Dear Homeopathy Supporter, You’ve received one urgent call to action from NASH but please read this entire second email to further understand how imperative your action is. The green button below leads to a page that allows you to comment on the U.S. Food and Drug Administration’s (FDA) dangerous new rules on homeopathy and to send a message to your members of Congress, all with a few clicks.Posted a comment before 12/30/19? You can comment again!If you posted a comment before December 30, 2019, we encourage you to post a second comment. The comment form has been redesigned so that you can now reach your members of Congress, the President and the Vice President plus the FDA again with a new message.
We are sending out this second notice because it’s important to understand that the FDA has recently announced a path that could lead to the beginning of the end of homeopathy in America—not sometime in the distant future, but within a few months.
We are all constantly barraged by messages predicting the end of something we may hold dear. But we are informing you that this is what is written down in the FDA’s new proposed rules for homeopathy—rules that are a recipe for the FDA to withdraw one homeopathic remedy after another from the marketplace starting this year.
How do we know it’s that bad? Because one of America’s largest manufacturers of homeopathic products has put out a statement entitled, “The End of Homeopathy in America? It’s Our Choice” detailing how these new rules will affect businesses. They concluded that many manufacturers will cease production of homeopathic products in favor of other less endangered natural and alternative health products.
We do not believe that the end of homeopathy is necessarily inevitable. There is much hope.
First, the homeopathy community is in discussions with the FDA about making important changes to its proposed rules.
Second, our hope lies in YOU!
To impress upon the FDA that there is broad support for these changes, we are asking that you to do two very important things:
Submit a comment to the FDA docket and to members of Congress about homeopathy. When you’re ready to do that, you can click the green button below.
Forward this email to your clients, colleagues, students and any contacts that you have and get every family member in each household—regardless of age—to submit a comment to the docket.
You may know that the FDA has been working since 2017 on new rules (called “guidance” by the agency) to regulate homeopathy. The first set were so flawed that the agency withdrew them recently. That’s because people like you made such a big noise by deluging the FDA with comments and contacting members of Congress to complain about the proposed rules.
In their place the FDA has now released a revised guidance. This one has some helpful changes and some detrimental changes. Unfortunately, the detrimental changes were 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 comment on this new draft.
If you are familiar with these changes, you can go directly to the FDA Comment page on the site of Americans for Homeopathy Choice. There you can within a minute or two make a comment on this new guidance and send a message to your members of Congress with just a few clicks.
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.