FDA is scheduling a Public Hearing on April 20 and 21, 2015 to obtain comments from stakeholders on the application of the enforcement policy related to homeopathic remedies. FDA indicated that they have not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over 25 years. FDA also notes that, during that time, the market for these products had grown from what was described as a multimillion dollar market in 1988 (the time of the publication of Compliance Policy Guide (CPG) 400.400 that outlined enforcement policies). Today the market is reported to have grown to approximately $2.9 billion.
The Federal Register (FR) Notice (here) that announces the Public Hearing indicated that there are about 1200 products listed in the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). But, since 2004, there have been about 500 products added to the HPCUS, the official publication recognizing homeopathic agents.
Homeopathic products are not subject to FDA approval, as long as there is an appropriate monograph published in the HPCUS. FDA does, however, regulate such products under its compliance policies. This public hearing is designed to obtain input from stakeholders relative to the change in the marketplace for these product to help FDA better understand how it may have to revise its enforcement polices given the large growth in the industry and how to treat products that are marketed as homeopathic, but potentially deviate from the monographs. Remember that just labeling a product as homeopathic does not exempt it from meeting the provisions of the new drug or biologic drug requirements, respectively under 201(p) of the Federal Food, Drug and Cosmetic Act (FDCA) or 351 of the Public Health Service Act.
In the FR notice, FDA discusses in greater detail its goals for the Public Hearing and provides additional history relative to the marketing of homeopathic products. The eight questions that the Agency is asking to be addressed at the hearing include:
- What are consumer and healthcare provider attitudes towards human drug and biological products labeled as homeopathic?
- What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
- Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA’s regulatory oversight of drugs labeled as homeopathic? If so, please explain.
- Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
- Is there information regarding the regulation of homeopathic products in other countries that could inform FDA’s thinking in this area?
- A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
- Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?
- Do consumers and healthcare providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and healthcare providers to be better informed about products labeled as homeopathic?
FDA is also welcoming stakeholders to provide any other information that may be useful in guiding the need to revise the Agency’s enforcement policies. It appears that FDA may be looking for a formal process to evaluate homeopathic products, but that is not entirely clear as to where this would take the FDA. The Agency is, however, clearly concerned about the marketplace associated with the large number of products labeled as homeopathic to assure they can understand the products in an effort to protect the public health and to further assure that a product labeled as homeopathic does not cross the drug or biologic line in terms of its claims and ingredients.