Food and Drug Law Commons^™

The Dope On Marijuana Consumption And Impaired Driving, Samuel D. Hodge, Jr., Lauren Williams

Cleveland State Law Review

Marijuana is the most frequently used psychotropic drug in the United States, following alcohol consumption. Its use is becoming socially acceptable as more and more states legalize recreational consumption. Nevertheless, marijuana is still a drug, and individuals must understand that it has adverse health effects and potential therapeutic benefits.

Marijuana can influence a user’s judgment and impair a person’s driving abilities. A significant problem with its consumption and driving is that there is no statistical link to show what level of marijuana in the blood causes impairment. Roadside tests for the appropriate blood alcohol content to show intoxication are well …

The War On Drugs: Moral Panic And Excessive Sentences, Michael Vitiello

Cleveland State Law Review

The United States’ War on Drugs has not been pretty. Moral panic has repeatedly driven policy when states and the federal government have regulated drugs. Responding to that panic, legislators have authorized severe sentences for drug offenses.

By design, Article III gives federal judges independence, in part, to protect fundamental rights against mob rule. Unfortunately, the Supreme Court has often failed to protect fundamental rights in times of moral panic. For example, it eroded Fourth Amendment protections during the War on Drugs. Similarly, it failed to protect drug offenders from excessive prison sentences during the War on Drugs. This Article …

Smoking Out A Compromise: Splitting The Difference Through A Public Policy Approach To Resolving The Graphic Cigarette Warning Label Circuit Split, Amelia B. Larsen

Cleveland State Law Review

The imposition of graphic warning labels is necessary; the tobacco market exploits the lower class by capitalizing on their under-education regarding the negative health consequences of smoking. This injustice can be corrected by providing the most direct and clear communication imaginable to consumers to ensure they are completely informed of the peril they are placing themselves in when they choose to smoke—the graphic warning labels provide this kind of communication. This Note discusses why the FDA’s warning labels meet First Amendment constitutional scrutiny and serve a substantial governmental interest regarding the country’s public health, socioeconomic equality, and economy. Part II …

Food For Sport Or Faustian Bargain: Regulating Performance Enhancing Dietary Supplements, Jennifer Kay Braman

Cleveland State Law Review

The defining line between legal and illegal substance-between dietary supplement and drug is horribly skewed. Accordingly, Part I of this Note will investigate the complexities that exist with regard to the classification and regulation of dietary supplements, looking at the history leading to the passage of the governing Dietary Health and Supplement Act of 1994. Part II will focus on supplements that consumers may use for performance enhancement purposes, and the regulation of sports products. Part III will look at the regulatory debate over dietary supplements, the andro product example and the interrelationship between drugs and sport. Part IV will …

Prescription Drugs And The Duty To Warn: An Argument For Patient Package Inserts, Alan R. Styles

Cleveland State Law Review

It has been more than ten years since the Food and Drug Administration proposed regulations which would have required detailed patient information for all prescription drugs. The proposed regulations, intended to promote the safe and effective use of prescription drugs, would have required a manufacturer to supply non-technical, non-promotional information, referred to as patient package inserts, directly to the patient. This note will analyze the need for patient information in satisfying the tort objectives of informed consent and public safety. The note will then analyze the practical effect of the learned intermediary and informed consent doctrines upon the manufacturer's and …

Regulation Of Pharmaceutical Advertising, Anthony S. Zito Jr.

Cleveland State Law Review

Federal trade commission regulation of pharmaceutical advertising is a subject of considerable current interest. The criteria for determining the acceptability of these advertisements are still evolving, and a definitive set of rules has not yet been fully articulated. Nevertheless certain trends are developing.' One of the major objectives of this paper is to predict the ultimate form of these rules.

The Doctor, The Patient, And The Fda, Herbert L. Ley Jr.

Cleveland State Law Review

There have been considerable charges and counter-charges the United States Food and Drug Administration's role in protecting the consumer, at least as far as the medical profession is concerned. The FDA has absolutely no intention nor desire to assume the role of the physician or to interfere with the bona fide practice of medicine. Why the complaints by some the FDA's actions on drugs, including drug labelling, drug recall and the withdrawal of certain drugs from the market, constitute attempts to interfere with the practice of medicine? It is possible that one of the reasons, and perhaps the principal one, …

Legal Aspects Of Drug Abuse, C. William O'Neill

Cleveland State Law Review

In discussing the existing drug laws in this country, it is useful to break them down into two categories: First, the Federal and state laws directed at marijuana and narcotics and, second, the Federal and state laws governing hallucinogenic drugs, such as LSD. Laws regulating and prohibiting the use of and traffic in the various drugs arose in response to public concern over their abuse. Federal regulation began with the Harrison Narcotic Drug Act of 1914, which was aimed at opium and other "hard" narcotics. In 1937 Congress enacted the Marijuana Tax Act, modeling it largely after the Harrison Act, …

Governmental Regulation Of The Drug Industry, J. Mark Hiebert

Cleveland State Law Review

In today's world of increased government participation in business, certain industries are frequently spotlighted for particular attention. The communications industry is one, the drug industry is another. In both cases the special attention is fitting, for the communications industry, like the drug industry, each in its own way, reaches the very fiber of American life. Each has the inherent capability of changing our political and social order. At any rate two points are basic: first, the drug industry directly affects the foundations of our society and therefore is a reasonable concern of government. Secondly, the drug industry has a legitimate …

Investigational Drugs And The Law, George F. Archambault

Cleveland State Law Review

Moving directly to the subject "Investigational Drugs and the Law" and being concerned primarily with preventative law, a topic not unlike preventative medicine, what is it that must be known as a lawyer in this specialty field in order to aid physicians and pharmacists involved in clinical research, in clinical pharmacology research, in hospital administration, and in nursing and pharmacy practices to keep them from legal pitfalls? It is necessary to tackle the subject in a two-pronged manner: (1) the federal and state statutes, and (2) case law.

Retail Druggist's Warranty Of Drugs, Thomas M. Schmitz

Cleveland State Law Review

Jurisdictions retaining a contractual warranty theory hold that a retail druggist warrants the wholesomeness, fitness, and merchantability of his products. This warranty applies to all drugs whether they are prescription drugs, proprietary drugs ,brand name drugs, or drugs sold in the original sealed containers. Liability for the sale of a prescription drug may be exempted if the patient relies on the physician's judgment, and liability for the sale of a brand name drug may be relieved if there is reliance on the manufacturer's reputation. Jurisdictions construing product warranty as a strict liability in tort will invariably hold a retail druggist …

Due Care By Physicians In Use Of New Drugs, Edward T. Haggins

Cleveland State Law Review

How careful must a physician be in using new drugs on his patients? Before discussing these questions, we must look at three problems: (1) What role does the physician play in the new drug picture? (2) What are some of the new drugs and their side effects, and (3) What steps must a new drug go through before it is placed on the market for public consumption?

Food Additives: Legal Recognition Of A Scientific Problem, Robert E. S. Post

Cleveland State Law Review

Food additives could create one of the nicest legal problems that courts have ever had to face. We are not concerned with theories of negligence, warranty, privity, or statutory interpretation as it applies to any of these three concepts. The real problem is twofold: establishment of harm arising from the presence of an additive or additives; and establishment of a judicial policy to contemplate the fact that, if and when such harm does befall someone, it will happen in spite of the utmost good faith on the part of the manufacturer, and in the face of legislative and administrative authorization …

Federal Food, Drug, And Cosmetic Act - 20 Years Of Health Protection, Irvin Kerlan

Cleveland State Law Review

Twenty years of major public health protection have been provided since enactment of the Federal Food, Drug, and Cosmetic Act of 1938. The Food and Drug Administration, a constituent of the United States Department of Health, Education, and Welfare, enforces this Act and thereby carries out the purpose of Congress to insure that foods are safe, pure, and wholesome, and made under sanitary conditions; drugs and therapeutic devices are safe and effective for their intended uses; cosmetics are safe and prepared from appropriate ingredients; and that all of these products are honestly and informatively labeled and packaged. Man and animals …

Food Additives Law And Practice, Milton Oppenheim

Cleveland State Law Review

A decision of the United States Supreme Court on Dec. 15, 1958, interpreting the Federal Food Drug & Cosmetic Act, has focused attention on the use of coloring and other materials in foods, drugs and cosmetics. This requires a complex study of the effects of the various food additives, contaminants and chemicals upon the individual, whether intentionally added or accidently produced, in foods, drugs and cosmetics. Evaluation of the tremendous group of food additives can best be approached in the light of the benefits intended by the manufacturer or grower using them.