Food and Drug Law Commons^™

Federal Preemption Of Prescrption Drug Labeling: Antidote For Pharmaceutical Industry Overdosing On State Court Jury Decisions In Products Liability Cases, 22 J. Marshall L. Rev. 629 (1989), John F. Del Giorno

UIC Law Review

No abstract provided.

Charting The Future Course For Corporate Management Of Health Risks, Michael S. Baram

Faculty Scholarship

Corporations engage in technological activities of benefit to society, but thereby also create new health risks for workers, consumers, and communities. Government regulatory agencies deal with this chronic problem by conducting risk analyses and imposing various duties on private firms. Despite agency efforts and corporate compliance, health risks continue to arise and take their toll. To what extent will private firms voluntarily assume greater responsibility for preventing these health risks? This question is of increasing social importance, because the limitations of regulatory efforts are now obvious, whereas health risks are now being identified at what appears to be an increasing …

The Lulling Effect: The Impact Of Child-Resistant Packaging On Aspirin And Analgesic Ingestions, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

In 1972, the Food and Drug Administration imposed a protective bottle cap requirement on aspirin and other selected drugs. This regulation epitomizes the technological approach to social regulation. The strategy for reducing children's poisoning risks was to design caps that would make opening containers of hazardous substances more difficult. This engineering approach will be effective provided that children's exposure to hazardous products does not increase. If, however, parents leave protective caps off bottles because they are difficult to open, or increase children's access to these bottles because they are supposedly "child proof," the regulation may not have a beneficial effect. …

Regulating Carcinogens In Food: A Legislator's Guide To The Food Safety Provisions Of The Federal Food, Drug, And Cosmetic Act, Richard A. Merrill

Michigan Law Review

On March 9, 1977, the Food and Drug Administration (FDA) announced that a study in laboratory rats conducted by the Canadian government confirmed that saccharin is an animal carcinogen. For this reason, the agency stated, the sweetener must be banned from human food.

The studies which Congress mandated, to be accompanied by the recommendations of the Secretary of HEW, are likely to generate a fundamental reexamination of the nation's current food safety policies. This Article attempts to aid this inquiry by explaining the requirements of the present law. The Article describes the several statutory provisions that govern the regulation of …

Consumer Protection And Prescription Drugs: The Generic Drug Substitution Laws, Jillena A. Warner

Kentucky Law Journal

No abstract provided.

Legislative Notes: The Fda's Over-The Counter Drug Review: Expeditious Enforcement By Rulemaking, David Selmer

University of Michigan Journal of Law Reform

This article attempts to show that the OTC drug review has distinct advantages over traditional drug regulation. Part I outlines briefly the traditional case-by-case approach to drug licensing and describes FDA enforcement efforts prior to the OTC drug review. Part II sets forth the new rulemaking approach and considers the use of advisory panels. Part III examines several procedural questions associated with the review and concludes that the use of monographs as regulatory standards will afford the FDA an expeditious enforcement mechanism by resolving complex scientific issues at the administrative rather than the judicial level. Judicial review should be available, …

The Prosubstitution Trend In Modern Pharmacy Law, Sidney H. Willig

University of Michigan Journal of Law Reform

This article explores the legal problems presented to the practicing pharmacist by drug substitution. It delineates the practical and economic realities bearing on substitution and the arguments both in favor of and against limited legal substitution. After describing the current status of the law on the subject and the various resultant liabilities of the pharmacist, the article then suggests means by which substitution might be made an acceptable practice in certain circumstances.

A Dichotomy In Consumer Protection - The Drug Device Definition Dilemma, Ronald L. Styn

Indiana Law Journal

No abstract provided.

Legislation--The Fair Packaging And Labeling Act: Its Legislative History, Content, And Future, Wesley E. Forte

Vanderbilt Law Review

The Fair Packaging and Labeling Act (FPLA), which became effective on July 1, 1967, was designed to protect consumers by requiring informative labeling and nondeceptive packaging for consumer commodities. The statute has been described as "an information bill. The first part is information largely about the label .... The second part of the bill is really, in a way, to try to eliminate the confusion in words so we have a common terminology, so we all speak the same language.... It is like establishing an alphabet ... in size designations." The author seeks to provide an insight into the new …

The Department Of Consumers, W. E. Forte

Vanderbilt Law Review

In 1872, Congress began protecting the American consumer by enacting legislation to prevent mail fraud. From this modest beginning, the consumer protection activities of the federal government have proliferated until today there are at least 33 government agencies engaged in 296 consumer protection activities. In 1961, the estimated annual expenditures by the federal government for direct consumer protection activities totaled 272 million dollars and the number of full-time federal employees engaged in such activities was almost 22,000. Expenditures for consumer advancement, a broader concept, were estimated at 681 million dollars in 1961 and the number of full time federal employees …

Products Liability Based Upon Violation Of Statutory Standards, Joseph H. Ballway Jr.

Michigan Law Review

Regulatory enactments controlling production and distribution can give rise in several different ways to civil liability on behalf of persons injured by non-conforming merchandise. For instance, if a statute codifies existing common-law rules of negligence, its effect is merely to place the weight of legislative authority behind ordinary negligence principles. Since an injured party's recovery under such a provision still depends largely upon his proving in the traditional manner that a defendant failed to exercise due care, this kind of statute merits no further discussion. On the other hand, if particular legislation expressly states that a violator may be subjected …

Recent Developments In Food Products Liability, F. Reed Dickerson

Articles by Maurer Faculty

No abstract provided.

The Basis Of Strict Products Liability, Reed Dickerson

Articles by Maurer Faculty

This paper was presented before the Division of Food Drug Cosmetic Law, Section of Corporation, Banking and Business Law of the American Bar Association at the Annual Meeting in St. Louis, August 9. It Is a companion paper to "Restatement or Reformation?" by William J. Condon, which appeared in the August, 1961 issue of this magazine. Mr. Dickerson Is Professor of Law at Indiana University and author of Products Liability and the Food Consumer.

Group Interests In The Field Of Food Law, Reed Dickerson

Articles by Maurer Faculty

No abstract provided.

The Liability Of Retail Dealers For Defective Food Products, Robert C. Brown

Articles by Maurer Faculty

No abstract provided.