It is happening again that the FDA is wanting to change regulations and make it more difficult to get homeopathic remedies all in the name of protecting you. The current debate is an extension of the public hearings from 2015. This had to do with the safety and efficacy of homeopathic remedies. I am sure all of you loyal readers contacted the FDA and responded with astounding support of its safety and usefulness.
Since December of 2017 the FDA is now proposing a different wording of their guidance that puts the burden of proof of a remedies safety and efficacy on the manufacturer. Essentially this makes homeopathic remedies in the same class as allopathic drugs.
Their new proposed guidance is less clear than the existing regulatory framework, Compliance Policy 400.400 (adopted in 1988). Therefore this has led to a lot of confusion as to what extent the FDA wants to control homeopathy. Because of this it looks as though if the FDA wanted to include any homeopathic remedy, they could.
This was not the focus of the original hearings in 2015. They were about the safety of combination remedies that had a report of adverse effects. Combination remedies have not been regulated in the past and have slipped through a deeper scrutiny because of the safety of single remedies and the guidelines for their manufacturing. Combination remedies have become a bigger piece of the market. I am sure they are capturing potential profits that the allopathic drug companies would love to keep.
It seems that the FDA's entire conversation about homeopathic remedies is based on an allopathic drug model. Their desire to have the same level of level of drug trials and double blind studies is absurd for how homeopathy is done. For example: there are 100's of different remedies that include cough. Each one is particular to each individual expression of that individual cough. And cough is only one indication. The remedy is NEVER for a single symptom or diagnosed condition. It is ALWAYS for the totality of symptoms. 100 people could be diagnosed with cough and there could be dozens of different remedies indicated for that group; each person being prescribed a remedy for their particular version of cough.
How could double blind trials and statistical evidence be brought for homeopathy? It simply does not fit the allopathic model. Yet, the FDA is moving towards this type of regulation. This would make the cost of bringing a homeopathic remedy to market so expensive that it would make it impossible to get approval. And if they decided that all homeopathic remedies were unsafe and needed this type of approval it would end the availability of homeopathic remedies.
The absurd part of all of this is that homeopathy has been used and practiced for over 200 years and has a proven efficacy and safety. Either the FDA is blatantly trying to regulate homeopathy out of existence or it is being very ignorant of its history. The proposed new guidelines need to be refined to better define what the FDA is really trying to accomplish.
If combination remedies are a potential threat to public safety (which they aren't) then it needs to be defined in the new guidelines so that there is no room for misinterpretation or confusion about the intent. I know that combination remedies are very popular and do help people. But as a classical homeopath I never use them or recommend them. To me personally, it would be fine if they were further regulated as long as it did not drift into further regulation of single homeopathic remedies.
No provings have ever been done when 10 different remedies in many different potencies are combined to make a new remedy. The combination remedies are not necessarily the combination of each single remedy. A new energy and remedy is formed from the combined substances and this has never been addressed. Yet I do believe they are safe. Any substance that has been diluted beyond Avagrado's number of dilution has nothing left of the original substance. Therefore it must be safe at least in the physical form.
The problem the FDA needs to reconcile is the question of whether homeopathy is physical or energetic medicine. They have not ever addressed this. The common argument is that if there is nothing in it then it must be a placebo. Yet we all have seen results far better than placebo.
Another way that homeopathy has tried to bend to the materialistic stamp of physical Allopathic medicine (which the FDA is an extension of) is a result of our latest technology boom and nano-science. Now there are studies trying to substantiate homeopathy by analyzing remedies and using nano particles to describe them. Nano-particles by description are in the realm of the physical. But trying to describe homeopathy in the physical is binding it to the drug model of disease treatment. There has to be something there for it NOT to be a placebo.
I say we need an evolution in thinking. It is time to acknowledge that we are spiritual beings having a physical bodily experience. That the vital force is not a physically quantifiable aspect of our being. And as Hahnemann says it rules with unbounded sway. If these truths were recognized and understood it would upset the current status quo to such an extent that mankind itself would suddenly evolve to a much higher state. The understanding and treatment of dis-ease would naturally evolve to homeopathy. This would be a big upset for the people in power who are currently controlling the conversation. This might be the reason why the FDA ignores the 200 plus years of homeopathy's safety and efficacy.
If you would like to read the draft proposal and make comments you can do so HERE. Comments are closing March 28, 2018. Please make your comments respectful.
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