The FDA is concerned that businesses may begin distributing kits for which efficacy has not been established for the purpose of testing hair for the presence of abused drugs. Hair analysis refers to any RIA in vitro test procedure for detecting such drugs. FDA scientists have reviewed the published literature on RIA hair analysis and have concluded that the test is unproven with respect to drug detection. Further, FDA review of agency records shows that there is no FDA regulated product on the market that has been demonstrated to be effective in RIA analysis of hair for the presence of drugs of abuse. It is FDA's view that RIA hair analysis for the presence of abused drugs is an unproven procedure and is not supported by the scientific literature or well-controlled studies and clinical trials. The FDA's policy on RIA in vitro diagnostic devices is outlined. 8 references