1994 Petition in re homeopathy signed by Randi, Kurtz + 40 Others
Petition Regarding Homeopathic Drugs
Docket # 94P-0316/CP 1
Dockets Management Branch,
Food and Drug Administration
Room 1-23
12420 Parklawn
Rockville, MD 20857
The undersigned, as agent for 42 individuals, hereby submits this petition pursuant to FDA laws and regulations that require all commercially available drugs to be proven safe and effective and be adequately labeled for their intended uses.
Action Requested
The FDA Commissioner should initiate a rulemaking procedure, similar to the OTC Review, to require that all OTC homeopathic drugs meet the same standards of safety and effectiveness as nonhomeopathic OTC drugs. In the interim, the Commissioner should issue a public warning that although the FDA has permitted homeopathic remedies to be sold, it does not recognize them as effective.
Statement of Grounds
Although homeopathic products are not recognized as effective by the scientific community, the FDA has tolerated their marketing because a provision of the 1938 Food, Drug, and Cosmetic Act recognized substances listed in the Homeopathic Pharmacopeia as drugs. However, nothing in the law prohibits the FDA from requiring homeopathic remedies to be proven effective to remain on the market.
FDA Compliance Policy Guide 7132.15, issued in 1988, states that "nonprescription homeopathics may be sold only for self-limiting conditions recognizable by consumers . . . [Their] labeling must adequately instruct consumers in the product's safe use." However, the guide warns that compliance with its requirements "does not establish that [a product] has been shown by appropriate means to be safe, effective, and not misbranded for its intended use."
The FDA's laissez-fair regulatory policy has enabled dozens of companies to market hundreds of products with claims (often simply in the name of the product) that are unsubstantiated. All of these products are misbranded because they do not indicate on their label that they can remedy nothing. Nor do they state how much of any ingredient the product contains in a way that the average consumer can understand. Nor can adequate directions for use be written for products that don't work. Because the FDA permits their sale, consumers are being misled into thinking that the remedies are effective, not only for symptomatic relief but for the treatment of serious diseases.
Products designated as 24X, 12C, or higher, should contain no molecules of the original substance from which they are prepared. Yet they are being marketed as though they are potent remedies.
One homeopathic manufacturer even advertises that "unlike most over the counter medicines, Medicine from Nature works in harmony with the body's natural defenses and gets to the cause of your illness or discomfort." [See Exhibit A] Many other manufacturers have made similar claims.
Exhibit B provides an overview of the homeopathic marketplace.
Exhibit C is the National Council Against Health Fraud's position paper.
Environmental Impact
None
Certification
We certify that this petition includes all data, information, and views upon which this petition relies, and that we know of no reliable scientific data or other information that are unfavorable to this petition.
Agent for Petitioners
Stephen Barrett, M.D.
P.O. Box 1747
Allentown, PA 18105
FDA Homeopathy Petition
List of Signers, August 1994
(Titles for Identification Only)
Seth Asser, M.D., pediatrician, Assistant Professor of Pediatrics, University of California; Coordinator, NCAHF Task Force on Children's Health Threats
Robert Baratz, D.D.S., M.D., Ph.D., Assistant Clinical Professor of Medicine, Boston University School of Medicine
Stephen Barrett, M.D., author, editor, consumer advocate. Recipient, FDA Commissioner's Special Citation Award for Public Service.
Paula Benedict, M.P.H., R.D., Public Health Nutritionist, San Bernadino County Dept. of Public Health
Wayne Bidlack, Ph.D., Professor, Food and Human Human Nutrition, Iowa State University
John Bolton, M.D., Assistant Clinical Professor of Pediatrics, University of California Medical School (San Francisco)
Michael Botts, Esq., former Assistant Attorney General of Iowa, specializing in health-fraud cases
Bruce Brown, former FDA public information officer
Paul E. Brown, M.D., internal medicine specialist, Lakeview Clinic, Waconia, Minnesota
John E. Dodes, D.D.S., President, New York Council Against Health Fraud; Lecturer, School of Dentistry, State University of New York/Stony Brook
Donald Driscoll, Esq., public interest attorney, Oakland, California
John H. Ellis, Ph.D., Emeritus Professor of History, Lehigh University
Daniel B. Futch, D.C., M.P.S., vice president, National Association for Chiropractic Medicine; vice president, Orthopractic Manipulation Society, U.S.A.
Martin Gardner, science writer, former staff member, Scientific American
Saul Green, Ph.D., research biochemist, former researcher, Memorial Sloan-Kettering Cancer Center
Victor Herbert, M.D., J.D., Professor of Medicine, Mt. Sinai School of Medicine; Recipient, FDA Commissioner's Special Citation Award for Public Service
Wallace Janssen, FDA Historian; former director of public information for the FDA
Leon Jaroff, contributor to and former senior editor (science) of Time magazine; founder and former managing editor, Discover magazine
William T. Jarvis, Ph.D., Professor of Preventive Medicine, Loma Linda University; and President, National Council Against Health Fraud
Manfred Kroger, Ph.D., Professor of Food Science, The Pennsylvania State University
Paul Kurtz, Ph.D., Chairman, Committee for the Scientific Investigation of Claims of the Paranormal
Marvin Lipman, M.D., Clinical Professor of Medicine, New York Medical College; chief medical advisor, Consumers Union; former member of two FDA advisory committees
William London, Ed.D., Associate Professor of Health Education, Kent State University
James A. Lowell, Ph.D., Professor of Molecular Biology, Pima Community College
Paul MacCready, Ph.D., engineer, inventor, board chairman, Aerovironment, Inc.
Gabe Mirkin, M.D., Associate Clinical Professor of Pediatrics, Georgetown Medical School
Grace P. Monaco, J.D., specialist in health law; former member of FDA advisory committee
Merlin Nelson, Pharm.D., M.D., former Assistant Professor of Pharmacy Practice, Wayne State University School of Pharmacy
Robert L. Park, Ph.D., Executive Director, The American Physical Society; former chairman, Physics Dept., University of Maryland
James Randi, author, lecturer, investigator of psychic/paranormal claims
Jack Raso, M.S., R.D., editor/publisher, Nutrition Forum newsletter
John H. Renner, M.D., President, Consumer Health Information and Research Institute
David B. Roll, Ph.D., Acting Dean and Professor of Medicinal Chemistry, University of Utah College of Pharmacy
Paul Saltman, Ph.D., Professor of Nutrition, University of California, San Diego
Wallace Sampson, M.D., F.A.C.P., Clinical Professor of Medicine, Stanford University School of Medicine; member, Cancer Advisory Council for the State of California; Board Chairman, National Council Against Health Fraud.
Marvin J. Schissel, D.D.S., dentist, private practice, Woodhaven, New York
Elie Schneour, Ph.D., Sc.D., Director, Biosystems Research Institute, San Diego, California
Varro E. Tyler, Ph.D., Professor of Pharmacognosy, Purdue University College of Pharmacy
Lewis Vaughn, author and magazine editor
Mahlon W. Wagner, Ph.D., Professor of Psychology, State University of New York/Oswego
Elizabeth M. Whelan, Sc.D., M.P.H., President, American Council on Science and Health
James Harvey Young, Ph.D., Professor of History, Emory University; former member of FDA National Advisory Food and Drug Council.