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Executive Summary

PEDIATRIC FORMULA 44 ANTITUSSIVE "SOOTHING" CLAIM IS MISBRANDING, FDA told manufacturer Richardson-Vicks in a July 3 regulatory letter. "The final regulations of antitussive preparations do not contain any provisions for labeling an antitussive product with 'demulcent' or 'soothing' claims to supress cough," FDA said, asserting that Pediatric Formula 44 is in "serious violation of the [FD&C Act] and regulations." Although such claims were reviewed by a panel for the proposed monograph for Cough, Cold, Allergy, Bronchodilator and Anti-Asthmatic Products, the agency noted, "there were insufficient data submitted to establish that any ingredients reviewed are generally recognized as safe and effective for such a claim." The claim was not included in the final monograph, which became effective August 1988. FDA also objected to inferences in the company's promotional material that the soothing effect was "attributed to ingredients other than...dextromethorphan bromide," the active antitussive ingredient in the product. The agency cited claims such as "pediatrician-recommended ingredient in a special patented syrup that gently bathes your child's irritated throat for uniquely soothing relief no conventional syrup can provide"; or, "unlike thin cough medicines, our more viscous formula coats irritated cough receptors in the throat to relieve coughs from the start." Richardson-Vicks was to have responded to the agency by the week ending July 20 on what changes it would make in the Pediatric Formula 44 labeling and promotional material. FDA said the response should also include the amount of product manufactured by the company in the last twelve months and the amount in distribution.

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