Updated at 4:17 p.m. ET to include comment from homeopathic pharmacists.
The Food and Drug Administration said it plans to crack down on the sale of some homeopathic products.
The agency unveiled a new, risk-based approach to regulating homeopathic treatments Monday that aims to protect the public from dangerous products.
"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 announcing the new policy.
"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," Gottlieb says.
Homeopathy is an ancient practice based on the idea that small traces of substances that cause diseases can actually be used to treat illness. But critics have long charged that there is no scientific evidence to support homeopathy and that some homeopathic products could be dangerous.
Critics have been especially concerned about products being contaminated with dangerous substances, or sold for serious conditions for which other, proven treatments work.
The FDA has issued warnings about specific products in the past, and the Federal Trade Commission has required better labeling of homeopathic products.
But over the past decade, the homeopathic drug market has grown "exponentially," according to the FDA, becoming a nearly $3 billion industry in the United States.
The FDA has seen a "corresponding increase in safety concerns, including serious adverse events" resulting from homeopathic products, the FDA says.
In response to the growth and continuing concerns, the FDA convened a public hearing to revisit a 1988 decision not to regulate homeopathic products like standard medical treatments.
Under the new policy, the FDA will more carefully scrutinize these products, especially those sold to treat infants and children, those containing ingredients with significant safety concerns, such as belladonna, and those sold for serious conditions such as opioid addiction, heart disease and cancer.
"We respect that some individuals want to use alternative treatments, 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," Gottlieb says.
Mark Land, president of the American Association of Homeopathic Pharmacists, said in an email that the group "shares the FDA's commitment to protecting public health," and noted 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.
During a briefing for reporters about the proposed new policy, FDA officials stressed that the agency had no intention of requiring most homeopathic products that are on the market to undergo formal FDA review, however, or to remove most homeopathic products. So people who believe such products help them will still have access to many of them, the officials said.
The proposed policy will be open for public comment for 90 days. The agency will review the comments before making the policy final.
The agency's move was praised by long-term critics of the industry.
"I think that it's about time that these snake oil salesmen were held accountable for what they're selling," says Paul Offit, a pediatrician at the Children's Hospital of Philadelphia. "The consumer will clearly benefit."
RAY SUAREZ, HOST:
The Food and Drug Administration is saying today it plans to regulate homeopathic drugs much more tightly. These drugs are both popular and controversial. NPR health correspondent Rob Stein joins us now with the details. Rob, welcome.
ROB STEIN, BYLINE: Nice to be here.
SUAREZ: First, as a reminder, what is homeopathy? And how does it supposedly work?
STEIN: Yeah. Ray, homeopathy is an alternative form of medicine that started in Germany at the end of the 18th century. And it's based on an idea known as like cures like. And the idea is that if you give people very tiny amounts, trace amounts of something that can cause disease, it could actually cure disease. And homeopathy's become increasingly popular in the United States. It's now estimated to be about a $3 billion industry, selling products for everything from the common cold to cancer.
SUAREZ: It's been controversial for a long time, but why?
STEIN: Well, a lot of doctors and many scientists and scientific organizations basically say, look. This stuff doesn't work. There's no scientific evidence to support the idea that this idea actually works. And that people are essentially wasting their money. I mean, the critics will go as far as to call this stuff snake oil and call the companies that sell these products snake oil salesmen. And the concern also is that beyond just wasting your money, this stuff could be dangerous if it gets contaminated with something or if it's given in doses that are too high, or if people with serious conditions like cancer or heart disease take this stuff and it doesn't work and they are not taking the stuff that will really help them.
SUAREZ: Well, this is a product that's created to be put into your body. Why wasn't it regulated in the past?
STEIN: Yeah. So the FDA basically has taken what it's called sort of a hands-off approach to homeopathy. It's basically said that, look. It's not going to regulate these products like other drugs. It's not going to require these products to go through the formal FDA approval process to prove that they work, to prove that they're safe.
That said, you know, the FDA did on occasion take action when there were some really serious concerns. Like, there were some products that were being sold to soothe teething babies that ended up containing a substance known as belladonna, which can cause seizures and even deaths. And it went after some products - zinc-containing products that caused some people to lose their sense of smell. There were even some products identified that contained strychnine, which is a toxic chemical that is used to poison rats.
SUAREZ: So the change is - what's the FDA saying it's going to do now that it didn't before?
STEIN: Yeah. So the FDA basically is saying it's going to take a whole new approach to regulating homeopathy and homeopathic products. It's basically going to start to treat these products like any other drugs. Now, that said, the FDA has made a point of saying, look. We're only going to go after situations where we're really concerned, situations like where products are being marketed to really vulnerable groups, like babies or young children or the elderly, or if these products are being marketed for serious conditions that people might not be getting treated for otherwise, or if it's being given in some unusual way, like being injected or something like that.
SUAREZ: Now, normally it's really hard to get a drug approved. And if you make health claims about any substance, it's really hard to get past federal scrutiny. Does this mean homeopathic products are going to be banned?
STEIN: No. No, the FDA made a point of saying, look. You know, it's not like we're going to pull all this stuff off the market tomorrow or require all these drugs to go through a formal FDA approval process. In fact, many of the products that are on the market are going to stay on the market because the FDA knows these products are popular. People swear by them. But they're putting the industry on notice that when there's a problem they're going to go after it hard, and they're going to go after it fast.
SUAREZ: That's NPR's Rob Stein. Rob, thanks a lot.
STEIN: Sure. Nice to be here. Transcript provided by NPR, Copyright NPR.