FDA Delays Cosmetic GMP Proposed Rule Until October 2025

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FDA Delays Cosmetic GMP Proposed Rule Until October 2025

In 2022, the Modernization of Cosmetic Regulations Act was passed, establishing requirements for adverse event reporting, safety substantiation, facility registration, and product listing.

The Act also mandated that the FDA provide a proposed rule for cosmetic Good Manufacturing Practices (GMPs) by the end of 2024. However, the deadline for the proposed rule has since been extended to October 2025.

The industry anticipates that the proposed rule will offer clear guidelines on microbial quality control, testing, and documentation practices.

The rule’s agenda highlights that “Cosmetic products that are contaminated, do not conform to a manufacturer’s established specifications, or have incorrect packaging, labeling, or labels, could be unsafe for consumers. Contamination, a common reason for cosmetic product recalls, can be introduced during manufacturing or processing of a cosmetic product and render cosmetic products injurious to health.”

The extension of the proposed rule timeline provides brands and manufacturers with additional time to prepare for these changes and ensure compliance.

Microchem will continue to monitor the progression of these regulations closely. To learn more about routine microbial testing and our GMP-compliant services, contact our lab: [email protected].

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FDA Delays Cosmetic GMP Proposed Rule Until October 2025

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