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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.

Comment Now

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

June 2021 Update

Meeting with Congressman Bentz's Office: This morning we were finally able to have the long awaited meeting with Congressman Bentz's health legislation aid in DC, Jessica Kelley! Prior to the meeting, we learned that Jessica has an MA in Healthcare Administration and a law degree, so we were optimistic that she might be especially interested in the issue of the FDA and homeopathy.

There were four of us on the Zoom call with Jessica, all constituents of Congressman Bentz and all dedicated volunteers with AFHC. While the call lasted only 15 minutes, it was very positive! Jessica had little knowledge about homeopathy, but she showed genuine interest in our personal testimonies and asked for more information about what homeopathy is. We sent her a follow up email with information prepared by AFHC and will be in communication with her every 2-3 weeks to keep our cause in the forefront of her mind.

What we specifically asked Jessica to do was contact Congressman Ro Khanna's office. Khanna is the representative from California who has taken up our cause. He has already met with the FDA and has begun forming a team of legislators to work on the issue. Legislators from both sides of the aisle have joined the team, which will be very helpful as we move forward.

Medi Natura : The lawsuit filed against the FDA by MediNatura is still in court, however, the FDA blocked MediNatura's homeopathic medications from importation, labeling them "illegal." This leaves many, many patients without the medication they have been relying on. Furthermore, MediNatura has had to let a number of their employees go. This situation highlights the importance of this advocacy effort.

AFHC: Americans for Homeopathy Choice is a committed, well organized and positive organization. We encourage everyone who has an interest in preserving our access to homeopathic medicine to visit their website. https://homeopathychoice.org/

April 2021 UPDATE

April is a big month for AFHC! Over the past several months, we have been contacting our legislators' offices via phone and email to establish a relationship and begin having a conversation about our concerns regarding the FDA and its position on homeopathic medicine. On April 22nd, 600 of us will "Zoom-in" to Washington, DC, as a part of "Homeopathy on the Hill", to meet with our legislators (or the staff members responsible for health legislation) to familiarize them with homeopathic medicine and its status in our country as a unique, inherently safe system of medicine, and to give them an overview of the FDA's policy - and policy reversal - regarding these medicines. We will also be sharing our personal experience with homeopathy and asking our legislators to support a bill that is being introduced by AFHC and our bill sponsor. In preparation for this, we have done research on our legislators and their staff members to find points of connection and make this conversation as personal and fruitful as possible. We've also had several training sessions and a rather large handbook to read, so that we can be well informed about the issue.

AFHC is a very organized, positive group made up entirely of volunteers (with the exception of a few lawyers and a doctor who is coordinating the event in Washington, DC.) It's neat to hear how strongly people feel about homeopathy and their homeopath!

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 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.

https://homeopathychoice.org/

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 (Americans for Homeopathic Choice) 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 AFHC 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... but more on that later!

From McGuff Compounding Pharmacy

A PETITION FOR THE CALIFORNIA STATE BOARD OF PHARMACY TO SIGN THE FOOD & DRUG ADMINISTRATION’S MEMORANDUM OF UNDERSTANDING

The FDA has finalized its MOU between its agency and the Board of Pharmacy. If the Board agrees and signs the MOU, compounding pharmacies within California will only be allowed to ship 50% of all its prescriptions for compounded medications out of the state in which they are located. If the Board chooses not to sign the MOU, compounding pharmacies within all California will be permitted to only ship 5% of all its prescriptions for compounded medications across state lines. Not signing the MOU will have disastrous consequences:

• Patients depending on specialized, compounded medications will have less options of quality compounding pharmacies to choose from.

• Consumers will lose access to customized medications as no single pharmacy makes all compounded drugs needed. Further restrictions beyond the FDA’s MOU interstate limit will only result in more compounded prescriptions unable to be filled.

• Cost of compounded medications will increase for patients and physicians, due to not being able to support as many customers.

• California compounding pharmacies run the risk of being regulated out of business.

• The MOU, if not signed, will create artificial drug shortages across many states.

• Most importantly, patients’ overall well-being and quality of care will be compromised.

As part of the Department of Consumer Affairs (DCA), we call on the Board to live up to the DCA’s mission to “…protect California consumers by providing a safe and fair marketplace through oversight, enforcement, and licensure of professions,” and the Board of Pharmacy’s Mission Statement of protecting and promoting “the health and safety of Californians.”

A decision to sign the MOU would enhance the confidence California consumers have in the DCA and Board of Pharmacy to protect their health and safety.

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!

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.)

------------------------------------

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

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 Hahn

  stephen.hahn@fda.hhs.gov 

  Cc: 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

MEDINATURA UPDATE

March 22, 2021

I write this letter with a heavy heart.

Status Of MediNatura Injections:

Since June 2020 the FDA has blocked MediNatura’s injection imports and as of last week, we have zero injections in our warehouse. Months ago, we filed a lawsuit against the FDA’s proposal to drop the regulatory scheme they’ve used for 30 years for natural medicines. Last Tuesday, a federal judge rejected our second request for temporary access to our injections while the lawsuit is being decided. We will appeal this decision to the D.C. Circuit Court on 3/25/21. We expect the entire lawsuit to be decided this summer.

Background:
The FDA is proposing all homeopathic medicines be regulated according to their NDA process (the same process they require “Big Pharma” companies to approve new synthetic drugs). They have begun enforcing this against natural drug categories they consider risky. They issued a warning letter against homeopathic injections last June.

MediNatura filed a lawsuit which pointed out:

In the USA over the last 20 years, over 5 million of our injections have been used with zero deaths compared to almost 20,000 deaths from injected steroids and 50,000 deaths per year from opioid addiction. In Europe our injections have been used over 300 million times over 20 years with zero deaths. The FDA has tried to dismiss this safety data “anecdotal”.The NDA process is not economically feasible for the natural medicine industry. Since we can’t patent a natural medicine (like arnica) we can’t charge consumers “Big Pharma” prices. For example, the cost of fielding 2 “Big Pharma” clinicals for each of our 6 injections would cost $50 Million. This sum would represent hundreds of years of our small company’s total profits. The crux of our lawsuit is that the FDA has failed to adequately consider the “Reliance Interests” that their regulatory behavior of the last 30 years has engendered among thousands of doctors and hundreds of thousands of their patients. Judge Randall Moss’ initial ruling was that this argument has merit and deserves adjudication. This will be concluded this Summer.

Why We Fight:
Here are a handful of examples of why we continue fighting the FDA so you can provide your patients with our safe & effective injections – these came from letters doctors sent us last month:

New York: A CY YOUNG and World Series winning pitcher toward the end of his career was heading in the wrong direction career wise and was contemplating retirement. He heard from his peers about our practice and injection treatment and started injection therapy and physical therapy immediately. At his age and wear and tear on his arm and knees over the course of his career, he wanted nothing to do with steroid treatment fearing this would rupture his tendons and ligaments and therefore, ending his career. With MediNatura's injections, he was able to not only resume his career for 2 more years but also pitch at a very competitive level over the course of those 2 years. Like almost all the athletes and everyday patients we treat, he commented "I don't know what I would have done without these injections!"

Florida: A 45-year-old man with severe c-spine and t-spine damage, in addition to Complex Regional Pain Syndrome (CRPS) resulting from a catastrophic car accident. Prior to being treated at my practice, his pain was routinely controlled with corticosteroid injections which left him continually bloated, uncomfortable, and affected his blood pressure. I have been treating John … using MediNatura injections and phased out the corticosteroid therapy. John has lost the steroid "bloat", he no longer takes the ARB he was on to control his blood pressure, and his pain is better controlled.

New Jersey: An obese male patient of mine (definitely not a steroid candidate) was on the verge of an physical and mental breakdown when he came to me with extreme knee and back pain. He told me he had an issue with opioids and luckily did not take it to the addiction level. He heard from a friend about my practice and the (MediNatura) injections and to make a long story short, I have limited his pain which in turn increased his activity level and benefited his overall health.

Arizona: I had an elite athlete with a sprained ankle, training for a marathon. I injected MediNatura meds each week for 5 weeks leading up to the competition. I would not be able to do this safely and ethically with a cortisone injection. Most of my patients opt for a MediNatura injection; they have proven results and a safer treatment most importantly with no side effects.

New York: One of my patients, an award-winning actress, has had facial work done throughout the last five years, and can't believe after the procedure she is virtually pain free and the amount of reduced swelling she gets once I inject her post procedure with your products.

Texas: A 66 y/o female with fibromyalgia: The first day that I saw her she had a Fentanyl transdermal patch and was taking 3 hydrocodone a day. I gave her an IM injection of the Traumeel, Spascupreel, and the Neuralgo-Rheum and she called me 3 days later and told me she had removed her patch and had not has a hydrocodone since!

Next Steps:
The financial strain of our legal proceedings combined with not having injections to sell has forced us to take several painful economic decisions including furloughing our field sales force. MediNatura will now support our doctors via phone, email and internet. MediNatura continues our mission to provide safe natural relief via our portfolio of topical and oral medications (see attached). We encourage you to treat patients with natural medicines which do not have the side effects of synthetic drugs which can be hurtful, serious and occasionally fatal.

We thank you for all the good you do. While we fight an uphill battle, we hope for good news by summer.

Sincerely, Cliff Clive MediNatura CEO

April 2021 UPDATE

Regarding the Medi-Natura lawsuit against the FDA: The case was heard again in front of a panel of three judges. One judge very pointedly asked the FDA if they were blocking the importation of the injectable homeopathic medicine due to a safety concern. The FDA responded that there was "potential for harm." The judge refused to lift the injunction against the importation of the medicine.