Can we live without American homeopathy? Practitioners around the world need to join together to stop the U.S. Food and Drug Administration from destroying homeopathy in America By Bernardo Merizalde, M.D. December 2019 I don’t have to tell you that homeopathy is under attack worldwide. Right now in America, the U.S. Food and Drug Administration (FDA) is poised to regulate homeopathy out of existence one remedy at a time if we let them. Either the agency does not understand what it is doing—which is quite possible because it consulted with no homeopaths in the formulation of its new rules—or the FDA is simply trying to do through regulation what it cannot do through law. U.S. law specifically names homeopathy as a legal, regulated form of medicine. Our fellow homeopathic physicians at the American Institute of Homeopathy described the dire situation in a recent statement: "Homeopathic medicines are now in real danger. The newly revised Draft Guidance [the FDA’s proposed rules for homeopathy], if adopted as currently written, will be a recipe for the destruction of homeopathy as we know it in America." No matter what country we work in, homeopaths and their patients are unavoidably connected to what happens in America. Whether we like it or not, drug regulators around the world pay close attention to what the FDA does. And, the various homeopathic pharmacopeias across the globe are interrelated. The Homeopathic Pharmacopeia of the United States (HPUS) is one of the few explicitly recognized by law. The Crux of the Matter Here is the crux of the matter: The FDA is seeking the power to withdraw any homeopathic remedy at any time without having to justify that withdrawal. If the FDA obtains that power, it could theoretically withdraw all homeopathic medicines from the U.S. market with a single order. More likely, the agency will target for withdrawal vitally important polycrest remedies at a rate of one or two a month and use scaremongering tactics when they do. Here is a sample of those tactics from a news release from May 2019 regarding a company subject to enforcement action by the FDA: Some of the company’s products labeled as homeopathic are indicated for treating conditions in infants and children, and they are manufactured from ingredients such as nux vomica, belladonna, aconitum napellus, and gelsemium sempervirents that pose potentially toxic effects. For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. Here’s another release from April 2019 quoting the commissioner of the FDA who warns about “the use of toxic substances like snake venom that has the potential to cause harm and does not have demonstrated benefit.” A Preview To a trained practitioner these statements are nonsense. But they are almost certainly a preview of what we can expect if the FDA succeeds at forcing its new rules through. We can infer this because of what the rules themselves state: Since the issuance of CPG 400.400 [the previous rules], the Agency has encountered multiple situations in which homeopathic drug products posed a significant risk to patients. Such products either caused or could have caused significant harm, even though the product labeling and ingredient formulation appeared to meet the conditions of CPG 400.400. Let me translate. What the agency is saying is that properly manufactured and labeled homeopathic medicines can cause “significant harm.” Combine that with the repeated statements that many homeopathic medicines contain potentially harmful substances and that the public needs to be protected from these substances, and we now have a recipe for an ongoing campaign against homeopathy by the FDA. The legal legerdemain which will allow this campaign is two-fold. In the proposed rules the FDA declares that all homeopathic medicines are unapproved “new drugs.” This opens the way for the conclusion that they are “illegal” since all unapproved new drugs are illegal. The rules, referred to as “guidance,” then state: [T]his guidance is intended to provide notice that any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time. This is where it becomes clear that the FDA wants the power to withdraw any properly manufactured and labeled homeopathic medicine if it so chooses. All the remedies it mentions in the releases quoted above (and in many others) will have targets painted on them. It’s Easy to Help Defend Homeopathy If you’d like to help defend homeopathy, you can make a comment to the FDA challenging the new rules. Anyone on the globe can do this. The easy way to do it is to go to this page on the Americans for Homeopathy Choice website. This is the group heading up efforts in the United States to stop the FDA. It only takes a couple of minutes to make a comment if you decide to use the one provided by the site. These comments matter to the U.S. Congress. The more of them there are, the more the members of Congress pay attention. Let’s help our American friends get the attention they deserve. _______________ About the Author Bernardo Merizalde, M.D., is General Secretary of Liga Medicorum Homoeopathica Internationalis (LMHI), a world umbrella organisation for homeopathic doctors and homeopathic associations with members from 76 countries. He is a diplomate of the American Board of Homeotherapeutics and he is board certified in psychiatry and integrative and holistic medicine. How to Help To make a comment to the FDA, visit the FDA Comment Page on the website of Americans for Homeopathy Choice. The author grants permission to reproduce, reprint and repost this article freely in whole or in part without alteration.
Can we live without American homeopathy?
12/26/2019 9:04:42 AM