Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products

What you'll get

FDA's question-and-answer guidance on who must register a cosmetic facility and list each product under the 2022 law, with the timing, no fee and a small-business exemption that depends on average U.S. cosmetic sales over three years (under $1 million, adjusted for inflation) and is lost by makers of eye-area, injected or internal products or products meant to alter appearance for more than 24 hours. It runs 23 pages, much of it on how to submit, so a body-care maker can go straight to the small-business questions in Appendix B.