May 3, 2023
FDA intends to withdraw or revise and reissue this draft guidance as appropriate, based on the GMP rulemaking required by the Modernization of Cosmetics Regulation Act of 2022. See also Public Meeting: Good Manufacturing Practices for Cosmetic Products - 06/01/2023.
This document provides guidance to industry and other stakeholders (e.g., consumer interest groups, academia, other regulatory groups) on FDA’s current thinking concerning what constitutes Good Manufacturing Practices (GMPs) for cosmetics. It is intended to assist industry and other stakeholders in identifying the standards and issues that can affect the quality of cosmetic products.
This guidance revises the “Cosmetic Good Manufacturing (GMP) Guidelines/Inspection Checklist” by updating it to set forth current practice, and clarify certain topic areas based on recent experience. In addition, as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), FDA (or we) agreed to consider the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising this guidance. We reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our 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 FDA guidances means that something is suggested or recommended, but not required.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.