FDA Reconsiders Regulating Homeopathic Remedies, Schedules Hearing

Walk down the aisles of any health food store or even big-chain stores like Whole Foods and you're likely to find homeopathic medicine for ailments ranging from allergies and heartburn to colds. Those homeopathic brands should take note: For the first time in 25 years, the Federal Drug Administration is reconsidering how it regulates such products, and announced a public hearing Monday to seek input.

"FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry," the announcement said. "FDA is seeking input on a number of specific questions, but is interested in any other pertinent information participants would like to share."

The homeopathy section of the National Institutes of Health (NIH) defines homeopathy as an alternative medical system that was developed in Germany more than 200 years ago based on the idea "like cures like." The principle is if a substance causes a symptom, giving the person a very small amount of the same substance may cure the illness.

Although homeopathic remedies are regulated by the FDA, it does not evaluate them for safety and effectiveness, the NIH said, adding some homeopathic remedies can contain "substantial amounts" of ingredients that cause adverse reactions and side effects.

In addition to possible adverse side effects, according to the NIH, "There is little evidence to support homeopathy as an effective treatment for any specific condition."

Cynthia Schnedar, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research, said the FDA hasn't decided if it will change its regulation of homeopathic products, but rather the hearing is a kind of fact-finding mission.

“At this stage, we are gathering information about whether to adjust our current enforcement policy,” she said, the Washington Post reported.

Since 2009, the FDA has issued nearly 40 warning letters to companies that make homeopathic remedies, Schnedar said, as well as issuing warning to consumers about certain products, the Post reported.

Zicam cold remedies were among the products about which the FDA warned. In 2009, it warned consumers about certain Zicam cold remedies when more than 130 people reported they could no longer smell anything after using it. The loss of smell, possibly permanent, is a condition called "anosmia." The company eventually issued a recall.

The live Webcast of the FDA hearings can be found at Homeopathic Product Regulation.