The FDA has issued its first warnings against homeopathic medicines, and this is only the beginning. Action Alert!
The FDA has sent warning letters to four companies that sell injectable homeopathic medicine because, in the agency’s view, injectable homeopathic medicines “can pose a serious risk to patient health.” This is following a bad guidance the agency is in the process of completing that upends decades of safe regulation of homeopathic medicines. The FDA’s position on homeopathic injectables puts safe pain and cancer therapies in jeopardy. In our view, the FDA is using this initial attack as an entry point to eliminate homeopathic medicine entirely, and we cannot let it proceed unchecked.
The letters lay out two main reasons for FDA enforcement: the injectable route of administration and the presence of certain ingredients with the “potential for toxicity,” such as nux vomica, belladonna, mercurius solubilis (mercury), plumbum aceticum (lead), and snake venom. This is in line with the approach outlined in the FDA’s draft guidance which stipulates certain categories of homeopathic medicines that are targets for FDA enforcement actions. Recall, though, that the approach taken in this guidance gives the FDA free reign to go after all homeopathic drugs, which in our view is the agency’s endgame.
The FDA’s warning letters make clear that all injectable homeopathic medicines are in their crosshairs. This means that homeopathic mistletoe for injection is at risk, a safe cancer therapy that has been used for years. Studies show that mistletoe can improve symptoms and quality of life, and reduce chemotherapy and radiotherapy side effects, including in pancreatic, lung, colorectal, and breast cancers.
Is there really a safety issue with injectable homeopathic medicines that demands immediate FDA action? One of the products the FDA has targeted is Traumeel, a prescription-only homeopathic medicine for pain. According to the manufacturer, out of more than 200 million ampules sold, there have been 154 adverse reactions, including 7 serious adverse events. Traumeel is an alternative to opioids, which in 2017 alone killed 47,000 Americans. A randomized controlled trial found Traumeel to be effective in post-chemotherapy stomatitis (inflammation of the mouth and lips).
Other products show a similarly low rate of adverse events, especially compared with pharmaceutical drugs the FDA approves. A review of the evidence of adverse events related to homeopathy, which included data from 12 European countries, the US, Mexico, India, Israel and Brazil published between 1978 and 2010, found a total of just 1,159 adverse events. This equates to an average of just over 50 cases per annum across all 17 countries from which studies were conducted. By comparison, foodborne illness contributes to on average of 128,000 hospitalizations and 3,000 deaths annually in the US alone. Worldwide, an estimated 200 million people use homeopathy regularly, including 6 million in the United States. These data show that adverse events from homeopathic medicines occur at a very, very low rate.
Contrast this record of safety for homeopathic medicines with adverse events from FDA-approved drugs. From 1978 to 2010, there were more than 3.5 million serious adverse events and 571,398 deaths, according to the FDA’s database.
Regarding belladonna and nux vomica, which were two ingredients the FDA claims are “potentially toxic”: a search of the FDA’s adverse event database shows 82 adverse events from belladonna between 1986 and 2019. That averages to less than 3 adverse events a year. Nux vomica has one adverse event listed in the FDA’s database. Note that any homeopathic substance is diluted, often extremely diluted. It would seem the FDA’s concern about toxicity is more theoretical than based in fact.
This is only the beginning of the FDA’s onslaught. As we’ve reported previously, the FDA considers all homeopathic medicines on the market to be “unapproved drugs.” The agency is trying to assert the legal right to go after any homeopathic treatment it chooses. Injectables are only the beginning. In our opinion, homeopathic drugs were intended to be grandfathered when the Food, Drug, and Cosmetic Act came into being, and this is being ignored by the agency. The FTC has also targeted homeopathy, declaring that an over-the-counter homeopathic drug claim that is not substantiated by “competent and reliable” scientific evidence (read: hugely expensive drug trials) is considered deceptive if it doesn’t include the following disclaimer: 1) there is no scientific evidence that the product works; and 2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.
The FDA has very serious questions to answer. Why are safer alternatives to dangerous opioids, like Traumeel and CBD, being systematically attacked by this agency? Why is the FDA focusing on homeopathic medicines that are far safer than the pharmaceutical drugs they approve—or even foods?
We can infer some answers. The FDA gets a large part of its funding from drug company user fees, and for this reason sees Big Pharma as its client. Homeopathic medicines, like supplements and other natural products, compete with pharmaceutical drugs, so the FDA uses its enormous power to tilt the scales in favor of the drug companies. And because natural products and homeopathic medicines generally cannot be patent-protected like drugs can, they can’t afford FDA-approval and so cannot make disease claims. It is one among many ways cronyism is undermining healthcare in this country.
Action Alert! Sign our petition to reform our healthcare system that bars and undermines natural options like homeopathic medicine. Please sign our petition immediately.
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Nature over craporations!
This is not about health, this is about power and domination This dynamic needs to be replaced with respect ,and collaboration for all healing methodologies.
All forms of cure should be allowed, especially those with few side effects
What did we tale 200 years ago? Yes it was purely homeopathic and it works today. We can actually go outdoors and for free pick, cut, and dig roots for cancer cures. My daughter told me she was going to die if I didn’t help her with her cancer. She stopped all treatment and we filled her system full of everything available from G-d’s earth! Her Lymphatic cancer is gone! She is healthy and happy and today she is still having her herbal teas on a regular basis. Big Pharma has murdered too many people and now they have cut back on Pain relief so we find other ways. CBD was one of the cures for my daughter.
Congratulations on your daughter’s good news, may it always stay so.To cut and dig medicines is natural medicine and goes back thousands of years.Many useful medicines, from aspirin to Taxol for cancer originated in nature’s garden. My father used Gila lizard spit for diabetes.
Homeopathic is different. It is founded on an idea of opposites. If compound X causes headaches, then a very dilute solution of X will treat and cure headaches.
As a note, we are talking very dilute solutions here. With 6x and above being the threshold where there are no molecules of compound X left in the final product. They even developed a theory to explain this phenomena. “The water remembers the crystalline structure of ‘compound X’ and that explains the effectiveness.
Just so we are clear. If hitting your self on the head with a hammer causes headaches, just dissolve a tiny, tiny bit of hammer in some water and bingo, headache cured.
Much more likely that the placebo effect is at work. Heavens forbid that the water remember the crystalline structure of the Giardia that came out of a beaver upsteam
NO! There is not only a placebo effect. I was treated by homoepathic medicines more over 60 years.
My doctors never influenced me to believe in a placebo. At the moment I am being treated by a homeopath because of the consequences of a cortisone treatment, which was life-saving, and I am experiencing healing effects again that can never be achieved with placebo. My medications are extremely highly potentiated, but have a stunning effect.
By the way: the example with the hammer is simply stupid.
Please leave us a natural way to treat ourselves without big Pharmaceutical compiles racking in the $$$!
Wordy volumes do not get read! Your petition should be one short paragraph! I will not sign that opus.
Lobby them and Congress directly with research, as if they are not already aware! I don’t have time to edit your text.A Co gressman AND Senator should carry legislation at your request.
First they claim that “Homeopathic Medicines do nothing” because they contain nothing. Then they complain that they are potentially toxic! You cannot have your cake and eat it too!
Homeopathic medicines have been proven safe and effective for the past 200 years.
That is why they were “grandfathered in” to the US Pharmacopia.
They pre-date the FDA!!!
Stop attacking homeopathy !
FDA
Homeopathy saved my life. Why government deciding what should I use for treatment of my body? I demand to keep my 1st amendment.
I use and I want to keep using homeopathy. It works and it is safe.
Keep homeopathic medicines safe & legal!
Do you really think a petition will rehabilitate this federal organization of pharma whores? The FDA is owned by big pharma. Just as the FCC is owned by big telecom. Nothing is guarding the hen house now, except the fox. There is only one solution to these two problems. But, in the end, the sheeple always comply.
We need our hormones
Reform our healthcare system that bars and undermines natural options like homeopathic medicine
NASEM and the FDA have NO BUSINESS regarding homeopathic health care. Americans Demand Freedom for this choice that is far safer than all the recordings of all drugs and their Multiple Effects!! (Falsely referred to as side effects ).
Let them take care of their own back yard of toxic effects to our environment: air, earth, water and the 80,000+ toxic pesticides and dangerous chemicals placed into the environment affecting our air and food industry and ultimate lack of industry to actually PROTECT our Health Care for all individuals.
Do Something Meaningful !! Clean up the environment.
HANDLE THE FOOD HEALTH – create health for all. CLEAN THE AIR AND WATERS. ( the drug industry needs NO help). The people and the life Environment DO!! FIRSTDo No Harm!! Obstain from false witness.
Very emphatically, Judith M. Beavers RN. MSW. MA Certified Nutrition RX.
Population control. Kill off ALL animals, and the majority of humans too. Anti- Christ, Mark Of The Beast Agenda. Nobody is getting out of here alive. Death is glorified.
You do realize that your “used_for_years” link ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761165/ ), in your article above, doesn’t exactly help your case. Better read it more closely.
Is the FDA serving Big Pharma the same way EPA is serving our present government ? Is it the question of money prevailing on natural products and safety ? Research Homeopathy and compare it’s infinitesimal doses to mega-doses of antibiotics and vaccines. Homeopathy is safer and better. It is very recognized in Europe ( France, Germany ) . Try granules of Belladonna to fight sinusitis, laryngitis, or Echinacea . .In the eighties, I had a friend dying of a Pancreatic cancer who begged me for Sedatif PC because morphine was not effective enough for the pain. He died peacefully shortly after about a week worth of doses of 5 granules. Other friends of mine had a son covered with warts. After a 3 month homeopathic treatment the warts disappeared. Agree, it takes longer. And so on. Homeopathy is a wonderful natural help to cure many illnesses, and that’s why it is always attacked by the powerful pharmaceutical industry., because it is a much cheaper treatment.
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Our healthcare system must be reformed and stop undermining natural options. Follow the money and you know the motive.
Freedom of choice. Let us choose.
It is the right of each person to determine for themselves which remedy is best for their situation. It is clear that the extensive historical data shows homeopathy has a much safer track record than many other medicines and there is no true reason to attack access to homeopathic remedies. Therefore, please do continue to allow people the right to choose the method of treatment that makes the most sense for their individual situations, including the choice of homeopathy.
Please study about homeopathy before attacking it. Injectable homeopathic could be taken by mouth as far as toxicity goes. Imagine putting ‘injectable’ vaccines into a spoon and offering it to a patient – it would end up with one medical practitioner in jail!
I have been using homeopathic medicines for decades, for myself, my family, and my pets and I have learned of its healing power. This has been known by experts in the field for about 2 centuries, initially judging by outcomes in regular v. homeopathic hospitals during various epidemics from the 19th centuries.
Don’t let the idea of profits for allopathic practitioners blind you to the healing power of other systems, including Homeopathy.
If you cared as much about glyphosate & taking that off the market; if you cared as much about melamine in pet food killing thousands of animals; if you cared as much about the ingredients in pet food being unadulterated, then maybe we would trust the FDA. You don’t so we don’t!
I depend on homeopathics to maintain my health while I deal with significant medical issues.
Please do not ban something that many of us rely on.
Homeopathy in general is extremely safe with very little side effects or concerns at all… Having said that I am not a fan of injectable Homeopathy and I don’t know anyone who is.
The items described above except for those injected are completely harmless even if the whole bottle is taken orally.
Please consider that Homeopathy has been used for over 200 years and that it was in the original Physicians handbook and was and is considered very safe to use.
Please reform our healthcare system that bars and undermines natural options like homeopathic medicine.
CBD is great for pain.
The Queen has had a homeopathic physician since Queen Victoria’s time. If it is so bad and so useless why are your authorities banning it and basically saying the the Queen is an idiot! Maybe you need to get in touch with the powers that be in the UK and get them to give you the evidence that homeopathy WORKS! Good luck with your campaign. I really do think you need to be publishing the above information far and wide, as it makes your authorities look like the ignorant fools they are!
we must take advantage of other therapies besides surgery and scripts to maintain the health of the American people!
I am an RN with 16 years experience. I am thankful for both traditional and natural health options. Homeopathy has an important place in our history and in our future.
Stop taking away our freedom to choose our health care options!!
We need homeopathic medicine for healthy living.
I do not trust Trump, I don’t trust the FDA under Trump.
So sick and tired of our choices for health maintenance being threatened! Simple natural remedies should be a available!
We don’t need to be bombarded with chemicals!!!
Stop this insanity!!!
If you live in harmony with nature you don’t need substances that do nothing but hide symptoms and don’t cure anything!
Homeopathy works! Natural is better!
FYI:
BECAUSE THE QUEEN OF ENGLAND CARRIES THAT LITTLE TRAVEL SACHEL WITH HER WHEREVER SHE GOES FILLED WITH ALL HER HOMEOPATHIC REMEDIES THAT KEEP HER HEALTHY, WE WILL TAKE THEM ALSO WHEN IT BENEFITS US S OUR PRACTITIONER SAYS.
THOSE IN E U KNOW MORE THAN YOUR NANO-CONTROLLING ATTITUDE ALLOWS.
IS IT BECAUSE YOUR MEDICAL: HIGH PRIESTS AND PRIESTESSES WANT TO CULL THE POPULATION WITH TOXIC INGREDIENTS ? AND YOU PREFER BIG MONEY OVER THE VALUE OF OUR LIVES ? WHAT $LSE COULD YOUR CENSORING ATTITUDE BE DUE TO ?
LIVE AND LET LIVE !
STOP ANY ARROGANCE OF TRYING TO LOCK DOWN OTHERS” INTERDEPENDENT, INTELLIGENT, COMPASSIONATE RIGHTS TO CHOOSE WHAT REMEDIES AND TREATMENTS THEY WANT FOR MAINTAINING THEIR HEALTH.
GET SOME MATURITY AND UNLOCK YOUR ATTITUDE OF CENSORING OTHERS’ FREE CHOICES FOR AVENUES FOR HEALING USING ANY OF THE NUMEROUS ANCIENT WAYS OF HEALING THAT MAY BE 4,000 YRS OLD FROM INDIA, GREECE, BRAZIL, AND CHINESE HEALING SYSTEMS. THESE PATHS TO WELLNESS AND BALANCING THE IMMUNE SYSTEM EACH CONTAIN VIABLE, REASONABLE SOLUTIONS TO HEALING.
DOES THE FACT THAT SOME REMEDIES DO NOT COST AS MUCH AS A BIG PHARMA CORPORATION DEMANDS FOR THEIR PRESCRIPTION DRUGS BOTHER YOU?
ITS ALL ABOUT THE MONEY AS USUAL. RIGHT?
WELL THEN, THAT SEEMS TO BE YOUR CORPORATION’S UNDERLYING MOTIVE. NOTHING TO BE PROUD OF. MONEY OVER THE VALUE OF OUR DECISIONS WITHOUT YOUR CENSORING US AMERICAN ADULTS.
AT LEAST THE QUEEN OF ENGLAND IS NOT IN YOUR CLAMP- DOWNS AND ESCAPED YOUR CLUTCHES. AND SHE IS A GREAT, GOOD EXAMPLE OF THE WELL-KNOWN FACT THAT HOMEOPATHIC REMEDIES WORK DOWN THROUGH THE CENTURIES.
THIS IS AMERICA. YOUR CORPORATION DOES NOT OBEY OUR CONSTITUTIONAL RIGHTS THAT REMAIN. WE ARE STANDING UP FOIR OUR CONSTITUTIONAL FREEDOMS AND LIBERTY TO MAKE OUR OWN PURSUIT OF HEALTHY DECISIONS, INCLUDING CHOOSING – IF WE WANT THEM, – A REMEDY FROM AYURVEDIC, HOMEOPATHIC, OR ANCIENT CHINESE HEALING REMEDIES IF WE SO CHOOSE. WE CAN GO TO ANY PRACTITIONER OF THESE HEALING DISCIPLINES.
YOU ‘INTERFERRORS’ MUST STOP MEDDLING IN OUR PERSONAL CHOICES OF HEALING METHODOLOGIES AS YOUR ATTEMPTS TO SHUT DOWN PERFECTLY FINE HEALERS IS HEADING INTO A PRESCRIPTION FOR MEDICAL FASCISM.
IF YOU ARE IN AMERICA, WE BELIEVE IT BORDERS ON TREASON TO ATTEMPT TO CURTAIL AMERICAN’S CONSTITUTIONAL RIGHTS “TO LIFE. LIBERTY AND THE {URSUIT OF HAPPINESS,” E.G. CHOOSING HEALTHY PATHS THAT COME FROM KNOWN ANCIENT HEALING METHODOLOGIES.
THESE REMEDIES DO NOT HAVE DANGEROUS SIDE EFFECTS LISTED ON THE INSIDE WRAPPERS AND WHAT WE CHOOSE MAY IN FACT BE AFFORDABLE AND VERY EFFECTIVE FOR PEOPLE WHO HAVE NO HEALTH INSURANCE OR LIMITED INCOME. AS TODAY, WHEN 70 MILLION AMERICANS HAVE BEEN FURLOUGHED TO CULL THE POPULATION, THE DEEP STATERS’ SINISTER, SHORT-SIGHTED GOAL.
NONE OF US HAS MUCH TIME IN THIS DYING PLANET’S ATMOSPHERE, BEING SNUFFED OUT AND STIFLED FOR AIR BY GREED, HOMO IDIOTICUS’ CONTROLLING DECISIONS TO RAKE IN BIGBUCKS AND GET RID OF THE 98%. BUT FOR THE 2% FOOLISH MISERS, WHEN 445 NUCLEAR PLANTS MELTDOWN, THEY WON’T SURVIVE LONG EITHER. GET YOUR ATTITUDES IN ORDER.
CHANGE AT THIS END OF LIFE ON EARTH. YOUR BILLIONS HAVE NO VALUE ON THE OTHER SIDE.
SO BACK OFF AND ALLOW PEOPLE TO MAKE THEIR OWN CHOICES. FORGET WALL ST., BIG PROFITS AND ALL THAT CALLOUS ADDICTION TO ‘BUSINESS AS USUAL’. GAME OVER. SHARKS CANNOT FEED WHEN MINNOWS GO MISSING.
NO THINKING ADULT NEEDS A “HELICOPTER MEDICAL DEEP STATE CABAL” TO SUPERVISE THEM AND RESTRICT THEIR CHOICES OF HEALING AND BALANCING THEIR IMMUNE SYSTEM.
STOP TRYING TO CONTROL OTHERS ABOUT WHAT THEY PUT INTO THEIR PHYSICAL BODIES. IT’S NONE OF YOUR CONCERN. THIS IS A MATTER OF EACH PERSON’S RIGHTS TO CHOOSE THEIR OWN HEALTHY REMEDIES. STOP THE CENSORING NOW. GROW UP! WEAN YOUR CORPORATION FROM THE PROFIT MOTIVE. IT’S TIME FOR YOU TO FIND A NEW CAREER.
THE REMEDIES YOUR CORPORATIONS ARE ATTEMPTING TO CENSOR AND CURTAIL WORK FINE. THEY ARE FAR BETTER THAN ANY NEUROTOXIC NEEDLES OF ALUMINUM, FORMALDEHYDE, THIMEROSAL, AND MERCURY, – ONE DROP OF WHCIH CONTAMINATES AN OLYMPIC POOL. ALL OF THOSE NEUROTOXINS DO HARM AND ACCUMULATE. NO SAFE REASON TO TAKE THOSE PRESCRIBED CHEMS AS ANY BIO-CHEMIST CAN VERIFY. THAT WOULD BE INSANE.
ON THE OTHER HAND, THE REMEDIES WE CHOOSE TO KEEP OUR IMMUNE SYSTEMS HEALTHY AND STRONG ARE OUR CONSTITUTIONAL RIGHTS AND FREE CHOICES.
DROP THE ATTEMPTS TO LOBBY OUR CONSTITUTIONAL RIGHTS DOWN THE TUBES NOW! THIS CRAZED BILLIONS-DRIVEN MOTIVE HAS TO CEASE. CENSORSHIP OF OUR CHOICES FOR HEALTHY PATHS IS TOTAL BLINDSIGHTED, STUBBORNLY NUMBED-OUT IGNORANCE.
SOLUTION: “STOP IT ! “
Preserve all alternative medicine.
Keep your hands off!
I suggest everyone listen to Ross and Carrie’s investigation of homeopathic medicines. There is no medical benefit and the placebo effect is outweighed by someone using homeopathic medicine rather than seek treatment from verifiable and proven healthcare providers.
Also, why CVS and Walmart are being sued for selling homeopathy as real medicine.
If there are no side effects (as homeopathy does), it means it does nothing!
It has happened in the past and we know where it is gonna go! Yes, there seems to be an agenda for the FDA to suppress all meds that Big Pharma. Cannot control. My mom was saved by homeopathy , my family was saved by homeopathy, and I was saved countless times from the lYme disease, (countless tick bites ) that has decimated many of my friends..Let us not the FDA control the way we heal ourselves~! MK
Thanks to an incompetent FDA, covid 19 is still a problem. There are many Natural Health treatments that defeat the virus with no side effects, unlike your high cost “Drugs”
Get out of the way and Stop harming the Public with your disgusting corruption.
ellos son a la mierda, de mal
I have been using homeopathic remedies most of my life, and can vouch for their effectiveness and safety.
I’ve been using homeopathic remedies for over 40 years…with NO side effects, and no harm! Homeopathy works! It is simply that Big Pharma is in bed with the FDA!
Thank you for being a Guardian Watchdog for those of us who wish to live and treat themselves in accordance with God-given natural wisdom of homeopathy, herbalists, and organic farmers–ALL of us who are against being guinea pigs, manipulated by corporate greed and government croney-lobbyists of the chemical, GMO, and drug establishments! We shall overcome this darkness with continued Light of knowledge, awareness, and courage of all of us to speak out.
As someone who spent most of their adult life working in the natural holistic health industry, I continue to be appalled at how the pharmaceutical/medical drug cartels in league with the FDA & AMA continue to squelch and attempt to illiminate our freedom to choose how we want to take care of our health and that of our families, It’s all about money and control of every aspect of our live’s & death’s.
Homeopathy works without a lot of the drastic side affects of large pharmaceutical companies products.
The FDA is giving these companies carte Blanc approval of drugs that aren’t tested enough to prove safety.
As a Nurse this is alarming. Our patients safety and consumer safety is what should matter.
Hold FDA to a higher standard. Not Trumps imploding and erosion of the FDA and public safety.
Enough is enough. Who is behind these continuous attacks on homeopathy? It has proven itself for centuries and as far as I know there has been no deaths from using it. I use homeopathic remedies personally for years on as needed basis. I would use it any time over prescription drugs which have so many side effects. You are trying to kill a worth while alternative health solution to those who choose to do so. This is America and we should be able to make these choices. In Europe, India and other countries allow their use without any government invasion. It has been proven time after time to be safe. Therefore, what is the issue?
The order of battle should be to bust up the FDA. There is no reason for a food and drug administration. Tens of thousands may die from pharmaceuticals and there is hardly a whimper, but when three people get sick from a natural remedy, they make such a big stink of it. The FDA only does what their corporate masters command.
Please stop….and start to do the right thing. Is this too much to ask???