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FDA Update: Homeopathy Well-Represented at FDA Regulatory Hearings
April 22, 2015
FDA’s 2-day public hearing to gather information about the current use of products labeled as homeopathic concluded today. This hearing was not held to discuss the efficacy of homeopathic remedies, the ability of individuals to practice homeopathy, or to consider the removal of homeopathic remedies from the retail market. Rather it focused specifically on FDA regulations of and labeling requirements for OTC homeopathic products.
From the Meeting
A total of 45 people presented testimony over this 2-day period (you can see the full agenda here), and the overwhelming majority of these speakers were supporters of homeopathy and the existing FDA regulations for homeopathic remedies. More than 150 additional attendees filled the room and spilled into 2 overflow rooms, where the hearing webcast was broadcast as a live stream.
Two NCH board members were on-site during the entire 2-day hearing and NCH executive director, Alison Teitelbaum, presented testimony on Monday, April 20, 2015 regarding consumer access, choice, and attitudes about homeopathic products.
Hearing attendees also heard from representatives of the homeopathic manufacturing industry, homeopathic pharmacists, homeopathic and integrative medicine researchers, practicing homeopaths (including MDs, NDs, DOs, and CCHs), representatives of professional homeopathic and naturopathic organizations, and representatives of other consumer-facing organizations (including the Holistic Moms Network, and the Consumer Healthcare Products Association). The consistent message reinforced across these groups was that current FDA regulations of homeopathic remedies are sufficient and have served the public well for the last 25 years.
FDA panelists had the opportunity to ask follow-up or clarifying questions after each presentation. The questions showed a significant interest in homeopathic medicines and indicated that panelists were listening carefully to the speakers' presentations and that they wanted to accurately understand the viewpoints and research that were presented in each.
We believe that these 2 days laid the groundwork for ongoing collaboration and dialog with FDA regarding homeopathic drug products in the marketplace.
What Happens Next?
The public hearing was the first phase of information gathering for FDA – the transcript of the hearing should be made publicly available around June 5. The next phase of information gathering will begin this week, which is a public comment period. This comment period will remain open through June 22.
During this time members of the public will be able to provide comment to the FDA to further support current FDA regulations.
How You Can Help
NCH is currently working with several consumer education and advocacy groups to develop guidance for interested community members to use when submitting their comment. Once developed, we will share this guidance with the community as soon as we can. Remember – we have until June 22 to submit comment. We strongly urge community members to wait to submit their comments until after we provide guidance on how to best do so.
We also want to ensure that any comments submitted to FDA are respectful of the agency. Unfortunately, we have discovered that some individuals in the homeopathic community have sent very negative, disrespectful messages to FDA representatives about the hearing. We request that community members keep their comments respectful and constructive.
Please direct all questions about the FDA hearing and comment period to NCH executive director, Alison Teitelbaum at firstname.lastname@example.org.