FDA Publishes its Draft Guidance for Cosmetic GMPs

The U.S. Food and Drug Administration (FDA) has published its Draft Guidance for Cosmetic Good Manufacturing Practices (GMPs), an update to its Cosmetic Good Manufacturing Guidelines/Inspection Checklist, mostly to include ISO 227 16:2007 as part of an effort to harmonize GMPs internationally.

This draft guidance for GMPs provides non-binding guidance to the cosmetic industry on FDA’s current thinking concerning what constitutes Good Manufacturing Practices (GMPs) for cosmetics. This guidance revises the “Cosmetic Good Manufacturing Guidelines/Inspection Checklist” with current practice and experience. In addition, as part of an international harmonization effort with the International Cooperation on Cosmetic Regulations (ICCR), the draft guidance incorporates some guidelines set forth in the International Organization for Standardization's (ISO) standard for cosmetic GMPs (ISO 22716:2007).

The predecessor to this guidance, FDA’s “Cosmetic Good Manufacturing Guidelines/Inspection Checklist,” was based on documents and information dating before the early 1990s. Much of the material in the predecessor document has become outdated. In addition, there has been a great deal of progress in developing international consensus standards for cosmetics, specifically ISO 22716.