Food and Drug Law Commons^™

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.

States Are Making Their Own Decisions Regarding Marijuana Should Be Illegal: How Should The Federal Government React?, Joseph Tutro

Tennessee Journal of Law and Policy

No abstract provided.

The Urgency Of Official Non-Halal Labels In Restaurants As A Consumer Protection In Indonesia, Yudha Pratama Putra, Nurwahidin Nurwahidin, Nur Fatwa

Journal Of Middle East and Islamic Studies

Information about non-halal labels is regulated by Law No. 33 of 2014 concerning Halal Product Guarantees. Article 93 states that products originating from prohibited materials must include non-halal details in the form of images, writing, or the name of the material with a different color in the composition of the material, for example red. In 2014, the Head of the Halal Registration and Certification Center at the BPJPH Ministry of Religion explained that his party would regulate the use of non-halal labels for non-halal products in the Minister of Religion regulations. However, until now, this plan has not been realized. …

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 …

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

All Faculty Scholarship

Energy drinks first rose to popularity in the 1980s. Red Bull energy drinks were the first of its kind, opening the door to a new consumer and regulatory landscape. Since Red Bull first launched, multiple companies have released countless new energy drink products. Some energy drinks, like Red Bull, contain less than 100 mg of caffeine per 8 oz can. However, other energy drinks contain much higher amounts of caffeine. A 12 oz can of Celsius contains 200 mg of caffeine, and up until recently, Celsius offered a product called Celsius Heat, a 12 oz can containing 300 mg of …

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 …

The False Promise Of Rescheduling, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Over the past fifty years, marijuana advocates invested considerable effort trying to reschedule the drug under the Controlled Substances Act (CSA). Multiple times, they pe- titioned the Drug Enforcement Administration (DEA) to take marijuana off the highly re- strictive Schedule I and move it to one of the statute's less tightly regulated Schedules (II- V) or even deschedule the drug altogether. Along the way, they waged protracted legal battles with the agency over the tests and processes it uses for scheduling decisions. How- ever, advocates had very little to show for all their efforts. The DEA rejected every petition to …

Law School News: Supporting Rhode Island's Aquaculture 9-23-2024, Andrew Clark, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

The Addiction Restriction: Addiction And The Right To Bear Arms, F. Lee Francis

West Virginia Law Review

This Article is the culmination of a yearlong research project, and it is the first to address addiction and drug use in the area of Second Amendment law. I argue that addicts may be disarmed, if they are dangerous. My dangerousness test centers on illicit use and imminent danger. That is, do the facts and circumstances prove that an individual is in fact a danger? To put it another way, disarmament is appropriate when there exists demonstrable evidence that a person poses a significant and imminent risk of causing public injury. This Article develops and expands upon some themes and …

Green Amendments And Ham: How Green Amendment Jurisprudence Can Inform Maine’S Right To Food, Sarah M. Everhart

Maine Law Review

Maine’s constitutional right to food is the first state constitutional right to food and the extent of the rights created by the amendment is largely unknown. The right to food, as enacted in Article I, Section 25 of the Maine Constitution, provides: Section 25. Right to food. All individuals have a natural, inherent and unalienable right to food, including the right to save and exchange seeds and the right to grow, raise, harvest, produce and consume the food of their own choosing for their own nourishment, sustenance, bodily health and well-being, as long as an individual does not commit trespassing, …

Constitutionalizing The Human Right To Food In Maine: A People’S Tool To Advance Food Sovereignty In The U.S., R. Denisse Cordova Montes, Heather Retberg, Photini Kamvisseli Suarez

Maine Law Review

On November 2, 2021, Maine voters overwhelmingly supported a statewide referendum approving an amendment to enshrine the right to food in Maine’s constitution. This vote was preceded by a decade of food sovereignty advocacy in Maine. This advocacy was led by small farmers and homesteaders and supported by people looking to opt out of the industrial food system, which is dominated by a few corporate monopolies and promotes charity-based solutions to hunger. This vote was a resounding proclamation by the people of Maine in support of the right to food, the right to save and exchange seeds, and the right …

Realizing The Right To Food In Maine: Insights From International Law, Smita Narula

Maine Law Review

In November 2021, Maine made history as the first U.S. state to constitutionally recognize the right to food. Maine’s right to food amendment—which sought to address widespread food insecurity and corporate control of the food supply—proclaims food as a “natural, inherent and unalienable right,” and empowers Mainers to grow and consume food of their own choosing, affirming their right to food sovereignty. This Article makes three key contributions to scholarly examinations of this historic amendment. First, it situates the amendment within the broader landscape of domestic and global struggles for the right to food and food sovereignty. Second, the Article …

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 …

Are Healthy Foods “White People Food”: A Legal Analysis Of Disparities In Healthy Food Accessibility And Affordability At Grocery Stores And Restaurants In Low-Income Neighborhoods, Sara St. Juste

University of Miami Race & Social Justice Law Review

No abstract provided.

A Drug's Life: The Untapped Potential Of Secondary Pharmacology Studies In Drug Development, Christina Scott

The University of New Hampshire Law Review

The United States Food and Drug Administration has evolved over the past century to regulate new medicine and protect the public from harmful or ineffective drugs. Drug development and testing science have advanced rapidly alongside the FDA’s increased regulation, enabling pharmaceutical companies to assess a drug's potential adverse reactions by studying its reactivity with various proteins called "off-target receptors." Off-target proteins are often screened and reported in the Investigational New Drug Application as a percentage indicating the drug's binding strength to each protein, which suggests the strength of a particular adverse drug effect. Adverse drug effects often lead to unfavorable …

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

Utah Law Review

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 …

Where's The Beef? The Fifth Circuit's Attempt To Clarify Plant-Based Food Labeling Laws In Turtle Island Foods S.P.C. V. Strain, Andrew J. Kash

Villanova Environmental Law Journal (1991 - )

No abstract provided.

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 …

Consumption Governance: The Role Of Production And Consumption In International Economic Law, Timothy Meyer

BYU Law Review

Over the last decade, international economic conflict has increased dramatically. To name only a few examples, the European Union banned the import of products from deforested land and is poised to impose duties on carbon-intensive imports; the United States banned Chinese imports made with forced labor; and countries the world over threatened to impose digital services taxes on U.S. corporations, leading to a new multilateral agreement on apportioning income tax revenue among countries.

This Article argues that these conflicts represent a shift in norms governing the authority to tax and regulate international commerce. Different fields within international economic law describe …

Draining Chicago’S Food Swamps: Legal Approaches, Sofia Fernandez

DePaul Journal of Health Care Law

Public health is a collective responsibility of society to improve the health and wellbeing of communities, focusing on preventing disease and promoting health as opposed to providing medical care for those already ill.1 The law consists of rules issued and enforced by government entities “through which populations organize their governments, regulate social and economic interactions, and guide behavior.”2 Public health law exists at the intersection of these two fields, comprising “the legal powers and duties of the state to identify, prevent, and ameliorate risks to the health of populations, as well as the study of legal structures that have a …

Empirically Assessing Medical Device Innovation, George Horvath

Minnesota Journal of Law, Science & Technology

No abstract provided.

On The Defensive: Analyzing Insurers' Duty To Defend Pharmaceutical Companies For Contributing To The Opioid Epidemic, Madison Perry

Vanderbilt Law Review

Opioids have had a devastating impact on the United States. They have drained governmental agencies’ resources, decreased property values, and destroyed families and entire communities. A growing number of individuals, local governments, and states have filed lawsuits, aiming to hold pharmaceutical companies accountable for their negligent contributions to the epidemic. Such manufacturers, distributors, and retailers have called upon their insurers, asserting that their commercial general liability policies demand an insurer- backed and bankrolled defense. Courts are divided in their interpretation of the language contained within the at-issue policies. Some consider the claims made by certain states and local governments to …

The Costs Of Convenience: A Case For Regulating Online Food Marketplaces In The Public Interest, Angela Lee

Journal of Food Law & Policy

As digital platforms have become more popular, including those relating to food ordering and delivery, the range of both their positive and negative impacts have become more apparent. In response, governments in various jurisdictions have made efforts at regulating such platforms, as part of their mandate of balancing complex and often competing goals in the public interest. Unfortunately, attempts at governing digital platforms to date have largely proven ineffective at checking the power of the large corporations that are behind their growth and expansion. I argue that a critical assessment of these new forms of online food marketplace further supports …

Misinformation In U.S. Food And Agriculture: A Policy Analysis Of Impacts And Recommended Solutions, Jamie Woodside

Journal of Food Law & Policy

This paper aims to review the current state of play of misinformation in the U.S. food and agriculture sectors—delving into the roots of misinformation, its propagation through social media and traditional channels, and its consequences for the agricultural sector and society at large. Additionally, through an examination of existing laws, regulations, and potential legal remedies, this paper aims to shed light on the challenges posed by misinformation and offers recommendations for mitigating its harmful effects.

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 …

The Dark Side Of The Balloon: Restrictions On Foreign Investment In U.S. Farmland, Sarah Everhart

Journal of Food Law & Policy

This Article argues that if legislators truly want to strengthen our food system, they should shift their focus from preventing foreign investment in farmland to supporting domestic investment in farmland. According to the National Young Farmer Survey, finding affordable land to buy is the top challenge for young farmers. This Article begins with examining the history of restricting foreign ownership of U.S. farmland. This Article also explores the current landscape of foreign investment in U.S. farmland and the perceived threat associated with this investment. The Article also examines the current renewed interest in preventing foreign landholding and what has happened …