HANP to Testify: FDA Hearing on the Regulation of Homeopathy

May 7, 2015

Over the past few years the FDA has begun to further investigate the regulation of homeopathic medicines. Homeopathic medicines are one of the only natural medicines to have some kind of regulation by the FDA. This allows homeopathic medicines to be labeled differently than other supplements in that a homeopathic medicine can make an “Over The Counter” drug claim. This is a great advantage homeopathy has in the industry, however with all great things there can be great abuse. Some companies have begun to make RX claims stating that a homeopathic medicine can cure a disease such as asthma. There are a few problems when any product, in particular a homeopathic medicine makes these kinds of claims. The first is that homeopathy is highly individualized so what may be very effective for one person is not for the next. The second, more of a concern for the FDA is that doing this could potentially put the public at risk. Should there be a product on the market that says it could cure asthma the consumer may purchase this product thinking they can stop any of their other medications. While homeopathy is highly effective in treating many serious diseases, no product should make a general claim as this unless it is given under supervision of a qualified homeopathic doctor. The FDA is planning on making changes and so it is very important for the homeopathic community to come together. Much of the community including the HANP are going to encourage the FDA that while we believe the section under which “Homeopathic Drugs May be Marketed: (FDA’s CPG SEc. 400.400) is sufficient as written, we believe that the enforcement of that guideline should be clarified, in collaboration with the US homeopathy specialty organizations such as the American Association of Homeopathic Pharmacists, Homeopathic Pharmacopoeia Convention of the United States, American Institute of Homeopathy and the Homeopathic Academy of Naturopathic Physicians. We will be providing updates here as this process moves forward.