The FDA is threatening homeopathy’s future. Here’s how we can save it. Action Alert!
The FDA has proposed a new policy for regulating homeopathy—a policy which is a direct threat to many, many homeopathic medicines. To fully protect consumer access to these treatments, we need Congress to pass a law.
Congress and the FDA have always exempted homeopathy from the same drug requirements as pharmaceutical drugs. Now the FDA, with pressure from big pharmaceutical companies who compete with homeopathic medicine, wants to create an unnecessary policy. As you’ll remember from our previous coverage, the FDA’s new policy states that no homeopathic medicines have been “generally recognized as safe and effective” (GRAS/E) by the FDA or gone through traditional FDA drug approval; therefore technically speaking all homeopathic medicines currently on the market are being sold illegally. However, the FDA said it would prioritize enforcement on products with safety concerns.
Homeopathy has grown into a $3 billion market with increasing demand from consumers looking for alternatives to prescription medicine. If we want continued consumer options for our health we need to send a message to Congress.
In response to the FDA’s new proposal, homeopathy advocates are arguing for a return to the Compliance Policy Guide (CPG) used since 1988. This document, which has provided regulatory guidance for homeopathic remedies, provides a definition for homeopathic drugs, current good manufacturing practices and labeling requirements. Going back to the CPG would help protect our present access but would still leave homeopathic medicine vulnerable to future agency action. Homeopathy should remain permanently exempted from traditional drug standards.
For example, over-the-counter homeopathic medicines are subject to the FDA’s drug review process, which began in 1972 and has since continued. The purpose of this process was to establish that every over-the-counter drug is both safe and effective. At that time, the FDA exempted homeopathic drugs, deciding to review them “as a separate category at a later time after the present over-the-counter drug review is complete” due to the “uniqueness of homeopathic medicine.”
This means that, at any time, the FDA has the power to review homeopathic drugs and is not required by federal statute to treat them differently than other over-the-counter medicines.
Subjecting homeopathy to new drug efficacy requirements would likely eliminate many medicines from the market. Homeopathy has been around since the early 19th century; many of the preparations in the Homeopathic Pharmacopeia—the official compendium of homeopathic monographs and standards—were included based on a history of successful use. This means they can’t be patented now, since they aren’t novel; patents also expire after twenty years, so even if they were patentable when they were first developed, that protection would have ended long ago. Without patent protection, it would be impossible for a company to recoup the astronomical costs of conducting drug trials to prove efficacy, which is required for traditional FDA approval. Forcing efficacy studies for homeopathy would also be duplicative, since the criteria for inclusion in the Homeopathic Pharmacopeia require that a product be safe and effective.
To truly save homeopathy, what is needed is federal legislation that acknowledges homeopathic medicine’s uniqueness and the inapplicability of conventional drug standards. It should provide a definition of homeopathic products, guidelines for manufacturing standards, and recognize the long history of homeopathy’s safe use. This legislation could provide a framework by “grandfathering” homeopathic medicines that have a history of safe use rather than requiring an unnecessary review process. For new homeopathic products, a notification system, recognizing homeopathy’s uniqueness, could be devised.
Why is homeopathy unique? While most medicine is based on drugs—that is, the use of pharmacological agents to treat or suppress the symptoms of a disease—homeopathy is an attempt to prompt the body to cure itself. It is based on the idea of “like treats like.” When you chop a red onion, for example, it causes watery eyes and a runny nose in most people. Allium cepa is a remedy created from red onion; in very small doses, Allium cepa is intended to activate the body’s own mechanism for stopping watery eyes and a runny nose. Homeopathic medicine is often so diluted that the original ingredient is virtually undetectable.
Homeopathy’s distinct nature was recognized by Congress when the Food, Drug, and Cosmetic Act (FDCA) was passed in 1938. Congress defined “drug” in part as a substance recognized in the United States Pharmacopeia (USP), the official Homeopathic Pharmacopeia of the United States (HPUS), or official National Formulary (NF) or any supplement to them. The law, then, did not merge homeopathy with prescription medicines, but recognized them as distinct schools of thought in medical practice. The current proposal is most likely being pushed by big drug companies threatened by the increasing demand for homeopathic medicines that reduces their financial profit.
We need a permanent solution. Federal legislation is the only option that can legally protect homeopathy.
Action Alert! Write to your members of Congress and urge them to champion legislation that would grandfather current homeopathic medicines, while creating a notification system for new products. Please send your message immediately.
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Americans for Homeopathy Choice is fighting the FDA’s attempt to change the regulations on homeopathy. They filed a petition with the FDA to stop those regulations and instead create an Advisory Committee composed of homeopaths and consumers. It is important that everyone comment and support the Americans for Homeopathy Choice petition. Please go to this website and comment. It can be as simple as stating that you support the petition of the Americans for Homeopathy Choice. Please do it now!
https://www.regulations.gov/docket?D=FDA-2018-P-2962
Unfortunately, according to a health freedom legal expert, the FDA petition that was filed recently is likely to create more onerous restrictions for homeopathic remedies not identified under the Homeopathic Pharmacopoeia of the United States (HPUS), which include nosodes and the majority of currently available homeopathic remedies, known to be inert and not cause disease. As a consequence, the FDA could choose to restrict homeopathic remedies to only licensed medical physicians, who seek to benefit from the $3 billion homeopathy market (Think Cannabis). Another consequence is that this effort could stagnate in the court system when the FDA is sued for taking action per their policy guidance.
This is why, fundamentally, the law must change. Homeopathy is the people’s medicine and should remain accessible to all due to it’s long history of safety and efficacy. [See article https://www.naturalnews.com/2018-08-10-cover-this-video-as-a-feature-story-about-homeopathy.html%5D.
Brovo! Hope people keep remembering their own rights from the birth to choose what the best for them.
Rights first! Exactly! Without rights, all the science won’t matter.
Thank you for this response, Rosanne. While we support all efforts to protect homeopathy, we agree that a bigger fix is needed to ensure FDA doesn’t restrict access in the future, as outlined in the article. We’d like to carve out long term protections while we have the opportunity.
Thanks, Tim!
Do we have any Senators that are supportive of this?
Hi everyone, as President of Americans for Homeopathy Choice, we totally agree that the long term solution is very important. We have tried to explain as often as possible that our citizens petition is only one small but important step in our overall strategy. We totallly after that the bigger fix is crucial. Please read our article here if you’d like details on that overall strategy.
https://homeopathychoice.org/additional-insight-on-our-citizen-petition/
Hi Rosanne,
Americans for Homeopathy Choice took the initiative and that’s what was needed. If the Health Freedom legal expert engaged in the battle he/she could do it another way. We’re glad for whatever help we can get. The FDA is also threatening to remove vitamins and other important nutrients from the market. They’re totally controlled by Pharma, as is congress. It difficult to see how any effort will succeed.
Many people took an initiative, not only Homeopathy Choice. There was also an initiative taken by the National Health Freedom Action (non-profit group) by the legal expert I mentioned, that disagreed with the FDA guidance, requesting that FDA withdraw it. [see comments on the FDA draft guidance here: https://nationalhealthfreedom.org/nhfa/wp-content/uploads/sites/5/2017/05/NHFAs-FINAL-Comments-pdf-Draft-Guidance-Homeopathy-3.8.2018.pdf%5D.
I agree that it is hard to see how any effort will succeed when we are divided. Success is more likely if we move forward on the same page. The Homeopathy Choice initiative is choosing to proceed in a way that does not agree with all the voices. Thus, you see the two approaches. We know that the FDA is not an agency ‘of and for the people’ so petitioning the FDA, or begging for permission, will not benefit the people as a whole. As long as we can create new laws, we should be doing that to ensure who controls the narrative, for whoever controls the narrative, controls the outcome.
Thanks for that info Rosanne. I don’t know if National Health Freedom Action is prepared to take legal action. Their letter was a “request” , but FDA is good at ignoring request. Homeopathy Choice met with the FDA twice along with their lawyer. Maybe both organizations could work together. Coalitions are the way to power.
You do know that the passage of HEMP for medicine will help sink Big Pharma…we all need to realize that this country is “ripe” for takeover by the NWO/Soros/Illuminati through Agenda 21; T is part of the problem as he is nothing more than a puppet just as the last several presidents have been. He was going to limit what they could and could not do..if he did it sure was not much. With that said, I sure will write and support AHC; good luck,
This is important.
Why? To my friends, please remember that I went to Paris and interviewed Prof. Moussa about C60 Olive oil. (see C60.net). The amounts used in this study are tiny amounts, yes the amounts qualify as homeopathic trace amounts… and the finding was astonishing. This is why I do not do away with Homeopathy as quack science. Tiny amounts can make a big difference sometimes… and the FDA along with Big Pharma knows this.
We see this in other ingredients that can be harmful in mg amounts, but in trace amounts can be powerful allies for cell rejuvenation, such as hydrogen sulfide. (see http://news.revgenetics.com/hydrogen-sulfide ) while 50mg can cause bad symptoms in humans, tiny trace amounts seem to do wonders for aging.
Now back to C60 Olive Oil: The two ingredients in C60 Olive oil are described in the homeopathic bible the “Homeopathic Pharmacopeia” from the 19th Century. Now I am making this public for the first time here on this website, C60 is found in black soot (which is an ingredient allowed in the Pharmacopeia) and olive oil which is obviously great for health and also found in the Pharmacopeia.
Some science people say Homeopathy won’t do anything and are basically sugar capsules with trace amounts of the ingredients, while the FDA now goes the other extreme and wants to regulate it…
Well you can’t have it both ways.
You can’t say something cannot do anything because it has such tiny amounts of old 19th-century ingredients… and at the same time have the FDA demand regulation for these. If you don’t do anything, you will see natural remedies along with homeopathy become illegal. That is not what we want…
Please take action today and get your congressman in line. Tell them to keep their hands off of Homeopathy.
There are already a couple of homeopathic items which can no longer be obtained online. I found out last week when trying to order stuff I’ll need for the upcoming winter months. It won’t be long before herbs, spices, certain plants with edible flowers, and food itself will all be under gubmint control, as far as purchasing.
Tyranny, starvation while we feed the illegals, including Muslims and those in Sanctuary cities…please take take a moment and think about this..first read the Agenda and understand it; HAARP/etc. disasters, one after another…business and people as you and I lose their property when the USA condemns it; if that isn’t enough. the Trails and Ethanol are killing the whole of the planet..changing the ph so we do not get nutritious food or no food at all…we had a storm come through about three weeks go..wiped out thousands of acres of corn, wheat and hay…preplanned always…in passing…read your Constitution for this comment and sorry it is off subject but very important to We the People…Israel is a Terrorist country…$38Billion is planned for them; aiding and abetting is illegal as all get out..write your Congress representative and also the Senate…this is a big one..by the way just where is this administration getting all of its money?
Homeopathy may help people/pets and help Lyme etc. health issues. When something works they seem to want to ban it.
Could be Agenda related..part of it is to murder people for population control. With that being said, then why are we targeted? Those in Africa, Saudi, Iran, etc. give birth one each year for each reproductive female usually about age 10. Also, if they want us dead why do we have to wear seat belts of be fined, imprisoned? Just asking!
I have a friend that was diagnosed with cancer recently. He is of course doing chemo and radiation. This cancer is regarded as 90% death sentence and he found a homeopathic doc that has prescribed various ADDITIONAL treatments and dietary options that, for him, seems to have helped a great deal with his illness! The spot on his lung has been reduced by half so far. I never had much use for homeopathic medicine but I think YOU should be able to CHOOSE your own treatments!!
A lot of studies show CA as a stress related development…I do not know that..just mentioned in passing as I have read a few article related to this; Turmeric, curcumin can slow and sometimes beat Cancer..NANO silver the same thing, not collodial..NANO. Hemp is another natural product that can slow or rid one of cancer..it has polynutrients in it and those little polynutrients mean a whole lot to the body…
Hey there FDA——- I’m a retired nurse and have been on to you for at least 25yrs. And I have been warning everyone about all your mistakes. I have had first hand knowledge of you damn pills and treatments. Some of your treatments don’t do a damn thing to help people. So as long as you get your blood money for the pills–isn’t that so.?????????
Exactly and a couple of years ago the wonderful FDA came out and admitted they did not have time to thoroughly check out each new med…how is that for safety..notice the number of side effects with most of this new stuff? It is worse than being sick with whatever…a Dr. told me, when I asked him where they got these new names for drugs, do you just pick them out of the sky? He answered, “yes,” as a matter of fact we do.
“The FDA said it would prioritize enforcement on products with safety concerns.” Hmm, very strange statement by the FDA. First they say it is just water and can’t do a thing. Now there may be a safety issue? How could that be?
Now that is logical. Logic has no place in the FDA.
Like the white man…they talk out of both sides of their mouths?