Americans for Homeopathy Choice Action president Paola Brown provides an update on next steps to secure long-term access to homeopathic medicines in the United States.
In the wake of a new policy adopted by the U.S. Food and Drug Administration (FDA) regarding homeopathic medicines, the homeopathy community must now ask the U.S. Congress to intervene. The Congress needs to pass legislation that creates an appropriate regulatory framework which takes into account the unique nature of homeopathic drugs.
In the FDA’s finalized guidance document issued in December 2022, it classified homeopathic medicines as “unapproved new drugs.” That means they are subject to withdrawal from the marketplace at any time for any reason without notice or for no reason at all except that they are “unapproved new drugs.”
The FDA has already removed a set of homeopathic medicines with an unparalleled safety record from the market for the sole reason that they were “unapproved new drugs.” When asked in court by a federal judge whether the FDA had any evidence of safety problems, the FDA’s counsel replied, “No.”
To prevent any further erosion of access to homeopathic medicines, those of us who have worked under the Americans for Homeopathy Choice banner—now with over 120,000 members and growing—have shifted our fundraising and organizational efforts to our parallel sister organization called Americans for Homeopathy Choice Action to comply with legal requirements that allow us to lobby for legislation.
We have the same great leadership team, the same dedicated Homeopathy Action Team (HAT), and the same volunteers who have fostered a powerful movement to save homeopathy in America.
This is the team that supported our HAT volunteers when they held more than 200 meetings with members of Congress and their staffs during our Homeopathy of the Hill event this past spring. The HAT members asked Congress to support appropriations bill language that would prevent the FDA from using its funds to withdraw homeopathic medicines from the marketplace solely because they are “unapproved new drugs.” Under this proposed bill language, the agency would have to have a real reason to withdraw a specific product such a mislabeling or contamination.
The fate of this effort remains uncertain. And, even if the language were included in the appropriations bill, the limitation on the FDA would only last for the duration of the appropriation, that is, one year.
So, that’s why we are seeking a more permanent solution to preserving access to the full range of homeopathic medicines. Of course, all of us know that homeopathic medicines have been safely used for more than two centuries and were never intended to be treated as “new drugs” despite the FDA’s interpretation of the law.
This reclassification of homeopathic medicines is a technical change by the FDA to give it broad powers to move swiftly and decisively without any notice, hearing or public input when the agency believes a homeopathic medicine may pose a threat to the public.
We take safety very seriously and believe the FDA’s role in ensuring safety and proper labeling is important. But the FDA’s failure to provide a regulatory framework for bringing homeopathic medicines legally to market and its arbitrary removal of homeopathic medicines that pose no threat to safety are unacceptable.
We are therefore pushing for a regulatory framework tailored to the specific conditions and requirements of the manufacture, labeling, promotion, distribution and use of homeopathic medicines. Only with such a framework will it be possible both to ensure the safety of products and to protect access to the full range of homeopathic medicines.
For all those who want continued access to the full range of homeopathic medicines produced by a diversity of suppliers, we urge you to get involved in the effort to pass legislation that will provide a sustainable future for homeopathy in the United States.
You may be wondering, “How can I help?” Americans for Homeopathy Choice Action just finished our semi-annual pledge drive. We hosted a group of amazing speakers who shared their thoughts around homeopathic medicines, educating and inspiring all to learn more about homeopathy.
This year’s theme was “Homeopathy is My Super Power.” If you didn’t have a chance to see us live, we encourage you to watch the videos and consider making a donation. In order to keep our crucial efforts moving forward, we need your support.
To enjoy our pledge drive speakers and to donate, please visit: