FDA Hearing on Regulation of Homeopathic Medicine on April 20, 2015

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The FDA is holding a hearing to discuss the regulation of homeopathic medicine. What has spurred this interest by FDA in homeopathy? Homeopathy has been quietly treating and curing patients for over 200 years. What’s new is that homeopathy is now a billion dollar business, with Americans now spending $3 billion annually to purchase homeopathic remedies. With a growth rate reported to be 7%, the FDA has taken note with new documents outlining the ways that homeopathic remedies can now be marketed. While still claiming that homeopathic remedies have no medicinal effect, the FDA seeks to crack down on over the counter homeopathic remedies as well as prescription homeopathics and the manner in which they are marketed. The FDA states, “ The Federal Food, Drug, and Cosmetic Act (the Act) recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements (Sections 201 (g)(1) and 501 (b), respectively).”

What you can do

Anyone interested in supporting health freedom and the unrestricted use of the FDA’s pharmacopeia of homeopathic remedies, is urged to respond to the FDA. Regulation of homeopathic medicine may restrict access to these valuable remedies.  Contact the FDA at:

https://www.federalregister.gov/articles/2015/03/27/2015-07018/homeopathic-product-regulation-evaluating-the-food-and-drug-administrations-regulatory-framework

History of the FDA Action

On March 19, 2015, the FDA published a safety alert concerning over the counter homeopathic remedies for asthma.

The FDA followed with a notice of public hearing send out on March 27, 2015.

This hearing is intended 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.” The FDA invites input at the hearing and in writing from consumers, patients, caregivers, health care professionals, patient groups, and industry. The comment period on the document ends after 80 days, on June 22, 2015, however, the hearing was set just three weeks after the document was released.

The date of the hearing is April 20 and April 21 from 9 am to 4 pm at the FDA White Oak Campus in Maryland (address below.)  Register to speak at the hearing before April 13, 2015. See Registration and Request to Provide Oral Testimony for information on how to register or make an oral presentation at the hearing. Written or electronic comments will be accepted until June 22, 2015.

 

Information about the hearing, taken from the FDA’s website is below.

To submit a comment, please see the info below:

You may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You should annotate and organize your comments to identify the specific questions or topic to which they refer. It is only necessary to send one set of comments. Please identify your comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Address of hearing

FDA’s White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503A, Silver Spring, MD, 20993-0002. Participants must enter through Building 1 and undergo security screening. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

A live webcast will be broadcast here: https://collaboration.fda.gov/hprapril2015/

 

References:

https://www.nhmrc.gov.au/media/releases/2015/nhmrc-releases-statement-and-advice-homeopathy

http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074360.htm

https://www.federalregister.gov/articles/2015/03/27/2015-07018/homeopathic-product-regulation-evaluating-the-food-and-drug-administrations-regulatory-framework

About the author:
Melanie Grimes is a writer and a homeopath. She taught in the homeopathic department at Bastyr University and lectures internationally. You can follow her blog at: www.melaniegrimes.com