The U.S. Food and Drug Administration (FDA) recently announced a new guidance that could lead to the end of homeopathy in America in less than three months.
The consequential action taken by the FDA involves the elimination of the administrative framework for homeopathy that the agency used for 30 years, one that allowed manufacturers of homeopathic remedies to thrive while ensuring the quality and purity of homeopathic medicines. We are referring to the withdrawal of Compliance Policy Guide (CPG) 400.400 which has served the industry and consumers well.
Homeopathic medicines are now in real danger. The newly revised Draft Guidance, if adopted as currently written, will be a recipe for the destruction of homeopathy as we know it in America.
Under the new guidance ALL homeopathic medicines will be considered illegal. This is because the Draft Guidance declares all homeopathic medicines to be “new drugs” which have not undergone the agency’s pre-market approval process known as a New Drug Application (NDA). This “new drug” designation makes this new guidance particularly damning for homeopathy. Homeopathic medicines cannot be patented and therefore cannot justify the enormous expenditures that an NDA entails. If the FDA insists that a homeopathic medicine be put through the NDA process, the agency will essentially be issuing a potential ban on that medicine in the United States.
If the Draft Guidance is adopted unchanged ─ and especially if the designation of all homeopathic medicines as “new drugs” is allowed to stand ─ consumers will likely begin to see homeopathic medicines disappear from store shelves and practitioners’ offices as the FDA takes aim at one homeopathic medicine after another.
What’s more, if the Draft Guidance is finalized, the FDA will have little trouble defending its actions in any administrative procedure or court. The danger is real because the designation of homeopathic medicines as “new drugs” makes all of them illegal and the FDA can remove any illegal drug from the marketplace without notice and without additional justification merely because it is illegal.
It would be a simple matter for the American Institute of Homeopathy to produce evidence showing that homeopathy is extremely safe, with excellent clinical results backed by an extensive medical literature including hundreds of clinical trials which demonstrate its safety and effectiveness. We could also point to the very real public health emergency around antibiotic resistance and the immense potential for homeopathy to save lives as reason alone to protect homeopathy.
Sadly, none of that will matter if those who support and rely on homeopathy do not immediately unite to seek a better framework from the FDA.
If you’d like to do your part to protect your access to this extraordinary system of medicine in America, please take these steps immediately:
- Submit a comment to the FDA docket about homeopathy telling the agency that we need a 180-day extension in order to respond adequately to the FDA’s latest proposed rules. When you’re ready to do that, click here: https://homeopathychoice.org/fdacomment/
- Encourage all of your contacts, patients, and family members to also submit a comment to the docket by sending them a copy of this email.
We can and must save homeopathy in America but we must act now.
kamau kokayi MD