FDA Scrutinizes Homeopathy - Urgent Action Required!

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On the heels of a recent upswing in anti-homeopathy activity in Australia, Canada, and the UK, the FDA recently gave surprise notice of its intent to review the legal status of homeopathic products in the U.S. marketplace. The fact that this will be the first such FDA review in twenty-five years makes its timing more than a little suspicious. (1)

In recent years, numerous initiatives to defame homeopathic medicine have been orchestrated by well-organized, PhRMA-funded groups populated by individuals that are fond of calling themselves "skeptics." Skeptic organizations are known for their rabid anti-homeopathy misinformation campaigns designed to spread lies regarding the scientific basis and effectiveness of homeopathic treatment. In places like the UK and Australia, their recent efforts have met with a surprising degree of public relations success. Skeptics are known to be equally hostile to all alternative and holistic therapies across the board. 

This trend is in sharp contrast to positive developments in some other countries like India where it is estimated that more than 100,000 physicians prescribe homeopathic medicines. In Switzerland, homeopathic treatment is covered by public health insurance. A report commissioned by the Swiss Federal Office for Public Health recently concluded that...

"There is sufficient evidence for the preclinical effectiveness and the clinical efficacy of homeopathy and for its safety and economy compared with conventional treatment." (2)

Some historical background regarding homeopathy in the U.S. may be helpful. In 1938, Senator Royal S. Copeland of New York, who was also a physician well-versed in homeopathy, was able to secure the future of homeopathic medicine by making sure that it was included in a new set of laws passed by Congress called the Food, Drug, and Cosmetic Act. He was one of the principle authors of the law that led to the creation of what we now call the FDA. As a result, most homeopathic medicines were classified as over-the-counter (OTC) drugs. A much smaller number are prescription only. 



Since then, all new homeopathic products that meet with approval are listed in the Homeopathic Pharmacopoeia of the United States (HPUS). Oversight of the HPUS is entrusted to the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), which is an organization composed of scientists and physicians trained in homeopathic medicine. Although the HPCUS safeguards the Homeopathic Pharmacopoeia, it has no regulatory power over new homeopathic products. Regulation rests with the FDA

Unfortunately, the growing success and popularity of homeopathy has been accompanied by some unpleasant realities, one of which is the fact unscrupulous opportunists have chosen to market homeopathic products that are not approved by the FDA and not listed in the HPUS. Such products are homeopathic in name only and cast a bad light upon the legitimate homeopathic profession. These unregulated products are, ostensibly, what the FDA seems to be concerned about. However, given the historical animosity of mainstream medicine toward homeopathy, many are concerned that this may be a regulatory Trojan horse, a way of getting a foot in the door that will eventually lead to further measures that will restrict access to homeopathic medicines. 

Since homeopathic medicines were (and continue to be) known for their exceptional safety profiles, the FDA has not required that they be subject to the same degree of testing as conventional pharmaceutical drugs. To do so would constitute a monumental waste of resources that would inevitably lead to a conclusion that we already know, which is that homeopathic medicines are remarkably side effect free. One way to ensure that patients lose access to homeopathic care would be for the FDA to require that homeopathics be subject to the same approval process as pharmaceuticals. The untold millions of dollars that such a process would entail would constitute a serious hardship the industry and likely threaten the availability of homeopathic medicines. Naturally, the homeopathic community is very concerned about the true motives of the FDA. 

Technical input to the FDA regarding how to view the complex issue of unofficial homeopathic products that are not listed in the HPUS is being provided by professional homeopathic organizations including the American Association of Homeopathic Pharmacists (AAHP), the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), and the American Institute of Homeopathy (AIH). These organizations have worked hard over the years to maintain positive relationships with the FDA. However, while these organizations are best suited to the task, they are small in size and have little influence compared to the FDA and its conventional medical affiliates. 


This is why we are calling for a broad and inclusive grassroots response to this potential threat to the integrity and availability of homeopathic medicines to homeopathic practitioners and the general public. 

A public hearing will be held on April 20-21 during which representatives of the homeopathic community will make oral presentations. Furthermore, the FDA notice states that written and electronic comments will be accepted until June 22, 2015:

"FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry. FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share." (3)

Here's where your help would be most appreciated. FDA is making a broad request for input that encourages anyone to comment. If you care about continued access to homeopathic medicines please take the time to write a brief statement in support of this remarkably safe and effective healing modality. 

You can click here to go to the page where you can submit your comments. Just click on the green box at the upper right hand of the page that says, "Submit a Formal Comment."

Here are a few tips as to how to comment effectively: 

  • Keep it simple. A few short sentences or a paragraph are just as valuable as a longer entry. 
  • Keep it positive. This is an opportunity to promote the virtues of homeopathy. Avoid negative or harsh statements. Avoid criticism of conventional medicine. 
  • Circulate this article as widely as possible to family, friends, and colleagues. The more voices, the more impact our message will have. 
  • Make your voice heard. Trust your instincts and don't allow doubt to stop you. Everyone has a right to his or her opinion. 
  • FDA requests that you organize your comments into topics, noting the topic at the head of each comment. Unless you have extensive experience or knowledge of homeopathy, we recommend that you choose one or more of the three topics below to comment about. 

3 Recommended topics to focus your comments on:

  1. Safety of homeopathic medicines. This is a good topic to discuss. The safety of homeopathic medicines is a well-established, indisputable fact. There is nothing more important when it comes to the medical care of children. Of course, the same applies to adults. Give examples of your experience with homeopathy, its safety, and the rarity of side effects. 
  2. Effectiveness of homeopathic treatment. This is an opportunity to tell your story. Discuss how homeopathy has helped you and your family. It is equally helpful to discuss how homeopathy has helped acute medical problems like colds, flus, ear infections, sprains, and bruises, and chronic health problems like migraines, arthritis, hot flashes, and depression. 
  3. Freedom of medical choice. This is a general issue that anyone can discuss. At stake here is continued access to the medical therapy of your choice. The ability to have options when it comes to one's medical care should be a basic human right in any democratic society. 

Here is a sample that you can use as an example for your comment:

Re: Safety and Effectiveness of Homeopathic Medicines

Dear FDA Review Committee,

 I am writing to express my thoughts regarding the importance of continued access to homeopathic medicines to the general public. My family has used homeopathic medicine with great success for more than 15 years. I must admit that when I first began using homeopathy, I was skeptical. But I was surprised with the results and my family continues to use it because we have found it to be both safe and effective. Under the guidance of our doctor, homeopathy has eliminated my migraines and it has helped improve my husband's chronic issues with back pain. My husband and I are very pleased with the success we have had in using homeopathy for our children's ear infections, eczema, and coughs. In no case have we experienced any side effects that would make us concerned about continued use of homeopathic medicines. I strongly urge you to ensure that homeopathic medicines continue to be accessible to health care practitioners and to the general public. I believe that the ability to use the medical therapy of my choice should be a basic human right. I thank you for the opportunity to comment and hope that you will continue to protect access to homeopathic medicines for all Americans. 

Sincerely, Jane Doe 

Those with more extensive experience with homeopathy may want to address their comments to criticisms that skeptics tend to use in their attempts to discredit homeopathy. This is a more complex topic that requires some familiarity with the issues surrounding homeopathy. If you feel like you are up to the challenge, then by all means, speak your mind! 

Typical false arguments used by skeptics include the following: 

  • There is no scientific evidence in support of homeopathy. This is simply an outright falsehood. Any unbiased observer would come to the same conclusion: there is an abundance of research that points to the safety, biological activity, and efficacy of homeopathy. And the evidence is mounting with the passage of time. 
  • Homeopathy is nothing more than placebo medicine. The falsehood of this statement is clear from the evidence provided by research studies. It is also refuted by the positive results people witness in their own homeopathic care. Another argument against the placebo criticism is that homeopathy is effective in treating infants, children, and animals. These populations are much less likely to be susceptible to placebo effects. 
  • Personal stories about the benefits of homeopathy constitute unreliable "anecdotal" evidence. This claim is an insult to everyday common sense. There is no more important evidence of the power of homeopathy than patients' own reports of how it helped them with their health problems. Physicians learn valuable lessons when they take the reports of their patients seriously. 
  • Homeopathy can't be taken seriously because there is no plausible explanation as to how it works. This statement is an affront to science itself. No serious scientist dismisses a phenomenon on the grounds that it can't be explained. To the contrary, such a phenomenon should generate more interest on the part of scientists, not less.  
  • Homeopathic treatment is dangerous because it delays patients from getting the "real" medical care that they need. This is a bogus claim that ignores the fact that all trained professionals know when to refer patients for additional care. Conventional doctors do this, too. When indicated, patients are instructed to get emergency care, to seek second opinions, or to consult specialists. It should also be abundantly clear that the "real" medicine referred to in this criticism does not guarantee a successful medical outcome. In fact, many patients seek homeopathic care in order to avoid the side effects of conventional drugs


Thank you for your help in coming to the aid of homeopathy at this historic moment in time. It is important for the green health community to come together in order to prevent any further erosion of our rights to the holistic health care of our choice. Effective grassroots action will help preserve freedom of medical choice and will give this critical issue the attention that it deserves. Please take action now!



(1) http://www.greenmedinfo.com/blog/fda-pushing-regulate-homeopathy-out-existence1

(2) https://www.hri-research.org/resources/homeopathy-the-debate/the-swiss-hta-report-on-homeopathy/

(3) https://federalregister.gov/a/2015-07018

Larry Malerba, DO, DHt is a classical homeopath, osteopathic physician, and educator whose mission is to build bridges between holistic healing, conventional medicine, and spirituality. His new book is Metaphysics & Medicine: Restoring Freedom of Thought to the Art and Science of Healing. He is also the author of Green Medicine: Challenging the Assumptions of Conventional Health Care. Dr. Malerba is board certified in Homeotherapeutics, is Clinical Assistant Professor at New York Medical College, and past president of the Homeopathic Medical Society of the State of New York. Visit his website: www.SpiritScienceHealing.com

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Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.

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