FDA challenge

Carol

Member
Joined
Jun 26, 2018
Messages
93
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

Veterinarian
HA! Faculty
Joined
Dec 30, 2018
Messages
132
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 The FDA has proposed draft guidance that would make homeopathic medicines illegal.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 The newly revised Draft Guidance, if adopted as currently written, will be a recipe for the destruction of homeopathy as we know it in America.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 This is because the Draft Guidance declares all homeopathic medicines to be “new drugs” which have not undergone the agency’s pre-market approval process known as a New Drug Application (NDA).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

Administrator
Moderator
Veterinarian
Joined
Feb 23, 2017
Messages
2,053

Carol

Member
Joined
Jun 26, 2018
Messages
93
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

Member
Joined
Feb 11, 2018
Messages
40
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

Administrator
Moderator
Veterinarian
Joined
Feb 23, 2017
Messages
2,053
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

Member
Joined
Jul 16, 2019
Messages
197
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

Administrator
Moderator
Veterinarian
Joined
Feb 23, 2017
Messages
2,053

Dr. Jeff

Administrator
Moderator
Veterinarian
Joined
Feb 23, 2017
Messages
2,053
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

Administrator
Moderator
Veterinarian
Joined
Feb 23, 2017
Messages
2,053

Dr. Sara

Veterinarian
HA! Faculty
Joined
Dec 30, 2018
Messages
132
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
 

beccak

Member
Joined
May 8, 2017
Messages
52
This has been praying on me nonstop, day and night.

I have sent in this form a few times, now wondering if I should be calling my MOCs? Is there a committee wold be overseeing this? If so, do you know which one? I would reach out to each member directly if someone can point me in the right direction?
If not, I can reach out to my state rep (would not expect a quick response from either).

I was initially thinking in worse case scenario I could run up to Canada to get remedies, but if labeled "illegal', I would not be able to bring then back into the country.

Would this law put an end to all American homeopaths, human and animal, unless we happen to have the right remedy at home???
I don't think we could even legally give a remedy to a friend who is looking for one.

Concerned,
Becca
 

Dr. Sara

Veterinarian
HA! Faculty
Joined
Dec 30, 2018
Messages
132
Dear Becca,
It is great that you have let the FDA know your thoughts.
If you want to further channel your energy into safeguarding and promoting homeopathy, please visit the Americans for Homeopathy Choice website.
They have plenty of ways to get involved including Homeopathy Action Teams, where you can truly difference on a local and national level.
Cheers,
Sara
 

Dr. Sara

Veterinarian
HA! Faculty
Joined
Dec 30, 2018
Messages
132
More information from Americans for Homeopathy Choice on how you can help support homeopathy:

Hello Friends in the U.S. Homeopathic Community,

As you know Americans for Homeopathy Choice is committed to protecting access to homeopathic remedies. Our Homeopathy Action Team (HAT) represents one of our very important volunteer activities. We are currently mobilizing our volunteer network into a Congressional Advocacy Team which will connect with our Senators in all 50 states and our U.S. Representatives in each of the country’s 435 Congressional districts. It is so important that all organizations in the homeopathic community unite in our message to protect the freedom to choose homeopathy!

The Congressional Advocacy Team needs individuals from your organization. Sign up here!

We are making progress in filling the needed roles for the Congressional Advocacy Team! Volunteers have signed up to fill the role of State Captain, Senate Lead, or House Lead in many states. Some volunteers have offered to fill multiple roles until other volunteers can take over.

Please reach out to the members of your organization and ask them to consider what they can do to help represent homeopathy choice in their state!

The Congressional Advocacy Team needs:

State Captains: Each State Captains will help recruit and train Senate/House Leads to foster relationship development with members of Congress. He/she will oversee and encourage the volunteers in each state as they communicate with their congressional offices. Each State Captain will serve as the main AFHC point of contact for team members in each state. Sign up here!

Senate Leads: Each Senate Lead will cultivate a relationship with the Senator’s office and encourage others to respond to any AFHC action alerts. Ideally, the Senate Lead would be able to attend an in-person meeting at the in-state office of his/her Senator. Sign up here!

House Leads: Each House Lead will cultivate a relationship the U.S. Representative’s office and encourage others to respond to any AFHC action alerts. Ideally, the House Lead would be able to attend an in-person meeting at the in-state office of his/her U.S. Representative. Sign up here!

All training is provided by Americans for Homeopathy Choice. We will work alongside volunteers each step of the way to fully equip them for the role they choose.

Be sure that your organization is represented as we organize this important effort! Together we can maintain the freedom to choose homeopathy!





 

Weekly Digest

Weekly Digest
Subscribe/Unsubscribe

Members online

No members online now.

Latest posts

Top Bottom