FDA Letters about
Human research involving products regulated by the FDA must follow stringent guidelines. All such studies must be monitored by an Institutional Review Board (IRB) whose function is to assure the protection of the rights and welfare of the human subjects. IRBs are not required to register with the FDA, but investigators must submit a form to the FDA that includes the name and address of the IRB for their study. This enables the FDA—should it choose to do so—to conduct inspections to determine whether the research is being properly conducted and monitored. In recent years, some manufacturers and "alternative" practitioners have created IRBs and/or sponsored research in order to pretend that what they offer is part of a legitimate research project. This page indexes documents in which the FDA or an IRB issued a warning, termination letters, or other notice related to inappropriate research.
- Charles H. Farr, MD, PhD (6/2/97): International Bio-Oxidative Medicine Foundation
- L. Terry Chappell, MD (3/9/00): Great Lakes College of Clinical Medicine
- Anne O'Connell (7/11/07): Nevada Institutional Review Board
- Darren McDaniel (3/11/08): Coast Institutional Review Board
- Fred Lam, MD / American Association of Acupuncture and Bio-Energetic Medicine (11/13/08) (3/24/11)
- W. John Martin, MD, PhD (10/19/09): MI Hope Inc. dba Center for Complex Infectious Diseases
- Brian Riordan: Center for the Improvement of Human Functioning (7/3/12)
- William C,. Domb, DMD (5/13/15): Inland Institute of Aesthetic Dentistry Institutional Review Board
- Michael A. Arata, M.D. (9/15/12): Unapproved CCSVI treatment study
- Stanislaw Burzynski, MD, PhD (10/18/12):
- Chaovanee Aroonsakul, MD (10/16/01): Improper use of growth hormone for Alzheimer's disease
- Columbia University Health Science:
- Ralph M. Conti, M.D. (11/22/06): Illegal stem cell research
- Arthur Ericsson, MD (3/31/08): Anti-inflammatory drug
- Jerry I. Jacobson, DDS, DMD (1/25/01): "Resonance" device study
- Lenox Hill Hospital (11/8/06): Dr. Arthur Krigsman's unauthorized research on autistic children
- James F. NIcGuckin, Jr. , MD ((3/11/18): Unapproved CCSVI treatment study
- Trent Nichols, MD (2/24/05): Magnetic Molecular Energizer study
- Dino Prato / Envita Natural Medical Centers of America (6/14/06): illegal use of treated cell cultures
- Donald A. Rhodes, DPM dba South Texas Innovative Medicine (8/29/11): VECCTOR device stody
- Lloyd A. Shabazz, MD (2/23/01): Cancer treatment studies
- Richie C. Shoemaker, MD (5/13/04): Improper human study with veterinary drug
- William A. Shrader, Jr., MD (4/4/01): Enzyme potentiated desensitization study
- Jerald L. Tennant, MD (2/15/05): Scenar device
- University of Arizona (6/22/07): Failure of Gary Schwartz, Ph.D., to maintain privacy of experimental subjects.
- Charles Wallach / Bioenergy (6/7/02): Illegal commercial promotion and misleading claims made for a Pap-Imi device.
Letters to Sponsors
- Advanced Magnetic Research Institute / Dean Bonlie, D.D.S. (1/16/14): Magnetic Molecular Energizer
- International Association for Colon Hydrotherapy / Augustine R. Hoenninger, III, PhD, ND (3/21/03): Colon hydrotherapy devices
- KSM, Inc / Raymond F. Burgert, Jr. (3/14/07): Electromagnetic Treatment Device (ETD)
- Amy Holmes, MD (12/2/10): Allegedly submitting false information to the sponsor or FDA in required reports.
- Michael A. Arata, MD (9/13/16]
- Notice of initiation of disqualification proceedings (9/13/16): Unapproved CCSVI treatment study
- Follow-up letter offering a regulatory hearing (6/21/17)
- FDA Guidance for Institutional Review Boards and Clinical Investigators
- "Research" Associated with the Promotion of Questionable Theories, Products, and Services
This page was revised on May 2, 2018.