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Date: April 1, 2004
Contacts: Christine Stencel, Media Relations Officer
Megan Petty, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail <>


Report Offers Science-Based Process and Guidelines
To Evaluate Safety of Dietary Supplements

WASHINGTON -- To bolster the U.S. Food and Drug Administration's ability to evaluate the safety of dietary supplements, a new report from the Institute of Medicine and the National Research Council of the National Academies outlines a science-based process for assessing supplement ingredients, even when data about a substance's safety in humans is scarce. This approach to safety evaluation works within the regulatory parameters set by the Dietary Supplement Health and Education Act (DSHEA), which does not require manufacturers to provide safety data on their products. However, supplement makers, the public, and others need to increase their reporting of health problems related to supplement use in order to further improve the agency's ability to protect consumers, the report says.

"Approximately 29,000 dietary supplements are currently available to the American consumer, and while most are safe, questions have been raised about FDA's resources to identify and address the occasional problem products," said Barbara Schneeman, chair of the committee that wrote the report and professor of nutrition, food science, and internal medicine, University of California, Davis. DSHEA established in 1994 that dietary supplements are to be regulated like foods instead of drugs, meaning that they are considered safe unless proved otherwise and are not required to be clinically tested before they reach the market. It is therefore up to FDA to determine whether a particular substance on the market is harmful based upon information available in the public domain. "In some cases, data on an ingredient's safety in humans are scant or nonexistent," Schneeman said. "Our report describes how other types of data -- such as the results of tests in animals, or information on similar substances -- can be used in a science-based approach to determine whether a supplement poses a significant risk to human health."

The process provides a way to identify supplement ingredients that may pose risks, prioritize them based on their level of potential risk, and evaluate them for safety. The report categorizes different kinds of data that FDA can use to assess safety and offers guidelines for determining the significance of the evidence available on a particular substance. Given that supplements are assumed, rather than proven, to be safe before they are marketed, FDA does not need direct evidence of harm to humans to take action; rather the agency must show that a product poses an unreasonable risk to users, the report says.

Data from animal studies and validated in vitro tests may provide enough information on their own to warrant FDA action, even without direct evidence of harmful effects in people, the report notes. Furthermore, historical use is not always enough by itself to prove the safety of a supplement, even if it has been consumed for centuries or used in folk medicine, the committee determined. And because changes in how an ingredient is formulated or processed raise the potential for new adverse effects, a reformulated ingredient should be subject to the same regulatory oversight as a new one.

While the process recommended by the committee is designed to help FDA set priorities and carry out evaluations even when data are limited, the report recommends that manufacturers and distributors be required by DSHEA to report adverse events to FDA in a timely fashion to facilitate safety evaluations. Not only do supplement manufacturers not have to conduct pre-market safety tests, they also are not required to collect and report any health problems that they discover once the products are on the market. Lack of reporting significantly hampers the agency's ability to actively monitor supplement safety, the report says. The Office of the Inspector General estimates that FDA receives reports on less than half of 1 percent of all adverse events associated with supplements.

To further boost reporting, labels on supplements should include a toll-free number for consumers and health professionals to call in health problems or concerns related to the product, the committee said. Labels also should include the name and place of business of both the distributor and the manufacturer so that problems can be traced more easily to their source.

In addition, although manufacturers need not seek approval to market a supplement, DSHEA does require them to notify FDA of their intent to introduce a new compound. During this pre-marketing review period, supplement makers and distributors should be required to provide the agency with all available safety data, both favorable and unfavorable, on their new products. This change would not mean that supplement makers would be required to conduct pre-market testing.

FDA must have adequate resources to support the increased workload that implementing a comprehensive safety evaluation process entails. Congress should provide the agency with sufficient funding to collect and analyze data and carry out the consumer protection and education responsibilities mandated by DSHEA.

Annual sales of dietary supplements in the United States are approaching $16 billion. An average of 1,000 new products are developed each year. Although manufacturers are restricted from claiming that using their products leads to therapeutic benefits, surveys show that many people take supplements for purposes such as treating colds or alleviating depression. According to other survey data, the majority of consumers believe these products to be either reasonably or completely safe.

The study was sponsored by the Food and Drug Administration. The Institute of Medicine and the National Research Council are private, nonprofit institutions that provide science and health policy advice under a congressional charter. The Research Council is the principal operating arm of the National Academy of Sciences and the National Academy of Engineering. A committee roster follows.

Pre-publication copies of Dietary Supplements: A Framework for Evaluating Safety are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

[ This news release and report are available at ]

Institute of Medicine
Food and Nutrition Board
National Research Council
Division on Earth and Life Studies

Committee on the Framework for Evaluating the Safety of Dietary Supplements

Barbara O. Schneeman, Ph.D. (chair)
Associate Vice Provost, University Outreach, and
Professor of Nutrition
Department of Nutrition and
Division of Clinical Nutrition and Metabolism
University of California

Daniel L. Azarnoff, M.D.
D.L. Azarnoff Associates, and
Senior Vice President
Clinical/Regulatory Affairs
Cellegy Pharmaceuticals Inc.
San Francisco

Cindy L. Christiansen, Ph.D.
Chief of Statistics Section
Center for Health Quality, Outcomes, and Economic Research
Bedford Veterans Affairs, and
Associate Professor of Health Services
Boston University

Alice M. Clark, Ph.D.
Vice Chancellor for Research and Sponsored Programs, and
Research Professor
Research Institute of Pharmaceutical Sciences
University of Mississippi

Norman R. Farnsworth, Ph.D.
Pharmacognosy Graduate Program;
Program for Collaborative Research in the Pharmaceutical Sciences; and
Distinguished University Professor
Department of Medicinal Chemistry and Pharmacognosy
University of Illinois

Ted Gansler, M.D., M.B.A.
Director of Medical Information Strategy
American Cancer Society

James E. Gibson, Ph.D.
Research Professor of Pharmacology and Toxicology
Brody School of Medicine
East Carolina University
Greenville, N.C.

Stephen A. Goldman, M.D., F.A.P.M., F.A.P.A.
Managing Member
Stephen A. Goldman Consulting Services LLC
Morris Plains, N.J.

Philip S. Guzelian, M.D.
Director of Medical Toxicology;
Hepatobiliary Research Center; and
Professor of Medicine and Pharmacology
Department of Pharmacology
Health Sciences Center
University of Colorado

Elizabeth Jeffery, Ph.D.
Professor of Nutritional Toxicology
Department of Food Science and Human Nutrition
Division of Nutritional Sciences
University of Illinois

Loren D. Koller, D.V.M., Ph.D.
Loren Koller and Associates LLC
Corvallis, Ore.

Joseph Lau, M.D.
Tufts-NEMC Evidence-Based Practice
Institute for Clinical Research and
Health Policy Studies
Tufts-New England Medical Center,
Professor of Medicine
Tufts University

Russell J. Molyneux, Ph.D.
Research Chemist and Project Leader
Western Regional Research Center
U.S. Department of Agriculture
Albany, Calif.

Susan S. Percival, Ph.D.
Department of Food Science and Human Nutrition
University of Florida

Cheryl L. Rock, Ph.D., R.D.
Associate Professor
Department of Family and Preventive Medicine and the Cancer Prevention and Control Program
University of California, San Diego
La Jolla

Jerrold M. Ward, D.V.M., Ph.D.
Chief of the Infectious Disease Pathogenesis Section
Comparative Medicine Branch and Team SoBran
Division of Intramural Research
National Institute of Allergy and Infectious Diseases
Bethesda, Md.


Allison A. Yates, Ph.D., R.D.
Study Director

Marilee Shelton Davenport, Ph.D.
Staff Officer