Here’s what she had to say: “Good Afternoon, My name is Tanya Kell. I am here in the interest of the Public. Neither I nor those whom I represent, stand to gain or lose financially from any outcome of these hearings. I am the President of the North American Society of Homeopaths. Our professional society of homeopathic practitioners is modeled after the Registered Society of Homeopaths in England. We require extensive training in homeopathy and a broad understanding of its unique principals, as well as peer review and adherence to a code of ethics for membership. We are involved in shaping policy, creating educational standards and protecting the rights of both the homeopathic consumer and provider nationally and internationally. Our members have specialized knowledge of homeopathic medicines and inform the public on the use of those medicines according to standard homeopathic indications for each particular potentized drug. We have a sincere concern for maintaining an accurate and ethical reputation both for our members and for homeopathy as a whole. It is our desire to aid the Food and Drug Administration in evaluating and identifying the veracity of the word “homeopathic” on any particular drug label. Almost all of the products labeled “homeopathic” according to the FDA definition of the term that have generated FDA alerts and warning letters over recent years were not “homeopathic” according to the principles of our profession and of accepted homeopathic doctrine. Many of the complaints currently filed under the heading “homeopathic products” would disappear if all of the erroneous labeling were corrected. It is still possible to enforce a technically correct use of the word on drug labels and we believe it is in the best interest of the public to do so. It is up to the FDA to establish – much as the Department of Agriculture did for “organic” – criteria for accurate label usage of the word “homeopathic”. There is a long established record of both safety and efficacy in homeopathy. Homeopathic practice is based on hundreds of years of clinical experience by both physicians and non-physicians in this country and around the world. The Homeopathic Pharmacopia of the United States is an accurate document as to the preparation, origins and potencies of truly homeopathic products. The current regulatory structure is adequate to meet the needs of the consumer both in assuring product safety and consumer access. However, the homeopathic profession’s viewpoint must be considered in the regulatory agency’s determination of which products are sold to the public as homeopathic. According the the World Health Organization, homeopathy is the second most widely used form of medicine worldwide. It must remain broadly accessible to an informed American public.” To listen to a recording of the hearing, go to the FDA website; Tanya’s presentation is on April 20th, Part 4, one hour and five minutes into the recording. Upcoming Dates to be aware of: June 5 (on or about): Transcript of hearing available at the FDA website. June 22: Deadline for written submissions to the FDA. We would like to share that at the hearing, the staff of the FDA were respectful, interested and willing to listen to our comments. Their questions were pertinent and more well informed as the hearing proceeded. Generally they have found that the information offered by the homeopathic industry is good. Their only concern is with labeling. If you would like to make written comments, please consider reading the media guidelines that NASH provides to its members. We suggest that your comments –
Clients writing to the FDA need to avoid making medical claims or stating that homeopathy cures a medical condition. Clients could state that they have found homeopathy to be a safe and effective option for their healthcare needs. Please feel free to share this information with your homeopathic colleagues and clients. Click here to see how to submit your comments. |