Dear Homeopathy Patients and Practitioners,
We’re posting this urgent message today requesting that you do two very important things before January 23, 2020:
1. 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 for manufactured and labeled homeopathic medicines.
2. Forward this email to your contacts and get every family member in each household—regardless of age—to submit a comment to the docket.
The FDA recently issued a statement that they were withdrawing the previous guidance and will be replacing it with a new, revised guidance. The proposed new guidance has some helpful changes and some detrimental ones.
Unfortunately, the detrimental ones are very detrimental, and we must now pressure the FDA to revise this guidance considerably.
We can do that by getting a very large number of people to ask for an extension while commenting on this new draft.
If you are familiar with the changes the FDA made, you can go directly to the FDA Comments page by clicking the button below.
If you prefer, you can submit your comment through the Americans for Homeopathy Choice (AFHC) Voter Voice system. There you’ll find out how to make a comment that will help us get an extension. You will be asked to enter your contact information including name and email. AFHC created some background information to help you construct your own comment to the FDA while highlighting key issues relating to the most recent Draft Guidance.
Submit Comments Through AFHC Voter Voice
If you want to know more about the changes, here’s a summary of the most important points:
1. The new Draft Guidance, if adopted, will allow the FDA to withdraw even properly manufactured and labeled homeopathic medicines from the marketplace.
2. It is clear that the FDA intends to use this authority and has even mentioned specific medicines such as Belladonna, Nux vomica and Lachesis muta in its public statements regarding enforcement.
3. The authority for this kind of assault on homeopathy will result in the declaration by the FDA that all homeopathic medicines are “new drugs.” Homeopathic medicines have been around for 200 years. This nonsense 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.
4. Since the agency has already told us that it thinks that Belladonna, Nux vomica, Lachesis muta 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.
5. 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 both 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. The FDA may even prevent you from being able to order your remedies from abroad.
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. Homeopaths use them in ways that individualize treatment.
Help us get an extension so that there will be enough time to prepare a proper response to the FDA. We need the additional time to prepare materials to show the FDA step-by-step how to change the Draft Guidance in ways that will protect rather than imperil homeopathy. Please click on the button below to make a comment to the FDA in just a minute or two.
With urgency and gratitude,
Deb Dupnik
Executive Director
The National Center for Homeopathy
P.S. Please send this message on to anyone you can think of who cares about homeopathy. Time is running out!