FDA to Scrutinize Risky Homeopathic Products

Homeopathic treatments have become a big business, raking in billions of dollars of sales each year. . (Photo: Armin Staud/Shutterstock)

Homeopathic medicine: Some people swear by it while others question its validity. Up to this point, homeopathy has enjoyed a fairly hands-off approach from federal regulators, but the rules have changed. The Food and Drug Administration (FDA) has announced it's unveiling new rules for the regulation of homeopathic products, especially ones claiming to treat children and infants.

"In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer," FDA Commissioner Scott Gottlieb said in a statement. "In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients."

The FDA will examine products that contain ingredients with potential safety risks, those targeted toward infants and children, and ones that claim to treat serious and life-threatening conditions. However, the administration won't require these remedies to have formal FDA testing and won't pull the products from shelves, reports NPR.

Mark Land, president of the American Association of Homeopathic Pharmacists, said in an email to NPR that the group "shares the FDA's commitment to protecting public health," and said that the action "would not materially affect the vast majority of homeopathic drug products available in the United States."

"As always, AAHP is committed to ensuring that consumers have access to natural, safe, homeopathic medicines in the United States and throughout the world," Land said.

The story so far

Before reaching its decision, the FDA held public hearings in 2015 to decide whether or not to regulate homeopathic remedies in the same way the agency regulates traditional drugs.

In 2016, a policy from the Federal Trade Commission required makers of all homeopathic remedies to show reliable scientific evidence to back up any health claims.

Although the FTC has now vowed to scrutinize marketing claims, that doesn't mean products will vanish from store shelves. Manufacturers can still sell homeopathic products without scientific validation as long as they clearly state that either "there is no scientific evidence that the product works" or "the product's claims are based only on theories of homeopathy from the 1700s that are not accepted by most medical experts."

What exactly is homeopathy?

Homeopathy is defined as alternative treatments that use natural herbs, plants and minerals to cure ailments. It's based on the theory that "like cures like," which means if you take a dose of a substance that causes symptoms similar to those of your illness, the plant or mineral can — in theory — cure your illness, especially when that substance becomes diluted to the point that it's no longer

The practice has been around for centuries and it's been controversial for almost as long, mainly because it's not based on science.

According to the National Institutes of Health (NIH), "there is little evidence to support homeopathy as an effective treatment for any specific condition." NIH also notes that “several key concepts of homeopathy are inconsistent with fundamental concepts of chemistry and physics.”

"Homeopathy is an excellent example of the purest form of pseudoscience," Steven Novella, a neurologist at Yale, told NPR.

But many people use these remedies every day and swear that they have helped cure their illnesses in ways that standard medicine could not. So if it's helping some people, what's the big deal?

The big deal is that homeopathy has become a big business. Americans spent about $1.2 billion on homeopathic products in 2014.

Another issue is that these treatments can have side effects and can interfere with over-the-counter and prescription medications. They could cause a placebo effect, meaning they work for a short period of time but not for the long term, causing a person's condition to worsen before they seek medical help. Someone who is using homeopathy to control diabetes, for example, is not addressing the underlying condition, putting the person at great risk — and that type of scenario is the impetus for the FDA hearings and the FTC ruling.