SUPPORT NATURAL MEDICINE
The FDA and other regulatory boards in this country are moving to limit your access to homeopathy and natural medicine. If you would like to help in this effort to retain our right to choose natural medicine, visit the links below. You can make your voice heard or donate to help fight this threat.
1. Support Homeopathic Medicines
https://homeopathychoice.org/the-threat-to-homeopathy/
2. Support Compounded and Injectable Medicines Legal Fund:
https://www.gofundme.com/f/aanpcompoundedmedications
3. Contact your Congressperson and ask for support of HR-1959, both as a co-sponsor and also to get it out of committee. This legislation would stop most of the methods the FDA are using in the compounding-restriction process.
4. Resources to help you understand the bigger picture of what is happening to your rights:
https://restorativemedicine.org/journal/fda-fate-compounded-medicines/
Your story is powerful
From Americans for Homeopathy Choice
Help Empower Homeopathy, Leave a Comment
We are asking you to submit comments to the FDA, urging the agency to recognize homeopathy as a safe, beneficial, natural medicine.
Sending a comment voicing your opinion is important—and will only take a few minutes. If you are ready to submit a comment, you can visit the following webpage right now for instructions. Otherwise, read on for more information.
Why do we need your help? Right now homeopathy is under attack. The FDA is treating all homeopathic medicines as illegal. That means the agency now has the ability to remove them at any time or for any reason—or no reason at all other than that they are “illegal.”
Homeopathy is a safe, natural, yet effective alternative to pharmaceuticals and that everyone should have the right to choose. Tell the FDA to reconsider its decision by supporting a petition submitted to the FDA by Americans for Homeopathy Choice, an organization that has been at the forefront of protecting homeopathy
Twenty leading homeopathy organizations have come together to support the petition. Now, we are asking for your help in doing the same! We’re all submitting comments to the FDA in support of the petition. When you leave a comment through the AFHC website, it goes directly to the FDA, as well as members of Congress and other federal officials.
We know your time is valuable, so we pre-filled a comment for you in the link below. You can also submit your own comment—whatever works best! Just visit the following webpage for instructions:
https://homeopathychoice.org/fdacomment
Thank you for your support!
With gratitude,
Americans for Homeopathy Choice
AUGUST 2022 UPDATE
The efforts of Americans for Homeopathy Choice (AFHC) to protect access to homeopathic remedies continues!
Currently, the focus of the Homeopathy Action Team is to establish contact with local providers, retailers and schools, letting them know about FDA's draft guidance and how it has already blocked access to some homeopathic remedies.
In an effort to increase local awareness and support, we have had contact with Natural Grocer's and local Food Co-ops, in addition to informing local medical practitioners. We are providing updated information as it becomes available, and urging them to let me know if they encounter obstacles in obtaining remedies, so that we can begin compiling this information.
Additionally, we continue to keep our Congressmen informed of the situation. Their support will be important when legislation is introduced.
Please encourage friends to support AFHC! This is a wonderful, organized, intelligent, positive grassroots organization - volunteers are encouraged to "be a remedy" in every communication, as we work with Congress and the FDA to reaffirm what is already law.
SAVE HOMEOPATHIC MEDICINE
DECEMBER 2022 UPDATE
Dear Friends, Family, Providers and Retailers of Homeopathic Medicine,
There is a NEW and urgent need for you to take another simple step in the fight to protect your access to homeopathic medicines.
Recently I contacted you with a request to send a message to the President regarding the bold move FDA has taken in pushing their Draft Guidance through as policy. The results of the FDA's move were shocking and we need to respond quickly. You can either follow this link now, or read the full story down below. You will notice that the link gives you the option of identifying yourself as a consumer, educator, provider, acupuncturist, etc. The message will be tailored accordingly, but you may also edit it to suit your needs.
https://homeopathychoice.org/tell-fda/#/20/
Here is a review of recent events from the president of Americans for Homeopathy Choice:
Over Thanksgiving week, we reached out to you about a unique opportunity we had to communicate with the President and his advisors because the FDA had submitted its Draft Guidance to the Office of Information and Regulatory Affairs (OIRA) which operates by law within the Executive Office of the President. Thank you for your support in submitting comments to this office and to the President as we sought a meeting.
The turn of events after we sought this meeting shocked us.
We were able to schedule a meeting with this office and it was scheduled for yesterday Tuesday morning. Not only was the meeting scheduled, but it was confirmed and we received the teleconference meeting details. But on the morning of the meeting–literally hours before we were scheduled to meet with OIRA– we were notified that the meeting was canceled.
Why? According to OIRA, the office completed its review of the Draft Guidance as "consistent without change," meaning the office did not recommend any changes to the guidance. This is the reason they gave for canceling our meeting. Furthermore, the review was completed in about 7 business days. This is unusual because not only does the office have 90 days to complete the review but they also have a lengthy set of criteria they need to review. This indicates they would need time to properly review any document submitted to OIRA.
The office seemed to be in a big hurry to determine that the guidance was not economically significant, that it had no international impacts, that small entities would not be affected, and more. Oh, and of course, they made these conclusions without meeting with any stakeholders in the homeopathy community, like Americans for Homeopathy Choice. As you can imagine, we feel these conclusions are categorically false. The guidance has and does impact each of these areas and more.
Together with our attorneys who have years of experience with this type of scenario, we find the rushed timing of their regulatory review puzzling.
It also seemed clear to us that OIRA had no real desire to meet with us, which they would have done had they not concluded their review so quickly.
You already know that the Draft Guidance is anything but “reasoned.” At this stage, we need to assume that the Draft Guidance is now quickly on its way to being finalized. With your help, we have held it off for almost 5 years, but now this may be our final opportunity to tell the FDA that their guidance fails to regulate homeopathic medicines in accordance with the law.
Please take action! We don’t know how long it will take the agency to make its next move, so the sooner we communicate our concerns, the better! Our goal is to reach 40,000 comments!
https://homeopathychoice.org/tell-fda/#/20/
We need you to join in our efforts because your voice will change history. You are needed now more than ever!
Forward together for choice and good health,
Paola Brown, President
Americans for Homeopathy Choice
FEBRUARY 2023 UPDATE
In the last month, Senator Wyden has been conducting town hall meetings in each Oregon county. AFHC congressional leads (trained volunteers) were able to attend several of these meetings and had the opportunity to address Senator Wyden at consecutive town halls. He said, "I've been hearing a lot about homeopathy...I think this senator needs to start asking the FDA some questions."
This month, Senator Merkley is traveling throughout the state. AFHC was able to attend the Jackson County town hall, along with other congressional leads. While we did not have the opportunity to address the Senator directly, we were able to speak with one of his staff members and left an information packet with her. (She grew up with homeopathy and was very receptive.) Another AFHC congressional lead will be attending Merkley's town hall in Yamhill County tomorrow. This is an organized effort based on building positive relationships with Congress.
Next month we will be scheduling a Zoom meeting with Congressman Bentz's health legislative aid as a part of our annual Homeopathy on the Hill event, in order to inform the Congressman of the FDA's most recent actions and ask him to help in a very specific way... more on that later!
Your voice is important
From Dr. Chris’ Teacher, Dr. Paul Anderson
FDA RESTRICTIONS COMING
FDA "Divide and Conquer" strategy - it's like the '503a' and '503b" FDA Compounding process I've been involved in only worse. **See quote and link below about hormones.
BACKGROUND:
My view as an active participant in this: FDA found through the 503(a) compounding process which I've posted a lot about that using a nomination and Hearing process was long and messy. So they added a similar process for 503(b) - which is for larger scale compounding (almost manufacturing) for drug shortages - FDA removed the Hearing process and went to an "expert advisory panel" which I have given testimony to for things like EDTA and other medicines. The expert panel is autonomous and simply gives data to FDA which cuts out any Hearing (as I and many others have testified in for 503(a) compounding). Then the expert panel delivers the verdict to FDA and FDA moves to enact. ***Note this is what the process is for cBHT below.
FDA also then separated compounding into sub categories to not have them in the 503(a) or (b) processes and follow this new format. Some are:
503(b) as mentioned
Biologicals such as HCG, Insulin etc.
Peptides (were separated from Biologicals)
Hormones (as below)
Homeopathy (which now technically can be made to undergo NDA for each remedy.)
Others as well
AND the infamous "Difficult to Compound" list / process which DRUG MANUFACTURERS SUBMIT APPLICATION TO FOR PROTECTION OF THEIR Non cBHRT and other drugs. Getting on this list ALSO removes the drug / substance from compounding at any level with VERY FEW exceptions.
FROM THE REPORT: "The report concludes there is currently insufficient evidence to support the clinical utility of cBHT (Compounded Bio identical Hormones) — a multidimensional construct that reflects evidence about safety, effectiveness, therapeutic need, and patient preference."
MOVE TO 'DIFFICULT TO COMPOUND'
From the report: "The report recommends that the FDA’s Pharmacy Compounding Advisory Committee review 10 BHTs as candidates for the agency’s Difficult to Compound list, which prohibits pharmacies from compounding certain products that are complex in terms of formulation, delivery mechanism, and bioavailability (the extent to which the drug is absorbed by the body and has an active effect). These 10 candidates are: estradiol, estrone, estradiol cypionate, estriol, dehydroepiandrosterone, pregnenolone, progesterone, testosterone, testosterone cypionate, and testosterone propionate."
-----------------------------------
The 'Divide and Conquer' strategy works as FDA can point to 'expert panel advice' and mostly cut physicians, pharmacists and the public out. (YES, there is public comment but I've not to date seen one of those yield much - we did a 105 page one with lots of references for the last 503(a) slashing.)
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Dr. A’s Facebook page has links for information and a place to donate to the legal fund on his Facebook page.
https://www.facebook.com/paul.anderson.52687
Also, the IMC is the group working legally to address these issues. The IMC are doing all they can and have $$ for it but honestly any FDA opposition is mostly run over.
IMC = integrativemedicineconsortium.org
HOW TO HELP *Greatly at Risk* COMPOUNDED MEDICATION ACCESS:
1. Although the comment period is over for the 26 items below FDA will move to ban in 30 days. Be aware this is just the start. AND KNOW THAT THIS DOES NOT JUST AFFECT PHARMACY USE - EVERY PHYSICIAN AND MEDICAL OFFICE IS NOW CLASSIFIED A “compounder” so doctors and their offices cannot use them in any form other than Oral-OTC and will not be able to provide them to patients (beyond oral OTC supplement form). MANY OF THESE ARE USED IN SUPPOSITORY, TOPICAL and other non-oral forms - ALL THOSE WILL BE ILLEGAL. (Cancer and other patients rely on many of these).
2. Donate to the legal fund at this site and ask your patients to consider doing so as well. All funds are specifically used for legal and related costs. https://www.gofundme.com/f/aanpcompoundedmedications
3. Contact your US Congress person and ask that they support HR-1959 as co-sponsor and getting it out of committee. This legislation would stop most of the methods FDA are using in the 503(a) compounding restriction process. Free INFORMATION AS TO HOW TO DO THIS AND A VIDEO EXPLAINING THE BILL IS AT THIS LINK: https://www.consultdranderson.com/h-r-1959-preserving-patient-access-to-compounded-medications-act-of-2019/
4. Be informed of the larger process:
An article useful for physicians and patients covering the whole process: https://restorativemedicine.org/journal/fda-fate-compounded-medicines/
The actual “lists” and an FAQ on pages 6-8: https://www.consultdranderson.com/wp-content/uploads/securepdfs/2018/09/Anderson-Summary-FDA-503-Lists-and-Questions-09-15-2018-1.pdf
APPENDIX: THE LIST OF 26 SUBSTANCES: **NOTE THAT THIS REMOVAL RENDERS THESE SUBSTANCES ILLEGAL TO COMPOUND FOR ANY ROUTE OF ADMINISTRATION:
1. DHEA
2. acetyl-L-carnitine
3. alanyl-L-glutamine
4. Aloe vera
5. artemisinin
6. astragalus extract
7. boswellia serrata
8. cesium chloride
9. chondroitin sulfate
10. chrysin
11. curcumin
12. D-ribose
13. deoxy-D-glucose
14. diindolylmethane
15. domperidone
16. EGCG
17. germanium sesquioxide
18. glycyrrhizin
19. kojic acid
20. Nettle
21. NAD
22. NADH
23. rubidium chloride
24. (DCA) sodium dichloroacetate
25. vanadyl sulfate
26. (VIP) vasoactive intestinal peptide
Empower homeopathy
From one of ANM’s homeopathic injectables vendors, MediNatura, Inc.
FDA Targets Homeopathic Injection Providers
On June 11th, 2020, MediNatura, Inc. along with all other homeopathic injection providers in the US received an FDA Warning Letter. The letter stated that the prior rules that have been in place since the inception of the FDA relating to homeopathics have been reviewed and new rules have been put in place. The FDA is now requiring a New Drug Application (NDA) for all homeopathic injections on the market. The FDA now considers the MediNatura family of injections (Traumeel, Zeel, Spascupreel, Neuralgo-Rheum, Engystol, and Lymphymyost X) that have in the United States for over 30 years, available around the world for over 70 years, and backed by over 80 studies to now be considered new drugs.
We are currently responding to the FDA letter with our legal team to the best of our abilities to show the FDA we have always been evidence-based medicine at MediNatura. We are also seeking the support of the medical community in the United States that have depended on these safe and efficacious injections to treat their patients with pain for the last thirty years.
What I am asking of you is that you write a letter of response to the FDA, in support of the MediNatura injection family. The greater the response from the public and providers, like you, the more likely the FDA will be open to reviewing our current clinical data and use.
FDA
Contact: Dr. Stephen HahnCc: Dr. Patrizia Cavazzoni
patrizia.cavazzoni@fda.hhs.gov
This is of the utmost urgency. I, along with all MediNatura representatives across the country, am reaching out to each and every one of my doctors to ask you to help in creating a deluge of letters to the FDA explaining the safety, efficacy, and necessity of Traumeel, Zeel, Spascupreel, Neuralgo-Rheum, Engystol, and Lymphymyost X.
Thank you in advance for all you do everyday to keep your patients and our community healthy, safe, and in less pain.
Tessa Gates, MediNatura Representative
your COMMENTS are Valuable
From The Alliance for Natural Health
Federal agencies gag natural treatments
The FTC and FDA have been issuing hundreds of warning letters to block doctors, clinics, and companies from sharing the most basic information about how natural products can help our immunity. To ban information about natural health options during a health emergency is to fight with one hand tied behind our back.
The Alliance for Natural Health USA is sponsoring a petition to Congress to demand the federal government cease these attacks and reform our current healthcare system that blocks information about natural health products that can keep us healthy.
You can help put an end to this practice.
Take action by signing this petition today!