The time to stop this is now, before it gains momentum! Action Alert!
The FDA is holding a public hearing later this month to evaluate its enforcement policies for homeopathic drug products. It says the agency is seeking input on whether and how to adjust the policy to adjust for changes that may have occurred over the past twenty-five years.
Why is the FDA doing this? It appears that it has decided that it missed out on millions of dollars it could have charged Homeopathic manufacturers to go through the FDA approval process before granting these dilute natural medicines OTC drug status.
The Federal Food, Drug, and Cosmetic Act (the Act) recognizes as official the drugs and standards in the Homeopathic Pharmacopeia of the United States and its supplements (Sections 201 (g)(1) and 501 (b), respectively). Until recently, homeopathic drugs have been marketed on a limited scale by a few manufacturers who have been in business for many years and have predominantly served the needs of a limited number of licensed practitioners. In conjunction with this, homeopathic drug products historically have borne little or no labeling for the consumer. Today the homeopathic drug market has grown to become a multimillion dollar industry in the United States, with a significant increase shown in the importation and domestic marketing of homeopathic drug products.
Here is a little background: in 1938, in early FDA formation legislation, Sen. Royal Copeland (D-NY) succeeded in getting homeopathic drugs exempted from the usual drug approval process. In those days, FDA only had authority to require safety evaluation, but when an evaluation of efficacy was added homeopathic medicines remained exempt, because they had been around for hundreds of years were generally regarded as safe. Today, FDA required human trials cost more than $250 million dollars for each new drug approved. It appears that the FDA wants this money back and Big-Drug Companies want to get rid of the competition so that consumers don’t have access to any alternatives other than prescription drugs that have gone through the FDA multi-million dollar process
For anyone who knows anything about homeopathy, nothing could be safer than homeopathic remedies. And millions of Americans use them because they work safely and often more quickly than drugs, without the side effects. What has rankled the FDA is the fact that they cannot require new homeopathic medicines to pay their fees and submit to their approval or disapproval process. In the eyes of the FDA, it seems that the besetting sin of homeopathic preparations, as with supplements, is that they can under certain circumstances compete with FDA-approved Big Pharma drugs—the very drugs that pay the FDA’s salaries.
Aren’t homeopathic remedies already regulated by the FDA?
The short answer is, absolutely! Although they do not need to go through the New Drug approval process, they must undergo pre-market approval with a monograph from the Homeopathic Pharmacopoeia of the United States (HPUS), which involves some clinical verification of the efficacy of the substance. And the FDA has strict guidelines that must be followed for any new homeopathic medicine to be approved as homeopathic.
Since 1988, prescription and non-prescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the enforcement policies set forth in FDA’s Compliance Policy Guide (CPG) 400.400 entitled “Conditions Under Which Homeopathic Drugs May be Marketed” (see 53 FR 21728, June 9, 1988). The CPG defines a homeopathic drug as any drug labeled as being homeopathic which is listed in the HPUS, an addendum to it, or its supplements. The CPG includes conditions specific to ingredients, labeling, prescription status, and current good manufacturing practice. The CPG can be found at: http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm.
What does the FDA really want?
The FDA’s recent moves are probably intended to gain tighter control of homeopathy and make it harder for manufacturers to make so many products that compete with other prescription drugs made by Bid Drug Companies that have to go through the FDA multi-million dollar approval process. The efforts follows several court cases in California against Boiron, the world’s leading homeopathic manufacturer. In one case, the plaintiffs alleged that Boiron claimed that its Children’s Coldcalm product would provide relief from cold symptoms.
You can read our more detailed coverage of these cases here. But the takeaway is this: in none of the cases did the plaintiffs say they were physically harmed. They merely claim that the products did not relieve their symptoms as was claimed they would, and that they suffered minor economic loss by purchasing the product. (So apparently if your cough medicine doesn’t work well enough for you, you should sue the company!) Care to guess who initiated these cases? Upset consumers—or lawyers calculatedly trying to earn settlement fees?
For readers new to homeopathy, treatment is based on the idea that “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.
Practitioners of conventional medicine are often hostile toward homeopathy: one commentator called homeopathy “a fraud perpetrated on the public with the government’s blessing.” This kind of response is understandable considering that homeopathic medicine is often so diluted that the original ingredient is virtually undetectable. The mechanism of action is therefore uncertain. But there is scientific support for efficacy, in addition to anecdotal evidence from centuries of use.
Scientific Evidence Supporting Homeopathy
Here are some scientific studies from the past ten years showing that homeopathy can indeed be effective. These studies—which range from random controlled trials (RCTs, the supposed “gold standard”) to observational studies to meta-analyses—often look at homeopathy as an adjunct to conventional medicine. Here is just a sampling:
- Acute otitis media (when the middle ear gets blocked with fluid and infected with bacteria): a 2012 RCT showed that symptomatic improvement was quicker in the homeopathy group than the conventional therapy group, with a much lower antibiotic requirement.
- Allergies: a 2012 observational study revealed that homeopathy substantially improved allergy symptoms and the dosage of conventional medicine could be substantially reduced; a 2013 study listed the effectiveness of different homeopathic treatments for allergies based on the type of allergy.
- Asthma: in a study of individualized homeopathic treatment, there was evidence that it decreased the severity of asthma in children.
- Other studies show effectiveness of homeopathy for conditions ranging from chicken pox, diarrhea, and in a multi-center observational study, chronic sinusitis. Homeopathy could be an effective treatment for low-grade chronic inflammation, which is the root of many diseases, and could be a complement to conventional anti-tubercular treatment (a finding that is especially important as patients are becoming resistant to TB drugs).
- Further, as our friends at ANH-Europe have reported, the Swiss government reviewed a large body of evidence in 2011–2012 and found homeopathy to be both effective and cost-efficient.
Much more research is needed despite the abysmal lack of funding for it. At the very least there is promising evidence supporting homeopathy. What we don’t need now is for the FDA to move to shut it down when the industry is already under unfair attack in California.
Action Alert!
The timing of this is critical—it will be much easier for the FDA to hear us now, before the issue gains momentum. Write to the FDA immediately and tell them that current regulation of homeopathic remedies is more than sufficient to ensure public safety. Please send your message today!
Source: Alliance for Natural Health – USA
Stop the efforts of the FDA to take away citizen’s rights to use Homeopathy medicine as an alternative to the destructive side of conventional medicine. The freedom to choose between conventional medicine and Homeopathy medicine is the cornerstone of the right to choose. The intent of those individuals in government agencies such as the FDA who are in the pockets of the drug companies synthetically creating pharmacology drugs for treating various medical conditions causes more harm than health for United State’s citizens.
E. Grogan says:
My understanding is that homoeopathy operates on the same principle as vaccines – that a small amount of the “disease” will enhance immunity to it. So why is the govt wanting to force vaccines on everyone now, including adults, but against homeopathy? Can anyone explain this to me?
Linda J Solomon says:
Any treatment or procedure that takes away from allopathic medicine is a threat to them financially! Forget that homeopathy, holistic and anything alternative might heal the persons health challenge; the Hippocratic Oath went out the window with the bath water a long time ago. Personally, my body has gravitated toward alternative health care and healing most of my adult life; because that is what has worked for me. I am usually very sensitive to many chemical medications and how they affect me. Alternative practitioners find the root of the problem, they don’t just treat symptoms and they heal with natural; not chemical substances usually.
Marilyn Whittenberg says:
Homeopathy has been around for a long time. It is used all over the world and is effective and very safe. Anyone can use it with no side effects. I have worked in a health food store for over 25 years and have seen and experienced via customer comments about how much homeopathy has helped them. When I was a child, my doctor was a homeopath and I can remember him coming to our house with his little black bag, giving me one pill, charging very little, and leaving me feeling much much better. When we lost homeopathic doctors, we lost the knowledge of Miasms which are things inherited from our ancesters four to five generations back..for instance, psoriasis is an inherited miasm from someone in the past family having syphilis and passing it on in a different form, but devastating neverless.
Patricia Miller says:
There is nothing safer than Homeopathy. The drug companies cant make any money off these so they want to get rid of it. Isn’t there a name for that?
Mr. V. A. Karlski says:
The FDA and these AG’s are in the pocket of Big Pharma. The AG’s need to be in prison for these crimes and the FDA should be shut down TODAY! The USA has many serious issues and what is congress and the prez concerned about? Let’s take Old Hickory off the 20 dollar bill and stop the sale of vitamins and other pure natural ways to heal thyself. TAKE BACK YOUR COUNTRy or LOSE ALL OF YOUR RIGHTS. Is this NAZI land or the USA?
Sherri Monroe says:
Stop, just stop what you are doing right now because it is wrong Everyone knows the FDA is nothing but a bunch of mobsters using mob tactics. We know how you operate and we are watching you There is a place for Homeopathy for people who have been CRITICALLY INJURED by defective products that YOU approved. Homeopathy is there for those people. Just because YOU can not make any money off of it does not mean that you should ban it or control it so just STOP messing with Homeopathy
Glenn Frieder says:
Please protect our rights from pharmaceutical corruption
Harold Holguin says:
I take supplements and I do not want regulations that will add to the cost or limit the access to my choices of what I want to obtain to improve my health, so far I am very please with the way it is currently..
Lisa Oliver says:
The FDA’s current assault on homeopathic products appears to be driven more by the pharmaceutical lobby and its supporters, than by any verifiable danger to the public.
Millions of people worldwide have used homeopathy for over two hundred years.
Homeopathic products offer a less costly and safer alternative to many of the drugs that are marketed each year to the public and their health care providers.
I have been using homeopathic products for more than 35 years, and find them to be effective, and without adverse side effects. Additionally, they have provided me with benefits that prescription drugs cannot.
For those of us who have an intolerance to drugs, or conditions that could be compromised by pharmaceuticals and the more commonly used over-the-counter medications, homeopathic products are truly valuable.
Karen Young says:
The current regulation of homeopathic remedies is more than sufficient to ensure public safety.
Karen Young says:
The current regulation of homeopathic remedies is more than sufficient to ensure public safety. Please send your message today!
Josn says:
Those who cannot believe that homeopathic remedies work do not understand, and do not try to learn about this thing they oppose. I wish they would leave alone that which they do not understand. Homeopsthy does work, and often at energetic levels.
FDA–Leave homeopathy alone.
Linda Bieker says:
I choose to take care of my health and do not want to be forced to grow every herb known to get the choices that I want to have. People who choose homeopathic are generally well informed and concerned. There is no trust in modern day pharmaceuticals. They are more poisonous and harmful than choosing to use less aggressive and natural alternatives. Please stop your over extending control freak ways and allow people to care for themselves and to have some freedom of choice. Your attachment to pharmaceutical dollars is overreaching into my freedoms and choices.
Tonya King says:
Please don’t take away access to homeopathic approaches.
I have Fibromyalgia and several other medical issues that I treat myself with along with physician prescribed medications. Many pharmaceuticals interact with each other so many I can’t take. I use natural supplements in an interdisciplinary approach to ease pain and other symptoms. This approach works for me. Pharmaceuticals have not done enough good to warrant using without other disciplines.
Please don’t support regulation of holistic medications and approaches.
I want freedom of choice and that includes the type of medical treatment that i believe is best for me.
My 13yr old cat stopped eating. Took him to a vet who gave him a penicillin shot & pills for a possible infection. In 4days he still wouldn’t eat &was getting weaker. I looked up the side effects of the drug that said to not feed on empty stomach (she hadn’t instructed me not to). So, I called her, she sd to bring him bk in & gave him another penicillin shot that made the leg she injected it into go limp & that lasted over a month (norm is 3 days max), which she tried to blame on arthritis setting in. I told her he’d never had issues prior to that. I then took him to another vet who said it’s a bladder infection, gave him a different drug that got him eating better, but still not normal.
I finally found a local Homeopathic vet who gave me 3 tabs/;1/day + a liquid to administer 1x / day till gone. Within a few days he was running around playing like he was a kitten. 2 yrs later, he’s never had another infection.
I need to add, he’s developed pain in that leg the 1st vet damaged (Sciatic nerve) & there are no laws to protect animals against malpractice. Needless to say, I will be calling the Homeopath, NOT the conventional vet. Now, you tell me who & what should be more closely regulated??!!!
Homeopathic medicine is very safe and does not cause side effects like the drugs that are seen in commercials. A lot of people are seeking homeopathic medicine as an alternative, such as people with chronic illnesses and autoimmune diseases like Lupus and Hashimoto’s Disease. The current regulation of homeopathic remedies is more than sufficient to ensure public safety. I personally have used homeopathic remedies to care for myself and I can vouch for their effectiveness. They are already well regulated and are much safer than conventional drugs, so there is absolutely no need to change regulations for them. In the few cases against the world’s leading homeopathic manufacturer in California, in none of the cases did the plaintiffs say they were physically harmed. They merely claimed that the products did not treat them as they stated they would, and that they suffered minor economic loss by purchasing the product. Therefore there are no reasons for why the regulations on homeopathic medicine should be changed.
Thank you
Ask that all medical disciplines provide a scientifically consistent description of their bases and studies sufficiently powerful to prove that treatments do work beyond the possibility of chance.
Would you want your insurance payments or taxes to pay for treatment that someone believes will work but which has no function beyond that belief?
A few random studies of dubious validity do not qualify an entire medical discipline.
What of those which offer mechanisms that are not biologically or anatomically possible, results from vendors that cannot be reproduced by anyone else or cherry-picked from studies that are uncontrolled or of insufficient statistical power to avoid having made the conclusion by chance? They can incorporate as churches. Faith healers make a decent living but cannot charge insurance or government.
Is it unfair to expect apparently magical claims to be supported by physical evidence?
The FDA should stick to monitoring and testing drugs big pharma makes. Homeopathy is a kinder and gentler option without all the dangerous side effects of products manufactured by companies like Merck.
Homeopathy has been an effective source of healing and health in my life. I reccommend that no laws are passed to stop Americans from freely using remedies of their own choice and at their own discretion to enjoy good health all the days of our lives.
It is heartbreaking and almost disgusting what our government is doing to it’s people. It’s as if we don’t have a voice in this free country. Well, not so free anymore. I was proud to be a
US citizen but that is fading.. We can’t let this happen!!!!!
This neocon government suck’s more than ever along with those bastards FDA, is time to do a revolution…..
I wish I knew of some way to make homeopathy more acceptable or make people more
aware of it. What we’ve used within the family we have liked.
Homeopathy is junk science at best and snake oil hucksterism anytime. It should be criminal offense to offer this technic as a cure for anything.
I depend on supplements to stay healthy and have no money to see doctors. Current regulations are more than enough. This is just a way for the 1% to steal more of my money.