June 16, 2009
Dear Mr. Hemelt:
This letter concerns your firm’s marketing of the products Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size.
FDA has concluded that these products may pose a serious risk to consumers who use them. Specifically, FDA has received more than 130 reports of anosmia, (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products.
To protect consumers, and in light of the violations described below, we ask that within fifteen working days of receipt of this letter, you notify this office in writing of the specific steps that you have taken to correct the violations.
These products are available without a prescription, and they contain zinc gluconate (identified as zincum gluconicum on their labels) as their active ingredient. All are administered by direct application to the nasal cavity and, as described in the labeling, are intended for use in “adults and children 3 years of age and older (with adult supervision).” These products are referred to hereafter as the “Zicam Cold Remedy intranasal products.”
According to the labeling accompanying the Zicam Cold Remedy intranasal products, each of these products “reduces” the “duration of the common cold” and the “severity of cold symptoms,” including specifically “sore throat • stuffy nose •sneezing • coughing • congestion.” These claims make these products drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals.
We are not aware of any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective for the uses identified in their labeling.[1] On the contrary, as described below, there is evidence that these products pose a serious safety risk to consumers. Because they are not generally recognized as safe and effective for their labeled uses, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).
Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA‑approved application is in effect for it. There are no approved new drug applications (NDAs) on file with FDA for any of the Zicam Cold Remedy intranasal products; you market them without FDA approval.
We recognize that the labeling for Zicam Cold Remedy intranasal products identifies them as homeopathic drug products with an active ingredient measured in homeopathic strength—Zincum Gluconicum 2X. Nothing in the Act or the regulations issued under it exempts homeopathic drugs from the new drug approval requirements. We acknowledge that many homeopathic drug products are manufactured and distributed without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). The enforcement discretion set forth in the CPG is not unlimited, however. The CPG states that it “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” (emphasis added) The qualifying word “ordinarily” indicates that the CPG specifically contemplates that there may be circumstances where a product that otherwise may meet the conditions set forth in the CPG may nevertheless be subject to enforcement action.
A significant and growing body of evidence substantiates that the Zicam Cold Remedy intranasal products may pose a serious risk to consumers who use them. Specifically, FDA has received more than 130 reports of anosmia (loss of sense of smell, which in some cases can be long-lasting or permanent),associated with use of these products; some individuals also report loss of sense of taste.[2] By comparison, FDA has received few reports of anosmia associated with other widely-used intranasal products for treatment of the common cold that are marketed subject to approved NDAs or according to an OTC drug monograph. Further, there is evidence in the published scientific literature that various salts of zinc can damage olfactory function in animals and humans.
A homeopathic drug product marketed without an approved NDA is not subject to the enforcement discretion set forth in the CPG when there is evidence of a safety risk associated with the product, as is the case for the Zicam Cold Remedy intranasal products. Under these circumstances, the Agency enforces the Act’s new drug approval requirement, a provision that is essential to protect the public health by holding firms responsible for demonstrating, based on adequate and well-controlled clinical investigations, that a product is safe and effective for each of its intended uses before marketing it. Therefore, an approved NDA is required for the Zicam Cold Remedy intranasal products, regardless of their homeopathic status. Your introduction of the Zicam Cold Remedy intranasal products into interstate commerce, without an approved application, violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a).
Additionally, Zicam Cold Remedy intranasal products are misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), because their labeling does not bear adequate warnings regarding the risk of anosmia associated with the product. In light of this failure to bear adequate warnings, these products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), taking into account the considerations set forth in section 201(n) of the Act, 21 U.S.C. § 321(n).
The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. A description of the new drug approval process can be found on FDA’s internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD‑240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
In addition to the reports FDA has received directly from consumers, the agency is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associatedwith Zicam Cold Remedy intranasal products. Please contact Elisabeth Walther at the contact information below to arrange submission of all reports you have related to loss of sense of smell associated with Zicam Cold Remedy intranasal products. Please indicate which of these reports have been previously submitted to FDA.
Additionally, if another firm or firms manufacture the products identified above, your reply should include the name and address of all such firms. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Attention: Elisabeth Walther, Pharmacist.
Sincerely,
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
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