FDA Amends Color Additive Regulations for Bone Cement and Sutures

Summary

The FDA is updating its regulations to allow the safe use of FD&C Blue No. 2-Aluminum Lake on alumina in bone cement, in response to a petition from Biomet, Inc. The agency is also reclassifying FD&C Blue No. 2 in sutures, as the color additive is used in devices rather than drugs.