The FDA is finally getting on board with the idea that homeopathy is a pre-scientific holdover.
Throughout the history of medicine, many people have held incorrect beliefs about various treatments and remedies. From bloodletting to lobotomies, many of these have since been re-evaluated and abandoned. Leading medical experts say that homeopathy is a similarly pre-scientific holdover. And now the Food and Drug Administration may be taking them seriously.
The agency is considering a new, tougher approach to regulating homeopathic treatments. The policy draft, which is open to comments until March, states that the FDA will more carefully scrutinize homeopathic products that pose safety risks to the public. These include products sold as treatments for sick children, cancer patients, and remedies for opioid and alcohol addictions.
“I wouldn’t even call them remedies,” says Aaron Kesselheim, an associate professor of medicine at Harvard Medical School and director of the program on regulation, therapeutics, and the law at Brigham and Women’s Hospital. “Homeopathic products are not backed by the evidence that we understand and expect from products that have been formally evaluated and approved by the FDA.”
Homeopathy is based on an 18th-century idea that heavily diluted preparations of plant extracts and toxic metals can be used to treat diseases because “like cures like.” This was first espoused by a German physician named Samuel Hahnemann, who observed that high doses of plant extracts (like cinchona) produced severe adverse effects (like headaches, hives, and fever). By diluting these heavily, Hahnemann believed the same extracts could treat diseases that produced similar symptoms (like malaria).
Today, homeopathic practitioners and brands like Boiron and Hyland use the same process of extreme dilution to make treatments for nausea using the vomit-inducing syrup of ipecac, for example. And while it’s easy to confuse these homeopathic treatments with other herbal remedies, what’s most distinct—and most controversial—about homeopathy is the claim that a remedy becomes more potent as it is diluted, Kesselheim says. Modern scientific research has repeatedly shown that there is no evidence to support this.
So why do people continue to turn to homeopathy? Lack of trust in Big Pharma, the desire for alternative treatments, and the promise that homeopaths will spend time giving patients personalized attention and prescribing holistic remedies all play a role.
“I think people are trying to find a better way [for treatment],” says Susan Sonz, director of the New York School of Homeopathy. “People are looking for something that’s safe and effective, which pharmaceuticals have gone away from. All you have to do is watch one of their commercials and listen to all of the side effects.”
Many homeopathic products are also easily available, unlike prescription pharmaceuticals. These remedies are sold over the counter, alongside dietary supplements and herbal medicines. And they have grown into a nearly $3 billion industry over the last decade.
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Regulators in the UK, Canada, and now the US are starting to notice. But simply policing the sale of contaminated products and standardizing homeopathic licenses may not be enough. “It legitimizes these fields and basically helps to spread the pseudoscience, which hurts everyone,” says Timothy Caulfield, a professor and research director at Health Law Institute of the University of Alberta. “It hurts the students that are taking [homeopathic] courses. And it hurts the public that is being subjected to treatments after students learn this pseudoscience.”
In recent years, the FDA has received more than 130 reports of loss of sense of smell associated with the use of homeopathic cold remedies. (Specifically, nasal gels and swabs containing higher-than-usual amounts of zinc.) The agency has also issued warnings about several other products, including infant teething tablets that contained high levels of a toxic substance called belladonna that was linked to the deaths of ten children .
Cases where homeopathic products have dangerous levels of plant and metal extracts are rare, though. They are more likely to be diluted to make supposedly more potent remedies. But less-potent versions—or contaminated ones—can have serious effects, Kesselheim says.
Even if these products don’t cause physical harm, using them can be hurtful in other ways, Kesselheim says. “Sometimes the danger from homeopathic products can be if people take them and are diverted away from drugs that actually are studied, and are safe and effective.”
Homeopathic products are not shown to be effective for treating any kind of health condition, he says. At best, they have a placebo effect because they are diluted so much that there’s little to no active ingredient left. But homeopaths believe this dilution in water or alcohol helps retain the “memory” of the original substance, and invoke quantum physics as an explanation for how the final mixture then triggers a healing response in the body.
But in addition to defying actual physical principles, this idea “doesn’t pass the fish poop test,” Caulfield says. “Why doesn’t the water hold the memory of all the other substances that it’s been associated with? It’s probably passed through you and me. It’s probably had fish swimming in it at one point. Why is it selectively holding the memory of just one substance?”
If someone feels better after going to a homeopathic practitioner, or after taking a homeopathic tincture, it does not mean the remedy was the actual cause of that improvement, Caulfield says. But having those options around, and being exposed to them, can make people believe just enough that they may want to try homeopathy instead of going to their regular doctor for everything from a simple cold to a getting treated for a serious illness, he says.
The FDA’s efforts to rein in the homeopathic industry are just the first step, Caulfield says. More health professionals, associations, and regulatory agencies around the world need to lend a stronger voice to the cause. Only then will homeopaths stop peddling magic water.
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