The Food and Drug Administration's (FDA) current regulation of homeopathic drugs provides sufficient, substantial oversight of these products, according to testimony presented by the American Herbal Product Association (AHPA) at a public hearing held by FDA on April 20-21. The hearing, "Homeopathic Product Regulation: Evaluating FDA's Regulatory Framework After a Quarter-Century," was held to gather input on appropriate regulatory policy for homeopathic medicines.
AHPA's testimony, presented by Will Woodlee, partner at Kleinfeld, Kaplan and Becker, LLP, highlighted several points that demonstrate the adequacy of FDA's current regulatory framework for homeopathic medicines in protecting public health and ensuring consumer access to safe products.
Woodlee stressed that, under the existing framework, companies are required to register their facilities and to list their drug products with FDA, which, along with other investigative and surveillance tools, provides the agency with the means to identify manufacturers, marketers, and products as candidates for education, administrative action, or enforcement action, as necessary or appropriate.
The current regulatory framework also provides FDA with sufficient information on adverse events associated with over-the-counter (OTC) homeopathic drug products to allow the agency to protect the public health, according the AHPA's testimony. Manufacturers are required to maintain records of all adverse events reported to them and must maintain records and reports regarding complaints. When required, firms must investigate these complaints and, upon request, make their files available during FDA inspections.
Woodlee also noted that FDA's existing regulatory framework for homeopathic drug products appropriately reflects the small saety risk inherent to these highly diluted products. In addition, AHPA is not aware of any data indicating that consumers perceive appropriately marketed OTC homeopathic drug products as substitutes for prescription drugs, and AAHPA believes FDA currently has adequate enforcement authority to address and OTC homeopathic drug products that inappropriately marketed for non-OTC indications or without adequate directions for use.
For m ore information, visit www.ahpa.org or www.fda.gov.
homeopathic drug regulation