The FDA has announced its intention to regulate homeopathic remedies more thoroughly in order to protect the public from potentially dangerous products. A public hearing has been convened in order to revisit a 1988 decision to not regulate and test these treatments with clinical trials, as the law requires for other drugs and medical treatments.
The new regulations will specifically target products sold to treat infants and children, as well as those marketed to treat more serious conditions, such as cancer, and those containing potentially dangerous substances, including belladonna.
Homeopathy is a traditional practice that consists in using small traces of substances that cause diseases in order to treat them. Several studies have pointed to the ineffectiveness of homeopathic remedies, including a 2002 systematic review of literature on these remedies, as well as a more recent Australian study, which assessed 68 claims and found no evidence that any of these remedies work as intended. However, because of a 1938 rule exempting homeopathic remedies from many of the regulations on other drugs, the FDA has had a difficult time following up on these claims.
“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," Don Ashley, director of the FDA's Office of Compliance, said during a call announcing the new policy.
While the FDA has issued warnings about specific products, such as teething tablets that were found to be tied to seizures and deaths in infants earlier this year and zinc products that contributed to users losing their sense of smell in 2009, this more general regulation will enable the Agency to crack down on the industry as a whole.
Over the past decade, the homeopathic market has grown to a nearly $3 billion industry in the United States, and the FDA has reportedly seen a corresponding increase in safety concerns.
"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,” FDA Commissioner Scott Gottlieb said in a statement announcing the new policy. "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.”
The FDA noted that most homeopathic remedies are not harmful or considered high-risk, and these treatments will continue to be readily available to consumers.
The proposed policy will be open for public comment for 90 days.
The Federal Trade Commission ruled last year that companies producing homeopathic remedies would be required to either prove their effectiveness or include a disclaimer noting the lack of scientific evidence supporting health claims.