AANP Board member Amy Rothenberg, ND, DHANP, provided expert testimony at a recent FDA hearing intended to assess whether or not the agency should change its regulatory approach to homeopathic products. “AANP believes that FDA's current approach is working well," Dr. Rothenberg commented. “The low cost of these medicines, as well as the consistent quality of product, make them appealing to both physician and patient. Over decades of use, we have not found problems or variability with quality of the homeopathic product, and no toxicity has been reported."
FDA could decide to regulate homeopathic products the way it does over-the-counter drugs. If that were to occur, the makers of homeopathic medicines would have to demonstrate the safety and effectiveness of their products before they could be sold in drug stores and natural food shops. The FDA would also likely review the accuracy and soundness of product labeling.
Dr. Rothenberg is board certified by the Homeopathic Academy of Naturopathic Physicians. She and her husband, Dr. Paul Herscu, founded the New England School of Homeopathy, the largest and oldest continuous postgraduate study of homeopathy in the country. Drs. Rothenberg and Herscu also lecture widely on the subject.
AANP told the FDA that clarification and closer enforcement of current labeling guidelines is warranted, and recommended the agency collaborate with AANP, the American Association of Homeopathic Pharmacists, and the Homeopathic Pharmacopoeia Convention of the United States. Of particular importance, Dr. Rothenberg stated, “is having properly labeled homeopathic products stay available OTC (over the counter).”