FDA considers tighter oversight of homeopathic remedies
Agency calls 2-day public hearing in late April
After nearly 25 years, FDA is taking initial steps to consider if the regulatory framework for homeopathic medicines should be revised and if these products need to come under the same scrutiny as OTC drugs.
In late April, the agency called a 2-day public hearing to gather information on medications labeled homeopathic.
Concern, even from supporters of homeopathic medicine, centered on the issue of improper labeling of homeopathic remedies.
“The general theme going through the meeting was that an area that really needs to be enforced is the correct labeling of homeopathic,” Gary Kracoff, BSPharm, of Johnson Compounding and Wellness Center in Massachusetts, and a faculty member at the Center for Education and Development of Clinical Homeopathy, told Pharmacy Today.
“People use the word homeopathy as a generic term to mean nonpharmaceutical,” said Kracoff, who also testified at the hearing.
Homeopathy, which traces its roots to the end of 18th-century Germany, is based on a philosophy that “like cures like.” Homeopathic remedies are prepared from what is called a mother tincture and then repeatedly diluted. Most traditional homeopathic remedies contain few to no molecules of the original substance.
In general, robust clinical evidence for homeopathic remedies is lacking, although more scientific data are available now than before, which FDA said will help inform its enforcement policies.
An FDA spokesperson told Today that harm can occur when a patient chooses to treat a serious disease with a homeopathic remedy rather than an FDA-approved product that has been scientifically proven to be safe and effective. For instance, OTC asthma products labeled homeopathic are widely available. FDA recently warned that patients should not rely on them to treat such conditions.
Generally, pharmacists tend to recommend FDA-approved drugs, and not complementary or alternative medicines, such as homeopathic remedies.
Like a drug, homeopathic remedies can include a disease claim on the product.
“Homeopathic products, even if they are not truly homeopathic, get a pass,” Adriane Fugh-Berman, MD, an associate professor of pharmacology and physiology at Georgetown University Medical Center, told Today.
Fugh-Berman, who testified at the hearing, gave the example of the homeopathic cold remedy Cold-Eeze, which contains 13.3 mg of zinc per lozenge.
“Although Cold-Eeze isn’t really homeopathic to a homeopath, it can be labeled that way if it’s pharmacologically active because of the mother tincture,” said Fugh-Berman.
She said if the company were just selling zinc lozenges without the homeopathic claim, they wouldn’t be able to say it treats colds.
Fugh-Berman also pointed out that the recommended usage for Cold-Eeze is six lozenges a day, which is 10 times the recommended dietary allowance of zinc for adult females and 8 times for males. She said this can suppress copper and iron absorption and cause other toxic effects.
Adverse effects caused by a similar homeopathic zinc product, Zicam, have resulted in litigation and an FDA Warning Letter to the manufacturer, according to Fugh-Berman.
FDA said some safety concerns with products labeled as homeopathic coupled with explosive growth of the industry over the past 25 years are the main reasons the agency is looking into revisiting its approach. FDA said there is no defined timeframe outlined for the next steps, if any, it will take.
Labeling under scrutiny
According to FDA literature, it was decided in 1988 that drug products labeled as homeopathic could be placed on store shelves and sold without FDA approval. Premarket approval for homeopathic drugs lies in accordance with monograph approval by the Homeopathic Pharmacopoeia Convention of the United States.
Fugh-Berman said homeopathic remedies are not a dangerous class of medication and that few cases of adverse effects have been reported. In the cases where it did harm—Zicam, for example—pharmacologically active amounts were present.
Kracoff said traditional homeopathic remedies either help the patient or do nothing and that labeling needs to be better enforced to guide and inform patients.
“Leaving aside the question of whether homeopathic preparations are effective or not, my issue is with the labeling—it’s uninterpretable and covers a range of products that include products with pharmacologically active effects and products with no active substances in them,” she said.