This guidance is intended to assist owners or operators of cosmetic product facilities that are subject to the requirements related to facility registration and responsible persons that are subject to the requirements related to cosmetic product listing under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance document discusses FDA’s compliance policy for these requirements. FDA intends to delay enforcement of these requirements for six months to help ensure that industry has sufficient time to submit facility registration and product listing information.
This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate. 21 CFR 10.115(g)(2).
This guidance is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. 21 CFR 10.115(g)(5).
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.