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Executive Summary

VIRAL RESPONSE SYSTEM's VIRASPRAY I IS A NEW DRUG requiring an NDA submission because labeling suggests that the drug should be used in a heated air system, FDA told the firm in a Feb. 6 letter. Viraspray I is a drug/device product consisting of hexylresorcinol 0.05% in the firm's Viralizer heated nebulizer device. Viral Response obtained an abbreviated premarket clearance ]510(k)[ for the Viralizer device in 1983, but never applied for preclearance to alter the device by adding hexylresorcinol. FDA explained that although hexylresorcinol can be marketed OTC under the oral health care monograph, "we are not aware of any OTC hexylresorcinol oral health care spray drug products that have been marketed with directions for use that involve simultaneous delivery in a heated air system." However, FDA added, if Viral Response changes the labeling to stipulate that the drug should be used without simultaneous delivery of heat, the agency "would consider the product subject to the OTC Drug Review as an oral health care spray." The agency also objected to labeling of the firm's phenylephrine spray product, Viraspray II. The agency said that although label instructions state that heat should not be used, "the directions for use on the outer carton do not specify if heat should or should not be used." "In order to reduce the likelihood of possible misuse of the product, the instructions to use 'with heat off' should be made more prominent than currently displayed in the package insert . . . and must also be included in the directions on the outer container," FDA stated. The agency pointed out that if the directions are written with directions for concurrent use with heat, then Viraspray II also would require an NDA. FDA's letter also objects to advertising claims the firm has been making for the Viralizer device. Viral Response, FDA said, "continues to place advertisements in newspapers and magazines, such as the Jan. 16, 1989 edition of USA Today, which make what we consider false and misleading claims relative to destroying rhinovirus and helping to eradicate the common cold." The agency said that "such claims misbrand the Viralizer device because it has not been shown to be effective for this use, and because such claims promote the device for an intended use which requires a premarket submission to the FDA, which has not been provided." FDA's complaints about the firm's ads echo objections made in a June 1988 regulatory letter to the firm. FDA notes that Viral Response continued to make the claims even though firm President Robert Krause indicated a Jan. 5 meeting that the company "would eliminate claims from ]its[ advertising relating to the destruction of rhinovirus, as well as other claims which have not been approved by the ]FDA[ in an appropriate submission." FDAers say that the agency wants the firm to submit a 510(k) for the cold and rhinovirus claims. It is possible that upon review of the abbreviated application, FDA may determine that the claims warrant the submission of a full premarket approval application. Viral Response placed full page ads in USA Today as well as in recent editions of The New York Times in response to an article in the January edition of Consumer Reports that contended that the device is neither safe nor effective. Viral Response's ads include a letter from Alfredo Jalowayski, PhD, University of California at San Diego, who states that his research indicates that the device is safe. However, Jalowayski says: "Is this remedy helpful in reducing common cold or allergy symptoms? The answer to this question awaits further clinical research."

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