Food and Drug Law Commons^™

Mobile Methadone Clinics: A Necessary Step In Fighting The Opioid Epidemic, Laurel E. Via

University of Richmond Law Review

Part I of this Article will discuss the rise in opioid use disorder, the need for effective treatment, and the utility of methadone maintenance treatment options, as well as the history of the ban on mobile clinics. Part II will discuss the NPRM issued by the DEA on February 26, 2020, and explain the likely impact of the rule. Part III will provide an overview of the NPRM in its current form, explain its likely impact as written and show that mobile clinics are effective treatment options, and then argue that while a great start, the NPRM should be amended …

Brewing Green Beer: Building A Regulatory Scheme Robust To Changes In Brewing Technologies, Daniel Pashang Withers

Texas A&M Law Review

New beer brewing technologies provide brewers with options to produce beer in more eco-friendly, less resource-intensive ways; however, as brewers adopt these technologies, they may find themselves straddling between the regulatory schemes of the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) and the Food and Drug Administration (“FDA”). The two agencies have divided control over beers based on their ingredients, which places some beers under the TTB’s purview as “malted beverages” and others under the FDA’s purview. These distinctions have implications for the regulatory hurdles that brewers must overcome to market their products. Additional regulations that eco-friendly, green beers …

Cle Working Paper No. 3/2021--A Roof Over Our Stomachs: The Right To Housing In Canada And Its Implications For The Right To Food, Tasha Stansbury

Centre for Law and the Environment

In 2019, the Canadian government passed the National Housing Strategy Act, legislating for the first time a human right to housing in Canada. This was largely the result of pressure from housing advocates to align Canada’s legislation with the right to housing embedded in international human rights instruments. Despite similar efforts, food rights advocates have not had the same success in having the right to food recognized in Canadian law. This paper considers the question of whether, and how, food rights advocates can use the process of achieving a legislated right to housing as a model in pursuing the legislation …

Hitting The Trip Wire: When Does A Company Become A "Marijuana Business"?, Lauren A. Newell

Law Faculty Scholarship

Like the alcohol industry was during Prohibition, the marijuana industry is a profitable one. And, as bootlegging was then, selling marijuana in the United States is currently illegal. Despite the number of states that have legalized or decriminalized the sale of marijuana for medical or recreational use under state law, marijuana sales remain illegal as a matter of federal law under the federal Controlled Substances Act of 1970 (“CSA”). Individuals and entities that violate the CSA face substantial criminal and civil liability, including prison time and fines, alongside a host of additional negative consequences arising from business, tax, bankruptcy, and …

Food And Drug Regulation: A Statutory Approach, Adam I. Muchmore

Books

This is the first chapter of a new casebook on food and drug regulation. This book presents food and drug regulation as a statutory subject. It is organized around the structure of the Federal Food, Drug, and Cosmetic Act, and emphasizes guided reading of statutes, regulations, and federal register documents. Cases are presented primarily when they involve major issues of statutory interpretation, are historically significant, or are in one of the areas where case law plays a major role.

The book is designed to work with a Statutory and Regulatory Supplement provided as a PDF. The statutes and regulations in …

Food And Drug Regulation: Statutory And Regulatory Supplement, Adam I. Muchmore

Books

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.

Pediatric Off-Label Use Of Covid-19 Vaccines: Ethical And Legal Considerations, Elizabeth Lanphier, Shannon Fyfe

Scholarly Articles

After briefly contextualizing ethical and legal precedents regarding off-label use, we offer an analysis of the ethical permissibility of and considerations for pediatric off-label Covid-19 vaccination based on individual benefits, risks, and available alternatives. Our analysis challenges the ethics of the blanket prohibition against off-label pediatric Covid-19 vaccination in the VPA, as it blocks clinicians from providing the care they may determine to be clinically and ethically appropriate for their patient. At the same time, our analysis acknowledges that Covid-19 creates population-level ethical considerations that are at times in tension with individual health interests.

Supply And Demand: Navigating Emergency Regulatory Developments In The Fight Against Opioid Use Disorder, Eva Bogdewic

Upper Level Writing Requirement Research Papers

No abstract provided.

Off-Label Use In The Twenty-First Century: Most Myths And Misconceptions Mitigated, 54 Uic J. Marshall L. Rev. 1 (2021), James Beck

UIC Law Review

No abstract provided.

The Tobacco Control Act’S Pmta And Mrtp Provisions Mean To Protect The Usa From Any New Tobacco Products That Will Not Reduce Health Harms—But Fda Isn’T Cooperating, Eric N. Lindblom

Journal of Health Care Law and Policy

No abstract provided.

Social Justice As A Necessary Guide To Public Health Disaster Response, Stephen S. Hanson

Journal of Health Care Law and Policy

No abstract provided.

The Spirit Is Willing: A Proposal For American Single Malt Whiskey, Raymond Cleaveland

Seattle University Law Review

Over the past twenty-five years, small, independent American distilleries have carved out a new niche in the United States liquor market: craft single malt whiskey. Inspired by the success of single malt Scotch and other single malts, American craft distillers are now fighting for their own shelf behind the bar and in the liquor store aisle. In 2018, a cadre of these distillers petitioned the U.S. Treasury Department’s Alcohol and Tobacco Tax and Trade Bureau to formally recognize a new category of whiskey in the Code of Federal Regulations: American Single Malt Whiskey. For purposes of consumer protection, the Treasury …

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 …

American Edibles: How Cannabis Regulatory Policy Rehashes Prohibitionist Fears And What To Do About It, Connor Burns, Jay Wexler

Seattle University Law Review

Why can’t we buy a cannabis muffin with our morning coffee? For much of the past century, the answer was simple: cannabis was illegal. Now, however, with more and more states legalizing cannabis for adult use, the answer is far less clear. Even in those states that have legalized cannabis, the simple action of buying and eating edibles at the same location has somehow remained a pipe dream despite consumer demand. Digging a little deeper, we can see how contemporary alarmism—by rehashing the same prohibitionist rhetoric demonizing cannabis for over eighty years—has once again arisen with a new target: cannabis-infused …

Food Justice For All: Tailoring Urban Agriculture Law To Aid Disadvantaged Communities, Seth Stevens

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Kentucky’S Hunger Crisis: A Preventable & Overlooked Tragedy, Ryan Quarles

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Hemp's Arbitrary 0.3% Thc Legal Standard And The Consequences Of Applying Such Standard, Michelle Bodian, Shawn Hauser

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Impossibility Defence: Supreme Court Case Summary: Han Fang Guan V Public Prosecutor, Kwang Chian Lee

Singapore Law Journal (Lexicon)

In Han Fang Guan v Public Prosecutor [2020] SGCA 11, the Court of Appeal (“CA”) clarified the law regarding “impossible attempts”, which are attempts to commit an offence that could not possibly have been consummated in the circumstances. The accused Han Fang Guan (“Han”) was charged with the capital charge of attempting to possess one bundle containing not less than 18.62g of diamorphine (also known as heroin) for the purpose of drug trafficking, an offence under section 5(1)(a) read with section 5(2) and section 12 of the Misuse of Drugs Act (Cap 185, 2008 Rev Ed) (“MDA”).

Ignoring Drug Trademarks, Erika Lietzan

Faculty Publications

If you walk into a pharmacy with a prescription for Merck’s ZOCOR, which contains simvastatin, the pharmacist will probably give you a product containing simvastatin made by another company. The pharmacist will dispense a “generic” simvastatin product. State generic substitution laws, passed in the 1970s to help the government save money by switching patients to cheaper generic drugs, either permit or require this substitution. But drug brand names -- such as ZOCOR -- are trademarks. Like other trademarks, they distinguish goods in the market from others, and they signal the source of the goods. These state laws essentially treat the …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …