MILWAUKIE, Ore., July 23 While the causal relationship between intranasal zinc preparations and anosmia is examined in a new study published in the July issue of Archives of Otolaryngology-Head & Neck Surgery, the study's practical application on public health is reduced to supporting action taken last summer by the U.S. Food and Drug Administration (FDA) in removing related products from the marketplace.
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Contrary to the position taken by Terrance M. Davidson, M.D., and Wendy M. Smith, M.D. in their recently published study, "The Bradford Hill Criteria and Zinc-Induced Anosmia," action by the FDA against products containing intranasal zinc gluconate demonstrates the agency's competency in regulating homeopathic medicines to protect the public's health. Drs. Davidson and Smith of the University of California evaluated 25 patients who apparently developed anosmia after using intranasal zinc gluconate, as well as reports of clinical, biological and experimental data. Beyond showing that zinc was the causative agent, Davidson and Smith then presumed that the system needs strengthening rather than acknowledging its success last summer. In fact, the FDA had monitored the reported cases of claimed zinc-induced anosmia and took appropriate action in a judicious manner--an action supported by the American Association of Homeopathic Pharmacists to protect public health.
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Homeopathic medications are regulated by the FDA and have been used safely in the United States since before the passage of the Federal Food, Drug, and Cosmetic Act in 1938. Homeopathic medicines have an extraordinary record of safety. FDA's Compliance Policy Guide (CPG 7132.15) "Conditions Under Which Homeopathic Drugs May Be Marketed" has been an effective and workable way to regulate homeopathic drugs since 1988.
To learn more about the regulatory process and the association's work to better the understanding and appreciation of homeopathic medicines by both professionals and consumers, visit www.homeopathicpharmacy.org.
About the AAHP
Founded in 1923, the AAHP is a not-for-profit corporation of the State Commonwealth of Virginia, representing the interests of homeopathic manufacturers, distributors, and individual pharmacists in cooperative efforts with regulatory agencies and other organizations nationally.
The AAHP functions as a trade association within the homeopathic pharmaceutical industry to represent the opinions and interests of homeopathic product manufacturers and distributors, to the FDA, other regulatory agencies and other trade associations. In addition, the association promotes high standards in manufacturing and distributing, communicates regulatory changes to member companies through a regular newsletter and promotes professional communication, education, and research within the homeopathic community.
SOURCE American Association of Homeopathic Pharmacists
