AAHP Statement Regarding FDA Action Against Zicam Intranasal Zinc Products
June 19, 2009–The American Association of Homeopathic Pharmacists (AAHP) acknowledges the U.S. Food and Drug Administration’s (FDA) action to protect the public by sending a Warning Letter to Matrixx Innovations, Inc. in connection with that company’s sale of Zicam intranasal zinc medications. According to FDA, these intranasal zinc products have been associated with a number of cases of loss of smell. Matrixx now has an opportunity to respond to FDA’s concerns about the safety of their products.
Homeopathic medicines have an extraordinary record of safety. Consumers and healthcare professionals alike should be assured that the FDA’s action in regards to certain Zicam products, does not apply to this class of drugs as a whole. Rather, the FDA’s advisory relates only to the nasal application of a specific zinc product.
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. 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 and, as shown by FDA’s action on June 16th, it allows FDA to take action when action is required to protect the public.