FDA Entertains Discussion of Homeopathic Regulation

Rockville, MD—The U.S. Food and Drug Administration (FDA) held two days of hearings in late April to gather information about whether or not homeopathic remedies should be more strictly regulated.

Homeopathy is a field where symptoms are treated with diluted doses of a substance that can cause similar symptoms.

The industry is not regulated through a New Drug Approval process, but it “must undergo pre-market approval with a monograph from the Homeopathic Pharmacopoeia of the United States (HPUS), which involves some clinical verification of the efficacy of the substance,” according to the Alliance of Natural Health USA. But, companies must register their facilities and list their drug products with FDA annually. Products must also be made according to good manufacturing practices and report adverse events to the agency. This appropriateness of this regulation, which has been called into question.

Some groups have petitioned FDA to consider stronger regulation for homeopathic products. FDA has issued 40 warning letters to producers of homeopathic remedies since 2009, including one targeted at the maker of zinc gluconate products linked to a loss of smell in 130 cases. Some feels this action underscores the existing and sufficient power the agency has to regulate this industry.

Critics are not only concerned with the safety of these homeopathic drugs, but they also question if they even work. According to some field experts, studies show no evidence that these drugs are effective. Proponents of the industry, conversely, assert that these remedies do work—evidenced by patients that have benefitted from homeopathic products.

Will Woodlee, partner at Kleinfeld, Kaplan, and Becker, LLP,, who testified at the trial on behalf of the American Herbal Products Association, stated, “In light of the adequacy of the existing regulatory framework for OTC homeopathic drug products, AHPA urges FDA not to increase regulatory burdens on manufacturers of such products, which could limit consumer choice and access to self-care products that, in some cases, have been available for many decades.”

Posted on 4/24/15