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NCH Update on Homeopathic Regulatory Issues
December 21, 2016
Understandably, the recent FDA warning against homeopathic teething tablets and FTC policy statement on homeopathic labeling requirements have surprised and concerned our homeopathy community.
Over the past 2 months, NCH has fully immersed itself in monitoring and understanding these issues and planning an appropriate response. Most recently, NCH organized and moderate a meeting of key stakeholders from several homeopathic organizations and leaders in the industry. Below is a summary of the current landscape:
- The American Association of Homeopathic Pharmacists (AAHP) is on the front line of this situation. They are in direct negotiations with the FTC. They have a long-standing working relationship with the FTC regarding advertising and believe they will be able to settle this favorably.
- We – the homeopathic community - need to support the AAHP because they know the details, communication pathways, and history of advertising regulations with the FTC. AAHP also has legal and public relations support.
- The message from the AAHP is to share up-to-date scientific information about the proven effectiveness of homeopathy with consumers and the larger public to correct misconceptions that have proliferated through the media.
- Industry experts have also advised the homeopathic community to stay positive and reinforced that it is not helpful to attack federal agencies. At this time, there is no need for community members to contact the FDA or FTC directly; to do so might be harmful to ongoing negotiations.
- These issues are complex and require deep understanding of the governmental agencies involved. To learn more about the history of these issues, you can visit the NCH website.
We also wanted to clarify that:
- The FTC and FDA have both been scrutinizing homeopathy for the past two years – this is not something new. As regulatory agencies, they have the right to do so within their scopes of work.
- The FTC policy statement is specifically around advertising for homeopathic medicines sold over the counter (OTC). They are requiring scientific proof of effectiveness for advertising purposes. Without clinical studies to back up effectiveness claims, the FTC considers it false advertising
- The FDA, through a special exemption, does not require proof of effectiveness through clinical research. They accept HPUS documentation.
- The FTC ruling affects all homeopathic products that are sold OTC, not just combination remedies. Prescription products come under the FDA.
What NCH Is Doing In Response
NCH has been very active, both behind-the-scenes and publicly:
- We have been in close communication with AAHP to obtain the correct and most up-to-date information regarding these evolving situations. We have been in discussion with AAHP as to the best supportive responses and the best timing for these responses.
- We formed a Board of Directors-level FDA/ FTC Taskforce to closely monitor the situations and develop strategies for responding to challenges.
- We published a statement regarding the FDA teething tablet warning on our website and on social media and answered many inquiries from the homeopathic community.
- Two weeks ago, we hosted a community-wide summit of more than 10 homeopathic organizations to share correct information and plan a strategic response.
- We are organizing a workgroup of representatives from these organizations to develop a strategic, unified community response, in coordination with AAHP input.
- We have collected all original documents (i.e., the FTC and FDA statements; AAHP and AIH press releases; letters of response) and posted them on the NCH website for reference.
- We have consulted an experienced public relations expert regarding the best response and timing for both the immediate situation and a strategy for future challenges to homeopathy.
- Previously, we sent NCH representatives to both the FDA hearing and FTC workshop held in 2015. The proceedings of these events were published in Homeopathy Today (Winter 2015) and are available to members for reference. Prior to that we developed and conducted a survey of nearly 20,000 homeopathy users regarding consumer experience and attitudes about OTC homeopathic medicines. The results of this survey were presented via public comment to the FDA and in-person at the FTC workshop.
As stated above, much of NCH’s work has been behind the scenes, as is usual in dealing with governmental and regulatory issues. However, we are working every single day with our partners, allies, and industry experts to protect access to homeopathic medicines and dispel misunderstandings about their effectiveness.
At this point, there is no need for community members to take action. If and when we determine that there is a need for community members to act publicly, we will let you know. For now, the situation is still evolving; we are monitoring it and are poised to respond.
We are optimistic about this situation and are hopeful that these matters will be settled favorably, resulting in an increased governmental understanding of homeopathy and continued open access for consumers to our health-giving medicines. We will update you on the progress.