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FDA–anti-homeopathy? – Issue
This alert is for those who prefer (or need) non-drug options for dealing with a health challenge. The future availability of homeopathic remedies in the United States appears to be threatened.
Homeopathy is a 200-year-old system of medicine based on the principle that highly diluted substances can be used to treat symptoms similar to symptoms that would be caused by large doses of those same substances in healthy people. Homeopathy works because the “substance” becomes so diluted that only the energy of it is left. For this reason, homeopathy has been viewed for centuries as one of the safest treatment options available.
With the U.S. Food and Drug Administration’s (FDA) new Draft Guidance, Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry (released in December of 2017), the FDA’s enforcement policy is changing entirely and the 1988 CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed is being rescinded. The deadline for submitting comments to the FDA has been extended to May 21, 2018. If this change goes into effect, the reality is that requiring non-patentable homeopathic remedies to meet pharmaceutical drug testing requirements will be too expensive for costs to ever be recovered, so it would be expected that most homeopathic products will not qualify to be available for sale.
There are two dramatically opposing positions about the credibility and safety of homeopathy. AHHA’s review of the history, articles, and research has revealed conflicting interpretations of this healing modality.
ISSUE: Should the FDA change the homeopathy Guidelines?
AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in learning more about this month’s issue, the following related articles were selected to serve as a foundation for learning more about this issue.
PRO
FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs (12/18/17)
U.S. Food & Drug Administration
FDA to step up enforcement of homeopathic medicine (1/11/18)
by Diane Romza-Kutz, Fredric Roth
Thompson Coburn, LLP
FDA to crack down on “harmful, unproven homeopathic drugs” (12/18/17)
by Rich Haridy
New Atlas
FDA takes on homeopathic drugs with potential safety risks (12/19/17)
by Michael Nedelman
CNN
My Christmas Wish Came Early: FDA Cracks Down on Homeopathy (12/22/17)
by Julianna LeMieux
AmericanCouncil on Science and Health
FDA takes more aggressive stance toward homeopathic drugs (12/18/17)
by Laurie McGinley
The Washington Post
Homeopathic products and practices: assessing the evidence and ensuring consistency in regulating medical claims in the EU (September 2017)
European Academies Science Advisory Council
CON
The Case FOR Homeopathic Medicine: The Historical and Scientific Evidence (updated 12/6/17)
by Dana Ullman, MPH, CCH
Homeopathic Family Medicine
What You Need to Know About the FDA’s War on Homeopathy (2/1/18)
Living Whole
Letter to FDA (2/8/18)
American Institute of Homeopathy
Critique of Proposed Regulations of Homeopathic Medicines and Alternative Proposals (3/6/18)
by Dana Ullman, MPH, CCH
Mercola
Patricide by the FDA on Homeopathy (3/19/18)
by Scott C. Tips
Whole Foods Magazine
Is the FDA Trying to Ban Over-The-Counter Homeopathy? (2/2/18)
by Larry Malerba, DO
GreenMedInfo
Comments by: National Health Freedom Action (NHFA) [Link no longer available] (3/8/18)
on Docket ID. FDA-2017-D-6580 – FDA DRAFT GUIDANCE Comments Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry
American Institute of Homeopathy Accuses European Academies Science Advisory Council of Deliberate Scientific Bias (October 2017)
American Institute of Homeopathy
We encourage you to go to post your comments. You are also invited to share additional resources you have found relating to this issue.
To review past ISSUES, visit the Special Update eReport Archives.
I rely on homeopathic medicine and it has cured ailments that western medicine and allopathic doctors could not, not only does it help me live a better quality life but it is much safer the all the drugs on the market I know cause I had terrible side effects with fda approved drugs, please don’t take me best method of healing away from me this is injustice and we should have the freedom to treat pur ailments how we want to
It is rather odd that the FDA is so concerned about alternative treatments and the so called danger thereof, when the drug industry posts the deadly and damaging side effects of the drugs currently marketed and prescribed by physicians in the USA. Europe has used homeopathy and alternative medicine for years but yet we do not have the benefit of making a choice between alternative medicine administered by trained individuals in everyday or life and death matters…in USA, it is all about MONEY.
Homeopathic are the SAFEST MEDICINE on the planet!!! I have used on them on myself, my children, friends, and pets for almost 70 years!!! I am in my 7o’s. I DONOT take any RX drugs and I never have. I use homeopathic remedies and other natural healing constituents. Much of the world uses HOMEOPATHIC REMEDIES AS ITS MAIN MEDICAL SYSTEM. I am sick to death of the FDA killing people with their supposedly safe drugs when people could be using SAFE homeopathics. HOMEOPATHIC REMEDIES ARE PROVEN TO WORK AND TO BE SAFE. READ THE RESEARCH. THERE ARE HUNDREDS UPON HUNDREDS OF SOLID RESEARCH PAPERS. Thank you YANENA
Leave Homeopathy alone! I’ve been using homeopathy successfully for fifty years and it is a wonderful healing modality. Why you want to destroy it is just proof that Big Pharma is behind this!!!
Nice article.
I have relied on homeopathics for half of my life due to reacting to most all allopathic meds. I hope nothing changes for me & those who need a natural choice for healing.
I’m an MD which uses Homeopathy around 30 years with good results – Medecine Based Evidence!
Do not limit or in other ways remove a method of treating illnesses that is as old as recorded history. It has worked well for millions of people and the only reason it is being restricted is for pharmaceutical companies to control what we choose to do with our own bodies.
I have been using homeopathic remedies for years, and I can truly say, they work! Even our pets respond well to the remedies, and they know nothing of the falacious “placebo effect.”
Howdy! Would you mind if I share your blog with my zynga group? There’s a lot of folks that I think would really appreciate your content. Please let me know. Many thanks