Law Commons^™

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Joanna K Sax

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Restructuring Local School Wellness Policies: Amending The Kids Act To Fight Childhood Obesity, Rebecca Edwalds

University of Michigan Journal of Law Reform

Childhood obesity is a major problem plaguing the United States. Over one-third of children are overweight, and there is little indication that this trend will reverse in the near future. The federal government has attempted to combat childhood obesity through the National School Lunch Act, which regulates the quality of foods federally subsidized schools may serve to children, and provides broad goals for physical activity. These basic goals leave extensive room for states to implement different standards, and they are not sufficient to effectively confront the childhood obesity problem. This Note proposes amendments to the National School Lunch Act that …

Curb Your Enthusiasm For Pigouvian Taxes, Victor Fleischer

Victor Fleischer

Pigouvian (or "corrective") taxes have been proposed or enacted on dozens of products and activities that may be harmful in excess: carbon, gasoline, fat, sugar, guns, cigarettes, alcohol, traffic, zoning, executive pay, and financial transactions, among others. Academics of all political stripes are mystified by the public’s inability to see the merits of using Pigouvian taxes more frequently to address serious social harms.

This enthusiasm for Pigouvian taxes should be tempered. A Pigouvian tax is easy to design—as a uniform excise tax—if one assumes that each individual causes the same amount of harm with each incremental increase in activity on …

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs , Joseph A. Cohen

Journal of Law and Health

This article reviews the federal government’s attempts to control the influx of synthetic drugs, particularly synthetic cannabinoids and cathinones, into the U.S. recreational drug market since 2008. It offers three recommendations targeted at Congress, the DEA, and the Department of State on ways to prevent and control synthetic drug use in America: (1) Congress should grant the DEA a new “immediate scheduling” authority; (2) the DEA should improve information sharing with states; and (3) the Department of State and the DEA should prioritize the development of a global early warning system.

When Truth Cannot Be Presumed: The Regulation Of Drug Promotion Under An Expanding First Amendment, Christopher Robertson

Faculty Scholarship

The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes …

Private Parties And The Ffdca: How Creative Litigants Have Circumvented Section 310 And Undermined The Nlea’S Express Preemption Amendments, Joe Dages

Catholic University Law Review

No abstract provided.

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio

Law Student Publications

This comment argues that the FDA should regulate ecigarettes, but in doing so, it should take a minimalist approach to regulation. Instead of continuing its attempts to regulate tobacco products under the drug and device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), an incredibly stringent statute, the FDA should focus its efforts under the Tobacco Control Act ("TCA"), which is tailored specifically to regulate tobacco products. While the FDA has extensive regulatory options under the TCA, much of this authority should not be applied to ecigarettes. Part II will provide background information on ecigarettes generally as well …