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Vicks warning vanishes

This article was originally published in The Tan Sheet

Executive Summary

FDA posted to its Web site then promptly removed a warning letter to Procter & Gamble regarding Vicks DayQuil and NyQuil Plus Vitamin C on Oct. 14. An agency spokesman said the agency sent no such letter to the firm and an "internal systems error" caused the erroneous post. The spokesman did not say whether FDA plans to send P&G the warning letter. Portions of the letter and media reports suggest FDA takes issue with the products' combination of active drug ingredients and a dietary ingredient, vitamin C, which P&G labels here as an inactive ingredient. P&G makes no health claims related to vitamin C, but the product labels carry both drug facts and supplement facts labeling. FDA policy says products simultaneously marketed as both supplements and drugs are unapproved new drugs. The agency previously warned Bayer that two separate aspirin products combining the drug with plant sterols or calcium were unapproved new drugs. The company relabeled Bayer Women's Low Dose Aspirin without calcium-related bone health claims, and removed aspirin from its Heart Health Advantage product (1"The Tan Sheet" June 8, 2009). Although P&G has not been warned by FDA, the firm said it "clearly differentiated" the Vicks active ingredients from the vitamin C and believes it is "marketing within the FDA regulations and will work with the FDA to resolve the concern together.
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