The agency has issued several warnings in recent years about over-the-counter products that may be ineffective or even harmful.
The U.S. Food and Drug Administration (FDA) announced yesterday that it will take a new approach to regulating homeopathic drugs. This comes after the agency issued several warnings in recent years about products, marketed as homeopathic, that have been linked to serious side effects and even a few deaths.
The proposed new approach will focus on “risk-based enforcement,” according to an FDA press release, which means the agency will pay closer attention to homeopathic treatments that are marketed for serious diseases without supporting evidence, that contain potentially harmful ingredients, or that don’t meet standards for manufacturing.
Of course, it’s good news that the FDA wants to protect us from harmful or ineffective products. But what does the agency’s announcement say about homeopathic remedies as a whole? And what does it mean for the millions of Americans who use them on a regular basis?
To learn more, Health reviewed the FDA’s position on homeopathy, and spoke with Michelle Dossett, MD, a staff physician and researcher at the Benson-Henry Institute for Mind Body Medicine at Massachusetts General Hospital. (Dr. Dossett is not involved with FDA policy, but she studies homeopathy and is board-certified in both internal medicine and integrative medicine.) If you’re concerned—or just curious—about homeopathic medicine, here are a few things you should know.
Homeopathy has been practiced for more than 200 years
Homeopathy is a form of alternative medicine that was developed in Germany in the 1700s. “The idea is that you can take a substance that, in large doses, would cause a certain set of symptoms in a healthy person,” says Dr. Dossett. That substance gets diluted down to barely detectable amounts, she explains. Then, the thinking goes, “you can use that same substance to treat those same symptoms in someone suffering from them.”
These substances can include plant extracts, minerals, chemicals, and human and animal excretions or secretions. Some of the most well-known homeopathic remedies on the market today include arnica (a plant-based gel used to treat bruises and sore muscles) and zinc (a mineral used to treat respiratory symptoms and the common cold).
The evidence on homeopathy is limited
Some studies have suggested that homeopathic remedies can be effective forms of treatment, says Dr. Dossett, for conditions such as upper respiratory infections, allergies, and sleep problems. Many of these products are available over-the-counter, she says, but her research suggests that seeing a homeopathic provider—who can do a thorough assessment of your symptoms and make specific recommendations—may be more effective than self-medicating.
However, most rigorous scientific studies have concluded there's little evidence to support the use of homeopathic medicine, according to the National Center for Complementary and Integrative Health. A 2015 review from the National Health and Medical Research Council in Australia concluded that studies showing homeopathy’s effectiveness have been too small or too flawed to consider reliable and that there is “no good quality evidence to support the claim that homeopathy is effective in treating health conditions.”
The FDA may be responding to “a few bad apples”
In 2016, the FDA warned parents against using homeopathic teething tablets and gels containing belladonna, a toxic chemical, after it received several reports of seizures or deaths in babies who had used them. An FDA analysis later confirmed that some tablets did contain levels of belladonna that could be harmful, although the American Institute of Homeopathy has argued that the agency’s research was incomplete and misleading.
The FDA has also issued warnings about homeopathic zinc nasal sprays that may damage users’ sense of smell, and various products whose labels include potentially toxic ingredients—like nux vomica, marketed for a variety of ailments, which contains the poison strychnine.
Not every homeopathic product is necessarily dangerous, however. “I think the FDA is really responding to a few bad apples out there in the last few years, and really wants to protect the public’s health with respect to those few products,” Dr. Dossett says.
Other products the FDA has issued warnings about may have made health claims that aren’t supported by science and that aren’t allowed on over-the-counter products—for example, that they can treat serious conditions like asthma or cancer.
Most homeopathic products won’t be affected
The field of homeopathy has grown exponentially in the last decade, becoming a nearly $3 billion industry, according to the FDA. That growth has come with an increase in safety concerns, the agency notes, as well as an increasing number of poorly manufactured products that may pose health risks.
Homeopathic products are subject to federal requirements that prohibit adulteration and mislabeling. But these requirements haven’t been enforced since 1988, says the FDA—and thus, products currently on the market “may not meet modern standards for safety, effectiveness, and quality.”
That’s one reason the FDA is reviewing its enforcement policy, but it doesn’t mean that all homeopathic products will be affected. Many products will likely fall outside of the risk-based categories defined in the new policy and will continue to be available, the agency says. “We respect that some individuals want to use alternative treatments,” said FDA Commissioner Scott Gottleib, MD, in the agency’s press release. “But the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”
When in doubt, ask your doctor
The FDA will encourage public feedback on its new draft guidelines during a 90-day comment period, and it always encourages doctors and patients to report any side effects or quality problems associated with homeopathic products or any other type of supplement or drug to its MedWatch database.
Dr. Dossett says she supports the FDA’s decision to focus more closely on products that may pose a danger to the public. But she also believes that homeopathy—when used responsibly—can be a helpful form of complementary alternative medicine.
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“My advice is to go with large and well-known manufacturers of these products that have a good track record for safety and to communicate with your health-care provider about what you’re using,” she says. “Like with any drug, it is important to be careful about what you’re taking.”