Volume 50 Issue 3
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Table of Contents
> Dietary Supplements of Botanicals and Other
Substances: A New Era of Regulation
> The Federal Trade Commission's Regulation
of Advertising Claims for Dietary Supplements
> The Statutory Basis for the FDA's Food Safety
Assurance Programs:
From GMP, to Emergency Permit Control,
to HACCP
> USDA's Agenda for Change to Improve Food
Safety
> Keeping Food Safe
> Current Regulatory Issues Related to Animal
Drug Use
> The Impact of the New Products Liability Restatement on Prescription Products
> Assessments of Pharmaceutical Advertisements:
A Critical Analysis of the Criticism
> Current Product Equivalency Issues
> Effects of Products Liability on Bulk Suppliers
of Biomaterials
> Medical Device Regulation in the European
Union
Dietary Supplements of Botanicals and Other Substances: A New Era of Regulation
Author: Stephen H. McNamara
Issue: 50 Food and Drug Law Journal341-348 (1995)
In response to intense pressure to reduce the regulatory burdens on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994 (DSHEA). While the legislation imposes some significant new requirements for dietary supplements, on the whole it is viewed as a very positive development for those who sell such products. This article focuses on the changes that the DSHEA has made in the way dietary supplements are regulated by the Food and Drug Administration, as well as the opportunities these changes present for additional marketing and for attention by the United States Pharmacopeia.
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The Federal Trade Commission's Regulation of Advertising
Claims for Dietary Supplements
Author: C. Lee Peeler and Susan Cohn
Issue: 50 Food and Drug Law Journal 349-355 (1995)
This article discusses the role of the Federal Trade Commission (FTC) in the regulation of advertising, illustrates the application of the Commission's regulatory approach to dietary supplements, and suggests some likely implications of the Dietary Supplement Health and Education Act of 1994 for the FTC.
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The Statutory Basis for the FDA's Food Safety Assurance
Programs:
From GMP, to Emergency Permit Control, to HACCP
Author: Edward Dunkelberger
Issue: 50 Food and Drug Law Journal 357-383 (1995)
The Food and Drug Administration's (FDA's) 1994 mandatory Hazard Analysis and Critical Control Points (HACCP) proposal for the seafood industry and its advance notice of public rulemaking requesting comments on mandatory HACCP for all food processing have raised a number of questions concerning the statutory authority for the intensive degree of regulation that the proposals would entail. In consideration of these issues, this article reviews the history and statutory basis of other food safety assurance regimes implemented or considered by the FDA, including: promulgation in the late 1960s of food good manufacturing practices under the authority of section 402(a)(4); development of the emergency permit control program for low acid canned foods under the authority of section 404 in the early 1970s; and congressional consideration throughout the 1970s of food surveillance legislation that would have authorized imposition of HACCP-type controls on all food companies.
These precedents support the view that, contrary to the FDA's assertion in the preambles to its proposals, mandatory HACCP controls for the food industry (with attendant access to company records) would not be authorized under sections 402(a)(4), 701(a), and 704. If the FDA wishes to adopt mandatory HACCP regulations for any class of foods, it may do so only under the authority and prescribed limitations of section 404 (emergency permit control).
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USDA's Agenda for Change to Improve Food Safety
Author: Michael R. Taylor
Issue: 50 Food and Drug Law Journal 385-388 (1995)
Improving the safety of the food supply is a high priority at the U.S. Department of Agriculture (USDA). The Department has embarked on a course of fundamental change in its organization and programs relating to food safety. Organizational changes include the separation of food safety from marketing functions and the consolidation of all food safety activities within the Food Safety and Inspection Service (FSIS). FSIS also has conducted an intensive review of its organization to determine how it can most effectively perform all of its food safety functions.
Changes are needed in the current inspection program to better protect public health. The system needs to target dangerous bacteria, better define industry's responsibilities, and utilize a built-in preventive philosophy. FSIS is proposing changes to achieve these objectives, including a requirement that all meat and poultry plants implement Hazard Analysis and Critical Control Points systems. The adoption of public health-oriented targets, guidelines, and standards for pathogenic microorganisms is a key element of FSIS's strategy. FSIS also is exploring ways to foster scientific and technological innovation within the industry to reduce pathogens, and is addressing potential food safety hazards throughout the chain of production, processing, distribution, and sale.
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Keeping Food Safe
Author: Robert C. Post
Issue: 50 Food and Drug Law Journal 389-393 (1995)
Two years ago, the outbreak of foodborne illness on the West Coast involving ground beef contaminated with E. coli 0157:H7 bacteria focused attention on a critical gap in the system of meat and poultry inspection. The Food Safety and Inspection Service (FSIS) has since embarked on sweeping changes to its program that will reform the way meat and poultry is inspected and the way the agency's organizational resources are used to meet its food safety mandates. A proposed rule published earlier this year details recommendations for changes through pathogen reduction and Hazard Analysis and Critical Control Points systems. The long overdue changes will affect the full range of food production activity, from the farm to the slaughterhouse and processing facility, transportation and product export/import, wholesale and retail sale, and consumption both in and out of consumers' homes. This regulatory reform will require substantial public input to meet public health needs effectively.
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Current Regulatory Issues Related to Animal Drug Use
Author: Caroline Smith DeWaal
Issue: 50 Food and Drug Law Journal 395-397(1995)
The use of animal drugs has changed dramatically in the last twenty years, as has the meat and poultry processing system. The use of animal drugs as a production tool to facilitate growth rather then to treat illness should be viewed under the microscope of food safety. There must be an evaluation of the extent to which such drug use may increase residues in food, result in human allergic reactions, promote resistant bacteria, cause death or injury to animals, or drive the evolution of more potent bacteria. This article discusses these issues and describes the pivotal role played by the Food and Drug Administration's Center for Veterinary Medicine in making such assessments about animal drug use.
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The Impact of the New Products Liability Restatement on Prescription Products
Author: Teresa Moran Schwartz
Issue: 50 Food and Drug Law Journal399-413 (1995)
In May 1995, the American Law Institute adopted a new Restatement (Third) of Torts: Products Liability. It replaces section 402A of the Restatement (Second) of Torts, which has greatly influenced the common law development of products liability law for three decades. The new Restatement adopts true strict liability for manufacturing defects, a liability standard closely resembling negligence for warning claims, and a risk/utility test for defective design claims. Section 8 of the Restatement singles out prescription products — both drugs and medical devices — for special treatment. For manufacturing defects, it adopts strict liability. For warning claims, it adopts a negligence standard and recognizes the learned intermediary rule, except where vaccines are given in mass immunization programs. For design claims, it narrows considerably the standard of liability, thus making such claims, which already are difficult, even more difficult for plaintiffs to pursue.
The impact of the new Restatement may not be forecasted with certainty, but it is likely to be influential. Section 402A had an enormous influence on courts in encouraging the expansion of liability for product-related injuries. Today's judiciary may be inclined to move in a more prodefendant direction in response to the new Restatement's provisions.
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Assessments of Pharmaceutical Advertisements:
A Critical Analysis of the Criticism
Authors: William C. MacLeod and J. Howard Beales
Issue: 50 Food and Drug Law Journal 415-449 (1995)
The impact and accuracy of pharmaceutical advertising has inspired decades of study and debate, yet the first systematic assessment of the subject was a 1992 study designed to measure pharmaceutical advertising accuracy. This study concluded that a significant number of pharmaceutical advertisements contain misleading and inaccurate information. Close examination of the data from the study reveals that the authors' conclusions are not supported. Among the shortcomings in the study were a sample of reviewers that did not represent the target audience of the advertisements, a questionnaire that invited biased responses, and the failure to establish statistical significance for any finding. The pattern of the reviewers' responses to most questions was indistinguishable from a random scatter, but the responses were significantly different from the pattern that accurate reviewers identifying real problems would have produced. The study authors' recommendation — more federal regulation and possible peer review of pharmaceutical advertisements — failed to take into account the resultant costs of the suppression of truthful information.
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Current Product Equivalency Issues
Author: Theresa L. Gerrard
Issue: 50 Food and Drug Law Journal 451-453 (1995)
This article discusses some of the practices of the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) in licensing biotechnology products and determining product equivalency after alterations in the manufacturing process. A change in the manufacturing of many therapeutic or diagnostic recombinant products will not trigger a request for a new clinical trial if the "new" product is shown to be biochemically equivalent to the "old" product. The key questions asked by CBER in its review are related to how the manufacturing changes will affect the product's safety, purity, and potency, and whether there are tests in place to detect any changes in the product after its manufacturing process has been changed.
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Effects of Products Liability on Bulk Suppliers of Biomaterials
Author: Frederick D. Baker
Issue: 50 Food and Drug Law Journal 455-460 (1995)
It has been widely reported that medical implant manufacturers are unable to purchase critical raw materials due to sellers' fears of product liability litigation. This article discusses the common law principles that govern the liability of raw material suppliers, pending federal legislation (the Biomaterials Access Assurance Act of 1995), and the impact of this issue on the industry.
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Medical Device Regulation in the European Union
Author: Linda R. Horton
Issue: 50 Food and Drug Law Journal 461-476 (1995)
Medical devices in the European Union (EU) have been selected as an area in which "new approach" directives will be applied in something of an experiment in international regulation. The "old approach" involved control systems that emphasized harmonization through detailed regulations and oversight carried out by EU member states' ministries. The new approach was conceived as a way to impose uniformity; harmonization would be achieved through essential requirements that are both general and mandatory, and complemented by European standards that are both detailed and voluntary. The new approach also is noteworthy in its call for government/private sector partnerships to carry out functions that traditionally or elsewhere had been thought of as government roles. This article discusses some issues of implementation of the medical device directives, including administration, classification, registration, standards, clinical investigations, and labeling.
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