FDA Seeks Input on Regulation of Homeopathic Medicines

Last week’s announcement by the Food and Drug Administration (FDA) that it is seeking input on its oversight of homeopathic products appeared to be big news, both within the industry and across the broader news spectrum, no doubt because the homeopathic drug industry has grown significantly in recent decades.

Homeopathy is a form of alternative medicine based on the concept that a disease can be treated with minute quantities of natural substances that would, if given in larger amounts to a healthy person, produce symptoms of disease.  The practice of homeopathy has been around for more than 200 years and has its share of both critics and adherents.

The term “drugs”, as defined in the Federal Food, Drug and Cosmetic Act, encompasses articles recognized as such in both the United States Pharmacopoeia (USP) as well as the Homeopathic Pharmacopoeia of the United States (HPUS).  This latter reference has been in continuous publication since 1897 and determines which ingredients, including allowable potency levels, are officially monographed homeopathic ingredients.

FDA’s over-the-counter (OTC) drug review was established in 1972 to evaluate the safety and efficacy of OTC drug products but, at that time, the agency deferred action on homeopathic medicines.  Current regulation of homeopathic drugs falls under the auspices of a Compliance Policy Guide (“Conditions under Which Homeopathic Drugs May be Marketed”) issued in 1988.  All homeopathic medicines must be manufactured in compliance to FDA’s Good Manufacturing Practices regulation, must meet FDA’s strict labeling requirements and manufacturers must report serious adverse events to the FDA.

Nevertheless, these homeopathic products have not been evaluated by the FDA for safety and efficacy.  As such, the agency is asking for input from interested parties (manufacturers, health care professionals, consumers, etc.) as to whether the framework for regulating such products needs to be addressed.  Some of questions to be considered include:

  • current enforcement policies and/or whether there may be suitable alternatives
  • consumer and healthcare provider attitudes towards these products and whether there is sufficient information available to each in order to make informed decisions regarding their use
  • data sources that could be shared with the  FDA for the agency to better assess risk and benefit profiles of products labeled as homeopathic 

While no formal recommendations will be forthcoming at the meeting, scheduled for April 20-21, the information presented should foster much discussion as to how the current regulatory framework will change in the years ahead.