Dana Ullman, MPH, CCH
America’s Food and Drug Administration (FDA) has actually had a good and long-term working arrangement with homeopathy and the homeopathic community. However, the FDA is presently in the process of establishing new guidelines for the manufacture and marketing of homeopathic medicines in the USA. Recently, several homeopathic organizations have posted “warning letters” claiming that “the end of homeopathy” may be near.
Most American homeopathic organizations have recently sent out letters expressing deep concern and outright fear that homeopathic medicines may become “illegal.” However, American Association of Homeopathic Pharmacists ((AAHP) disagrees with this “sky is falling” mentality…and I agree with them. If there is any homeopathic organization that should be most concerned on THIS subject, it would be the manufacturers of homeopathic medicines themselves, and yet, this organization which has dealt with the FDA more directly than any other organization, is not worried. They are concerned about certain FDA attitudes and actions, but they do not believe that homeopathic medicines will become illegal or not available.
I encourage people to go to the AAHP’s website and read what they have written on this subject: click HERE!
At present, the FDA is planning to eliminate the previous regulatory guidelines by which homeopathic medicines can be marketed and is replacing them with guidelines that the FDA maintains for ALL drugs, called the “risk benefit analysis.” The previous regulatory guidelines had been in use for several decades, and they provided for great safety in the use of homeopathic medicines.
Despite some potential problems from the new FDA guidelines, there is also the chance that the new regulations may provide a similar amount of freedom and safety as the old guidelines. Because there is so little “risk” involved in using homeopathic medicines, the American public is much more likely to experience the many benefits that homeopathic medicines provide.
However, the FDA today tends to believe that there is not strong evidence that homeopathic medicines work, and thus, they can be triggered to stop the manufacture and marketing of individual homeopathic medicines if there is any suspicion that an individual homeopathic medicine may be “dangerous.” Despite the fact that dozens of studies in many of the most respected medical journals in the world have found clinical benefits from the use of homeopathic medicines in double-blind and placebo controlled studies, the problem with this homeopathic research is that there are very few studies testing homeopathic medicines that have been replicated by other independent scientists. And because conventional scientists place great importance on the “replication” of studies by other scientists, there are only a limited number of studies that have achieved this higher standard.
Please know that the FDA cannot make the entire body of homeopathic medicines illegal and stop them from being available to the American public. However, they can choose to make specific homeopathic medicines not available. For instance, if a homeopathic manufacturer makes Nux Vomica 30C, but due to an error in manufacture, they make Nux Vomica 1C, and if a consumer or a group of consumers experience toxicity from this medicine, the FDA could stop the availability of this one medicine from this ONE company, not from EVERY company!
For the record, I have talked with an attorney who is highly regarded as the most knowledgeable and experienced attorney who specializes in health law and the FDA, and he has asserted with authority that the FDA does NOT have the power to “outlaw” homeopathic medicines as an entire field. Instead, they must list specific medicines…and while this is possible for them to do so, they must provide evidence as to why a specific medicine poses risks.
Now is not the time for fear-mongering or villainizing the FDA
I am personally concerned that some of the recent predictions about the possible “end to homeopathy” is creating a lot of FEAR, and worst still, this fear is villainizing the FDA as the bad guys. Because homeopathy has had in the past a good working relationship with the FDA, I am concerned that efforts to make the FDA into “the bad guys” will simply antagonize them to homeopathy. Here’s where one’s own fear helps to create the very thing that we don’t want to happen.
There are certain members of our homeopathic community who are extremely antagonistic to most forms of government, and they seek to attack any and all forms of regulation. I personally think that we can and should accept that homeopathic medicines, like all other drugs and products, benefit from some form of regulation…and I’m sure that the vast majority of homeopathic advocates agree with me here. I believe that we are much more likely to obtain better regulation and more friendly regulation to homeopathy when we do not demonize the FDA.
Instead, NOW is the time to work to educate the FDA about the many benefits that homeopathic medicines have. Here’s where YOU can play a role…
The FDA Wants to Hear from YOU!
The FDA wants to hear from Americans about their use of homeopathic medicines, and I highly recommend that EVERYONE write to them. Go HERE to submit your comment…and please note that the FDA recently extended the deadline to March 23, 2020, by which all comments can be submitted.
Tell them about how your uses of homeopathic medicines have made your and your family’s life healthier and better…and please provide specifics. Please also consider citing this page here as a helpful resource that has verified that FOUR of the FIVE leading meta-analyses that have reviewed clinical studies in homeopathy have found a benefit from it as compared with a placebo.
The FDA has extended the time by which people can submit their comments until MARCH 23, 2020.
Sample letter to the FDA:
The FDA has had a long and good working relationship with manufacturers of homeopathic medicines since 1938 when the FDA was empowered to regulate drugs. Homeopathic medicines have maintained a stellar history of safety due to the extremely small doses of medicines that are utilized in this form of healing.
There is actually much more good scientific evidence on that BENEFITS that homeopathic medicines provide than most people realize. A meta-analysis of clinical studies on homeopathic medicines that these natural medicines, when prescribed during individualized treatment, are 1.5- to 2.0-times more likely to have a beneficial effect than placebo.
Further, this review of clinical research also found that four of the five leading meta-analyses that have reviewed the global benefits of homeopathic treatment have found that homeopathic medicines are more likely to provide a clinical benefit than a placebo.
You can learn about considerably more clinical research as well as basic science research at this website: https://www.hri-research.org/resources/essentialevidence/
In addition to this scientific evidence, I want to tell you about my and my family’s personal experience with homeopathy….(fill in YOUR own specifics here!).
 Mathie RT et al. Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Systematic Reviews, 2014; 3: 142. https://www.ncbi.nlm.nih.gov/pubmed/30699444
 Mathie RT, Lloyd SM, Legg LA, Clausen J, Moss S, Davidson JR, Ford I. Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Systematic Reviews 2014; 3:142. http://www.systematicreviewsjournal.com/content/3/1/142