The Food and Drug Administration announced on Monday its plans to more strictly regulate certain homeopathic medicines, in hopes it will be able to respond faster when such remedies prove dangerous.
"Today, we took an important step to better protect people who choose to take potentially harmful homeopathic drug products," FDA head Scott Gottlieb said during a call for reporters.
Products labeled "homeopathic" are widely available in American drugstores. They include some medicines that are marketed as "natural," as well as less overtly alternative therapies, such as some zinc-based cold remedies. In particular, the FDA plans to more closely scrutinize products it considers high-risk, including anything intended for children, products that claim to treat serious conditions (such as addiction), and products that have received safety complaints. The majority of homeopathic treatments aren't considered high risk, said Janet Woodcock, who directs drug evaluation at the FDA, during the same call. Those treatments may continue to be sold, under no closer watch than they had been.
Homeopathy is a traditional Western medical practice that became standardized in the late 1700s, according to the FDA. Homeopathic remedy-makers generally don't have to prove to the FDA that their products are safe and effective using clinical trials. Homeopathic companies are also allowed to claim on their packaging that they treat certain simple conditions, such as colds and allergies. However, several large studies have found that homeopathic drugs don't work.
While it's unusual for products not to have to prove themselves effective in order to make health claims, homeopathy has a special exemption in part because the Federal Food, Drug, and Cosmetic Act—passed in 1938—was sponsored by a congressman who was himself a homeopathic practitioner. New York Senator Royal Copeland, a Democrat, added into the act a provision recognizing the Homeopathic Pharmacopoeia of the United States, a list maintained by trained homeopaths that sets standards for homeopathic ingredients' quality and purity. An FDA policy dating to 1988 states that over-the-counter remedies made under homeopathic principles don't have to undergo clinical trials.
Because of how the law is currently written, it's difficult for the FDA to crack down on homeopathy drugmakers with whom the agency has safety concerns, said Don Ashley, director of the agency's Office of Compliance, during the announcement call. "I'll have to say, we've actually found it challenging to be able to respond to some of the higher-risk products we've encountered over the years," Ashley said. In one high-profile example, the FDA collected hundreds of reports that linked homeopathic teething medicines with seizures in babies for over 10 years before those products were recalled.
In addition, although homeopathy traditionally calls for treatments to contain infinitesimally small—and therefore likely safe—amounts of toxins, in recent years, regulators say they've noticed an uptick in the concentrations of homeopathic treatments' ingredients. "We're seeing a lot of toxic products," Woodcock added.
Officials are hoping their proposed changes will make it easier for the government to pursue companies for safety concerns. "With this new proposed draft guidance, we'll have the risk-based categories we need to protect public safety," Ashley said.
Like all changes to FDA regulation, the proposed homeopathy guidelines will be open for public comment for 90 days. After that, officials will read and consider the comments and write up a final guideline, which will replace the 1988 document that's now the law of the land.