Creative Science Marketing Unapproved New Animal Drug: FDA

An FDA 5/23 Warning Letter to Creative Science Inc., Ballwin, MO, says the company’s P-Bloc product is a new animal drug that is not generally recognized among experts as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. Further, the letter says, the company’s drug listing file shows P-Bloc to be a human prescription drug, while information provided to the agency during a 3/2017 inspection indicates that it is for animal use only. The incorrect product listing has been removed from FDA’s online NDC directory, the letter says, in an effort to maintain an accurate database to protect and promote the public health.

Creative Science was told to respond with a list of steps taken to comply with the law, with documentation of the steps and a timetable for completion.