The U.S. Food and Drug Administration (FDA) has issued new draft guidance titled “Guidance for Industry: Cosmetic Good Manufacturing Practices” (GMPs) aimed at helping industry and other stakeholders identify standards and issues that affect the quality of cosmetic products. Noting that the previous guidance was based on documents and information from the early 1990s and is now “outdated,” FDA indicated that the updated guidance provides clarification on certain topics based on new information. FDA also indicated that as part of an “international harmonization effort” with the International Cooperation on Cosmetic Regulations (ICCR), it considered the current International Organization for Standardization (ISO) standard for cosmetic GMPs (ISO 22716:2007) when revising the guidance. “We reviewed ISO 22716 and decided to incorporate, modify, or exclude specific aspects of it into this guidance based on our experience,” said FDA.
ISO is a non-governmental organization that develops and publishes international consensus standards. In September 2007, ICCR and regulators from the United States, Canada, the European Union, and Japan identified a need for standardized GMPs for the cosmetic industry and agreed to follow ISO standards for cosmetic GMPs when developing or updating guidelines. See FDA News Release, June 2013.