The Food and Drug Administration is going to evaluate how it regulates homeopathic medicines in the wake of new research that claims there is no evidence the products are medically useful.
The agency will hold a public hearing next month on the regulatory framework for products labeled homeopathic, an alternative form of medicine. This class of medicine is based on the belief that a disease can be cured by small doses of what will make healthy people sick, according to the FDA.
Homeopathic products are available through a pharmacist or over the counter as creams, lotions, sprays or pills. For example, some products use ginseng or other herbs as active ingredients.
The FDA currently classifies homeopathic medicines as drugs, and requires manufacturers to meet agency labeling standards and manufacturing requirements. However, they are not required to have an expiration date due to the unique nature of the product, the agency’s regulations said.
Homeopathic medicines have grown into a multi-million-dollar market, but there are still conflicts over their benefits.
A team of researchers with the Australian government recently assessed all available scientific and clinical evidence of homeopathic products. The results were startling.
The researchers couldn’t find any “good-quality, well-designed studies with enough participants” that showed homeopathic products were better than a placebo or equal to another treatment, according to a statement from Australia’s National Health and Medical Research Council issued earlier this month.
Homeopathic drugs have caused health issues before. For instance, in 2009, the manufacturer of the cold and allergy drug Zicam voluntarily recalled nasal products using zinc in the drug after some consumers claimed they lost their ability to smell.
Just last week, the FDA warned consumers to avoid over-the-counter asthma products labeled as homeopathic. The agency couldn’t confirm that the products were in fact safe or effective.
The meeting, to be held at the FDA’s Maryland headquarters on April 20-21, will give consumers, doctors and industry an opportunity to discuss regulation of the products.
