Browsing HLS Student Papers by Title
Now showing items 154-173 of 498
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FDA vs. Ephedra: Dietary Supplement Regulation Under DSHEA
(2002)The Dietary Supplement Health and Education Act of 1994 (DSHEA) dramatically changed the way dietary supplements are regulated in the United States. DSHEA created a new category of products defined as “dietary ... -
FDA's Role in the Silicone Breast Implant Story
(1997)This paper will present the history of FDA's policy regarding silicone breast implants, as well as an analysis of the strengths and weaknesses of these actions. Although FDA Commissioner David Kessler's essential judgment ... -
The FDA's Treatment of Structure/Function Claims under the Dietary Supplement Health and Education Act
(2001)Demand in the United States for dietary supplements and herbal products has exploded in past years. One report states that demand for dietary supplements has increased almost 50 percent since 1995.1 Congress, therefore, ... -
The FDA's Use of Adverse Publicity
(1998)Of all the regulatory tools available to the FDA in fulfilling its duties, one of the most contentious and problematic is its use of adverse publicity. Whether it is because of its quasi-statutory status, the questionable ... -
FDA's Use of Negative Publicity as an Enforcement Mechanism
(2003)This paper analyzes FDA’s use of negative publicity as an enforcement mechanism, both generally and in the specific instance of the agency’s regulation of phenylpropanolamine ... -
The FDA’s Role in the Development of Bioterrorist Countermeasures
(2004)As the agency that approves drug products used to treat bioterrorist diseases, the FDA plays a significant role in the domestic preparation against a bioterrorist attack. The changes that occurred at the agency in response ... -
Federal Enforcement of the Controlled Substances Act: Striking a Balance Between Enforcement and the Regulation of Medical Practice
(2009)In the Controlled Substances Act of 1970, Congress made the conscious decision to vest the regulation and control of drugs in two executive branch departments. The Attorney General, through the DEA, is responsible for law ... -
Federal Preemption in the Area of Direct-to-Consumer (DTC) Advertising of Prescription Drugs
(2006)FDA involvement in the policy space of direct-to-consumer (DTC) advertising of prescription drugs raises the question whether state-law based lawsuits based on such advertising are preempted. Congress and the Supreme Court ... -
Federal Preemption of Municipal Tobacco Ordinances:New York City and the Federal Cigarette Advertising and Labeling Act
(2011)In contrast to the Family Smoking Prevention and Tobacco Act of 2009, which appears to preserve a strong role for states and cities to participate in and strengthen tobacco regulation, the Federal Cigarette Labeling and ... -
Federal Preemption of State Liability Claims under the FDCA
(2006)Although the FDA has a history of working in cooperation with state governments, in recent years the Agency has increasingly sought to pre-empt certain state law rights of action and tort claims. Parts II and III of this ... -
Federal Regulation of Gene Therapy: Who Will Save our Germline?
(2003)This paper will attempt to address some of these more complex issues involving human gene therapy and the encompassing regulations. The first section will deal with the science of gene therapy and will briefly touch upon ... -
A Felony To Drink Small Beer~ Reflections on Food and Drug Metaphors in Shakespeare
(1995)Some things don't change. Garlic and onions have always smelled less than perfumy on the breath--in Shakespeare's day and now. The images of food and drugs in Shakespeare are ubiquitous and reflect some of the same societal ... -
Fen-Phen Litigation Against American Home Products Corporation: The Widespread Use of Fenfluramine (Pondimin) and Dexfenfluramine (Redux) for Weight Loss, The Health Problems Associated with Those Drugs, the Resulting Litigation Against American Home Prod
(2000)The fen-phen affair has spawned thousands of lawsuits and a multitude of scientific studies concerning valvular heart disease. It has also led to a lively debate over off-label prescriptions, medical monitoring, and class ... -
First Amendment Scrutiny of FDA'S Fight Against Misbranding: Placing Labeling on the Spectrum of Speech
(1995)In order to further the Food and Drug Administration's (FDA) mission of "assur[ing] that the products it regulates are safe and truthfully labeled," the Federal Food, Drug, and Cosmetic Act (FD&C Act) gives FDA the power ... -
Fixing a 510(K) Loophole: In Support of The Sound Devices Act of 2012
(2014)The current medical device regulatory system contains a dangerous loophole. While the voluntary recall of a harmful medical device removes it from the market, new devices that claim they are substantially equivalent to ... -
Flying Below the Radar Screen: The Absence of Information About the FDA
(2001)This paper is a study of how the American people interact with and understand a complicated governmental agency, the FDA. Part I examines the traditional role of media in providing information to people about government; ... -
Folic Acid and the American Food Supply: A historical account of the FDA's creation of the current folic acid regulations
(2003)During the 1980s, scientific studies began to uncover a link between the B-vitamin folic acid and a reduction in the prevalence of neural tube defects, including spina bifida and anencephaly. When Congress passed the ... -
Fomentation About Fermentation: A Study on Ingredient Labeling on Alcoholic Beverages
(2002)Since the creation of the Federal Food and Drug law in 1906 up until a district court decision in 1976, the Food and Drug Administration (FDA) shared concurrent jurisdiction with the Bureau of Alcohol Tobacco and Firearms ... -
Food Addiction: Current Understanding and Implications for Regulation and Research
(2014-03-18)The idea that some processed foods can be addictive has gained support in recent years. Animal and human studies show extensive overlap between the neuronal signaling involved in palatable food consumption and drug ... -
Food Allergies and Food Labeling: An International Problem
(2001)The United States should step up to the plate and pass a regulation requiring the inclusion of allergens on ingredient labels regardless of the amount of allergen in the food. This regulation would put some teeth into the ...