FDA Seeks Power to Ban Homeopathic Remedies
The U.S. Food and Drug Administration (FDA) has proposed new guidelines for homeopathic remedies that would give it the power to ban properly formulated homeopathic products currently legal under the Food Drug & Cosmetic Act which governs the FDA.
New Enforcement Priorities
The proposed guidelines state that the FDA will prioritize enforcement actions against homeopathic remedies containing the following:
- Infectious agents with the potential to be pathogenic.
- Controlled substances, that is, drugs for which one must get a doctor’s prescription.
- Multiple ingredients that, when used in combination, raise safety concerns due to possible interactions, synergistic effects, or additive effects of the various ingredients.
- Ingredients that pose potential toxic effects, particularly when those ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process.
These broad categories suggest that the FDA is aiming at removing a significant number of currently available remedies from the market.
These Priorities Make No Sense
We believe that none of the priorities mentioned by the FDA makes sense in the context of homeopathy. We know of NO product properly labeled homeopathic which contains an agent that:
- Has the potential to be pathogenic.
- Could be considered a controlled substance.
- Is dangerous because it combines multiple homeopathic ingredients.
- Poses potential toxic effects because of concentrated ingredients (which would mean we are not talking about a homeopathic product since those are always diluted) or because of low dilution during a manufacturing process which is “not adequately controlled.”
If the FDA were to discover a product containing such agents, it would mean the product is not homeopathic and is therefore improperly labeled. The FDA already has ample authority (under what is called Compliance Policy Guide 400.400 which currently governs homeopathic remedies) to take action against such products. This is a key reason why we are urging the agency to withdraw its proposed new guidelines and reaffirm CPG 400.400.
If You Use It, You May Lose It
In a strange twist the FDA’s proposed guidelines would allow the agency to ban 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 in great enough numbers choose to try homeopathic remedies for “the prevention or treatment of serious and/or life-threatening diseases and conditions,” that alone could trigger a move by the FDA to ban 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 act directly on the physiology and organs of the body. Homeopathic remedies, on the other hand, seek to engage the natural healing ability of the body itself to resolve disease.
Remedies Would Become “Unapproved”
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 banned 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 undergo the NDA process would be a de facto permanent ban.
The legal 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.
Homeopathy Under Assault Worldwide
Homeopathy is not just under assault in the United States. Enemies of homeopathy now have the upper hand in Australia and Great Britain. Both governments after a review by their respective national health services decided to stop paying for homeopathic remedies prescribed by doctors.
But, a review by the Homeopathy Research Institute of the report on which the Australian decision was based turned up the following: 1) previously undisclosed conflicts of interest among panel members making the recommendation, 2) the failure to mention an initial report on homeopathy that was favorable, and 3) faulty guidelines for reviewing homeopathic trials that excluded all trials which showed homeopathy remedies to be effective and therefore assured a negative recommendation.
A separate Australian review panel evaluating pharmacies recommended banning homeopathic remedies from that country’s pharmacies. The government did not implement the ban, but has not rejected it either and so may act at a later date.
In the United States the entire set of proposed FDA guidelines (technically called “guidance” by the FDA) assumes that pharmaceuticals are more effective and safer than homeopathic remedies. It also assumes that highly dilute and therefore inherently safe homeopathic products should be treated as if they are as risky as pharmaceuticals (a strange contradiction if pharmaceuticals are supposedly safe).
Homeopathic Remedies Haven’t Been Banned—Yet
There has been no outright ban of homeopathy anywhere yet. But the enemies of homeopathy are advancing and attempting to move toward such a ban. Together, we can stop them by enlisting the help of all those who want to maintain freedom of choice in their health care decisions.