FDLI Publications: Food and Drug Law Journal 56-2

Volume 56 Issue 2

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> Remarks of the Acting Principal Deputy Commissioner of Food and Drugs
> FDA's Implementation of FDAMA: An Interim Balance Sheet
> HACCP: We've Only Just Begun
> "Dot.Com Medicine"-Labeling in an Internet Age
> Fathoming Food Packaging Regulation Revisited
> Functional Foods: Regulatory and Marketing Developments
> Clearing Away the Junk: Court-Appointed Experts, Scientifically Marginal Evidence, and the Silicone Gel Breast Implant Litigation
> Considerations When Choosing a Threshold of Regulation for Acute Dietary Exposure to Pesticides

Remarks of the Acting Principal Deputy Commissioner of Food and Drugs
Author: Bernard A. Schwetz
Issue: 56 Food and Drug Law Journal 123-130 (2001).

This article is an updated version of a speech that was presented at FDLI's 44th Annual Educational Conference on April 18-19, 2001, by the Acting Principal Deputy Commissioner for the Food and Drug Administration (FDA). It is a commentary on the recent activities and the current and future challenges of FDA. Some priority initiatives FDA has been implementing in the past few years include applying the Food and Drug Administration Modernization Act and strengthening FDA's science base. FDA also has established the Office for Human Research Trials in the Office of the Commissioner. This new office will aid FDA in research involving human participants. FDA also is concerned with improving the safety of the nation's food supply. In the device arena, FDA has approved new devices for monitoring diabetes and robotic surgical devices. This article addresses the bovine spongiform encephalopathy (mad cow disease) epidemic, citing to the fact that not one case of mad cow disease has been reported in the United States. Biotechnology, cloning, and vaccine usage also are addressed with a discussion on potential FDA remedies.

FDA's Implementation of FDAMA: An Interim Balance Sheet
Author: Linda A. Suydam & Milan J. Kubic
Issue: 56 Food and Drug Law Journal 131-136 (2001).

This article is an updated version of a speech that was presented at FDLI's 44th Annual Educational Conference on April 18-19, 2001, by the Senior Associate Commissioner for the Food and Drug Administration (FDA). This article focuses on the changes brought about by the enactment of the Food and Drug Administration Modernization Act (FDAMA). It also discusses the state of the FDA before and after FDAMA's enactment.

HACCP: We've Only Just Begun
Author: Margaret O'K. Glavin
Issue: 56 Food and Drug Law Journal 137-142 (2001).

The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) introduced the first major change in meat inspection in nearly a century, called the Hazard Analysis and Critical Control Points (HACCP) system. This article discusses the implementation of HACCP, its effectiveness, and how FSIS and industry have succeeded in lowering the incidences of foodborne pathogens. Furthermore, the article addresses the effects HACCP has had on industry and how industry and FSIS have worked together to follow HACCP and achieve the universal goal of protecting the public's health.

"Dot.Com Medicine"-Labeling in an Internet Age
Author: James M. Wood & Howard L. Dorfman
Issue: 56 Food and Drug Law Journal 143-178 (2001).

Once nothing more than a communication tool for universities and the government, the Internet has now become the fastest growing form of borderless communication and commerce. It also has changed the face of medicine. It is able to disseminate rapidly huge amounts of information, and is a source of medical information for approximately 98 million people in the United States. The Internet also has increased the efficiency of patient care and facilitated collaborative research among investigators who may be located great distances from each other. Even manufacturers and distributors of medicines have utilized the Internet to increase their sales. This new-found freedom of information, however, brings with it undefined responsibilities as well as liability concerns. This article discusses the regulatory and legal issues confronting manufacturers and distributors of approved prescription products, such as whether a manufacturer's website content is labeling or advertising; how the Food and Drug Administration, via the Federal Food, Drug, and Cosmetic Act regulates in cyberspace; the implications of direct-to-consumer promotion; and the learned intermediary doctrine.

Fathoming Food Packaging Regulation Revisited
Author: Jerome H. Heckman & Deborah W. Ziffer
Issue: 56 Food and Drug Law Journal 179-196 (2001).

The Food and Drug Administration's (FDA's) implementation of the Food Contact Notification (FCN) system in January 2000 ushered in a new era for the regulation of food-contact materials. Under the new system, petitioners can obtain explicit FDA clearance for their products within a time frame that is much more consistent with current global marketing requirements. Although it is possible now to obtain explicit clearances for food-contact materials within a more reasonable amount of time, manufacturers are still free to determine for themselves whether a particular product complies with the Federal Food, Drug, and Cosmetic Act. Thus, this article begins with an analysis of the application of the law to food packaging materials by restating the available alternatives to obtaining explicit FDA clearance for food-contact materials. Thereafter, as there are many situations where explicit FDA clearance is necessary or desirable, this article discusses the true administrative law sea change that the Food and Drug Administration Modernization Act of 1997 set in motion by authorizing the FCN system. It then concludes with a description of the FCN program and a guide for submitting notifications.

Functional Foods: Regulatory and Marketing Developments
Author: Ilene Ringel Heller
Issue: 56 Food and Drug Law Journal 197-226 (2001).

The burgeoning market for so-called functional foods is raising a multitude of complex public health issues. This article reviews the maze of regulatory requirements for foods, dietary supplements, drugs, medical foods, and foods for special dietary use-all of which are relevant to the sale of functional foods. This article next examines how those requirements are being applied in the marketplace and will assess the impact of the current regulatory framework on consumers. It concludes by making specific recommendations to the Food and Drug Administration to ensure that functional foods are regulated in a manner that maximizes health benefits and minimizes health risks.

Clearing Away the Junk: Court-Appointed Experts, Scientifically Marginal Evidence,
and the Silicone Gel Breast Implant Litigation
Author: Peter J. Goss, Debra L. Worthington, Merrie Jo Stallard, & Joseph M. Price
Issue: 56 Food and Drug Law Journal 227-240 (2001).

Ensuring the reliability of expert witness testimony in cases involving FDA-regulated products presents a court with significant challenges. Judges and jurors generally lack scientific training, and therefore are susceptible to the specious arguments of "junk science" experts. The Supreme Court's decision in Daubert v. Merrell-Dow Pharmaceuticals has reduced significantly the influence of "junk science" by requiring judges to screen expert testimony for reliability and for relevance. But in order for Daubert to be effective, courts must become conversant in the science surrounding their cases. They can accomplish this by appointing independent experts to testify and consult on complex scientific matters. The silicone gel breast implant litigation of the mid-1990s demonstrates how judges can use independent experts successfully to nullify the corrosive effect of junk science on legal outcomes.

Considerations When Choosing a Threshold of Regulation for Acute Dietary Exposure to Pesticides
Author: Elizabeth A. Julien, Leila M. Barraj, Barbara J. Petersen, & J. Robert Tomerlin
Issue: 56 Food and Drug Law Journal 241-254 (2001).

Recently, the Environmental Protection Agency's (EPA's) Office of Pesticide Programs announced its revised policy of choosing a percentile of acute dietary exposure to pesticide residues. The revised policy incorporated a number of improvements suggested during a public comment process. While these improvements are important, the EPA should continue to evaluate the policy and determine 1) whether it meets the applicable statutory requirements of the Food Quality Protection Act; 2) whether it is consistent with the consumer protection efforts of other federal programs and agencies; and 3) whether the policy is scientifically defensible. This article examines these questions in detail. This article also discusses whether EPA's policy on a threshold of regulatory concern for acute dietary exposure to pesticide residues (i.e., the population's 99.9th percentile exposure estimate) is in line with the recommendations of the 1983 National Academy of Sciences report, and whether it provides consistent criteria for consumer protection.