FMC releases video to file Charge Complaints

information collection provisions in FDA’s cosmetic labeling regulations and new statutory provisions for cosmetic labeling, facility registration, and products listing. 

Comments are due by midnight on 30 Jun 2023.  

MoCRA amended the Federal Food, Drug, & Cosmetic Act (FD&C Act) by requiring, operators and owners of facilities manufacturing or processing cosmetic products to register with FDA and renew their registrations biennially. Facilities will also need to notify FDA of any changes to information that was required as part of registration. FDA may suspend registration if it is determined that a cosmetic product manufactured or processed by a registered facility has a reasonable probability of causing serious adverse health consequences or death. Upon notice that FDA intends to suspend registration, the responsible person for the facility may submit a corrective action plan for addressing the reasons for possible suspension of the facility registration. MoCRA also added the requirement for responsible persons to submit a product listing for each of their cosmetic products to FDA. 

MoCRA also requiress, manufacturers of cosmetic products to label products intended for use only by licensed professionals to bear a label that the product must be administered or used only by licensed professionals, in addition to providing the same information on the label that is required of cosmetic products intended for consumers. MoCRA also added the requirement for cosmetic product labels to include contact information through which the responsible person can receive adverse event reports. Other requirements introduced by MoCRA include facility registration and cosmetic product listing.