The Food and Drug Administration plans to move ahead with new rules that jeopardize homeopathic providers’ and patients’ abilities to obtain critical homeopathic remedies.
If you or your loved one receives homeopathic care — or you are someone who simply values patient choice — these proposed new measures by the FDA should concern you. Fortunately, as we will explore later, there is action you can take to protect your rights.
If implemented, these new FDA rules (which were not voted on by elected members of Congress) also endanger the livelihoods of thousands of respected homeopathic practitioners across the US who will be unable, in many instances, to carry out their work if the FDA fully implements its proposed new rules regime.
A forced closure of homeopathic businesses via the FDA’s new rules would greatly reduce, if not eliminate, the $1.2 billion that the homeopathic industry generates each year for the US economy and the thousands of jobs that it supports – in labs, pharmacies, clinics, and homeopathic schools.
In a document called a “Draft Guidance” issued last year and available on the Administration’s website, the FDA says it plans to “prioritize enforcement and regulatory actions for homeopathic drug products marketed in the United States without the required FDA approval.”
Currently, the FDA does not recognize any homeopathic remedies as medicine, which subjects them to the same approval process as any other supplement on the market. The proposed new rules would change that.
This represents a catch-22 for the homeopathy community; obtaining FDA approval for homeopathic remedies is virtually impossible. The FDA is now suggesting that, without its approval which is permanently out of reach, homeopathic remedies would be banned. If the FDA indeed instantiates its new regulations, there will be no legal recourse for homeopathic providers and patients.
The most respected homeopathic care organizations in the United States have drafted a petition to urge the FDA to reconsider its hastily planned enforcement against all homeopathic remedies, with no clear way of distinguishing legitimate medications from sub-par ones.
Resistance to new enforcement regimes by the FDA is not a radical position; the petition is supported by the following mainstream homeopathic groups:
The issue of fake or substandard medications is real and deserves attention from regulatory authorities; however, the FDA has proposed to carve out a special legal regime against homeopathy products as a whole, regardless of whether they are labelled properly.
What we need is smarter, more efficient regulation in all healthcare industries. This is not what the FDA is offering in its latest proposed rules. Instead, it suggests implementing sweeping new measures that unfairly target the centuries-old medical practice of homeopathy.
Patients across the United States – for many of whom, conventional treatments using pharmaceutical drugs does not work — rely on these legitimate, alternative remedies to support their health.
It’s critical to understand that, once the FDA passes these new regulations targeting homeopathy, getting them overturned will be virtually impossible and may take years. We must act now to stop the adoption of these measures before they are instantiated into law. We encourage you to show solidarity by signing our online petition.
We understand that your time is valuable, so we’ve tried to make the process as straightforward and time-efficient as possible. Filling the form is quick and easy, and we have even provided pre-filled comment forms.
The aim is to achieve 100,000 comments by December 2nd. We urgently need a large showing from the homeopathic community (providers and patients) that demonstrates widespread support. Your voice standing up for homeopathy is a small but critical contribution to the movement to encourage the FDA to rethink its regulatory approach in regards to homeopathy. Please consider signing the petition today.