The U.S. Food and Drug Administration (FDA) has proposed new guidelines for homeopathic remedies that would give it the power to remove properly formulated homeopathic products currently legal under the Food Drug & Cosmetic Act which governs the FDA. Please read our updated statement about the FDA’s newly released 2019 draft guidance.
The FDA’s proposed guidelines would allow the agency to remove a particular homeopathic remedy simply because an increasing number of people are using it. This is because such remedies “may cause users to delay or discontinue medical treatments [using pharmaceuticals] that have been found safe and effective.”
In other words, the FDA believes it is a threat to public health if people choose to try an inherently safe homeopathic remedy BEFORE resorting to a pharmaceutical product that may list serious and even fatal side effects. The FDA implies that if consumers choose to try homeopathic remedies for “the prevention or treatment of serious and/or life-threatening diseases and conditions” in great enough numbers, that alone could trigger a move by the FDA to remove some of those remedies because their use “raises public health concerns.”
It’s important to note that homeopathic remedies do NOT treat serious and/or life-threatening diseases and conditions in the manner that pharmaceuticals do. Pharmaceuticals, in their material dose size, are explicitly designed to act suppressively on the physiology and organs of the body to “control” symptoms. Homeopathic remedies, in contrast, with their very low “ultra-dilute” doses, are known to stimulate a “positive” or strengthening response that is observed as engaging the natural healing ability of the body to resolve dis-ease.
The FDA’s proposed guidelines would allow the agency to remove a particular homeopathic remedy simply because an increasing number of people are using it. This is because such remedies “may cause users to delay or discontinue medical treatments [using pharmaceuticals] that have been found safe and effective.
The proposed guidelines would also change the status of homeopathic remedies from a special category of medicine and put them into a group considered “unapproved.” This means that all homeopathic remedies would become technically illegal and could be removed at any time by order of the FDA.
Any homeopathic remedy which is withdrawn from the market by the FDA could not return unless it undergoes the agency’s New Drug Application (NDA) process, a costly process designed to weigh the risks and benefits of chemical drugs, which may have toxic effects. It makes no sense for homeopathic remedies which are inherently non-toxic and therefore pose no toxic threat to humans to go through a process that can cost tens of millions of dollars and take many years to complete in order to find out if they are toxic. In 200 years of use, there has never been a documented death or injury from a homeopathic remedy.
Moreover, since homeopathic remedies cannot be patented—they consist of commonly available substances—there would be no incentive for any company to pay for such a process. The requirement that a homeopathic remedy undergoes the NDA process would be a de facto permanent removal.
The position of Americans for Homeopathy Choice is that if the FDA were to reclassify all homeopathic remedies as “unapproved,” the agency would be violating the Food Drug & Cosmetic Act. The act already provides a process by which homeopathic remedies are approved for inclusion in the Homeopathic Pharmacopoeia of the US, which is administered by the Homeopathic Pharmacopoeia Convention of the United States. In our view declaring homeopathic remedies technically illegal would be illegal itself and would result in a vigorous court challenge. While we strongly believe our interpretation of the law is correct, there can be no assurance that we would prevail in court.
The FDA has, to its credit, been meeting with Americans for Homeopathy Choice and members of the homeopathy community during the past two years. We strive to create an understanding that for over two hundred years, homeopathic medicines have been used safely and effectively.
We want to empower homeopathy in the United States by doing two things:
There has been no outright removal of homeopathy anywhere yet. But the enemies of homeopathy are advancing and attempting to move toward such a removal. Together, we can stop them by enlisting the help of all those who want to maintain freedom of choice in their health care decisions.
There has not been an outright removal of homeopathy anywhere yet, but if things don’t change, FDA’s language indicates that such a removal will begin to happen. Together, we can stop this by enlisting the help of all those who want to maintain freedom of choice in their health care decisions.