If you want to know more, here’s a summary of the most important points:
- The Draft Guidance, if adopted, will allow the FDA to withdraw even properly manufactured and labeled homeopathic medicines from the marketplace. This is puzzling because these have never posed any sort of safety concern according to an initial review of public FDA records by Americans for Homeopathy Choice.
- It is clear that the FDA intends to use this authority and has even mentioned specific medicines such as Belladonna, Nux Vomica and Lachesis in its public statements regarding enforcement.
- The authority for this kind of assault on homeopathy will result from the declaration by the FDA that all homeopathic medicines are “new drugs.” We all know that legally speaking, this is nonsense. Homeopathic medicines have been around for 200 years.
But this nonsensical declaration means that under federal law all homeopathic drugs will become technically “illegal” and subject to withdrawal from the marketplace. If the FDA just “thinks” there is a problem with a homeopathic medicine, it can withdraw it forever without conducting any sort of investigation.
- Since the agency has already told us that it “thinks” that Belladonna, Nux Vomica, Lachesis and several other remedies are dangerous, we can anticipate that it will try to remove them from the marketplace as soon as the guidance is finalized.
- Once this happens, the only conceivable way these remedies could be reinstated is to go through what the FDA calls a New Drug Application (NDA). But that’s not going to happen for two reasons:
First, no one can patent homeopathic remedies because they are made from common substances. So, no company would be able to make back the huge cost of going through the NDA.
Second, the NDA is designed for pharmaceuticals and is unable to test the effectiveness of a medicine that is tailored to each individual rather than given to a large mass of people who supposedly have the same condition. Hence, it is unlikely that any homeopathic medicine would be ruled safe and effective by the FDA.
That means that when the FDA removes a homeopathic remedy from the market, it will be the equivalent of banning it forever. And, don’t think that you’ll be able to order your remedies from abroad. The FDA will just stop them at the border.
I could tell you more, but what I’ve told you so far should convince you that we must get the FDA to change its unreasonable and misinformed guidance to reflect the realities of homeopathic medicines – they are nontoxic, mild, effective and have few, if any, side-effects.
And, homeopaths use them in ways that individualize treatment. That this is the best way to treat patients was discovered by Samuel Hahnemann 200 years ago. (Pharmaceutical companies are only now discovering that Hahnemann was right. But this hasn’t sunk in at the FDA.)
Help us tell the FDA where they’ve gone wrong and get them to change the Draft Guidance in ways that will protect rather than imperil homeopathy.