FDA Targets Homeopathic Drugs for Safety Risks

January 30, 2018

At present, homeopathic drugs sold in the United States do not have to be approved by the Food and Drug Administration (FDA) the way conventional drugs do. Recently though, homeopathic drugs are coming under increased scrutiny. The FDA says it will target products with potentially harmful ingredients, and those being marketed for illnesses such as cancer, heart disease, and treatment of alcohol and opioid addictions.

One practice of homeopathy holds that the substances that cause disease symptoms can also cure them when introduced in miniscule amounts. No modern studies have been able to prove this, and in fact have instead shown that the effects of homeopathic treatment can range from no effect at all to actually harming patients. In one such case, 10 children died and 400 were injured from using homeopathic teething tablets and gels containing belladonna, a toxic substance. An analysis by the FDA lab showed some of the products to contain elevated and inconsistent levels of belladonna.

In past years, the FDA has issued warnings about products that contain strychnine, which is used as rodent poison, as well as products with zinc for intranasal use that may damage the user’s sense of smell. Other problematic homeopathic drug products were those advertised for asthma sufferers that did not provide effective asthma treatment.

Promise of Action by the FDA

The FDA will not require that all homeopathic products be approved because the process would be too arduous. The homeopathic industry offers treatments for everything from colds to cancer and generates revenues in the billions of dollars annually. Products not considered high risk will remain available to consumers, but others, such as treatments that must be injected, treatments for serious diseases, and products for children or the elderly, will get a much closer look from the FDA.

In a statement, FDA Commissioner Scott Gottlieb said poor manufacturing quality or unsafe ingredients in homeopathic products could put trusting consumers at risk. Many are spending money for treatments that have either little to no effect on serious ailments and in the worst case, “may cause significant and even irreparable harm.” Other countries are also moving to rein in the use of homeopathy. In Britain, the National Health Service (NHS) announced plans to end prescriptions for homeopathic drugs in July. There, the chief executive of the NHS qualified homeopathy as a misuse of scarce funds for what amounts to a placebo.

The FDA announcement came as the result of public hearings on its enforcement policies for homeopathic products held in April 2015. The hearings generated 9,000 public comments that led the FDA to propose its new “risk-based enforcement approach.”

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