Caprice Greystoke
This article was originally published in The Tan Sheet
Executive Summary
Met with FDA on April 21 to discuss its appetite suppressant product Spray-U-Thin (phenylpropanolamine). The meeting was in response to a February warning letter from FDA that charged that Spray-U-Thin is a new drug not covered under the OTC weight control drug monograph "based on the dosage...and the method and duration of administration of the active ingredient." FDA also cited misleading labeling claims and several good manufacturing practices infractions in the letter. Caprice Greystoke said it is continuing to manufacture and market the product while it attempts to address FDA's concerns