Hello from Americans for Homeopathy Choice! Thank you for taking the time to follow along as we inform you about the FDA threat to homeopathy. We trust it’s been an eye-opening look at what we work so diligently to do, each week, at Americans for Homeopathy Choice.
If you’d like to read the summary of today’s report, scroll down to the end of this post!
Outline:
- The FDA Guidance is now final. It is only a policy document and not the law.
- Homeopathy remains legal. The Food, Drug & Cosmetics Act recognizes all remedies listed in the Homeopathic Pharmacopeia of the United States. Therefore, homeopathic medicines are recognized by federal law.
- For the first time, the FDA is saying that homeopathic medicines are “unapproved new drugs” and that they are being “illegally marketed.”
- This does not make homeopathic medicines illegal. Nevertheless, this is having a “chilling” effect on the market.
- The FDA asserts that because homeopathic medicines are “unapproved new drugs,” they are subject to premarket approval requirements.
- The FDA knows that the new drug application process, which is designed to evaluate the risks of chemical pharmaceuticals, is not appropriate for homeopathic medicines, and also not financially feasible for manufacturers of homeopathic remedies.
- The Agency stated that it is using the designation of “unapproved new drug”
as an enforcement tool to give it the authority to remove homeopathic medicines
whenever necessary. - However, the FDA would have to pull medicines off the market one-by-one and would likely end up in court as a result. It could not, for instance, pull all versions of Aconitum napellus off the market all at once.
- But the FDA has other means to force medicines off the market, such as smear campaigns and blocking imports of homeopathic medicines which is already happening.
- Americans for Homeopathy Choice formed to fight this deeply flawed guidance, and we need your help now more than ever, so please consider joining the Homeopathy Action Team (HAT)!
- HAT enrollment has been temporarily reopened – the deadline to sign up is Tuesday December 13th!
- Please also consider donating to AFHC – we need financial resources to wage this fight!
- Lastly, be sure to sign up to our email list and text alerts if you haven’t already!
- We’ll see you after the New Year for the next Insider report and more updates.
Our job is not to change the world;
our job is to steward the gifts we’ve been given.
Summary of Today’s Episode:
This is Paola Brown, president of Americans for Homeopathy Choice, here today with another report for Homeopathy Choice Insider. The most important development has been the finalizing of the FDA Guidance on homeopathy. The Guidance is now final, which means that it represents the current thinking of the FDA regarding homeopathy. This is a policy document. It is not the law and any statements in it are merely the thoughts of current FDA officials. This has led to some misunderstandings. Let me clear those up:
1. Homeopathy remains legal. The FDA has said for the first time that homeopathic medicines are “unapproved new drugs” and that they are being “illegally marketed.” That doesn’t make homeopathic medicines illegal. These medicines are written into the Food, Drug and Cosmetic Act which recognizes the Homeopathic Pharmacopoeia of the United States. Homeopathic medicines are therefore recognized in federal law.
2. The FDA asserts in its Guidance (which is not a law!) that because homeopathic medicines are “unapproved new drugs,” they are subject to premarket approval requirements. The Agency states that there are no FDA approved homeopathic medicines and that this is why FDA is going to treat homeopathic medicines as if they are being “illegally marketed.” (Again, this is just the FDA’s thinking and we do NOT agree with it.) The FDA therefore claims that it can remove any homeopathic medicine from the market at any time without any reason other than that it is being marketed illegally.
This is having a “chilling” effect on the market for homeopathic medicines. We are very concerned about that. This Guidance explains how the FDA will remove homeopathic medicines from the market. But it provides absolutely no path for homeopathic medicines to enter and remain in the market legally.
The FDA has stated that homeopathic medicines can go through the drug approval
process. But that process was designed for chemical pharmaceuticals to determine
whether their risks (usually toxic risks) are outweighed by their benefits. In addition, the
cost of such applications runs in the tens of millions of dollars. Since homeopathic
medicines are NOT patentable—they are made from commonly available
substances—there is no way for any company making such an application to recoup its
investment in the application.
The FDA knows this because we met with Agency personnel and explained it to them.
The FDA admitted that the new drug application process doesn’t work for homeopathic
medicines. The Agency stated that it is using the designation of “unapproved new drug”
as an enforcement tool to give it the authority to remove homeopathic medicines
whenever necessary.
The Guidance states that many homeopathic medicines fall outside the enforcement
priorities of the Agency. But because the Guidance is not law, the Guidance may be
disregarded by the Agency whenever it wishes to. It is true that the FDA would have to pull medicines off the market one-by-one and would likely end up in court as a result. It could not, for instance, pull all versions of Aconitum napellus off the market all at once.
But the FDA has other means to force medicines off the market, namely, conduct a
smear campaign using unfounded accusations to frighten consumers away and thus force companies to discontinue manufacture of the targeted medicines. Another way is blocking imports of homeopathic medicines – which is already happening.
Americans for Homeopathy Choice formed to fight this deeply flawed Guidance and we need your help now more than ever. Please consider signing up for the Homeopathy Action Team. This is a critical group for connecting us to Congress where we think we have a chance to pass legislation that will protect homeopathy.
We are a resource for members of Congress and their staffs. It’s important that WE are seen as the source of reliable information, NOT the FDA, NOT Wikipedia. One of our HAT members actually received a call from a Congressional staff person almost as soon as the Guidance was finalized. The staff person was concerned about this development and asking for updates.
This is why joining the Homeopathy Action Team is so important. The deadline to enroll is Tuesday, December 13. After the initial training, there is only a modest time
commitment each month.
There are two other things you can do: 1) Become a free member and sign up to receive our weekly Insider report and occasional alerts and 2) make a donation. We need financial resources to wage this fight.
Thank you so much. I’ll see you after the New Year with another Homeopathy Choice Insider report.
