorbed by such structures. The idea of closing your business down for this time, along with other connected issues, scares you, and you begin to wonder if your local government truly has your best …

Arizona V. Navajo Nation And Systemic Failures In The Tribal Water Allocation Scheme, Jennifer Horkovich

Fordham Environmental Law Review

When the United States Supreme Court’s decision in Arizona v. Navajo Nation was published in June 2023, Indian Country was hardly surprised with the Court’s ruling. There, the Court found that the United States had no affirmative duty to affirmatively protect the Navajo Nation’s water rights under the 1868 Treaty.1 The Court was clear: the treaty is insufficient for the Navajo’s current water needs, but the judiciary is unable to step in to find relief.2 This decision is another in a long series of cases on water allocation and the federal reserved water right, where tribes have been unable to …

Environmental Protection, Sustainability And The Prevention Of Satellite Collisions In Outer Space, Yun Zhao

Fordham Environmental Law Review

With space commercialization and privatization continuing apace, more space objects are expected to be launched and put into operation in the future, adding to the already large number of defunct satellites and space debris present in outer space. Hence, serious study should be devoted to possible mechanisms for dealing with potential collisions in outer space for the purpose of realizing environmental protection and space sustainability. In view of the inadequacy of the existing legal regime, this article explores possible such mechanisms (including a preventive mechanism, avoidance mechanism and compensation mechanism) from the perspective of interdependence theory and puts forward a …

Offshore Wind: A Comparative Of The United States And Norway

Fordham Environmental Law Review

No abstract provided.

Assessing The Human Right To Water And Sanitation In International Law And The Conflict In The Nile Basin

Fordham Environmental Law Review

Ethiopia’s construction and operation of the Grand Ethiopian

Renaissance Dam (GERD) on the Blue Nile has intensified the long-

standing water conflict involving Ethiopia, Egypt, and Sudan, and

highlights the urgent need for a new legal framework for the Nile

Basin’s governance. This article traces the history of the international

human right to water and sanitation and previous attempts to govern

water use in the Nile Basin. We argue that outdated colonial-era

treaties, which Egypt and Sudan insist on using as a baseline for

negotiations, are a significant obstacle to resolving the Nile conflict

and managing the region’s water resources …

Debts And Desertion: Bankruptcy Law And The Orphan Well Crisis

Fordham Environmental Law Review

The issue of orphan wells—unplugged and unproductive oil and

gas wells with no responsible operator—poses a significant

environmental and public health threat in the United States. The scale

of this crisis is alarming: there are over 120,000 documented orphan

wells and potentially millions more undocumented. These wells are

often significant sources of methane emissions and other toxins that

exacerbate climate change and endanger the health of surrounding

communities. This paper examines the orphan well crisis, exploring

how wells become orphaned and the environmental and health

impacts associated with them. Furthermore, it delves into how the

situation is likely to worsen …

Time To Abolish The Dea: Evaluating The Agency’S Failures And Calling For Community Investments, Ifetayo Harvey

Fordham Law Review

No abstract provided.

Expecting Medication Surveillance, Jennifer D. Oliva

Fordham Law Review

In response to federal financial incentives and mandates, all fifty states, the District of Columbia, and three U.S. territories administer electronic prescription drug monitoring programs (PDMPs). Federal and state policymakers justified the implementation and enhancement of ubiquitous prescription drug monitoring by contending that expansive state drug surveillance was a necessary weapon in the war against the American drug overdose crisis. As is often the case with tools designed for law enforcement surveillance, however, PDMPs have proven susceptible to mission creep. Although pioneer PDMPs were paper-based systems that limited their surveillance to a narrow class of heavily regulated controlled substances, modern …

State Drug Laws, Mason Marks

Fordham Law Review

States have long enacted drug laws that depart from federal laws and regulations. In the early twentieth century, several states prohibited marijuana while it remained federally unregulated. In the 1960s, states started criminalizing psychedelic substances. Shortly thereafter, in the early 1970s, they started reversing the trend to criminalize drugs by reducing or eliminating criminal penalties associated with personal marijuana use. State-level decriminalization accelerated in the 1990s and 2000s.

More recently, states have extended drug policy reforms to other substances, including psychedelics, stimulants, and opioids. Some states have eliminated criminal penalties while others have replaced criminal penalties with fines or diversion …

Tele-Induction Of Buprenorphine For Opioid Use Disorder: Regulatory Flux And Public Confusion, Stacey A. Tovino

Fordham Law Review

No abstract provided.

Towards Critical Environmental Justice Approach In Multicultural Divided States: Lessons From The Israeli Regulative System, Manal Totry-Jubran

Fordham Environmental Law Review

This article draws upon the evolving framework of the Critical Environmental Approach in examining the conceptualization and manifestation of the Environmental Justice approach and its pillars within the regulatory system of multicultural and divided societies. These are states comprised of marginalized ethnic and minority groups that frequently face instances of social and environmental injustice. Employing this perspective through a case study show that gradual and anecdotic but unorganized and incoherent incorporation of Environmental Justice pillars lacks the capacity to effectively address long-standing historical environmental injustices and fails to challenge the prevailing social framework. In fact, it runs the risk of …

Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu

Fordham Law Review

The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be …

The Tin Man Needs A Heart: A Proposed Framework For The Regulation Of Bioprinted Organs, Linda Foit

Fordham Law Review

Each day, seventeen people die in the United States while waiting for an organ transplant. At least part of this need could be met by bioprinting, a technology that allows the on-demand production of custom-sized organs from a patient’s own cells. The field of bioprinting is progressing rapidly: the first bioprinted organs have already entered the clinic. Yet, developers of bioprinted organs face significant uncertainty as to how their potentially lifesaving products will be regulated—and by which government agency. Such regulatory uncertainty has the potential to decrease investment and stifle innovation in this promising technological field. This Note examines how …

Climate Change, Competition & Conflict Along The River Nile: The Great Ethiopian Renaissance Dam & Shifting Customary International Water Law, Salma Shitia

Fordham Environmental Law Review

Decade-long negotiations between the Arab Republic of Egypt and the Federal Democratic Republic of Ethiopia surround the decision to build the hydroelectric power plant along the River Nile. For much of Ethiopia, the Grand Ethiopian Renaissance Dam represents a beacon of prosperity. For countless Egyptians, the structure embodies a potential catastrophe. Grounded in threats of displacement for Egyptian agricultural communities, some have compared the Grand Ethiopian Renaissance Dam crisis to disasters culminating in mass migration.

This battle for natural resource access has intensified as climate change exacerbates the region’s dire conditions. Specifically, exhaustible resource allocation amid climate change indicates that …

A Paper Tiger? Prosecutorial Regulators In China’S Civil Environmental Public Interest Litigations, Chunyan Ding, Huina Xiao

Fordham Environmental Law Review

In July 2015, China’s national legislature brought in prosecutor-led civil environmental public interest litigation (“EPIL”) for thirteen selected provincial areas of the country. After a two-year legal experiment, this prosecutor-led civil EPIL system was then established nationwide in July 2017. Yet, can it be said that prosecutorial regulators in China are in fact a paper tiger? Drawing upon content analysis of the 655 prosecutor-led civil EPILs and in-depth interviews with twelve frontline prosecutors and judges, this article examines the dynamics of regulatory practice and the motivation of the Chinese prosecutorial organs to engage in environmental regulation through litigation. Based upon …

The Yoga Analogy: Scaling-Up The U.S.’S Renewable Energy Sector Mindfully With New Technologies, Evolving Standards, Public Buy-In, Data Sharing, And Innovation Clusters, Kimberly E. Diamond

Fordham Environmental Law Review

This paper focuses on innovative renewable energy devices, exploring how scientifically-based industry standards that continuously evolve with engineering design technology, the public’s buy-in and feeling of connectedness with groundbreaking devices, and innovation clusters that accelerate device development through data sharing and public-private partnerships can all help advance the U.S.’s domestic renewable energy industry.

Part I analyzes challenges inherent to scaling- up novel renewable energy technologies while simultaneously developing the industry standards regulating them. Part II uses the Block Island Wind Farm, an offshore wind demonstration project, and Pavegen’s globally-deployed arrays of piezoelectric smart flooring tiles as examples illustrating the importance …

Environmental Racism: Using Environmental Planning To Lift People Out Of Poverty, And Re-Shape The Effects Of Climate Change & Pollution In Communities Of Color,, William C.C. Kemp-Neal

Fordham Environmental Law Review

In the mid-1900s the United States began to see a rise in concern for environmental awareness issues. In the early days the movement focused on things like clean air, water and pollution but by the 1970s-1990s many prominent environmental awareness groups began to form focused on the idea that in order to avert climate change the principal goal needed to be to reduce global greenhouse gas emissions. In 1987 a report was released called Toxic Waste and Race, which outlined an intimate link between the placement of environmental hazardous waste sites in communities of color, and greater instances of polluted …

Beyond Equity: Shared Natural Resources And Human Rights, Criminal Law, And The Use Of Force, Eian Katz

Fordham Environmental Law Review

Transboundary resource disputes are often analyzed by reference to two nebulous and conflicting principles that have emerged in international environmental law: “equitable and reasonable utilization” and “no significant harm.” Frequently overlooked in this context is the potential value of other canons of international law—especially human rights law, criminal law, and the rules governing the use of force—in adding definition to the muddled contours of these foundational precepts. This Article therefore undertakes an assessment of sovereign rights and obligations regarding shared natural resources which arise from these other bodies of law. In doing so, it offers new lenses through which to …

Squaring The Cercla: Superfund And The Superfund Task Force, Manny Marcos

Fordham Environmental Law Review

The Superfund Task Force recently released its final report on the implementation of its recommendations for improving the Superfund program. The Task Force was given five goals for improving the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA’s”), implementation. These goals are to expedite cleanup and remediation, re-invigorate responsible party cleanup and reuse, encourage foreign investment, promote redevelopment and community revitalization, and engage with partners and stakeholders. While the Task Force’s recommendations have improved CERCLA’s implementation, many of CERCLA’s structural flaws remain intact. Specifically, CERCLA still has a severe shortage of funding, an unfair liability scheme, perverse incentives, …

Covid-19 Impacts: How A Global Pandemic Amid The Sunsets Of The Ptc And Itc Made The U.S. Wind And Solar Industries More Resilient, Kimberly E. Diamond

Fordham Environmental Law Review

A cataclysmic event is sometimes the necessary catalyst for companies within certain industries to re- examine, radically shift, and replace their standard practices with technologically-advanced alternatives. In the United States, the occurrence of the Coronavirus pandemic (“COVID-19”) during the sunsets of the Production Tax Credit (“PTC”) and the Investment Tax Credit (“ITC”) created a unique confluence of factors that produced a perfect storm tantamount to such a cataclysmic event for companies in the wind and solar industries, particularly developers. Over the years, the domestic utility-scale wind industry has come to rely heavily upon the PTC, while the domestic utility- scale …