Dive Brief:
- The Food and Drug Administration plans to clamp down on homeopathic medicines, proposing Monday a new risk-based enforcement approach that would seek to rein in the marketing of certain untested or unproven products in what has become a nearly $3 billion industry.
- Under the planned approach, the FDA would target particularly risky homeopathic drugs, such as those marketed for serious diseases, containing potentially harmful ingredients or that don't meet manufacturing standards.
- In recent years, FDA investigations have found potentially toxic ingredients in products labeled as homeopathic, leading to a 2016 warning against homeopathic teething tablets containing belladonna, for example.
Dive Insight:
Historically, the market for homeopathic medicines has been small. Under the FDA's current enforcement policies, such products have been manufactured and distributed without the regulator's approval in the U.S. since 1988.
More recently, however, the numbers of products labeled as homeopathic has increased sharply, boosting the overall industry and driving up sales.
"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," said FDA commissioner Scott Gottlieb in a statement.
Homeopathy dates back to the 18th century and is rooted in a belief that trace amounts of a substance that otherwise might cause disease symptoms in a healthy person can be used to treat the sick.
The FDA's proposed toughening of enforcement won't target all homeopathic products — just those with the greatest potential to cause risk. This would include medicines with reported safety concerns or with ingredients associated with potential safety concerns, products that are dosed via routes other than oral or topical and products that don't meet quality, strength or purity standards.
The proposal will also clamp down on homeopathic treatments that "are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits."
As sales of homeopathic drugs have increased, so to have cases of poorly manufactured products, the FDA said.
There have been instances, for example, where homeopathic teething tablets and gels contained elevated and inconsistent levels of belladonna, an famous poison sometimes called nightshade. In a recent case, the FDA issued Homeolab Inc. a warning letter following an inspection that raised concerns over "inherently variable processes" preparing infant teething tablets made using belladonna.
The aim is not to take away the choice of consumers to use alternative treatments, but rather to put protection in place around the riskier corners of the industry, Gottlieb explained.
"The FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm," said Gottlieb.