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