On April 20-21, 2015, the Food and Drug Administration (FDA) held a public hearing at its White Oak Campus to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA seeks written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA seeks input on a number of specific questions, but is interested in any other pertinent information participants would like to share. Please refer to the following documents for more information:
- Federal Register Notice March 27, 2015 – announced public meeting and request for comments
- Federal Register Notice June 10, 2015 – extended comment period until August 21, 2015
- Federal Register Notice September 9, 2015 – reopened comment period until November 9, 2015
UPDATE: To allow interested persons additional time to submit comments, on September 9, 2015, FDA re-opened the comment period for the above notice of public hearing for an additional 60 days until November 9, 2015.
The agenda (PDF - 105KB) for the April 20-21 public hearing is available.
April 20 Presentations
- Edward Krenzelok, Rocky Mountain Poison and Drug Center (PDF - 299KB)
Adriane Fugh-Berman, Georgetown University Medical Center(PDF - 154KB) Michael DeDora, Center for Inquiry(PDF - 430KB) Lisa Amerine, Homeopathic Academy of Naturopathic Physicians(PDF - 25KB) Amy Rothenberg, American Association of Naturopathic Physicians(PDF - 101KB) Bruce H. Shelton, Arizona Homeopathic and Integrative Medical Association(PDF - 195KB) Jeannine Ritchot, Health Canada(PDF - 288KB) Alison Teitelbaum, National Center for Homeopathy(PDF - 104KB) Mark Land, Mark Phillips, Eric Foxman, American Association of Homeopathic Pharmacists(PDF - 297KB) Barbara A. Kochanowski, Consumer Healthcare Products Association(PDF - 851KB) Luana Colloca, University of Maryland – Baltimore(PDF - 4MB) Alyssa Wostrel, Integrative Health Policy Consortium(PDF - 267KB) Nancy Peplinsky, Holistic Moms Network(PDF - 124KB)
April 21 Presentations
Robert C. Dumont, Raby Institute for Integrative Medicine at Northwestern, LLC(PDF - 47KB) Will Woodlee, American Herbal Products Association(PDF - 28KB) Youngran Chung Northwestern University Feinberg School of Medicine(PDF - 37KB) Ronald Boyer, Center for Education and Development of Clinical Homeopathy(PDF - 131KB) J.P. Borneman, Gary Yingling, Todd Hoover, Homeopathic Pharmacopoeia Convention of the United States(PDF - 210KB) Al Lorman, Law Office of Alvin J. Lorman(PDF - 126KB) Terry Cotter, Terra-Medica Inc.(PDF - 132KB) Edward D. Pergament, Materia Medica Holding(PDF - 1.6MB) Ronald D. Whitmont, Bernardo Merizalde, David Riley, Michelle Dossett, American Institute of Homeopathy(PDF - 396KB) David Chipkin, Parmesh Banerji Life Sciences, LLC(PDF - 40KB) Yale Martin, Independent Retail Consultant(PDF - 39KB) Patrick Gibbons, Emerson Healthcare Group(PDF - 116KB) Gary Kracoff, Johnson Compounding and Wellness Center(PDF - 33KB) Peter Fisher, Royal London Hospital for Integrated Medicine(PDF - 21KB)
- Daniel L. Michels (PDF - 15KB)