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Executive Summary

OTC DOXYLAMINE WARNING "LACKS SOUND SCIENTIFIC FOOTING," NDMA asserts in a recent letter to FDA opposing the agency proposal. The letter from the Nonprescription Drug Manufacturers Association was in response to a July 19 letter from FDA asking for the association's position on the agency's proposed "hazardous" warning for OTC doxylamine products. "Warnings on OTC products are appropriate only when based on sound scientific data which are known to be relevant to the human condition," NDMA said. "With respect to doxylamine and the suggested warning, NDMA understands that its members which market doxylamine are addressing the scientific aspects of this issue." NDMA encouraged FDA "to consider the scientific information that its members may present to FDA on this subject to support the human safety of doxylamine." In response to a June 14 recommendation by FDA's Pulmonary- Allergy Drugs Advisory Committee, the agency suggested a general statement: "WARNING: Use of this product may be hazardous to your health. This product contains doxylamine succinate which has been determined to produce tumors in laboratory animals" ("The Pink Sheet" July 22, T&G-1). By a 5-1 vote, the committee recommended that consumers should be warned about the results of a study, conducted by the National Center for Toxicological Research, which showed an increase in heptacellular adenoma and carcinoma in male rats exposed to doxylamine ("The Pink Sheet" June 17, p. 2). The committee concluded that it was "not likely" that the data would translate into carcinogencity in humans. Doxylamine is an ingredient in Procter & Gamble's Nyquil and Pfizer's Unisom. Along with the letter, the association submitted what it called an "NDMA Position Paper on a Suggested Warning for Doxylamine: Policy Issues." The paper notes that the advisory committee "specifically avoided calling for use of a label warning about human risk at the meeting." NDMA opposes the proposed warning because "the language is not meaningful to the ordinary individual." NDMA argued that FDA's proposed language for the warning statement "is ... couched in theoretical, scientific expressions that provide no useful information to the consumer." The association added that "the warning does not tell the consumer what action to take. Its wording is frightening, yet it is not based on an identified hazard to humans." In addition, the association said that "unnecessary" warnings should be avoided on OTC labels because of the limited amount of label space. "Label space is at a premium," the NDMA position paper states. "For labeling to be effective, this space must be used judiciously, so that needed information can be easily read."

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