FDA challenge

Carol

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Jun 26, 2018
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54
Hi,
I’ve been reading more and more on the FDA banning homeopathic remedies. At first, I was not concerned, but now feeling it’s a real possibility??
Wondering what our homeopathic vets are hearing and feeling.
Thank you.
Carol
 

Dr. Sara

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Dear All,
I have mailed the following to my clients who use homeopathy. I am a member of the Advocacy for Homeopathy Working Group, which unites mixed consumer and practitioner groups like the NCH, practitioner groups like AIH and AVH, homeopathic pharmacists, and consumer groups, like Americans fo rHomeopathy Choice. There is a real danger to homeopathy, and grass roots efforts will make a big difference. You can share this information with any interested parties. The FDA cares more about consumers than they do about practitioners!
Cheers,
Sara


Please forgive this imposition in the holiday season. This will truly only take a few minutes. The FDA has proposed draft guidance that would make homeopathic medicines illegal.
This would be disastrous for homeopathy.
Please ask the FDA for an extension, and make any other comments desired.
Thank you,
Sara

Dear Friends of Homeopathy,

You have likely heard that 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. Please take a few minutes to submit your comments to the FDA at this link, or read on for more information:

Tell the FDA 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, go to this link:
FDA Comment - Americans for Homeopathy Choice

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 The newly revised Draft Guidance, if adopted as currently written, will be a recipe for the destruction of homeopathy as we know it in America.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 and other homeopathy organizations 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. 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:

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. When you’re ready to do that, go to this link:
FDA Comment - Americans for Homeopathy Choice

2. Encourage all of your friends and family members who support homeopathy to also submit a comment to the docket by sending them a copy of this email.

Thank you for your help!
 

Dr. Jeff

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Carol

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Jun 26, 2018
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Ditto here. And same question!!!
Wondering if fda has plans to take arnica cream and calendula cream off the shelves too! I have non homeo believing acquaintances that use that stuff and love it.
 

jsqueglia

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Feb 11, 2018
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I sent mine too!
Also have been considering buying some kits but really hoping the Homeopathic community can sway the FDA in Homeopathy's direction.
 

Dr. Jeff

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Fantastic, thanks so much to everyone who commented to FDA.

Yes @lizkunz and @kingsgrlie, now's a good time to stock up on remedies.

@jsqueglia, I sure hope you're right. Historically, challenges like this have not been successful for shutting down access to homeopathic medicines.

Nowadays...?
 

kingsgrlie

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Fantastic, thanks so much to everyone who commented to FDA.

Yes @lizkunz and @kingsgrlie, now's a good time to stock up on remedies.

@jsqueglia, I sure hope you're right. Historically, challenges like this have not been successful for shutting down access to homeopathic medicines.

Nowadays...?
Thanks, Dr. Jeff, can you make some suggestions on what to purchase to stock up on remedies?
 

Dr. Jeff

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The emergency kit remedies are a great place to start.

 

kingsgrlie

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The emergency kit remedies are a great place to start.

Thanks, Dr. Jeff - 30Cs are sufficient? How about 200Cs? I already have the professional kit of 6Cs for Koby.
 

Dr. Jeff

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6c, 30c, 200c, 1M, 10M, 50M and Q1-Q3 kits are typically what a professional homeopath would have.

A professional kit in 30 and 200 would be great but is pricey.

Perhaps go for emergency kits of 30 and 200.
 

Dr. Jeff

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Dr. Sara

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The deadline for commenting has been extended to 23 March. I am asking all of you to comment again on the FDA Guidance, and how it will affect you and your family. The proposed guidance would require each homeopathic medicine to go through the same approval process as every new conventional drug. This would make homeopathic medicines unavailable, as no manufacturer is going to pay for an expensive approval process for medicines that can not be patented.

People can comment multiple times, with different content. Send substantive comments with your experience of homeopathy, and encourage everyone you know and everyone in their families to submit a comment. You may also simply use the prepared comment. The FDA will listen to consumers. The consumer voice must be loud and clear!
Please share, share, share the link for commenting on the FDA guidance.

Consider sharing this on social media platforms to increase interest.

Thank you!
Sara
 

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