Food and Drug Law Commons^™

Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath

Washington Law Review

Where regulatory systems overlap, courts and scholars often focus on the undesirable aspects of the overlap—the ways in which systems conflict. One such context involves the regulation of prescription drugs and medical devices by the FDA’s premarket evaluation processes and by state common-law tort and products liability actions. FDA regulation and state common law are often described as separate, conflicting regulatory systems. This Article challenges that description by proposing a model in which FDA premarket evaluation and state common law function as a single regulatory system. This model brings order to the Supreme Court’s seemingly inconsistent medical products preemption cases, …

Journal Of Food Law & Policy - Fall 2019, Journal Editors

Journal of Food Law & Policy

No abstract provided.

School Of Law Faculty And Professional Staff, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Science And Risk Analysis In Cptpp/Sps-Plus: Role Model Or Unbearable Burden?, Kuei-Jung Ni

Journal of Food Law & Policy

Trade in food and agricultural products accounts for a major part of global trade, and the trade continues to alert domestic consumers to the risks associated with modern food processing and production methods. The Trans-Pacific Partnership Agreement (TPP), now rebranded as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), represents a new model of mega-regional trade pacts posed to set higher standards for promoting and streamlining trade liberalization. Because of concerns with national food safety regulations that could constitute forms of non-tariff barriers, the CPTPP, in contrast to the World Trade Organization (WTO), stipulates further rules on parties’ sanitary …

The Marketing Of Self-Care And Alternative Therapies In The U.S. In 2019: How Industry Stakeholders Appeal To Consumers’ Perceptions Of Novel Food Products And Additives, Melanie Marie Glover

Journal of Food Law & Policy

This article examines the current marketing techniques of food products and additives in the growing self-care industry in print and digital formats. It assesses how well consumers understand such advertising tactics, and what the industry and federal government agencies are doing (or not doing) to help consumers be mindful and savvy about their purchase choices. The discussion further showcases hot-topic food products and additives including CBD, Kratom, and plant-based meat as examples of both regulatory risk and opportunity. Lastly, the article advocates a collaborative effort among federal government agencies (FDA, FTC, USDA, etc.), industry stakeholders, and the public to help …

Going Hemp Wild: Understanding The Challenges And Opportunities For Fda Regulation Of Cbd In Food Products, Hannah Catt

Journal of Food Law & Policy

After the passage of the 2018 Farm Bill, champions of hemp began to tout opportunities for farmers and businesses involved with the crop. The industry has rallied around one of hemp’s major byproducts, cannabidiol, or CBD. However, the demand for CBD has left the Food and Drug Administration (“FDA”) playing catch-up. This article explains what CBD is, how it is derived, current FDA-approved uses, and a current path forward for the FDA in creating guidance for industry and consumers.

Agricultural Exceptionalism And Industrial Animal Food Production: Exploring The Human Rights Nexus, Charlotte E. Blattner, Odile Ammann

Journal of Food Law & Policy

The host of negative effects of animal agriculture on the immediate environment, workers, and local communities are well-documented, yet little is known about the global repercussions of animal agriculture, especially on human rights guarantees. This contribution attempts to begin filling this soaring gap. It examines the nexus between industrial animal agriculture (with a focus on concentrated animal feeding operations (CAFOs)) on the one hand, and specific international human rights violations on the other hand. Our emphasis is on the role of government in producing these violations, rather than on the agribusiness itself. Laws originally designed to govern small family farms—so-called …

Time For Change: Stepping Up The Fda's Regulation Of Dietary Supplements To Promote Consumer Safety And Awareness, George Kennett

Journal of Law and Health

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. …

Addiction-Informed Immigration Reform, Rebecca Sharpless

Articles

Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …

Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs

Journal of the National Association of Administrative Law Judiciary

The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …

Even Marijuana Needs A Zone: Utah’S H.B. 3001 As The Next Battleground For Zoning Ordinances And State Medical Marijuana Laws, Kyle A. Harvey

Brigham Young University Journal of Public Law

No abstract provided.

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Has The "M" Word Been Framed? Marijuana, Cannabis And Public Opinion, Robert A. Mikos, Cindy D. Kam

Vanderbilt Law School Faculty Publications

Over the past two decades, a growing cadre of US states has legalized the drug commonly known as “marijuana.” But even as more states legalize the drug, proponents of reform have begun to shun the term “marijuana” in favor of the term “cannabis.” Arguing that the “M” word has been tainted and may thus dampen public support for legalization, policy advocates have championed “cannabis” as an alternative and more neutral name for the drug. Importantly, however, no one has tested whether calling the drug “cannabis” as opposed to “marijuana” actually has any effect on public opinion. Using an original survey …

Marijuana’S Continuing Illegality And Investors’ Securities Fraud Problem: The Doctrines Of Unclean Hands And In Pari Delicto, Casey W. Baker

The Journal of Business, Entrepreneurship & the Law

Marijuana-related businesses have blossomed into an industry with an estimated total market value of $7.2 billion in 2016, with annual growth projected at 17%. Industry surveys report that 62% of marijuana-related businesses have offered equity stakes to investors and approximately one-half of marijuana-related businesses planned to actively seek investment funding in 2017. Along with the investment opportunity comes heightened fraud risk, with regulators cautioning investors against investment due to the lack of accurate and publicly-available information. Also, despite state-level decriminalization, marijuana possession, sale, and distribution continues to be a crime under federal law. The criminal nature of the marijuana industry …

Ensuring Economic Viability And Sustainability Of Coffee Production, Jeffrey D. Sachs, Kaitlin Y. Cordes, James Rising, Perrine Toledano, Nicolas Maennling

Columbia Center on Sustainable Investment Staff Publications

Coffee, the world’s favorite beverage, provides livelihoods for at least 60 million people across dozens of countries. Yet this beloved drink is experiencing a sustainability crisis. A sustained decline in world coffee prices has squeezed coffee producers, and thrown a tremendous number of producers below the global extreme poverty line. This report presents our research into sustainability within the coffee sector, including the results of our analytical and empirical modeling, and provides several recommendations.

The Future Of Dairy Cooperatives In The Modern Marketplace: Redeveloping The Capper-Volstead Act, Sarah K. Phillips

Dickinson Law Review (2017-Present)

Agriculture plays a fundamental role in the U.S. economy as a multibillion-dollar industry that feeds people all over the world. However, over the past decade, the dairy industry in particular has changed from a reliable sector of the greater agricultural industry into an unsettled, politically-charged, and fractured group. Dairy farmers’ consistently receiving low milk prices has facilitated this divide. Tired of being ignored and underpaid, dairy farmers are demanding change in the current dairy market structure.

Federal Milk Marketing Orders and a variety of statutes regulate the dairy industry, but the 1922 Capper-Volstead Act remains the most notable piece of …

When "Things" Go Wrong: Redefining Liability For The Internet Of Medical Things, Bethany A. Corbin

South Carolina Law Review

No abstract provided.

The "Natural" Response To Adjudicating Current Litigation When The Creation Of A Related Agency Rule Is Simultaneously Underway, Lauren Kostman

Cardozo Law Review

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

Forbidden Flower: How Allowing Medical Cannabis Flower In West Virginia Helps Heal Patients And The State Economy, Jordan Maddy

West Virginia Law Review

No abstract provided.

Committed To Treatment?: The Potential Role Of Involuntary Hospitalization In West Virginia’S Response To The Opioid Epidemic, Quentin T. Collie

West Virginia Law Review

No abstract provided.

Federal Regulatory Responses To The Prescription Opioid Crisis: Too Little, Too Late?, Lars Noah

Utah Law Review

Part I of this Article suggests that the medical establishment shares more blame for the crisis than many commentators seem to appreciate. Part II canvasses a variety of ways in which the federal government has responded to the opioid problem during the last few years before delving more deeply into the FDA’s role in the mess, assessing the different tools that it has tried to use as well as some that it failed to employ. This Article concludes that the agency should have allowed only a narrowly defined subset of physicians to prescribe opioid analgesics, even though the medical community …

Seeking Insurance Parity During The Opioid Epidemic, Valarie K. Blake

Utah Law Review

Private insurance covers almost 40 percent of people with opioid addiction. Yet, amid an epidemic with profound consequences for individual and public health, private insurers continue to fuel addiction by favoring addictive but affordable pain therapies over nonaddictive ones and by placing unreasonable, sometimes unlawful, hurdles and delays in the ways of addiction treatment. Action must be taken now to address these harms. Laws like the ACA and the MHPAEA need greater enforcement, while gaps in these laws can and should be addressed through broader federal and state initiatives. Private insurers must be regulated, and swiftly, to ensure that people …

From Health Policy To Stigma And Back Again: The Feedback Loop Perpetuating The Opioids Crisis, Nicolas Terry

Utah Law Review

Between 1999 and 2017, almost 400,000 people died from opioid overdoses, and since 2001, the opioid crisis has cost the U.S. more than 1 trillion dollars. In late 2018, the Department of Health and Human Services (HHS) Secretary opined that the country was “beginning to turn the tide” in responding to the crisis. Secretary Azar’s positive statements were based on preliminary CDC data that showed a national decline of 2.7 percent in drug overdose deaths from October 2017 to May 2018. However, data still show over half the states posting an increase in overdose deaths with a concentration of higher …

America’S Favorite Antidote: Drug-Induced Homicide In The Age Of The Overdose Crisis, Leo Beletsky

Utah Law Review

Nearing the end of its second decade, the overdose crisis in the United States continues to claim tens of thousands of lives. Despite the rhetorical emphasis on a “public health” approach, criminal law and its enforcement continue to play a central role among policy responses to this crisis. A legacy of the 1980s War on Drugs, statutory provisions that implicate drug distributors in overdose fatalities are on the books in many U.S. jurisdictions and federally. This Article articulates an interdisciplinary critique of these “drug-induced homicide” laws at a time of their increased popularity, expanding scope, and aggressive prosecution. That these …

Responsible Precautions For Uncertain Environmental Risks, W. Kip Viscusi, Joel Huber, Jason Bell

Vanderbilt Law School Faculty Publications

Uncertain future risks pose cognitive and analytical challenges to household decision makers. Risks with uncertain probabilities, coupled with potentially severe outcomes pose problems for decision-making and are prone to overreactions. Imprecision in risk estimates generates behavioral distortions such as ambiguity aversion. This article presents new empirical results indicating household overvaluations of uncertain threats posed by several drinking water risks: traces of prescription drugs in drinking water, plastic water bottles with bisphenol-A, and the weed killer atrazine in drinking water. Negative reactions reflect responses to ambiguous risks, but policies driven by these concerns may misallocate regulatory resources due to risk conservatism …

Marijuana Issues For Voters: Studying Issues Us States Have Had With Legalizing Marijuana, Kody Kesler

WRIT: Journal of First-Year Writing

In the United States, the legalization of medical and recreational marijuana in individual states, rather than the whole nation, is a great example of states being “laboratories of democracy.” Legalizing marijuana in the states first is essential to deciding how to go about the issue on the national level, once Americans are ready for it. In most states where it is legal, employees can still be fired for having marijuana in their system, even if they have a medical recommendation. The drug tests that employers use don’t test for the recent use of drugs like marijuana, but for a part …

Response To 'Reverse Al Capone-Ism' And The Tax Treatment Of Marijuana Businesses, Douglas A. Kahn, Howard J. Bromberg

Other Publications

Mr. Silverberg’s comment stresses that the proponents of the legalization of marijuana have not been able to convince Congress to legalize it, and so it is appropriate for Congress to penalize trafficking in that drug. Apparently, he sees our contention that the penalty adopted in I.R.C. § 280E is irrational and contravenes established punitive jurisprudence as a backdoor attempt to accomplish indirectly, by weakening the penalties on the marijuana businesses, what has not been able to be accomplished by those seeking its federal legalization. That was not the motive for our proposal and is not a fair reading of our …

Response To Dude, Where's My Deduction?, Douglas A. Kahn, Howard J. Bromberg

Other Publications

Mr. Pullin’s thesis is that marijuana should be excluded from § 280E when it is operated legally under state law. However, his preferred solution is that the federal government remove marijuana from Schedules I and II of the Controlled Substances Act of 1970 (CSA), thereby legalizing it for federal law purposes. Either action would exclude the marijuana business from § 280E.