Who should submit amendments to a cosmetic formulation (Form FDA 2512), and when?
Any firm, once having filed an original cosmetic formulation, is responsible for maintaining an accurate filing with FDA for that formulation. You can amend your formulation using the online VCRP system. Please submit changes to a brand name or ingredients within 60 days after beginning commercial distribution of the changed cosmetic product in the United States. Please submit other changes within one year after such changes occur (21 CFR 720.6) .