A booming homeopathic industry prompted the Food and Drug Administration to announce a crackdown on potentially risky alternative remedies that now slip through its regulatory cracks.
The homeopathic drug market grew "exponentially" over the past decade into a nearly $3 billion industry, the FDA said, resulting in a flood of products manufactured without the agency's approval.
New plans announced Monday place scrutiny on products aimed at children and infants as well as those marketed for life-threatening ailments like heart disease and cancer.
“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," said FDA Commissioner Scott Gottlieb 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's move follows a string of warnings issued on specific homeopathic products such as baby teething tablets and actions from the Federal Trade Commission to improve such products' labels.
Homeopathic remedies aim to treat illnesses with diluted forms of substances that cause an illnesses' symptoms.
The treatments are derived from plants, minerals and chemicals and proponents like actress Gwyneth Paltrow have pushed them into mainstream culture. Critics call it a potentially dangerous and unproven pseudoscience.
A 1988 FDA decision enabled drugs labeled as homeopathic to be produced and distributed without the agency's approval. The new policy laid out Monday would focus its enforcement powers on a range of such products including those with potentially dangerous ingredients, products marketed to treat life-threatening diseases and those aimed at vulnerable populations.
The president of the American Association of Homeopathic Pharmacists, Mark Land, told NPR that the proposal wouldn't affect the "vast majority" of homeopathic remedies available in the United States. The FDA noted that many products would "fall outside" the new risk-based categories.
"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, the FDA commissioner said.
A 90-day public comment period on the new guidelines will take place before the plans become final.