Manufacturers of Homeopathic Medicines Review FDA Test Results and New Application of Technology
MILWAUKIE, Ore., Feb. 14, 2017 — The U.S. Food and Drug Administration (FDA) announced on Jan. 27 that its laboratory analysis found inconsistent levels of some specific constituents in certain homeopathic teething tablets. While the industry fully supports and shares the agency’s efforts to safeguard public health, the American Association of Homeopathic Pharmacists (AAHP) cautions against over interpretation or premature conclusions of these test results. The results posted a few days later by the agency show the constituents were below toxicity levels in all samples that were tested.
The variations of nanogram constituent levels from tablet to tablet are the primary finding. The ultra-high dilution levels were detected by technology not previously applied to homeopathic drugs. It is inconclusive, however, that the findings at this level are relevant to the safety of products.
AAHP, representing the principal manufacturers and distributors of homeopathic medicines in the United States, welcomes a dialog with FDA on the appropriate application of this analytical method in manufacturing.
“The homeopathic industry prides itself on providing low-risk choices for consumers. We want to make sure we serve the health needs of the American public the best we can,” says Mark Land, president of AAHP. “We welcome a dialog with the FDA to further our mutual goal.”
The industry believes tandem analytical methodologies may be valuable research tools in process validation involving ultra-dilute products, but may be of limited practical use in the manufacturing of finished homeopathic drug products and safeguarding public health.
With understanding of the agency’s analysis, this isolated manufacturing issue could lead to industry-wide improvements.
For more information about homeopathic medicines or AAHP, visit theaahp.org.