Food and Drug Law Commons^™

Eating Is Not Political Action, Joshua Ulan Galperin, Graham Downey, D. Lee Miller

Elisabeth Haub School of Law Faculty Publications

Food and environment are cultural stalwarts. Picture the red barn and solitary farmer toiling over fruited plains; or purple mountains majesty reflected in pristine waters. Agriculture and environment are core, distinct, American mythologies that we know are more intertwined than our stories reveal.

To create policy at the interface of such centrally important and overlapping American ideals, there are two options. Passive governance fosters markets in which participants make individual choices that aggregate into inadvertent collective action. In contrast, assertive governance allows the public, mediated through elected officials, to enact intentional, goal oriented policy.

American mythologies of food and environment …

An Examination Of Trans Fat Labeling: Splitting The Third & Ninth Circuit, Jack Gainey

Washington and Lee Journal of Civil Rights and Social Justice

At first glance, consumer claims alleging misleading labeling would seem to find a simple resolution. Under 21 U.S.C. § 343, which governs misbranded food, a food product is misbranded if “its labeling is false or misleading.” However, controversial interpretation of seemingly straightforward statutory language, together with evolving case law, have blurred a once clear picture. Disagreement over the federal preemption of consumer claims regarding trans fat, underscored by a dispute regarding standing, have combined to create a divergence of opinions between courts across the country.

In 2011, the United States District Court for the Northern District of California considered a …

Crispr: Redefining Gmos—One Edit At A Time, Eric E. Williams

University of Arkansas at Little Rock Law Review

No abstract provided.

Agricultural And Food Law—Food Labeling And Biotechnology—The Food Fight Over Labeling Genetically Engineered Foods And A Natural Solution To Protect Agricultural Biotechnology In The Natural State, Katie W. Branscum

University of Arkansas at Little Rock Law Review

No abstract provided.

Indian Country Complexities And The Ambiguous State Of Marijuana Policy In The United States, Lauren Adornetto

Buffalo Law Review

No abstract provided.

Pay-For-Delay: How Brand-Name And Generic Pharmaceutical Drug Companies Collude And Cost Consumer Billions, Raymond J. Prince

South Carolina Law Review

No abstract provided.

Religion In The Time Of Measles: Prescriptions For Minimizing The Public Health Threats Associated With Religious Exemptions From Mandatory Vaccinations, Victor Diego Gonzalez

Cardozo Public Law, Policy & Ethics Journal

The note examines the legal and public health tensions surrounding childhood vaccination mandates, emphasizing the balance between individual rights and societal interests. It argues that while states have the authority to compel vaccinations under their police powers, the proliferation of nonmedical exemptions, particularly philosophical ones, undermines herd immunity and public health. The analysis advocates for stricter criteria for religious exemptions and educational measures to address vaccine hesitancy, while cautioning against eliminating religious exemptions entirely to avoid public backlash.

Up In Smoke? Unintended Consequences Of Retail Marijuana Laws For Partnerships, Lauren A. Newell

Cardozo Law Review

The article examines the legal challenges faced by partnerships in Colorado's retail marijuana industry due to the conflict between state and federal laws. While Colorado has legalized marijuana, federal law continues to classify it as illegal, creating uncertainty and risks for partnerships operating in this sector. The illegal purpose doctrine and preemption issues further complicate the legal landscape, threatening the validity and protections of such partnerships. The analysis highlights the need for legislative or judicial solutions to address these conflicts and provide clarity for businesses.

Beyond Zero-Sum Environmentalism, Jessica Owley, Shalanda Baker, Robin Kundis Craig, John Dernbach, Keith Hirokawa, Sarah Krakoff, Melissa Powers, Shannon Roesler,, Jonathan Rosenbloom, J. B. Ruhl, Jim Salzman, Inara Scott, David Takacs

Articles

Environmental law and environmental protection are often portrayed as requiring trade offs: "jobs versus environment," "markets versus regulation," "enforcement versus incentives." In the summer of 2016, members of the Environmental Law Collaborative gathered to consider how environmentalism and environmental regulation can advance beyond this framing to include new constituents and offer new pathways to tackle the many significant challenges ahead. Months later, the initial activities of the Trump Administration highlighted the use of zero-sum rhetoric, with the appointment of government officials and the issuance of executive orders that indeed seem to view environmental issues as in a zero-sum relationship with …

Tobacco Denormalization, Anti-Healthism, And Health Justice

Marquette Benefits and Social Welfare Law Review

None

Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Robin Jacob

Washington Journal of Law, Technology & Arts

The Future of Innovation in Medicine Conference (“Conference”) proceedings contained in this Symposium Issue are about the problem of incentivizing research into new uses for established medicines. Putting the problem into the wider context of financing pharma research generally gives an important perspective.

The Patent And Non-Patent Incentives For Research And Development Of New Uses Of Known Pharmaceuticals In Japan, Toshiko Takenaka

Washington Journal of Law, Technology & Arts

Japan is one of most innovative drug manufacturer-friendly countries because it revised its patent and drug regulation systems for providing patent and non-patent incentives for new use and treatment R&D based on its pro-patent and pro-medical science policies. This article provides an overview of the pharmaceutical industry and examines patent and non-patent incentives for drug R&D in focusing on incentives for developing new uses of and treatments for known drugs from a comparative law perspective. After discussing the difficulties in establishing infringement and in obtaining injunctions against generic drug manufacturers who infringe new use product patents, the article reviews measure …

Infringement Of Swiss-Type Second Medical Use Patent Claims In Germany—Recent Developments In Case Law, Matthias Zigann

Washington Journal of Law, Technology & Arts

Following recent regional court decisions on the infringement of second medical use patent claims, the German concept of manifest arrangement—previously believed to provide a safe harbor for generic pharmaceutical companies as long as they skinny-labeled their products—may be subject to a new interpretation. The German decisions are part of a Europe wide series of decisions on the same or similar subject matter and prove to be patent owner friendly.

Innovation In Known Drugs—The European Angle, Galit Gonen

Washington Journal of Law, Technology & Arts

Research into new uses for known drugs should be encouraged because the “repurposing” of known drug molecules can be a highly effective route of innovation for pharmaceutical companies. Investment in the development of these products should be rewarded. However, incentives that are designed to reward innovation must be in line with the size and value of the innovation in order to maintain a sustainable balance between incentivizing research and developing and encouraging a competitive market. In the context of encouraging innovation of new uses for known drugs, factors that facilitate access to drug development and innovation should also be considered …

Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Anon

Washington Journal of Law, Technology & Arts

A transcript of the symposium's proceedings.

The Impact Of Marijuana Legalization On Youth & The Need For State Legislation On Marijuana-Specific Instruction In K–12 Schools, Amanda Harmon Cooley

Pepperdine Law Review

State legalization of marijuana is a divisive and polarizing issue that has resulted in fragmentation between governments and citizens. Contrary to federal law, voters in many states have approved ballot initiatives legalizing the sale of marijuana to adults for their recreational use. This Article argues that any state that legalizes marijuana has a concomitant duty to amend its K–12 public school instructional statutes to provide for substantial marijuana education. No state has yet enacted such legislation even though current alternative educational methods fail to provide sufficient safeguards. Accordingly, this Article proposes new statutory remedies that could bridge the gap between …

Patents, Hidden Novelty, And Food Safety, Jeanette M. Roorda

Florida Law Review

This Note discusses how federal agency policy results in a lack of access to patent-protected genetically modified organisms (GMOs) for independent food safety testing. The U.S. GMO policy is a combination of biotechnology regulations and biotechnology intellectual property protections. Intellectual property protection for the developers of new organisms has increased as the technology has advanced from manual pollination to genetic modification methods. Initially the only protection available was in the form of trade secrets, but the protection has increased incrementally to now include full utility patent protection. This Note evaluates the interactions between U.S. Patent and Trademark Office (USPTO) GMO …

Conference Of Soviet And American Jurists On The Law Of The Sea And The Protection Of The Marine Environment, Milton Katz, Richard R. Baxter, O. V. Bogdanov, William E. Butler, Thomas M. Franck, Richard Frank, P. P. Gureev, John L. Hargrove, L. A. Ivanaschenko, Y. Kasmin, V. A. Kiselev, B. M. Klimenko, H. G. Knight, O. S. Kolbasov, A. L. Kolodkin, V. M. Koretsky, F. N. Kovalev, V. N. Kudrjavtsev, B. A. Kuvshinnikov, M. I. Lazarev, A. L. Makovsky, Charles W. Maynes, P. A. Moiseev, John N. Moore, A. P. Movchan, T. M. Starzhina, Robert E. Stein, Grigory I. Tunkin, E. T. Usenko, A. F. Vysotsky, A. K. Zhudro

Georgia Journal of International & Comparative Law

Included in the papers for the Conference of Soviet and American Jurists on the Law of the Sea and the Protection of the Marine Environment:

Introduction by Milton Katz and Richard R. Baxter, p. 1

Freedom of Scientific Research in the World Ocean by A.F. Vysotsky, p. 7

The International Law of Scientific Research in the Oceans by Richard R. Baxter, p. 27

Responsibility and Liability for Harm to the Marine Environment by Robert E. Stein, p. 41

Liability for Marine Environment Pollution Damage in Contemporary International Sea Law by A. L. Makovsky, p. 59

Protection of the Marine Environment …

Innovation And Reverse Payments, Ramsi A. Woodcock

Florida State University Law Review

Settlements of patent litigation between branded and generic drug makers that include a promise by the generic maker to stay out of the market, sometimes in exchange for a ‘reverse’ payment, increase the profits of drug makers at the expense of consumers. Some commentators argue that drug makers will invest these profits in innovation, ultimately making consumers better off. Drug market data suggest, however, that the resulting gains to consumers may still be insufficient to offset consumer losses from delayed access to generics. Even when innovation is taken into account, antitrust can most efficiently eliminate the risk of consumer harm …

Eating For The Environment: The Potential Of Dietary Guidelines To Achieve Better Human And Environmental Health Outcomes, Margaret Sova Mccabe

Law Faculty Scholarship

Agriculture and food production contribute significantly to greenhouse gas emissions and environmental pollution. Shifting human dietary patterns has the potential to reduce such environmental harms while also promoting human health. Government policy, in the form of the United States Dietary Guidelines (USDG), recommends what Americans should eat and could play an important role in shifting the food system to one that is more sustainable. However, the USDG are an overlooked aspect of U.S. food policy. While many countries have moved to synthesize environmental goals with dietary guidance, the United States has taken the opposite approach. In 2015, despite recommendations from …